bioihbjkbjnl/mcl2 huggingface dataset:
The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study
Condition: Burn
MeSH terms: Burns
Study type: Observational

Summary: 
      The relationship of body function, participation and quality of life in patients with burn: A
      longitudinal study
    

Detailed description: 
      Early rehabilitation to partial-thickness and full-thickness dermal injury are of vital
      importance for burn patient. Literature reviews have shown that burn patients experiences ADL
      and quality of life (QOL) difficulties. Due to varied severity, the outcome and expression of
      each patient also differs. The limitation of body function may consequently affect social
      participation and QOL thereafter.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators will have Normal Adult (n=30~40) and Burn Patient (n=80-90) from 14-74
        years old under consent of their family.
      
Keywords: Burn patient; Developmental Disabilities; Body function; Participation; Quality of Life; longitudinal study
Endotracheal Intubation Using Macintosh Laryngoscope, Glidescope, Airwayscope During Chest Compression With Adjustment Height of a Bed
Condition: Tracheal Intubation; Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a bed height make an effect to endotracheal
      intubation with Macintosh laryngoscope, Glidescope and Airwayscope during chest compressions
      in- hospital simulation cardiac arrest.
    


Intervention name(s): Macintosh laryngoscope; Glidescope; Airwayscope
Intervention type(s): Device; Device; Device
Intervention description(s): Direct Laryngoscope; Videolaryngoscope-1; Videolaryngoscope-2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: intubation; Cardiopulmonary resuscitation; Manikin study
Health Effects of Traditional Indigenous Chokeberry
Condition: Inflammation; Mental Health Wellness 1; Oxidative Stress
MeSH terms: Inflammation; Historical Trauma
Study type: Interventional

Summary: 
      American Indian populations continue to suffer disproportionately from health problems
      including such nutrition-related chronic diseases as diabetes and heart disease. This
      research project will therefore investigate how a traditional Indigenous food called
      chokeberry (Aronia melanocarpa) impacts epigenetic and metabolic health in relation to
      resiliency markers in American Indian participants. The process of research with American
      Indian communities is significant in that it can inform best practices in community
      engagement orientations, approaches, and models in future research settings.
    

Detailed description: 
      This study aims to explore the gene expression and metabolic changes that are mediated by
      consumption of Indigenous chokeberry (Aronia melanocarpa) in adult urban American Indians and
      to examine the associations between metabolic endpoints, adverse childhood experiences and
      mental health. The investigators are doing this research study to answer questions about the
      impact of adult urban American Indians ingesting one of their traditional Indigenous foods
      called chokeberry on epigenetic, metabolic and mental health markers of trauma and
      resilience.

      For this study, the investigators will be looking to determine:

        1. If there are gene expression changes that are mediated by consumption of traditional
           Indigenous chokeberry in urban adult Great Plains Indians.

        2. If there are associations between secondary outcomes such as metabolic endpoints (i.e.,
           8-OHdG, IL-6, lipids, glucose, CRP, blood pressure), epigenetic states, adverse
           childhood experiences, and mental health (historical trauma, resiliency, presence of
           anxiety and depression) in American Indians who have or have not consumed chokeberry as
           part of a controlled feeding study.
    

Intervention name(s): Chokeberry (Aronia melanocarpa) juice
Intervention type(s): Other
Intervention description(s): A water-infused chokeberry (Aronia melanocarpa) juice will be used as the intervention. The brand being used is called 'Superberries'.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: American Indian; Epigenetics; chokeberry; Aronia melanocarpa; Historical Trauma
Eradication of Gut Microbiota
Condition: Diabetes; Obesity; Osteoporosis; Inflammation
MeSH terms: Osteoporosis; Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the study is to assess the effect of eradication of gut microbiota on 1) glucose
      metabolism including postprandial plasma responses of the incretin hormones GIP and GLP-1,
      insulin, C-peptide and glucagon, 2) metabolomic profiles and resting energy expenditure (REE)
      3) appetite, satiety, food intake, gastric emptying and gall bladder emptying, 4) levels of
      markers of bone formation and resorption as well as serotonin, 5) markers of systemic
      inflammation, and 6) on the (prospective) composition of bacteria in faeces, blood and
      saliva. Thus, the overall objective is to provide detailed knowledge on the physiological
      role of gut microbiota combined with bioinformatic analyses of the functional implications of
      changes in bacteria composition on the level of both species and phylum.
    


Intervention name(s): meropenem, gentamicin, vancomycin (together)
Intervention type(s): Drug
Intervention description(s): 4 days antibiotic treatment, per oral, once daily: vancomycin 500 mg (Vancomycin "Hospira"), powder for concentrate; gentamycin 40 mg ("Hexamycin®"), solution; meropenem 500 mg (Meropenem "Hospira"), powder for concentrate; The three drugs are dissolved and combined to a cocktail (with approximately 100 ml of apple juice)
Intervention MeSH terms: Vancomycin; Gentamicins; Meropenem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff
Condition: Anesthesia Intubation Complication; Intubation Complication; Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      This study aims to compare effects of two different agents on complications due to tracheal
      tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the
      main complications.
    

