bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects
Condition: Enterovirus Infections
MeSH terms: Enterovirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to evaluate the immune response and safety profiles of two
      injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg
      dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.
    


Intervention name(s): EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose); EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose); EV71 vaccine ([1 μg total protein ] per dose)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Two vaccinations at 28 days apart; Two vaccinations at 28 days apart; Two vaccinations at 28 days apart
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Foot-and-Mouth Disease; Vaccines; Hand, Foot and Mouth Disease; EV71 vaccine
Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment
      with rosiglitazone/metformin will safely and effectively control glycemia as first line oral
      therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate
      superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
    


Intervention name(s): rosiglitazone maleate/metformin hydrochloride
Intervention type(s): Drug
Intervention description(s): rosiglitazone maleate/metformin hydrochloride
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HbA1c; Drug-naive; type 2 diabetes
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
Condition: Group B Streptococcal Infection
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and
      immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus)
      vaccine in women living with HIV and women without HIV,and their newborn babies from
      vaccination up to delivery/birth. Mothers and babies will be followed up for 6 months
      post-delivery.
    

Detailed description: 
      100 women who are pregnant and living with HIV will randomly receive two 0.5 mL (millilitre)
      intramuscular injections of GBS-NN/NN2 vaccine (60 women) or placebo (15 women).

      100 women who are pregnant and do not have HIV will randomly receive two 0.5 mL intramuscular
      injections of GBS-NN/NN2 vaccine (60 women) or placebo (15 women).

      Participants will be screened at 24 to 28 weeks gestation (Days -14 to Day -1) and the groups
      will be dosed in parallel. The first dose of vaccine or placebo will be administered at Day 0
      and the second dose will be administered 28±2 days later. Delivery is anticipated to be
      approximately 10 to 14 weeks after the first dose of vaccine.

      For the analysis of the immune response, the placebo groups will be combined. For safety, the
      placebo groups will be analysed separately and will be combined for comparison with the
      potential vaccine groups.
    

Intervention name(s): GBS-NN/NN2; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): GBS-NN/NN2 bound to Alhydrogel as an adjuvant.; Normal Saline 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, placebo controlled, double-blind, parallel group, multicentre study.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and
      pseudoephedrine compared to placebo (medication with no active ingredients) in participants
      with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen,
      dust or animal hair).
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), single-dose, single-blind (a
      clinical trial in which the person giving the treatment, but not the participant, knows which
      treatment the participant is receiving), double-dummy, placebo-controlled, three-treatment
      period, cross-over (participants may receive different interventions sequentially during the
      trial) study of JNJ-39220675 in participants with allergic rhinitis. The duration of study
      will be 20-64 days per participant. The study consists of 2 parts: Screening (that is, 30
      days before study commences on Day 1) and Treatment (consists of single-dose of either
      JNJ-39220675 solution [10 milligram], Pseudoephedrine tablet [60 milligram] or Placebo, in
      subsequent three-treatment periods, each separated with washout period of 6 days). All the
      eligible participants will be randomly assigned to 1 of the 6 treatment sequences.
      Participants will be given dose approximately 2 hours before entry into the environmental
      exposure chamber where they will be exposed to ragweed pollen for 8 hours. Efficacy will
      primarily be evaluated by measurement of nasal congestion that will be assessed through nasal
      cavity geometry that is, minimal cross-sectional area of nasal cavity by Acoustic rhinometry.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Placebo; JNJ-39220675; Pseudoephedrine
Intervention type(s): Other; Drug; Drug
Intervention description(s): Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.; Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.; Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Intervention MeSH terms: Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Allergy; Rhinitis; Allergic Rhinitis; JNJ-39220675; Pseudoephedrine
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone
      hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone
      hydrochloride tablets.
    

Detailed description: 
      Bioequivalence based on FDA Criteria.
    

Intervention name(s): oxymorphone; Oxymorphone
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; 40 mg tablets
Other intervention name(s): Opana; Opana
Intervention MeSH terms: Oxymorphone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Medication Therapy Management Intervention on Treatment Outcomes and Medication Adherence Among Adult Patients Comorbid With Diabetes Mellitus and Hypertension at Outpatient Clinics
Condition: Diabetes Mellitus; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional

Summary: 
      The goal of this interventional study was to assess the impact of medication therapy
      management on treatment outcomes and medication adherence among adult patients comorbid with
      diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia. The patients
      attending hospitals assigned to interventional group received medication therapy management
      services in addition to usual care.
    

