bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
Condition: Premature Birth; Intermittent Hypoxiema
MeSH terms: Premature Birth; Bradycardia; Hypoxia
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show
      diurnal variations in vaccination response, due to circadian regulation of the immune system.
      The investigators plan to investigate whether preterm infants also show differences in
      hypoxia/bradycardia rate upon morning vs. evening vaccination.

      Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours
      after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6,
      interleukin-1β and C-reactive protein get determined. To control vaccination response,
      pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected
      age.
    

Detailed description: 
      Intervention: First hexavalent vaccination given to very preterm infants either in the
      evening or in the morning.

      Primary outcome: rate of desaturations (SpO2 <80%) and bradycardias (Pulse rate <100/min) in
      first 24 h following vaccination in evening vs. morning vaccination group Secondary outcomes:
      cytokine levels (IL 6, IL 1ß, CRP) measured 24 h after vaccination, pertussis- and
      haemophilus-titers as measured before and after vaccination, i.e. at 4 months corrected age,
      in evening vs. morning vaccination group
    

Intervention name(s): Infanrix + Prevenar 13
Intervention type(s): Biological
Intervention description(s): Different time of application
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
Condition: Renal Impairment; Healthy Volunteers
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of varying degrees of renal function on
      the PK of TAK-954 following single-dose IV administration and to investigate the impact of
      hemodialysis on the PK of single IV doses of TAK-954.
    

Detailed description: 
      The drug being tested in this study is called TAK-954. This study will evaluate the effect of
      varying degrees of renal function on the PK of TAK-954 following single-dose IV
      administration and to investigate the impact of hemodialysis on the PK of single IV doses of
      TAK-954.

      The study will enroll approximately up to 40 participants. Participants will be enrolled in
      one of the 5 treatment groups based on their renal impairment which will be determined based
      on Cockcroft and Gault (CG) equation as follows:

        -  Group A TAK-954 0.2 mg: Healthy Participants

        -  Group B TAK-954 0.2 mg: Mild Renal Impairment

        -  Group C TAK-954 0.2 mg: Moderate Renal Impairment

        -  Group D TAK-954 0.2 mg: Severe Renal Impairment or End-stage Renal Disease (ESRD)
           Without Hemodialysis

        -  Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) With Hemodialysis

      All participants in groups A to D will receive a single dose of TAK-954 and two single doses
      in Group E.

      Enrollment in Group B (Mild) and Group E (ESRD requiring dialysis) will be based on
      assessment of safety and available PK data from Group C and Group D respectively.

      This multi-center trial will be conducted in Czech Republic and Hungary. The overall time to
      participate in this study is approximately 8 weeks. Participants in Groups A to D will remain
      confined to clinic for 3 days. For both treatments, participants in Group E requiring
      dialysis will remain confined to clinic for 3 days. All participants will make a final visit
      to the clinic 10-14 days after receiving their last dose for a follow-up assessment.
    

Intervention name(s): TAK-954
Intervention type(s): Drug
Intervention description(s): TAK-954 intravenous infusion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Evaluate the Effectiveness of an Experimental Urethane Dimethacrylate Resin Based Dental Composite Material
Condition: Dental Caries; Restorative Material
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This double blind randomized controlled prospective clinical trial will compare the clinical
      success of two tooth colored resin composite dental filling materials - TPH3 (Dentsply Caulk)
      and an experimental urethane dimethacrylate resin based composite resin (Dentsply Caulk) for
      wear resistance, staining and marginal seal using modified Ryge criteria to evaluate the
      posterior restorations for 24 months in duration
    

Detailed description: 
      The purposes of this clinical trial is to evaluate two composite resins used to restore Class
      I and Class II cavities in teeth of adults. The clinical study will evaluate the resin
      composite restorations placed in Class I and Class II cavity preparations for anatomic form,
      color match, marginal integrity, marginal discoloration, proximal contact, polishability,
      caries, sensitivity, gingival index, staining,wear, and thermal response for 24 months..
    

