bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence of Telmisartan / HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg HCTZ
      vs. its monocomponents
    


Intervention name(s): Telmisartan; Hydrochlorthiazide (HCTZ); Telmisartan/HCTZ fixed dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Telmisartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
Condition: Meningococcal Disease; Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Observational

Summary: 
      This safety surveillance study of GlaxoSmithKline's quadrivalent meningococcal ACWY conjugate
      vaccine (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age
      is a post-marketing study required by the United States Food and Drug Administration.

      It is an observational study of children 2-23 months of age who receive at least one dose of
      MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled
      as a KPSC health plan member.

      The objective of the infant study is to describe medical events that require emergency room
      visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23
      months of age in a health maintenance organization in the United States. Outcomes include
      medical events that require emergency room visits or hospitalizations in children 2-23 months
      of age following any dose of MenACWY-CRM vaccination. Events with a history of the same
      diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a
      pre-existing condition.
    


Intervention name(s): Meningococcal quadrivalent CRM-197 conjugate vaccine
Intervention type(s): Biological
Intervention description(s): This study is strictly observational. Decisions of vaccination are made by health care providers.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a
        Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan
        member.
      
Keywords: safety of Meningococcal quadrivalent CRM-197 conjugate vaccine; Children 2-23 months of age
MRI Study of Stomach Volumes and Satiety
Condition: Healthy
Study type: Interventional

Summary: 
      The GI MRI Research group at the University of Nottingham has been developing new,
      non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract.
      In collaboration with food manufacturer Unilever, the investigators want to image the abdomen
      of healthy volunteers after consumption of test meals of varying volume and energy density to
      determine levels of gastric distension and investigate possible correlations of this with the
      subjects' sense of satiety.
    

Detailed description: 
      The tone of the proximal stomach decreases on meal intake through a process of gastric
      accommodation, aimed at increasing the capacity of the stomach. An increased gastric volume
      progressively distends the stomach, and this distension has been shown to have an inverse
      relationship on appetite. The link is assumed to be based on activation of mechanoreceptors
      lying in the walls of the stomach. On activation, vagal discharges are triggered, leading to
      activation of hypothalamic neurons and regulation of feelings of satiety. Gasrtric emptying
      is also regulated by duodenal feedback mechanisms triggered by the arrival and amount of
      nutrients.

      Based on current knowledge, a high volume test meal would be expected to produce more gastric
      distension and satiety over a low volume test meal, and a low energy density food would be
      expected to empty from the stomach faster than a high energy density food. Going on this
      premise, study test meal 2 would be expected to empty faster than study test meal 1. These
      phenomena will be investigated using non invasive Magnetic Resonance Imaging (MRI) methods.
      MRI can measure gastric volumes serially and non-invasively with high spatial resolution.
      Ultimately, the findings from this study will provide novel insights on mechanisms of gastric
      distension and satiety.
    

Intervention name(s): Study test meal 1; Study test meal 2; Study test meal 3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers will be fed with a high volume, high energy density test meal.; Volunteers will be fed with a high volume, low energy density test meal; Volunteers will be fed with a low volume, high energy density test meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Gastrointestinal physiology; MRI; gastric volumes; satiety
A Trial to Assess the Effect of High Nitrogen Intake in Critically Ill Patients
Condition: Critically Ill
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The patients with sepsis are in high risk of malnutrition, which could contribute to
      infection, difficulty in weaning from ventilators. The investigators speculate whether
      nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the
      outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the
      investigators aim to compare high nitrogen intake with conventional nitrogen supply which
      were recommended in guidelines.
    


Intervention name(s): nitrogen supply
Intervention type(s): Other
Intervention description(s): Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: mechanical ventilation
Efficacy of Single Dose Rectal Diclofenac With Oral Diclofenac for the Relief of Perineal Pain Within 24 Hours After Episiotomy
Condition: Pain Relief After Episiotomy
Study type: Interventional

Summary: 
      Episiotomy is the commonest surgical procedure performed on parturient. It is usually
      associated with perineal pain which is particularly severe in the first 24 hours post repair.
      Perineal pain after episiorrhaphy if not adequately managed puts the woman into painful
      distress thus preventing good immediate post-partum care for the newborn. The aim is to
      compare the efficacy of single dose rectal diclofenac with oral diclofenac for the relief of
      perineal pain within 24 hours after episiotomy repair at Alex Ekwueme Federal University
      Teaching Hospital Abakaliki.
    

Detailed description: 
      Episiotomy is the commonest surgical procedure performed on parturient. It is usually
      associated with perineal pain which is particularly severe in the first 24 hours post repair.
      Perineal pain after episiorrhaphy if not adequately managed puts the woman into painful
      distress thus preventing good immediate post-partum care for the newborn.

