bioihbjkbjnl/mcl2 huggingface dataset:
Study of Rocuronium Onset Time According to Remifentanil Infusion
Condition: Anesthesia
Study type: Interventional

Summary: 
      The investigators therefore hypothesized that remifentanil could prolong the onset time of
      rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial
      pressure and heart rate) during the anesthetic induction sequence.
    

Detailed description: 
      It has been reported that co-administration of ephedrine reduced the onset time of
      neuromuscular block of rocuronium (1-3). It also provided an improved condition for the rapid
      tracheal intubation (2,4). This beneficial effect was attributed to the increased cardiac
      output and tissue perfusion to muscle, and therefore, a more rapid delivery of rocuronium to
      the neuromuscular junction was achieved (4-5). If so, any drugs which decrease cardiac output
      consequently can prolong the onset time of rocuronium.

      Remifentanil is the first ultra-short acting opioid with a rapid onset. During the total
      intravenous anesthesia (TIVA) with propofol and remifentanil, prior administration of
      remifentanil could reduce the propofol infusion pain without other significant complications
      (6). However, remifentanil can decrease the arterial pressure and heart rate (7-8), so that
      it is likely to decrease the onset time of rocuronium for the opposite principle that
      ephedrine increases it.

      The investigators therefore hypothesized that remifentanil could prolong the onset time of
      rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial
      pressure and heart rate) during the anesthetic induction sequence.
    

Intervention name(s): the order of drug administration
Intervention type(s): Drug
Intervention description(s): In group R, remifentanil was infused first before administrating propofol and rocuronium and in group P, it was administered last after the rocuronium injection. In other words, the order of drug infusion in each group is remifentanil-propofol-rocuronium in group R and propofol-rocuronium-remifentanil in group P, respectively.
Other intervention name(s): esmeron; ultiva; fresopol
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Everyday Activity Supports You (EASY) Pilot Study
Condition: Lifestyle
Study type: Interventional

Summary: 
      The investigators propose a 6-month, parallel, single-blind randomized controlled trial (RCT)
      feasibility study of a self-management program to reduce sedentary time and increase physical
      activity (Sit Less to Move More) in women aged 55-70 years. The primary aim is to determine
      feasibility and acceptability of the intervention; and the secondary aim is to test the
      effect of the intervention on the primary health outcome, physical activity (mean daily step
      count by accelerometry) at 6 months. The investigators will also conduct an economic
      evaluation and a process evaluation to guide a future larger study and to inform a scaled-up
      implementation plan.
    


Intervention name(s): Active Living Program; Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: active living; retirement
Ethyl-EPA Treatment of Prodromal Patients
Condition: Schizophrenia Prodrome
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia
      prodrome.
    


Intervention name(s): ethyl-eicosapentaenoic acid
Intervention type(s): Drug
Intervention description(s): 2 mg per day
Other intervention name(s): ethyl-EPA, an omega-3 fatty acid
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a randomized control trial of vertical climbing ergometer exercise for individuals
      with chronic low back pain. Using a parallel-arm design, participants will be randomized to 8
      weeks of supervised exercise using either the vertical climbing ergometer (CLMBR) or a
      recumbent cycling ergometer. This feasibility study will examine the safety, tolerability,
      and efficacy of vertical climbing exercise for individuals with chronic low back pain.
    


Intervention name(s): Vertical climbing ergometer exercise; Recumbent cycling
Intervention type(s): Other; Other
Intervention description(s): Exercise using the CLMBR, a vertical climbing exercise ergometer.; Exercise using a recumbent cycle ergometer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; exercise; vertical climbing
Photoplethysmographic Scaling of Dyspnoea
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      Timely prediction of impending respiratory failure is vital, yet relies on subjective
      clinical assessment of the patient's respiratory status. Pulse oximetry plethysmographic
      signal analysis is indicative of the effort to breathe and may provide an objective
      measurement of respiratory loading.
    

Detailed description: 
      Initiating invasive mechanical ventilation is a vital and delay-critical decision. Precise
      and timely prediction of impending respiratory failure would be highly consequential.
      Subjective evaluation of respiratory loading conditions is inconsistent, imprecise and may
      result in erroneous management. Photoplethysmographic (POP) waveform analysis provides a
      non-invasive, readily available tool to estimate breathing effort in a semiquantitative
      fashion.

      It is the aim of this study to examine:

        1. if the degree of dyspnoea, when clinically assessed by means of the respiratory rate and
           SpO2 values, correlates with the SpO2 wave variations (ΔPOP) in ICU spontaneously
           breathing COVID-19 and non-COVID-19 patients.

        2. if a ΔPOP threshold could be identified to adequately predict further need of
           orotracheal intubation and invasive mechanical ventilation.

      This study consists of three main steps:

        1. Clinical evaluation of dyspnoea based on:

           1.1. Respiratory rate

           1.2. Oxygen saturation (SpO2)

        2. Storage of SpO2 curve for ΔPOP computation according to a proprietary algorithm after
           offline POP analysis .

        3. Within a time frame of 10 days from when the first two steps are met, monitor for need
           of invasive ventilatory support.
    