Intervention name(s): urethane dimethacrylate; TPH3; Esthet-X HD
Intervention type(s): Device; Device; Device
Intervention description(s): Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent; light-cured resin composite for teeth; light cured resin composite for teeth made by Dentsply Caulk
Intervention MeSH terms: Urethane
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: restorative material
Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase IV, single site, randomized, open-label, parallel study comparing
      BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed
      with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
    

Detailed description: 
      This is a Phase IV, single site, randomized, open-label, 3 treatment group, parallel study
      comparing BYDUREON-BCiseTM plus FARXIGATM to BYDUREON-BCiseTM alone and FARXIGATM alone in
      patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.

      Patients who meet all inclusion and none of the exclusion criteria will enter a 1-week
      Lead-in Period, during which patients will be given a blood glucose meter and fitted with a
      blinded Continuous Glucose Monitor (CGM) and undergo a 14-day CGM assessment.

      After the 1-week Lead-in Period, approximately 60 subjects will be randomized at a 1:1:1
      ratio to one of three open-label treatment arms to achieve approximately 20 subjects per
      treatment arm.

      The study consists of a 2-week Screening Period, a 1-week Lead-in Period, a 14-week
      open-label Treatment Period and a 10-week Follow-up Period.
    

Intervention name(s): Exenatide 2 MG; Dapagliflozin 10 MG
Intervention type(s): Drug; Drug
Intervention description(s): Glucagon-like peptide-1 receptor; sodium-glucose co-transporter 2 (SGLT2) inhibitor
Other intervention name(s): Bydureon; Bydureon BCise; Byetta; Farxiga 10 MG
Intervention MeSH terms: Dapagliflozin; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TachoSil Paediatric Liver Trial (TC-019-IN)
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective is to assess the haemostatic efficacy and safety of TachoSil for
      control of local bleeding in paediatric patients undergoing surgical resection of the liver
      with our without segmental liver transplantation.
    


Intervention name(s): Fibrinogen human (TachoSil)
Intervention type(s): Drug
Intervention description(s): Resection of the liver with or without segmental liver transplantation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Surgical resection of the liver with or without segmental transplantation
Evaluation of an Oral Nutritional Supplement Containing AN777
Condition: Malnutrition; Sarcopenia
MeSH terms: Sarcopenia; Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of an experimental oral nutritional supplement containing AN777
      compared to another oral nutritional supplement in a malnourished, elderly population.
    


Intervention name(s): medical food with AN777; oral nutritional formula
Intervention type(s): Other; Other
Intervention description(s): Two(220 mL)servings every day for six months; Two (220 mL) servings daily for six months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical
      facilities. The objective of the study is to assess the efficacy and safety of Favipiravir
      compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19
      pneumonia.
    

Detailed description: 
      Upon signing the informed consent form and screening, 200 eligible patients with polymerase
      chain reaction (PCR) confirmed COVID-19 are randomized at a 1:1 ratio to receive either
      Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600
      mg), or SOC. The course of treatment by Favipiravir is 14 days.
    

Intervention name(s): Favipiravir; Standard of care
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg coated tablets; Drug: Standard of Care Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.
Other Name: Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc.
Other intervention name(s): AREPLIVIR
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Favipiravir; Areplivir; COVID-19; SARS-CoV-2; 2019-nCoV
Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs
Condition: Fracture; Rib, Multiple
MeSH terms: Fractures, Bone; Fractures, Multiple
Study type: Interventional

Summary: 
      To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block
      versus Thoracic Epidural in patients with multiple fracture ribs.
    

Detailed description: 
      Erector spinae plane (ESP) block is a recently described technique which may be an
      alternative to Paravertebral block (PVB) for providing thoracic analgesia. It involves
      injection of local anesthetic into the fascial plane deep to erector spinae muscle. ESP is a
      more superficial block with a better defined end-point injection between the bony transverse
      process and erector spinae muscle. A more superficial ultrasound-guided block will be faster
      to perform and less painful for the patient. ESP does not have the same risk of pneumothorax
      as PVB.