      Aim: To compare the efficacy of single dose rectal diclofenac with oral diclofenac for the
      relief of perineal pain within 24 hours after episiotomy repair at Alex Ekwueme Federal
      University Teaching Hospital Abakaliki.

      Materials and Methods: This was a randomized controlled trial that involved 146 women that
      had episiorrhaphy between June and December 2020. The women were randomized into two groups
      of 73 women each using computer generated random numbers. One group received 100mg of
      diclofenac suppository stat while the other group received 2 doses of 50mg of oral diclofenac
      12 hours apart, both for 24 hours after episiorrhaphy. Pain was assessed at 1, 4, 8, 16 and
      24 hours post episiorraphy using a Visual Analogue Scale. Maternal satisfaction for the mode
      of the pain relief was assessed using the Likert scale after 24 hours. Data obtained was
      analyzed using Statistical Package for Social Science software version 25.

      The perineal pain was categorized into: no pain (0cm), mild (1-3cm), moderate (4-7cm) and
      severe (8-10cm), while maternal satisfaction was categorized into: Very satisfied, Satisfied,
      Neutral, Dissatisfied, Very dissatisfied. Categorical variables were summarized using
      frequencies and proportion. Quantitative variables were summarized with means and standard
      deviation. Student t-test was used for comparison between the group means for continuous
      variables while Chi-squared test was used to compare categorical variables. Statistical
      significance was obtained when p-value was ≤ 0.05.
    

Intervention name(s): Diclofenac
Intervention type(s): Drug
Intervention description(s): Each were monitored for pain within 24 hours
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Chinese Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety and tolerability of HFB30132A when it is
      given by single intravenous infusion in Chinese healthy participants.
    

Detailed description: 
      This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study in
      Chinese healthy volunteers.

      The study will comprise of:

        1. A Screening Period of up to 30 days (Day -30 through Day -1);

        2. A Treatment Period during which participants will be resident at the Observation Unit
           from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day
           1) until at least 48 hours (Day 3) after IMP administration. Participants will be
           discharged on Day 3 after all safety and/or pharmacokinetic (PK) evaluations have been
           completed, and

        3. A Follow up Period lasting 270 days after the IMP dose.
    

Intervention name(s): HFB30132A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 will receive HFB30132A dose 2.; Participants randomized to placebo will receive the same volume of solution as participants on active treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 2
Condition: Healthy
Study type: Interventional

Summary: 
      Flavanols are plant-derived compounds commonly present in the human diet. Examples of
      flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,
      pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been
      associated with improvements in cardiovascular health. In this study, the investigators hope
      to learn more about the effects of long term consumptions of cocoa flavanols on blood
      pressure, platelet function and other metabolic parameters in healthy humans. This study is a
      continuation of a previous study investigating the consumptions of increasing amounts of
      cocoa flavanols on blood pressure, platelet function and other metabolic parameters in
      healthy humans
    


Intervention name(s): Control Capsules; Mars Cocoa Extract Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cocoa-based, flavanol-free, control-matched capsules consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).; Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 500 mg of cocoa flavanols per capsule consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Flavanols; Cocoa flavanols; Blood pressure; Platelet Function
Study of CM310 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.
    


Intervention name(s): CM310; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): CM310 injection; subcutaneous injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol will compare 24 hour glucose control for subject taking saxagliptin and
      metformin extended release (XR) versus metformin XR alone
    


Intervention name(s): Saxagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 5mg, once daily, 4 weeks; Tablets, Oral, 0 mg, once daily, 4 weeks
Other intervention name(s): BMS-477118
Intervention MeSH terms: Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Comparison of the VBM Intubating Laryngeal Tube and the I-Gel
Condition: Airway Management
Study type: Interventional

Summary: 
      A study comparing two second generation supraglottic Airway devices, the VBM intubating
      laryngeal tube and the I-Gel.
    

Detailed description: 
      This is a study comparing the use of a newer generation laryngeal mask to the 2nd generation
      widely used at present. The company responsible for the manufacture of this product is VBM
      Medizintechnik GmBH, Germany. The recent difficult airway society guidelines recommend the
      use of these newer generation devices and this has been the incentive to conduct this
      project. These newer generation supraglottic devices have an additional feature which is an
      extension of the mask with a balloon that sits in the oesophagus. The trial is investigating
      ease of placement of these devices, ventilatory pressures, leak pressure and ease of
      intubation through the VBM device compared to I-Gel. The position of the supraglottic device
      on insertion and the position of the endotracheal tube will be confirmed with a fibrescope. A
      follow up will take place on the same day and after 24 hours for symptoms of a sore throat
      postoperatively.
    