Detailed description: 
      In the literature there were studies about both local anesthetic agents and topical steroids
      and different densities of saline which were applied to decrease airway complications. In
      this study researchers intended to compare effects of local anesthetic agents and topical
      steroids applying around tracheal tube on airway complications which may occur in the first
      24 hours after surgery. All pediatric patients scheduled for elective surgery will be
      recruited. enrolled patients will randomly assigned in to three groups: Control group, local
      anesthetic group and topical steroid group.
    

Intervention name(s): Lidocaine 10% Spray; Mometasone nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): lidocaine will be apply on the cuff; mometasone spray will be applied on the cuff
Other intervention name(s): lidocaine; steroid
Intervention MeSH terms: Mometasone Furoate; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: intubation; anesthesia; corticosteroids; lidocaine; complication of intubation
Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound
Condition: Deep Partial Thickness Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism of
      epithelialization. However, it depends on the depth of the wounds and patient condition.
      Infection is one of the most common complications causing delay in wound healing which might
      affect to quality of patient's life. Generally, the standard treatment of partial thickness
      burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the
      broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not demonstrate
      the accelerating effect of wound healing. Therefore, the combination of substance which can
      promote wound healing to topical silver sulfadiazine cream might benefit for partial
      thickness burn wound treatment.

      The objective of this study was to compare the results of partial thickness burn wound
      treatment at burn unit, Siriraj hospital with topical cream containing 1% silver sulfadiazine
      plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The demographic data
      (age, sex, %body surface area burn), time of wound closure, pain and itching, dose and type
      of pain and itching medication, adverse effect of topical medication, some laboratory results
      and cost of expenses.

      This is the prospective, double blinded, randomize-controlled study. The sample sizes were
      partial thickness burn wound patients who were treated at burn unit, Siriraj hospital.
      Patients were allocated into 2 groups receiving treatment with either topical silver
      sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with
      repeated measure ANOVA and independent t-test.
    


Intervention name(s): Epidermal growth factor with silver sulfadiazine cream; Silver zinc sulfadiazine cream
Intervention type(s): Drug; Drug
Intervention description(s): Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream); Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream)
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine; Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Wound healing; Epithelialization; Safety
The Use of EEG in Alzheimer's Disease, With and Without Scopolamine - A Pilot Study
Condition: AD
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The objective of this study is to compare the electroencephalography (EEG) responses of three
      distinct groups of individuals to scopolamine: 1) a group of Alzheimer Dementia (AD)
      patients, 2) a group of individuals suffering from Mild Cognitive Impairment (MCI) and 3) a
      group of controls. The main purpose of this comparison is to discover ways to use these
      responses to distinguish between the group of AD patients and controls in order to develop a
      diagnostic tool for AD. The purpose of including the MCI group is to investigate whether this
      diagnostic tool can predict which member of the MCI group will develop AD later in life.
    


Intervention name(s): Scopolamine
Intervention type(s): Drug
Intervention description(s): 0.3 mg/mL, intravenously, once
Other intervention name(s): Scopolamine hydrobromide
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Scopolamine, AD, EEG, MCI
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study is designed as a multi-center, randomized, double-blind,
      placebo-controlled, parallel design, prospective, phase II clinical trial.

      An eligible subject who meets inclusion and exclusion criteria is randomly assigned to three
      groups: study group 1 (GV1001 0.56 mg), study group 2 (GV1001 1.12 mg) or placebo group. A
      randomized subject is administered either GV1001 or placebo in a total of 14 times and will
      be evaluated for the efficacy and safety at week of 24.
    

Detailed description: 
      GV1001 0.56 mg, 1.12 mg or placebo is subcutaneously administered once weekly schedule for 4
      weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of
      administration is 14 times.

        1. Control group (placebo): 30 subjects

        2. Study group 1 (GV1001 0.56 mg): 30 subjects

        3. Study group 2 (GV1001 1.12 mg): 30 subjects.
    

Intervention name(s): Normal Saline 0.9%; GV1001 0.56 mg; GV1001 1.12 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Normal saline 0.9% is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.; GV1001 0.56 mg is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.; GV1001 1.12 mg is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
Other intervention name(s): NS 0.9%; Tertomotide; Tertomotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GV1001; Alzheimer Disease
A Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection
Condition: Postoperative Ileus
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the safety of TZP-101 in comparison with placebo when administered
      post-operatively in patients who have undergone partial bowel resection.
    


Intervention name(s): TZP-101; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Emotion Regulation and Emotion Perception
Condition: Emotions
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of a brief, emotion regulation intervention
      on the ability to perceive other people's emotions.
    