      Epidural analgesia has become the standard of care. Although thoracic epidurals provide
      excellent analgesia for the management of rib fractures, they are limited to a certain
      population due to patient factors and side-effects. Many trauma patients have other injuries
      which contraindicate the use of epidurals, or which prevent positioning for insertion. There
      are disadvantages to thoracic epidural analgesia. They are technically challenging to insert,
      with a risk of dural puncture or spinal cord injury. Adverse effects include hypotension, and
      if opioids used, urinary retention and pruritus. Patients can develop a motor block and are
      unable to mobilize with an epidural in situ.
    

Intervention name(s): Ultrasound; Bupivacaine HCl Inj 0.25%; Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution
Intervention type(s): Device; Drug; Drug
Intervention description(s): Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.; Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml; infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Super 13 Pro & Prebiotics on the Human Intestinal Microflora
Condition: Probiotics; Prebiotics
Study type: Interventional

Summary: 
      This study aim to investigate the roles of the test article in improving gastrointestinal
      functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly
      divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The
      subjects took the test article, "Super 13 Pro & Prebiotics" or the control article, "The
      placebo without Super 13 Pro & Prebiotics" during the 4-week drug-intake period. Fecal
      specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the
      bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and
      Coliform.
    

Detailed description: 
      This study aim to investigate the roles of the test article in improving gastrointestinal
      functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly
      divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The
      subjects took the test article, "Super 13 Pro & Prebiotics" or the control article, "The
      placebo without Super 13 Pro & Prebiotics" three times a day during the 4-week drug-intake
      period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for
      analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens,
      Lactobacillus spp., and Coliform.
    

Intervention name(s): Super 13 Pro & Prebiotics
Intervention type(s): Dietary Supplement
Intervention description(s): "Super 13 Pro & Prebiotics" was given three times a day for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro & Prebiotics" or the control article, "The placebo without Super 13 Pro & Prebiotics" during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prebiotics; Probiotics; Microbiota
Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia
Condition: Smoking Cessation; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the effectiveness of tropisetron plus risperidone in improving
      cognitive symptoms in Chinese people with schizophrenia.
    

Detailed description: 
      Schizophrenia is a chronic and disabling brain disorder. People with schizophrenia may
      experience hallucinations, delusions, disordered thinking, movement disorders, social
      withdrawal, and cognitive deficits. In considering the high rate of cigarette smoking among
      people with schizophrenia, it is also likely that they smoke. People with schizophrenia who
      smoke tend to experience improved cognition, and tobacco withdrawal has been associated with
      deterioration of cognition. This suggests that nicotine may improve cognitive deficits or
      medication side effects in people with schizophrenia.

      Auditory sensory gating, a neural mechanism thought to reflect sensory information processing
      and affect cognition, is diminished in people with schizophrenia. Auditory sensory gating has
      been associated with the 7 nicotinic acetylcholine receptor, a brain receptor that is
      important for cognition and can be activated by nicotine. Activation of this receptor using
      an agonist medication, such as tropisetron, may produce the same positive effect that
      nicotine has on cognition. This study will determine the effectiveness of using tropisetron
      as supplemental therapy to the atypical neuroleptic risperidone in people with schizophrenia.

      Participants in this 12-week double blind study will be randomly assigned to receive either
      tropisetron or placebo. All participants will also follow a 6-mg risperidone regimen. Study
      visits will occur every 2 weeks throughout the study and final outcome assessments will
      include cognitive functioning and treatment safety and effectiveness.
    

Intervention name(s): Tropisetron; Placebo; Risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg/day; placebo; 6mg/day
Other intervention name(s): Navoban; Risperdal, Ridal, Rispolept
Intervention MeSH terms: Tropisetron; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess AR101's safety, tolerability and efficacy over an
      extended dosing period.
    