Intervention name(s): VBM Intubating Laryngeal Tube; I-Gel
Intervention type(s): Device; Device
Intervention description(s): The position of the VBM Intubating Laryngeal Tube will be assessed using a fibreoptic scope following balloon inflation of the cuff. Seal pressure will be assessed with the presence of the inflated cuff. Endotracheal intubation through the intubating laryngeal tube with a size 7 VBM reinforced tube will be assessed using a fiberoptic scope.; The position of the I-Gel will be assessed using a fibreoptic scope. The seal pressure will be assessed with the specified design of the I-Gel in the absence of a cuff. Endotracheal intubation through the I-Gel with a size 7 reinforced endotracheal tube will be assessed using a fiberoptic scope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Supraglottic device; Fibre optic scope; Endotracheal intubation
Efficacy and Safety In Poorly Controlled Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to gain safety and efficacy information in patients with type 2
      diabetes, who have not previously taken any oral antidiabetic medications, and who have an
      HbA1c value of greater than or equal to 10%, despite diet and exercise.
    


Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 diabetes drug-naive
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central
      Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal
      cord, providing communication between the brain and the arms and legs. In people with MS, the
      fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates,
      causing nerve impulses to be slowed or stopped. As a result patients with MS may experience
      periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of
      coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the
      ability to think and/or remember. These periods of illness may come (exacerbations) and go
      (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases
      the ability of the nerve to conduct electrical impulses. This study will evaluate the effects
      of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the
      effects on muscle strength and spasticity. The study will also examine the possible risks of
      taking Fampridine-SR.
    


Intervention name(s): Placebo; 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP); 15 mg fampridine-SR (4-aminopyridine, 4-AP); 20 mg fampridine-SR (4-aminopyridine, 4-AP)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo for 15 weeks; 2 week up titration (10 mg)
12 weeks stable dose (10 mg)
1 week down titration (10 mg); 10 mg twice daily for 1 week
15 mg twice daily for 14 weeks
2 week up titration (10 mg x 1 week, 15 mg x 1 week)
12 weeks stable dose (15 mg)
1 week down titration (10 mg); 2 week up titration (10 mg x 1 week, 15 mg x 1 week)
12 weeks stable dose (20 mg)
1 week down titration (15 mg x 3 days, 10 mg x 4 days)
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Walking Ability; Muscle strength; Spasticity
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Condition: Lymphatic Disease; HIV Infections
MeSH terms: Lymphadenopathy; Lymphatic Diseases
Study type: Interventional

Summary: 
      The objective of this Phase III, randomized, double-blind, placebo-controlled study in
      patients with immunologic deficiency is to determine the effect of isoprinosine in producing
      an immuno-restorative response within the study observation period (including the 2-month
      period following cessation of the 28 days of treatment), measured by one or more of the
      following immunologic parameters:

        -  Increase in natural killer (NK) cell activity.

        -  Increase in total T-cells (OKT-11).

        -  Increases in absolute number and percentages of T-helper cells (OKT-4).
    


Intervention name(s): Inosine pranobex
Intervention type(s): Drug
Intervention MeSH terms: Inosine Pranobex
Masking: Double
Primary purpose: Treatment
Keywords: T-Lymphocytes; Immune Tolerance; Inosine Pranobex; Killer Cells; T-Lymphocytes, Helper-Inducer; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
A Computerised Test for Assessing the Early Reading Skills
Condition: Learning Disorders
MeSH terms: Learning Disabilities
Study type: Interventional

Summary: 
      This study was to develop a computerised test with an adapted peripheral to assess the
      emerging literacy knowledge of children with mobility difficulties. The software was
      implemented using a game-like design controllable by a peripheral device without needing fine
      movements.
    

Detailed description: 
      Conventional tests for assessing the early reading skills of preschool children on school
      entry are not accessible to children with mobility limitations. This paper presents a
      game-like computerised test featuring an appealing scenario that is accessible to these
      children. It was developed on a platform that creates 2D vector graphics and contains three
      phases of interactive content accessible through an adapted peripheral. Conventional tests
      were also used to validate the effectiveness of the game. The two types of tests had the same
      degree of predictive power when completed by thirty three preschool children without mobility
      impairment.
    

Intervention name(s): synthetic test; computerised test
Intervention type(s): Other; Other
Intervention description(s): The children performed the synthetic test with no time restriction.; The children performed the computerised test with no time restriction.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: early reading skills
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet
      and Joins tablet in the treatment of osteoarthritis of the knee.
    


Intervention name(s): LAYLA tablet; JOINS tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet twice a day; 1 tablet at each time, 3 times a day
Other intervention name(s): LAYLA 405.4mg; JOINS 200mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LAYLA; Non-inferiority; 100mm pain VAS