bioihbjkbjnl/mcl2 huggingface dataset:
Bmgim Music Therapy Method in Reducing Stress in Patients With Inflammatory Bowel Disease
Condition: Bowel Diseases, Inflammatory; Crohn Disease; Colitis, Ulcerative
MeSH terms: Crohn Disease; Colitis; Intestinal Diseases; Inflammatory Bowel Diseases; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      Inflammatory bowel disease (IBD) is a term that defines a chronic disease characterized by
      inflammation of the intestine. It includes ulcerative colitis (UC) and Crohn's disease (CD).
      The objective of the study was to administer a treatment based on a group adaptation of the
      BMGIM in patients with inflammatory bowel disease (IBD) and assess its impact on state of
      mind, quality of life, anxiety, depression, immunocompetence as a marker of well-being, and
      levels of acute and chronic stress.

      To achieve the objectives a quasi-experimental, quantitative, qualitative, analytical, and
      prospective study was performed. 41 patients with IBD divided into a test group (24
      patients), who received 8 sessions over 8 weeks, and a control group (17 patients). A saliva
      sample was taken from each patient before and after each session to determine cortisol levels
      (acute stress) and IgA (immunocompetence) using ELISA. A series of questionnaires were
      completed as follows: HADS (perceived anxiety), MOOD (state of mind), and CCVEII (quality of
      life). Similarly, a hair sample was taken before the first and after the last session to
      determine the cumulative cortisol level (chronic stress) using ELISA.
    


Intervention name(s): BMGIM Music Therapy Method
Intervention type(s): Other
Intervention description(s): The BMGIM method is today one of the models recognized by the international music therapy community, deserving this distinction those approaches that develop a solid theoretical and practical body, with specific training programs as training for new therapists, and that also promote the scientific research as a way to develop the method and Music Therapy.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Music Therapy
Neural Mechanisms Underlying Alcohol Induced Disinhibition
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1
      ("Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted
      Self-administration of Ethanol (CASE)"; ClinicalTrials.gov identifier: NCT01063166). The
      functional magnetic resonance imaging blood-oxygen-level-dependent (fMRI BOLD) activity
      related to disinhibition measured with the Stop Signal task will be assessed during a
      continuous infusion of alcohol, clamping the arterial Breath Alcohol Concentration (aBAC) at
      60 mg% for approximately one hour. It will be examined whether this fMRI BOLD activity is
      associated with the initial drinking trajectories and the alcohol consumption at age 18 and
      at age 20 identified in specific aim 1. Furthermore, fMRI will be used with the Taylor
      Aggression Paradigm to determine which brain areas mediate increased physical aggression
      during the same continuous infusion of alcohol as described above. All participants will
      undergo an alcohol and a placebo fMRI session.
    


Intervention name(s): Ethanol; Placebo - half-normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of 6% ethanol in half-normal saline for approximately 1 hour: The dosage is controlled by a physiologically-based pharmacokinetic (PBPK) model of alcohol distribution and elimination, developed by O'Connor and his associates at the Indiana Alcohol Research Center (IARC) (Ramchandani et al, 1999). PBPK Parameters that determine the dosage and frequency of the infusion for a specific individual are estimated by means of morphometric variables (age, height, weight and gender).; Intravenous infusion of half-normal saline for approximately 1 hour: The dosage is equal to the infusion dosage estimated by the PBPK model of alcohol distribution and elimination (Ramchandani et al., 1999) for the drug - ethanol condition.
Intervention MeSH terms: Ethanol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Residents living within 15 km (9.5 miles) from downtown Dresden
Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population
Condition: Diagnoses Disease
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The investigators aimed to study the cut-off of high sensitivity troponin T using SYSMEX
      HLSCL Machine in Thai population at percentile 99.
    


Intervention name(s): SYSMEX HLSCL
Intervention type(s): Device
Intervention description(s): Diagnostic device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Acute Myocardial Infarction; Cardiac marker; Troponin
A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg)
      dose of intranasal esketamine compared to placebo, on next day driving performance and
      repeated administration of 84 mg intranasal esketamine on same-day driving performance as
      assessed by the mean difference of standard deviation of lateral position (SDLP) from an
      on-road driving test.
    


Intervention name(s): Placebo (Intranasal); Esketamine; Alcohol; Placebo (Oral)
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.; Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.; Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).; Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine,(CAIV-T) in Healthy Infants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine.
    