Intervention name(s): Pulse oximeter; ECG
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): In both groups, pulse oximeters provide continuous monitoring of oxygen saturation (SpO2).
Also, SpO2 curve can be recorded for off-line analysis.; ECG signal is used to monitor respiratory rate (RR).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Spontaneously breathing ICU (COVID and non-COVID-19) adult patients with sinus rhythm,
        under any form of non-invasive respiratory support.
      
Keywords: breathing; effort; plethysmography; pulse oximetry; dyspnoea; mechanical ventilation
Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to perform the re-examination of Menactra® administered in the
      routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.

      Primary objective:

        -  To describe the safety profile after 1 dose of Menactra® administered from 9 months to
           55 years of age under standard health care practice.
    

Detailed description: 
      Subjects aged 9 months through 55 years and who are given study vaccine during routine
      health-care visits will be enrolled in the study.

      They will be followed-up for up to Day 42 following vaccination.

      No study vaccine will be supplied or administered as part of this study, subjects will be
      monitored following routine vaccine administration in clinical settings.
    

Intervention name(s): Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular. 2 doses 3 months apart; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Menactra®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®; Meningococcal Vaccine
Probiotics for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to
      placebo, when given for 6 months.

      By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either
      probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients
      are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of
      monthly letters.

      The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei
      F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109
      CFU/capsule.

      The hypothesis is, that there is a clinical difference between the group receiving probiotics
      and the group receiving placebo.
    

Detailed description: 
      Background: In management of IBS, no treatments have showed great efficacy. IBS is a
      non-fatal disease, so safety is a high priority in the choice of treatment. Probiotics is a
      dietary supplement and have no adverse effects. In some studies it has shown beneficial
      effect on some of the IBS patients symptoms, but some of the results are questionable. The
      studies have to be of longer duration, with more patients and the probiotics have to be
      capsules instead of milk based drinks.
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules with probiotics containing the strains : Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12. Dose/capsule : 2 x 109 - 10 x 109 CFU.; Placebo capsules containing maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS; Irritable bowel syndrome; Probiotics; Treatment; Adequate relief
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent
      Pneumococcal Conjugate Vaccine) in healthy infants.
    


Intervention name(s): LBVE; Prevnar13
Intervention type(s): Biological; Biological
Intervention description(s): Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh; 13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients
Condition: Eczema; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser
      formulated with surfactants and preserved with sodium hypochlorite, is effective at
      decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or
      eczema.
    

Detailed description: 
      Staphylococcus aureus colonization and potential infection represent a common clinical
      finding in patients with atopic dermatitis (AD) and may contribute to exacerbation of the
      disease. Atopic patients are commonly colonized with S. aureus on both lesional and
      non-lesional skin. Antibiotic treatment of clinically infected patients can often improve the
      bacterial infection as well as reduce the overall severity of AD. More recently, measures to
      reduce S. aureus colonization have been shown to decrease the clinical severity of Atopic
      Dermatitis in patients with clinical signs of secondary bacterial infection of the skin.

      Given the increasing incidence of recurrent skin infections caused by S. aureus, measures
      such as dilute sodium hypochlorite (bleach) baths have been adopted by many physicians in an
      effort to decrease infection rates and disease severity in patients with atopic dermatitis,
      recurrent impetigo, cellulitis, folliculitis, boils and abscesses. There is some controversy
      in the literature regarding the efficacy of anti-staphylococcal treatments in improving AD in
      patients without active clinical infection as one review noted limited benefit while another
      study showed that dilute bleach baths improved AD.

      Bleach baths are widely used in pediatrics and adult medicine. A common regimen consists of
      adding ½ cup of household bleach into ½ tub of warm bath water, resulting in a 0.009% sodium
      hypochlorite concentration. (www.bleachbath.com) CLn® BodyWash contains several common
      surfactants to clean the skin and 0.006% sodium hypochlorite concentration for preservation,
      and is further diluted when lathered onto the skin with water. This over the counter product
      is delivered in a sealed, easy to use dispenser, which can be used in the bath or shower,
      lathered on and rinsed off after 1-2 minutes of skin contact. CLn® BodyWash may be a
      convenient alternative to bleach baths.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients with Atopic Dermatitis
      
Keywords: Eczema; Atopic Dermatitis; Compromised Skin; Inflamed Skin
Effect of Urocortins in Patients With Heart Failure
Condition: Heart Failure; Endothelium
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Despite modern advances in treatment, heart failure continues to carry a poor prognosis with
      high morbidity and mortality rates. Hence, there remains a major interest in the development
      of novel therapeutic agents for this debilitating condition. Urocortins have recently shot
      into limelight with their potential role in the pathophysiology and treatment of heart
      failure.

      Recent studies by the investigators group (REC no: 09/S1103/41) have confirmed that Urocortin
      2 and 3 are potent arterial vasodilators, the effects of which are reproducible and well
      tolerated in healthy male volunteers. Previous studies using heart failure models in
      animals1-7, as well studies in heart failure patients (Urocortin 2), suggest that there is
      great scope for Urocortins as novel biomarkers and as potential therapeutic agents in heart
      failure. With this in mind, the investigators wish to study the local vasomotor effects of
      these peptides in greater detail in patients with heart failure.
    