Detailed description: 
      Decision to close enrollment was made on January 2, 2020.
    

Intervention name(s): Mindful Breathing; Habituation; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Training in a mindful breathing skill that reduces emotional distress; An exposure procedure that reduces emotional distress through habituation; No emotion regulation intervention, placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Emotion Dysregulation; Empathy; Emotion Perception
Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients
Condition: Hepatitis B Virus (HBV)
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Hepatitis B virus (HBV) infection is a worldwide health problem. It has been proved that the
      persistence of HBV is associated with the failure to stimulate an efficient HBV-specific
      immune response. T101, the Chinese counterpart of TG1050, is a replication-defective
      adenovirus serotype 5 (Ad5) expressing multiple HBV-specific antigens (core, polymerase and
      envelope) and is used as therapeutic vaccine for chronic hepatitis B patients. The
      application of T101 aims at inducing a broad HBV-specific cellular immune response and
      ultimately eliminating HBV infection.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, single dose (SD) and multiple
      dose (MD) administration study.

      Primary Objective: Safety and tolerability;

      Secondary Objective:

        1. Antiviral activity of T101 (HBsAg levels).

        2. Cellular (HBV-specific) and humoral (AD5 neutralizing antibodies, NAd5) immune responses
           to T101.

      Key Inclusion Criteria:

        1. Chronic hepatitis B patients with positive HBsAg.

        2. Patients must be receiving antiviral treatment with nucleoside analogs and have negative
           HBV DNA (defined as HBV DNA <20 IU/mL).
    

Intervention name(s): T101 Group; Placebo Group
Intervention type(s): Biological; Biological
Intervention description(s): Single Dose (SD) Cohort:
In each group, 3 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+9VP (Group1)/1.0E+10VP (Group2)/1.0E+11VP (Group 3) on D1.
Multiple Dose (MD) Cohort:
In each group, 9 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+10VP (Group1)/1.0E+11VP (Group2) on D1, D8, D15.; Single Dose (SD) Cohort:
3 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1.
Multiple Dose (MD) Cohort:
6 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1, D8, D15.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis B virus (HBV) infection
Effect of Audistim® Day/Night on Hearing Comfort and Patient Quality of Life of Patients With Chronic Tinnitus.
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Tinnitus is a widespread problem that affects the quality of life of millions globally.

      Few treatments have been found to be effective for subjective tinnitus and to have a
      significant improvement on quality of life. In subjective tinnitus, neither an external nor
      endogenous sound source is present; instead, the tinnitus is caused by abnormal bioelectric,
      biomechanical, or biochemical activity in the inner ear and/or central nervous system.

      The precise role of the numerous extra-auditory structures that contribute to the
      pathophysiology of tinnitus is difficult to establish. Some of them participate in the
      creation or in the chronification of tinnitus and some in the psychological reactions to the
      tinnitus.

      Audistim contains ingredients with a specific composition based upon the multifactorial
      causal theory; which involves auditory, attentional, memory, and emotional systems. These
      different systems are being targeted by the ingredients and their specific proportioning.
      Also the antioxidant theory is involved in the creation of Audistim, it states that the
      reactive oxygen species play an important microcirculatory role in the pathology of the inner
      ear and the peripheral and central pathways. These components help to treat the multitude of
      causing factors and in that way improve the quality of life.
    

Detailed description: 
      Participants are allocated in test (dietary supplement) or placebo group according a ratio
      1:1.

      The participants are asked to consume daily the investigational product for 3 months. The
      effect of the dietary supplement is assessed by comparing chronic tinnitus evolvement between
      groups.
    

Intervention name(s): Plant extracts, vitamins and mineral; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Day tablet every day during 3 months : Magnesium (75 mg), Ginkgo Biloba extract (40 mg), hawthorn extract (37,5 mg), L-Theanin (50 mg) , Niacin (16mg), Quercetin (25mg), B12 Vitamin (2,5 µg), B6 Vitamin (1,4 mg), Thiamin (1,1 mg)
Night tablet every evening during 3 months : Magnesium (37,5 mg), Ginkgo Biloba extract (40 mg), Eschscholzia californica extract (40 mg), Zinc (10 mg), Melatonin (1mg), Lemon balm extract (80 mg), Tryptocetyn (65 mg); Day tablet every morning during 3 months : Excipients; Night tablet every evening during 3 months : Excipients
Other intervention name(s): Audistim Day Night
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
Condition: Hyperlipidemia; Hypertension
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan
      co-administration and Livalo fixed combination drug in healthy male subjects.
    


Intervention name(s): Pitavastatin, Valsartan; Livalo® fixed combination drug
Intervention type(s): Drug; Drug
Intervention description(s): Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet); Livalo® fixed combination drug(1 tablet)
Other intervention name(s): Livalo, Diovan; Livalo, Diovan
Intervention MeSH terms: Valsartan; Pitavastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: pitavastatin; Livalo