Detailed description: 
      The objective of this study was to compare the safety and tolerability of one and two doses
      of influenza virus vaccine, trivalent, types A and B, live cold-adapted liquid (CAIV-T) with
      placebo when administered intranasally to healthy infants aged 6 < 24 weeks.
    

Intervention name(s): CAIV-T
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Risk Profile for Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The objective of this study is to assess the risk profile in patients with atrial
      fibrillation, which represents the degree of changes (remodeling) in the atrial tissue and
      which can help to predict in which patients rhythm control will be successful. This risk
      profile will consist of a combination of underlying (heart) disease and risk factors, as
      measured with use of parameters obtained with echocardiography, circulating biomarkers and
      other relevant clinical data. Ultimately this risk profile can be used to guide type of
      (rhythm) control therapy in individual patients with atrial fibrillation.
    

Detailed description: 
      Atrial fibrillation is responsible for substantial morbidity and mortality.Identification of
      patients with AF that is difficult to treat may improve the outcome of rhythm control
      therapy. Left atrial size or volume could be a useful tool to select patients that will
      benefit from rhythm control therapy.Beside echocardiographic parameters,atrial fibrillation
      has been also associated with circulating biomarkers in blood like collagen metabolism,
      inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. Beside more
      accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less
      well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive
      physical activity, esophageal problems and increased body mass index) may also predict the
      outcome of rhythm control.It seems also plausible that recurrent atrial fibrillation within
      one month after start of rhythm control is associated with a different risk profile than late
      atrial fibrillation recurrences.During this study we will try to identify patients with
      atrial fibrillation who are more or less likely to respond to rhythm control therapy.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with short-lasting symptomatic paroxysmal or persistent AF
      
Keywords: Atrial Fibrillation; Arrhythmia; Rhythm control
Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate whether and to what extent co-administration of multiple doses of itraconazole
      affect single dose pharmacokinetics of BI 425809 in healthy male subjects
    


Intervention name(s): BI 425809; Itraconazole; BI 425809
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose BI 425809 tablet; multiple doses of Itraconazole capsules; single dose BI 425809 tablet
Intervention MeSH terms: Itraconazole; BI 425809
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will use scintigraphy techniques to measure gastric emptying rate of liquid and
      solid food at baseline and after administration of GSK716155 or placebo.
    


Intervention name(s): GSK716155; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): albiglutide subcutaneous injection; placebo injection
Other intervention name(s): GSK716155
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: healthy; pharmacodynamics; glucagon-like peptide 1; pharmacokinetics; scintigraphy; radiation; albiglutide
Promoting Optimal Healing After Laceration Repair Study
Condition: Neuralgia, Perineal
MeSH terms: Neuralgia; Lacerations
Study type: Interventional

Summary: 
      The goal of this research is to investigate three different methods of perineal skin closure
      during second-degree perineal wound repair and determine which method is associated with the
      least amount of patient pain.

      Null hypothesis: There will be no difference in patient pain among the three different
      methods for second degree perineal wound repair.
    

Detailed description: 
      At the University of Michigan, there are currently two standard techniques for repairing
      second-degree perineal lacerations that differ only in management of the perineal skin :

        1. Closure of the deep tissues and superficial perineal skin using a continuous 3-0 Vicryl
           suture

        2. Closure of the deep tissues with a continuous 3-0 Vicryl suture and reapproximation of,
           but not suture-closure of the perineal skin.

      The primary goal of our study is to compare patient pain amongst the following three perineal
      skin repair techniques after second degree laceration:

        1. Perineal skin closure with suturing

        2. Not suturing the perineal skin

        3. Closure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue.

      In all women, the deep vaginal and perineal tissues will be closed using a continuous 3-0
      Vicryl suture, as is current standard practice.

      Aim: To assess and compare patient pain among the three groups at intervals of 1 day, 2
      weeks, 6 weeks and 3 months postpartum.
    