Detailed description: 
      This study is enrolling participants by invitation only. This is an open-label,
      international, longer-term extension study for eligible subjects who have participated in one
      of the Aimmune AR101 clinical studies.
    

Intervention name(s): AR101
Intervention type(s): Biological
Intervention description(s): AR101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AR101; Characterized Peanut Allergen; OIT (oral immunotherapy); Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adults; Desensitization; CPNA (Characterized Peanut Allergen)
Study Determining the Frequency of Duchenne Muscular Dystrophy and Late-onset Pompe Disease
Condition: Duchenne Muscular Dystrophy; Pompe Disease (Late-onset)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Glycogen Storage Disease Type II
Study type: Observational [Patient Registry]

Summary: 
      This is a multicenter prospective non-drug screening study. The working period is 12 months.
      There is no research product to be followed or used in the study.

      Demographic data, medical and family histories of the patients included in the study will be
      collected at the first admission. The following laboratory values of the patients will be
      collected:

        -  Alanine Transaminase (ALT)

        -  Aspartate Transaminase (AST)

        -  Gamma Glutamyl Transferase (GGT)

        -  Creatine Phosphokinase (CPK)

        -  In addition, physical examination information and Abdominal USG and Liver Biopsy
           Results, if any, will be collected. Following the above scans, enzyme analysis for
           late-onset Pompe disease in boys and girls and adolescents with high CPK levels and
           molecular genetic tests for Duchenne muscular dystrophy in boys and adolescents with
           high CPK levels will be performed.
    


Intervention name(s): Laboratory Tests
Intervention type(s): Genetic
Intervention description(s): Acid Alpha IgGlucosidase alpha enzyme test for Late Onset Pompe Disease and gene sequencing test from the same sample in samples with low enzyme activity
Genetic Analysis for DMD (only in boys): Detection of dystrophin gene for duplication and deletion with MLPA (Multiplex-ligation dependent probe amplification) and re-screening for other mutations by gene sequencing in patients without MLPA deletion / duplication.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Boys and girls with unexplained transaminase elevation for at least 3 months
      
Biospecimen description: 
      -  Acid Alpha IgGlucosidase alpha enzyme test for Late Onset Pompe Disease and gene
           sequencing test from the same sample in samples with low enzyme activity

        -  Genetic Analysis for DMD (only in boys): Detection of dystrophin gene for duplication
           and deletion with MLPA (Multiplex-ligation dependent probe amplification) and
           re-screening for other mutations by gene sequencing in patients without MLPA deletion /
           duplication.
    
Keywords: CPK; Transaminase; DMD; Pompe
Characterization of the Inhibitory Effects of Fevipiprant (QAW039) on Activation of Eosinophils and ILC2 Cells by Prostaglandin D2 Metabolites
Condition: Atopic Asthma
Study type: Interventional

Summary: 
      The aim of this study is to draw blood from patients with well-defined atopic asthma that
      will be subsequently used in invitro experiments to investigate the activation potency of
      Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2. The
      inhibitory activity of a potent DP2 receptor antagonist, Fevipripant, shall be determined.
    

Detailed description: 
      The inhibitory activity of a potent DP2 receptor antagonist shall be determined. For these
      experiments eosinophil granulocytes and ILC2 cells will be isolated from the collected blood
      samples and used in specific assays in respect to their functional reactivity against the DP2
      receptor antagonist Fevipiprant after respective stimulation using Prostaglandin D2
      metabolites or Prostaglandin D2. Major rationale is to show and determine the EC70 of the
      effectivity of Fevipiprant against Prostaglandin D2 metabolite triggered activation of
      eosinophil granulocytes and ILC2 innate lymphoid cells.
    

Intervention name(s): Blood Sampling
Intervention type(s): Procedure
Intervention description(s): Blood samples used within in vitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science