Detailed description: 
      This study aimed to assess the impact of medication therapy management intervention on
      treatment outcomes and medication adherence among patients comorbid with diabetes mellitus
      and hypertension at outpatient clinics in Southwest Ethiopia. A cluster randomized controlled
      trial was conducted at outpatient clinics of public hospitals in Southwest Ethiopia from
      March to December, 2022. Hospitals were randomly assigned to either the interventional or the
      control group. The patients attending hospitals assigned to interventional group received
      medication therapy management services in addition to usual care and those attended hospital
      assigned to control group received the usual care only. A systematic random sampling
      technique was used to select the study participants from each hospital. The differences in
      proportion between the groups was determined using the Pearson chi-square. The independent
      sample t-test was be done to compare means between groups and paired t-test was used to
      compare means in between intervention and controlled group. The p-value of < 0.05 was used as
      a cut-off point to declare statistical significance.
    

Intervention name(s): Medication Therapy Management
Intervention type(s): Other
Intervention description(s): The medication therapy management intervention was delivered via the five (5) core components which include medication therapy review, personal medication record, medication-related action plan, intervention, and documentation and follow-up. The interventions was also given via educating patients about diabetes, hypertension, complications of diabetes and hypertension, impact of having diabetes and hypertension, antidiabetes and antihypertensive medications, goals of therapy for diabetes and hypertension, health promoting behaviours (healthy diet, regular exercise, salt reduction, & smoking cessation), drug adherence, and self-monitoring of the diseases.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were two groups of study population.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Treatment outcomes; Medication adherence; Diabetes Mellitus and Hypertension; Southwest Ethiopia
A Study of Survival and Outcome After Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      The objective of this study is to determine the natural history of acute ischemic stroke from
      large vessel thromboembolism in the brain. The target population is a stroke cohort with a
      known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale
      (NIHSS) score >10 who are eligible for mechanical thrombectomy but without receiving the
      treatment. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled
      patients will be followed for 90 days after the index event.
    

Detailed description: 
      The objective of this observational study is to determine the natural history of acute
      ischemic stroke from large vessel thromboembolism in the brain. The target population is a
      stroke cohort with a known infarct volume who presents within 8 hours from symptom onset with
      a NIH Stroke Scale (NIHSS) score >10. Functional outcome as defined by the modified Rankin
      Scale (mRS) of all enrolled patients will be followed for 90 days after the index event. This
      is a prospective, single arm, multi-center trial. Up to 200 patients at up to 30 centers will
      be enrolled in the study. It is anticipated that up to 150 evaluable patients will be needed
      for analysis. The sample size estimate is based on the primary study functional outcome at 90
      days as defined by a mRS of 0-2. Assuming that this observational study will have as outcome
      of 25% (37/150) mRS 0-2 at day 90, the expected two-sided exact binomial confidence interval
      is (18%, 32%). This sample size is adequate to estimate the mRS outcome of 0-2 at day 90 for
      the natural history of acute ischemic stroke.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom
        onset and with an imaging-defined large cerebral vessel occlusion and a known infarct
        volume will be enrolled and followed for 90-days.
Effects of Exercise Training on Mechanoreflex and Metaboreflex Control in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The investigators hypothesize that exercise training would improve the mechanoreflex and
      metaboreflex control in heart failure patients.
    


Intervention name(s): Aerobic Exercise Training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant
      blind, investigator blind and sponsor open), placebo controlled study to investigate PK,
      safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous
      dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.
    


Intervention name(s): 450mg; 150mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): following a single subcutaneous dose of PF-06480605 450 mg; following a single subcutaneous dose of PF-06480605 150 mg; following a single subcutaneous dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: IBD; PK
Challenging the Inflammatory Response System in Insomnia Disorder
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      The main purpose of this study is to understand how insomnia (compared to good sleep) may
      affect the response of the body to a repeated physiological challenge, such as inserting the
      hand in ice-cold water for several times in a row. In particular, the investigators are
      interested in the response of markers that can be associated with stress, such as blood
      pressure and stress hormones.
    

Detailed description: 
      Sleep is critical for the regulation and maintenance of biological systems, and sleep
      deficiency, such as insomnia, has been shown to be associated with elevated risks for
      cardiovascular, metabolic, and mood disorders.

      Despite the high prevalence of insomnia in the population, the investigators understanding of
      the biological consequences of the disorder with respect to inflammatory, autonomic, and
      stress system markers is limited, and often not consistent.

      In addition, insomnia may not only alter the basal activity of these systems, but may change
      their reactivity to other stressors and challenges. In support of this assumption are
      findings showing that poor sleep quality in healthy individuals is associated with a stronger
      biological response to a stressful challenge, such as the cold pressor test. This test
      involves the immersion of the hand in ice-cold water. It is one of the most commonly used
      laboratory physiological challenge tests, provoking not only unpleasantness, but also
      increases in stress and inflammatory markers.

      Investigations of such system's reactivity to challenge may elucidate systems abnormalities
      that the investigators do not capture by only assessing basal system's levels. For example,
      in patients with rheumatoid arthritis, basal inflammatory levels are normal, but the response
      to a physiological stress challenge (cold pressor test) is amplified.

