bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Electroencephalography Evaluation of Sedation in COVID-19
Condition: Conscious Sedation; Pathologic Processes; Electroencephalogram; Acute Respiratory Distress Syndrome; Corona Virus Infection
MeSH terms: Coronavirus Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pathologic Processes
Study type: Observational

Summary: 
      Sedation of severe COVID-19 disease are often complicated. We try to find a correlate for
      this observation by encephalographic studies.
    

Detailed description: 
      Sedation of critically ill ventilated coronavirus patients, continues to be a challenging
      issue. Also, neurological symptoms of severe COVID-19 disease have been described frequently.
      Difficulties in sedation of these patients have been discussed repeatedly. The aim of this
      study is to investigate whether an encephalographic correlate can be found. Appropriate
      processed encephalographic techniques have been used for anesthesia monitoring for many
      years.

      The aim of our study is to collect unrelated processed and raw EEG data of sedated COVID-19
      patients and to investigate the correlation to the necessary sedation.
    

Intervention name(s): Encephalography measurement
Intervention type(s): Other
Intervention description(s): Encephalography measurement and partially aggravated sedation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Critically ill COVID-19 patients requiring advanced intensive care treatment with existing
        intubation-requiring acute respiratory distress syndrome under invasive ventilation.
        Adequate depth of sedation is usually required for appropriate therapy, which is frequently
        challenging in COVID-19 patients.
Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study
Condition: Acute Schizophrenia Episode
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized
      patients with acute schizophrenia episode, and to compare the different drug regimens that
      may be involved in order to clarify the characteristics of the population for taking
      aripiprazole and provide reference for clinical rational drug use.
    

Detailed description: 
      The control of acute schizophrenia effectively and rapidly will build up the confidence of
      patients on treatments. These early effects may influence the long-term compliance and
      prognosis of patients. Aripiprazole is an important drug in first line treatment of
      schizophrenia. However, at present in China, the application of aripiprazole in some patients
      with acute schizophrenia is not appropriate, leading to poor control of the positive symptoms
      of the acute phase.

      The purpose of this single-arm, open-label trial is to study the situation of the use of
      aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the
      different drug regimens that may be involved in order to supply important information for
      optimizing treatment strategies of hospitalized patients characterized by positive symptom.

      The hospitalized patients characterized by positive symptom with acute schizophrenia episode
      were recruited. At the time of enrollment, the demographic, symptomatic and laboratory data
      was collected. After the completion of the baseline assessment and examination, the patients
      were given aripiprazole. Clinical evaluation was performed at 1、2、4 and 8 weeks after
      treatment, including the therapeutic efficacy and adverse drug reactions ,and monitoring of
      laboratory data.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator.
Other intervention name(s): Aripiprazole Orally Disintegrating Tablets; Bosiqing®
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aripiprazole; Acute schizophrenia episode; positive symptoms
Quantifying the Influence of Expert Modeling
Condition: Competence; Self-efficacy
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about the effects of various types of simulation
      preparation methods on novice nurses' competence and self-efficacy. Participants will be
      recruited from an academic course (N424 Integrated Practicum). Participants will be
      randomized to three intervention groups (i.e. expert modeling video, voice over PowerPoint,
      and traditional readings). All participants will complete self-efficacy surveys and two
      simulations. During simulation, participants will be scored based on their competence
      according to a performance rubric. The hypothesis is that participants in the expert modeling
      group will demonstrate more change in competence and report more change in self-efficacy
      scores than participants in other groups.
    

Detailed description: 
      Investigators will compare self-confidence and competence scores between the three groups
      after the pre-test and posttest simulations. The self-efficacy survey is an 7-item scale that
      involves participants rating their self-efficacy about providing care for multiple patients.
      Participants rate their self-efficacy on a 1 to 5 (not confident to very confident scale).
      The survey takes 5 minutes to complete. The self-efficacy survey has been used in many
      simulation research studies previously with novice nurses. Competence will be measured with a
      rater-observation measure which has previously been used in simulation research.
    