Intervention name(s): Urocortin 2, Urocortin 3 and Substance P
Intervention type(s): Drug
Intervention description(s): After a 20-min infusion of intra-arterial saline, ascending doses of Urocortin 2 (3.6, 12 and 36 pmol/min [15, 50 and 150 ng/min] to achieve estimated end-organ concentrations of 0.6, 2 and 6 µg/L, respectively), Urocortin 3 1200, 3600 and 12000 pmol/min (5, 15 and 50 micrograms/min) [to achieve estimated end-organ concentrations of 199, 600 and 2000 micrograms/L respectively] and substance P (a control endothelium-dependent vasodilator that evokes endogenous t-PA release [2, 4 and 8 pmol/min]) will be administered intra-arterially.
Baseline blood samples will be taken at the start of the study for full blood count, cholesterol, glucose, renal function Bilateral venous blood samples will be taken at baseline, immediately before the start of Ucn2/Ucn3 infusion and at the end of each dose of Ucn2/Ucn3 for subsequent measurement of plasma Ucn 2 and 3 concentrations and other hormones.
Intervention MeSH terms: Substance P; Neurokinin A
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Urocortin 2; Urocortin 3; Forearm venous occlusion plethysmography; Heart failure; Endothelium; Substance P
Yoghurt Consumption, Body Weight Management and Glycemic Control of T2DM Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Body Weight
Study type: Interventional

Summary: 
      The study investigates the effects of consumption of yoghurt enriched with vitamins B
      compared to plain yoghurt, on body weight management and glycemic control of overweight/obese
      T2DM patients. It also investigates the effect of plain yoghurt consumption on gut hormones
      response of T2DM patients.
    

Detailed description: 
      In a large number of epidemiological studies, low-fat dairy consumption has been associated
      with lower risk of T2DM. However, the number of randomized clinical trials which examine the
      impact of yoghurt consumption on glycemic control and body weight management of T2DM patients
      is small and include yoghurts fortified with vitamin D or probiotics. According to our
      knowledge, fortification of yoghurt with other classes of vitamins beyond vitamin D has not
      been examined. Vitamins of B-complex hold key-role in energy metabolism. In the state of
      diabetes mellitus, the requirements for this vitamin class may be higher because of their
      water solubility and increased excretion. Two groups of patients participated in the study.
      One group received yoghurt enriched with vitamins B and one group received isocaloric plain
      yoghurt. In addition, in order to investigate the effect of plain yoghurt on gut hormones,
      responses to a mixed meal tolerance test were evaluated in the beggining and the end of the
      dietary intervention.
    

Intervention name(s): Plain yoghurt; Vitamin B yoghurt
Intervention type(s): Other; Other
Intervention description(s): cups of 200 g yoghurt; cups of 200 g yoghurt
Other intervention name(s): Conventional yoghurt
Intervention MeSH terms: Vitamins; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: yoghurt; vitamins B; body weight; glycemic control
Menstrual Effects On Mood Symptoms in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      Background and Rationale for Study: Estrogen and progesterone are female hormones that
      regulate the menstrual cycle and likely serve an important role in the regulation of mood.
      Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild
      dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days
      post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual
      mood changes that range from mild symptoms to severe worsening that require hospitalization.
      Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but
      confirmatory research is lacking.

      Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms
      throughout the menstrual cycle and to determine if women with BD have: 1) a) increased
      severity and persistence of depression and mania symptoms in the late luteal (premenstrual)
      vs early follicular phase, b) larger change in mood symptoms from the late luteal
      (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in
      the late luteal compared to the early follicular phase. The secondary aims are to determine:
      1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar
      women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory
      vs anovulatory cycles, c) antimanic drug treatment.
    

Detailed description: 
      Study Design: Women with BD (15 depressed, 15 euthymic), and 15 healthy women will enter the
      study. Over 3-months, subjects undergo monthly visits to assess mood and function, at the
      follicular and luteal phases. Ovulation is confirmed with: 1) urine dipstick tests to detect
      ovulation (LH surge) days8-14 from the onset of menses; 2) serum progesterone levels 7-days
      post-ovulation (LH surge). Subjects record their mood and physical symptoms on the daily
      self-report LifeChart and the Daily Rating Form.

      Study Population: Women with Bipolar I or II Disorder, between ages 18-45. Primary Outcomes
      Measures: 1) a) mood severity - scores on the Structured Interview Guide for the Hamilton
      Depression Scale (SIGHADS) for depression, Mania Rating Scale (MRS) for mania/hypomania, and
      LifeChart mood ratings depression and mania/hypomania, for the late luteal and early
      follicular phases; b) persistence of symptoms - proportion of days with mild/moderate/severe
      depression or mania/hypomania. 2) Relapses - # bipolar episodes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample and outpatient psychiatric offices
      
Biospecimen description: 
      whole blood
    
Keywords: Bipolar Disorder; Menstrual Cycle; Depression; Mania or Hypomania; Predictor