      To the investigators knowledge, no studies have measured how insomnia may affect the
      reactivity of biological systems to a stressful challenge, which may serve as an important
      indicator of system's dysregulation and associated disease risk.

      In this light, the primary goal of this proposal will investigate whether stress-related
      systems are more reactive to a physiological stressful challenge in insomnia disorder
      compared to healthy controls.
    

Intervention name(s): Cold Pressor Test
Intervention type(s): Behavioral
Intervention description(s): Repeated immersion of hand in ice-cold water
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  Individuals suffering from insomnia disorder

          -  Healthy control sleepers
      
Keywords: insomnia, inflammation, stress
Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      After a stroke, most patients have poor ankle control and difficulty walking. Considering
      that proper foot placement will provide a more balanced and controlled gait, the aim of this
      study was to investigate the immediate effect of non-elastic ankle taping providing eversion
      support on gait balance in stroke patients.
    

Detailed description: 
      The study included 30 stroke patients. Participants were randomly assigned to two groups:
      intervention group(n=15) and the control group(n=15). The control group received 45 min of
      conventional physiotherapy. The intervention group received 45 min of conventional
      physiotherapy after nonelastic taping, which provides eversion support. The gait balance of
      both groups was evaluated using the Dynamic Gait Index before and after treatment. . Pre- and
      post-intervention data were statistically analyzed and compared.
    

Intervention name(s): Nonelastic taping; Conservative physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Non-elastic taping was placed on the ankle of the affected side with a plaster band starting from the middle of the sole of the foot and extending from the lateral side of the foot to the level below the knee to provide eversion support.; The conventional physiotherapy programme included range of motion exercises, balance and gait training and neuromuscular electrical stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: balance; gait; immediate; stroke; taping
To Exam the Effects of Phyllanthus Niruri Extracts on Human Neutrophils
Condition: Neutrophil; Phyllanthus Abnormis Poisoning
MeSH terms: Poisoning
Study type: Observational

Summary: 
      To exam the effects of Phyllanthus niruri extracts(corilagin, phyllanthin and brevifolin) on
      human neutrophils
    

Detailed description: 
      Phyllanthus niruri extracts have anti-inflammatory effects in various cellular systems
      (monocytes, neutrophil). However, the underlying effects and mechanisms of Phyllanthus niruri
      extracts on neutrophils have not yet been investigated in detail.

      In this study, first we would like to systemic exam the effects of corilagin, phyllanthin and
      brevifolin, three major active components, on human neutrophils.

      Further to clarify whether Phyllanthus niruri extracts have any effect on neutrophils that
      may provide some insights on the ability of these compounds to modulate the innate immune
      response in acute organ injury.
    

Intervention name(s): venipuncture
Intervention type(s): Procedure
Intervention description(s): Plan to enroll 240 health people who are 20-35 years of age. People with received veinpuncture. Blood will be collected at time and drawn into Heparin-coated tube.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Voluntary healthy donor (20-35 years old) do not have coagulopathy, systemic infective
        disease and severe liver and renal function impairment.
      
Biospecimen description: 
      Seperation of human neutrophils were according to a standardized procedures and following
      steps: using 3%(w/v) dextran sedimentation for 30 min, then gradient centrifugation in
      Ficoll-Hypaque, and hypotonic lysis of erythrocytes. The purified neutrophils were determined
      by the Trypan blue exclusion method and need to contained >98% viable cells. Then they were
      suspended in without calcium ion HBSS buffer (pH 7.4), and stored at 4 °C for analysis
Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional

Summary: 
      The main purpose of this study is to compare artesunate-mefloquine combination therapy given
      for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum
      malaria.
    

Detailed description: 
      This will be a randomized, open-label comparison of two versus three days
      artesunate-mefloquine treatment in patients with uncomplicated falciparum malaria. Primary
      endpoints will be 63-day parasitological cure rates in the 2 treatment groups. Secondary
      endpoints will be parasitological failure rates at each of the weekly follow-up visits to Day
      56, occurence of treatment-emergent adverse events on days 0, 1 and 2, mefloquine blood
      concentrations on days 7, 14 and 28, and in vitro drug sensitivity profiles for parasite
      isolates as measured by inhibitory concentrations. Genotyping of parasites for known markers
      of drug resistence will be performed.
    

Intervention name(s): Artesunate; Artesunate; Mefloquine; Mefloquine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6 mg/kg/day for 2 days (total dose 12 mg/kg); 4 mg/kg/day for 3 days; 15mg/kg at T=0 and 10 mg/kg 6-24 hours later; 8 mg/kg daily for 3 days
Intervention MeSH terms: Artesunate; Mefloquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artesunate; Mefloquine; Plasmodium Falciparum; Thailand; Uncomplicated Plasmodium Falciparum malaria