Intervention name(s): Common readings and educational handouts; Expert Modeling; Voice Over Power Point
Intervention type(s): Other; Other; Other
Intervention description(s): Participants in all groups have common readings related to policies for nursing care in acute care facilities. There will be additional handouts related to performing safety checks and a focused physical assessment.; 70 minutes of expert modeling videos; 60 minutes of Voice Over PowerPoint presentations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: simulation; competence; self-efficacy; novice nurses
A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This clinical trial aimed to gather safety and immunogenicity data in COVID-19
      vaccine-experienced healthy adults. The main questions it aims to answer are:

        -  The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron
           XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013
           against the current SARS-CoV-2 circulating variant.

        -  The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19
           vaccine-experienced participants 18 through 55 years of age.

        -  Explore the protective efficacy by documenting confirmed COVID-19 cases after
           vaccination.
    


Intervention name(s): RQ3013; RQ3025; RQ3027
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.15mL/dose containing mRNA 30μg; 0.15mL/dose containing mRNA 30μg; 0.15mL/dose containing mRNA 30μg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: mRNA vaccine; SARS-CoV-2
Brief Integrative Therapy for Post-Traumatic Stress Disorder
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its
      effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following
      childhood sexual abuse. This study will also promote the development of skills that are
      necessary for increasing quality of life and improving self-esteem.
    

Detailed description: 
      BIT integrates interpersonal, problem solving, affect regulation, and psychoeducational
      components. In this study, BIT is used to encourage women to focus on current issues and
      problems. The BIT therapist will help patients identify the impact of PTSD on their
      functioning, help them identify effective coping strategies for dealing with trauma-related
      distress, and encourage them to establish and maintain a certain degree of independence from
      the therapist.

      Patients receive 15 weekly sessions of BIT. Assessments occur pre-treatment, post-treatment,
      and at a 3-month follow-up, and include self-report measures, clinician administered PTSD
      scale questions, interviews, and evaluations of lifetime stressors.
    

Intervention name(s): Brief Integrative Therapy
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child Abuse, Sexual
Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services
Condition: Anxious-Depressive
Study type: Interventional

Summary: 
      The aim of this study is to assess and compare the benefits of twopsychological interventions
      added to the usual treatment of patients whocome to mental health. Patients will be randomly
      assigned to the followingconditions: Mindfulness-Based Stress Reduction (MBSR),
      Attachment-BasedCompassion Therapy (ABCT) and a Treatment As Usual (TAU) Group.
      Theparticipants in the two psychological intervention groups will also receive
      usualpsychological/psychiatric treatment managed by their specialist. Mindfulnessand
      Compassion groups will be composed of 33 participants each, and TAU group will be composed of
      64 participants (total sample n = 130).

      The principal hypothesis is that 'ABCT + TAU' will be more effective than'MBSR + TAU' for
      treating depressive and/or anxiety symptoms in patients attending mental health settings.
      Secondary hypothesis are: 1) 'MBSR + TAU'and 'ABCT + TAU' will be more effective than 'TAU
      alone' for treatinganxiety and/or depressive symptoms in patients attending mental health
      settings; 2) mindfulness will be a mediator of the 'MBSR + TAU' program improvements, while
      self-compassion will be a mediator of the corresponding'ABCT + TAU'; and 3) 'ABCT + TAU' will
      present more cost-effectiveness than 'MBSR + TAU' and both ABCT + TAU' and 'MBSR + TAU'
      programs will present more cost-effectiveness than TAU alone.
    


Intervention name(s): Mindfulness based Intervention; Compassion based Intervention; TAU
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months; ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.; Usual specialized treatment in mental health (psychological or/and psychiatric)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mindfulness; Compassion; Mental Health Services
Study of GSK961081 in Healthy Volunteer Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK961081 is a new long-acting bronchodilator being developed for the treatment of chronic
      obstructive pulmonary disease (COPD). This study is the first clinical study in humans. The
      purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of GSK961081 in healthy male subjects.
    