Intervention name(s): Suturing of the perineal skin; Closing perineal skin with surgical glue; No suturing of the perineal skin
Intervention type(s): Procedure; Procedure; Procedure
Other intervention name(s): n-Butyl 2-cyanoacrylate; Indermil®; surgical glue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: perineal wound; perineal tear; perineum; pain; childbirth
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
Condition: Polio Immunity
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a lower dose of inactivated polio vaccine
      (IPV) injected into the skin (intradermal administration) can work equally well or better
      than the standard dose injected into the muscle (intramuscular administration). There are
      more immune cells in the skin than in the muscle, and other vaccines have been shown to
      require a lower dose when administered intradermally. The study is being done in participants
      infected with HIV because HIV-infected people are known to respond less well to vaccines than
      other groups, so it is particularly important to know if IPV might work better in
      HIV-infected people if administered intradermally.

      If it is possible to lower the dose of IPV by intradermal administration, this would make
      inactivated polio vaccine more affordable in the developing countries where it is most needed
    

Detailed description: 
      Oral polio vaccine (OPV) will not be sufficient to eradicate polio. OPV has failed to provide
      adequate polio immunity in certain immunocompromised populations, such as people with AIDS.
      Also, OPV can mutate and form neurovirulent strains capable of causing polio outbreaks.
      Inactivated polio vaccine (IPV), which cannot mutate into neurovirulent strains and which is
      more effective in populations that have failed to respond to OPV, will be needed globally to
      eradicate polio, but it is unaffordable for many developing countries. Because there are more
      immune cells in the skin than in the muscle, intradermal administration of IPV may be a way
      to increase the efficacy and reduce the dose (and thus the cost) of IPV. We plan to conduct a
      clinical trial randomizing 231 HIV-infected adults to receive a booster of two-fifths dose
      intradermal IPV, one-fifth dose intradermal IPV, full dose intramuscular IPV, or two-fifths
      dose intramuscular IPV. We will measure polio immunity before and after vaccine
      administration. Through this study, we will determine the optimal booster dose of intradermal
      IPV, whether intradermal works better than intramuscular IPV administration, and whether
      intradermal IPV is effective in an immunocompromised population. The data from this trial
      could contribute to global polio eradication.
    

Intervention name(s): IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose
Intervention type(s): Drug
Intervention description(s): Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.
Other intervention name(s): IPOL (Sanofi Pasteur)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner)
      prospective study designed to collect perioperative and postoperative data to compare the QOL
      of ProFlor vs. Lichtenstein inguinal hernia repair.
    

Detailed description: 
      The primary objectives of this study will be to evaluate the immediate and short-term amount
      of post-operative pain, the quality of life (QOL), as well as return to normal activities
      (work) for the two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS)
      assessments will be held at regular intervals to evaluate these objectives.

      The secondary objective of the study is to identify any short-term study related
      complications/adverse events.

      The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4 weeks.
      The first and 4th week's visits are mandatory office visits (if possible). If not available
      for office visit, a CCS assessment will be mailed or will be conducted via phone.

      Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for
      presentation at an international meeting such as the AHS, EHS, or APHS if decided by the lead
      investigator.
    

Intervention name(s): ProFlor Hernia Repair System; Lichtenstein hernia repair
Intervention type(s): Device; Device
Intervention description(s): The 3-D hernia mesh will be used in the repair of your inguinal hernia.; The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.
Other intervention name(s): 3D mesh; Polypropylene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Open Inguinal Hernia
Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
Condition: Peripheral Nerve Injury, Virtual Reality, Rehabilitation
MeSH terms: Peripheral Nerve Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of virtual reality-based motion
      therapy in peripheral nerve injuries in the hand.
    


Intervention name(s): virtual reality; routine treatment
Intervention type(s): Device; Behavioral
Intervention description(s): In addition to the routine hand rehabilitation programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days a week, 20 minutes) virtual reality based movement therapy program will be applied.; 20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective annual release study was designed to assess the safety of a trivalent
      influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season
      not previously contained in the trivalent intranasal FluMist vaccine.

      Three hundred healthy adults will receive a single dose of vaccine or placebo and will be
      followed for 180 days after study vaccination.
    

Detailed description: 
      This prospective, randomized, double-blind, placebo-controlled release study will enroll
      approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly
      assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by
      intranasal spray. Randomization will be stratified by site.

      This study will be conducted at 3 sites in the United States of America. Each subject will
      receive one dose of investigational product on Study Day 1. The duration of study
      participation for each subject is the time from study vaccination through 180 days after
      study vaccination.
    

Intervention name(s): Trivalent Influenza Virus Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.; Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Trivalent, Influenza, FluMist, Vaccine, Prevention