Intervention name(s): GSK961081 15mcg SD; GSK961081 3mcg SD; GSK961081 50mcg SD; Placebo SD; GSK961081 100mcg SD; GSK961081 200mcg SD; GSK961081 300mcg SD; GSK961081 100mcg RD; GSK961081 300mcg RD; Placebo RD
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose delivered via solution for nebulisation; single dose delivered via nebulsier; single dose delivered via solution for nebulisation; single dose via nebuliser; single dose delivered via solution for nebulisation; single dose via nebuliser; single dose via nebuliser; repeat dose via nebuliser; repeat dose vai nebuliser; repeat dose via nebuliser
Other intervention name(s): Placebo; GSK961081 200mcg SD; GSK961081 50mcg SD; GSK961081 300mcg SD; GSK961081 100mcg SD; GSK961081 3mcg SD; GSK961081 100mcg SD
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: first time in human study; COPD; long-acting bronchodilator
Education Given on Their Attitudes Towards Violence Against Women and Their Conflict
Condition: University Students; Attitudes; Conflict; Education; Women; Violence; Awareness
Study type: Interventional

Summary: 
      Introduction: Violence against women is the violation of human rights faced by women of all
      ages, cultures and education levels everywhere. It can be experienced in many different ways,
      either individually or socially.

      Aim: The study was conducted to investigate the effects of education given to university
      students on their attitudes towards violence against women, and their conflict and awareness
      levels.
    

Detailed description: 
      Methods: The sample of this randomized controlled experimental study comprised 87
      (experimental group=45; control group=42) university students studying in health-related
      fields. The students in the experimental group received in one session education on violence
      against women and conflict, whereas the students in the control group did not receive any
      education. The study data were collected with the Personal Information Form, Attitudes
      towards Violence Scale among University Students, and Conflict and Violent Awareness Scale.
    

Intervention name(s): Education
Intervention type(s): Behavioral
Intervention description(s): Education covers women's education on violence, conflict and awareness.
Other intervention name(s): Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Awareness; Conflic; Education; Student; Violence against women
Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period, crossover
      study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a
      single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime or
      piperacillin/tazobactam or aztreonam) in healthy volunteers. Participants will be
      administered single doses of SPR741 alone, a single dose of SPR741 in combination with 1 of 3
      different partner antibiotics, and the partner antibiotic alone in a randomized sequence.
      Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are
      planned to participate in the study. Women of childbearing potential will not be eligible to
      participate.
    

Detailed description: 
      This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period crossover
      study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a
      single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime,
      piperacillin/tazobactam, and aztreonam) in healthy volunteers. Participants will be
      administered a single dose of SPR741 alone, a single dose of SPR741 in combination with 1 of
      the 3 different partner antibiotics, and a single dose of the partner antibiotic alone in a
      randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18
      to 55 years of age are planned to participate in the study. Women of childbearing potential
      will not be eligible to participate. The study will consist of 3 phases: a screening phase, a
      treatment phase, and a follow-up phase.

      The 3 treatment arms will be enrolled and dosed in parallel or in a staggered manner, as
      needed for scheduling.

      All participants in the study will be monitored for safety after administration of the last
      dose of investigational product.
    

Intervention name(s): SPR741; Ceftazidime; Piperacillin/tazobactam; Aztreonam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 400 mg IV over 1 hour; 1.0 gram IV over 1 hour; 4.5 grams IV over 1 hour; 1.0 gram IV over 1 hour
Intervention MeSH terms: Tazobactam; Piperacillin; Ceftazidime; Piperacillin, Tazobactam Drug Combination; Aztreonam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety; tolerability; pharmacokinetics; drug-drug interaction; SPR741; antibiotic
Study of Tolerability and Safety of Adding Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With TD1 Melitis
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of
      INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in
      patients with established T1DM.
    

Detailed description: 
      The primary objective of this study is to assess the safety and tolerability of 12 weeks of
      subcutaneous (SC) daily administration of INGAP-P (600 mg SC once a day in three separate
      injection sites) with ustekinumab (two single injections of 45 mg SC, one as pretreatment two
      weeks before INGAP-P treatment begins and the second one after 2 weeks of INGAP-P treatment)
      in adult patients with established type 1 diabetes mellitus (T1DM). Safety will be evaluated
      by assessing local tolerability, recording incidence of hypoglycemia, performing safety
      laboratory measures at frequent intervals, and following subjects very closely for any
      adverse events (AEs).

      Secondary objectives of this study are to generate preliminary data on the efficacy of
      INGAP-P and ustekinumab in adult patients with established T1DM, specifically by change from
      baseline to Week 12 in: 1) Maximal C-peptide (Cmax) during mixed meal test (MMT) and glucagon
      stimulated test (GST); 2) C-peptide release (AUC) during MMT and GST; 3) Fasting C-peptide;
      4) Fasting glucose (before breakfast and after at least 8 hours of fasting); 5) Longer term
      glycemic control as reflected by glycosylated hemoglobin (HbA1c) and 1,5-anhydroglucitol
      (1,5-AG); and, 6) Total daily insulin dose relative to body weight.
    

Intervention name(s): INGAP Peptide, Ustekinumab
Intervention type(s): Drug
Other intervention name(s): INGAP Peptide; Ustekinumab (Stelara)
Intervention MeSH terms: Ustekinumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes mellitus; INGAP; Ustekinumab
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of
      SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
    

Detailed description: 
      -  Part A: Comparison between SB4 and EU sourced Enbrel

        -  Part B: Comparison between SB4 and US sourced Enbrel

        -  Part C: Comparison between EU sourced Enbrel and US sourced Enbrel
    

Intervention name(s): SB4; EU sourced Enbrel; US sourced Enbrel
Intervention type(s): Biological; Biological; Biological
Intervention description(s): SC administration; SC administration; SC administration
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Pharmacokinetics
The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury
Condition: Total Knee Arthroplasty; Tourniquet-Induced Ischemia-Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The release of tourniquet produces reactive oxygen species which can cause injury. Propofol
      is chemically similar to phenol-based free radical scavengers.

      Plasma total antioxidant capacity is a well-established marker of the overall protective
      effect of antioxidants in body fluids.The aim of the study is to investigate the effects of
      propofol on ischemia-reperfusion injury in total knee arthroplasty (TKA).
    


Intervention name(s): Propofol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Propofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Propofol; antioxidant capacity; total knee arthroplasty; Propofol,antioxidant
Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage
Condition: Chronic HBV Infection; Drug Withdrawal
MeSH terms: Infections; Communicable Diseases; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Substance Withdrawal Syndrome
Study type: Observational

Summary: 
      As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA)
      transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host
      interactionsduring chronic hepatitis B viral infection.The distribution pattern of serum HBV
      RNA levels in the natural course of chronic HBV infection remains unclear. Furthermore,serum
      HBV RNA was associated with response to NAs. So it may be another clinical surrogate marker
      for intrahepatic cccDNA level after long-term NAs treatment and be used to monitor NAs
      therapy. The aim of this study was to evaluate thelevels of HBV RNA during the natural
      courseof CHB and the role in distinguishingthe natural phases of HBV infection and to
      investigate whether serum HBV RNA level at the end of long-term NAs treatment had a similar
      or better predict effect on off-therapy relapse than serum HBsAg titer.
    


Intervention name(s): serum HBV RNA
Intervention type(s): Diagnostic Test
Intervention description(s): serum HBV RNA level was determined by using HBV-SAT kit at different time point
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic Hepatitis B virus infection receiving or not receiving NAs treatment
      
Keywords: HBV RNA; HBsAg; cccDNA; Nucleos(t)ide analogue; virological relapse