bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC
      Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in
      Korean healthy adults.

      The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV)
      including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B).
      However, two antigenically distinct lineages of influenza B (Victoria and Yamagata)
      co-circulate annually in the United States. Predicting which lineage of influenza B will
      predominate during a season is challenging, and cross-protection by immunization against the
      other lineage is expected to be low. One proposed alternative is to produce a quadrivalent
      influenza vaccine (QIV) including an influenza B virus from each of the two circulating
      lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4
      vaccine components WHO recommends for use in the 2013-14 influenza season (northern
      hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the
      additional public health benefit compared with traditional TIV.
    

Detailed description: 
      This study is the first in human trial of GC3110A and is designed as an adaptive Phase I/IIa
      to ensure participants protection. Part A is an open-label and single arm study in 9 healthy
      volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited
      adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days
      after vaccination. Part B is a randomized (2:1), double-blind, active controlled study and a
      total of 75 volunteers will participate in this part. Adverse events assessment will be done
      according to the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled
      in Preventive Vaccine Clinical Trials'.
    

Intervention name(s): Quadrivalent influenza vaccine; Trivalent influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): GC3110A, 0.5ml, intramuscular, a single dosing at Day 1; GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
Other intervention name(s): GC3110A; GC Flu Pre-filled Syringe Inj.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: QIV; Quadrivalent Influenza Vaccine; Influenza vaccine; Vaccination
Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and serum concentrations
      of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple
      doses and routes to healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and serum concentrations of a human
      monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and
      routes to healthy, HIV-uninfected adults.

      Participants will be randomly assigned to one of six groups. Participants in Group 1 will
      receive 2.5 mg/kg of VRC07-523LS by intravenous (IV) infusion at Weeks 0, 16, 32, 48, and 64.
      Participants in Group 2 will receive 5 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16,
      32, 48, and 64. Participants in Group 3 will receive 20 mg/kg of VRC07-523LS by IV infusion
      at Weeks 0, 16, 32, 48, and 64. Participants in Group 4 will receive 2.5 mg/kg of VRC07-523LS
      by subcutaneous (SC) injection at Weeks 0, 16, 32, 48, and 64. Participants in Group 5 will
      receive 5 mg/kg of VRC07-523LS by SC injection at Weeks 0, 16, 32, 48, and 64. Participants
      in Group 6 will receive 2.5 mg/kg of VRC07-523LS or placebo by intramuscular (IM) injection
      at Weeks 0, 16, 32, 48, and 64.

      Participants will attend numerous study visits throughout the course of the study, beginning
      at Week 0 through Week 112. Visits may include physical examinations, blood and urine
      collection, HIV testing, risk reduction counseling, and questionnaires.
    

Intervention name(s): VRC07-523LS; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in; Sodium Chloride for Injection USP, 0.9%; administered by IM injection
Other intervention name(s): VRC-HIVMAB075-00-AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Pilot Open Label Clinical Trial to Evaluate the Combined Impact of Two Mobile Health Products on Health Outcomes in Overweight Adults With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient
      Cloud (a mobile application for capturing data directly from subjects, enabling entry of
      diary and quality of life data into internet-enabled devices) in combination with an activity
      tracker (Fitbit Flex) on health outcomes in overweight people with Type 2 Diabetes.
    


Intervention name(s): lifestyle modification instructional and motivational sessions
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain?
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo
      Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive
      the correct application of the method described. The placebo group will receive a medical
      adhesive tape. The control group will not receive any form of intervention.
    

Detailed description: 
      The group Kinesio taping receive the correct application of the method described with tension
      paper off (10-15%). The placebo group will receive a medical adhesive tape. The control group
      will not receive any form of intervention.
    

Intervention name(s): Kinesio Taping
Intervention type(s): Other
Intervention description(s): Kinesio taping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the lumbar spine.
Other intervention name(s): -Bandages; -Tape; -Taping; -Kinesio Tex; -Kinesio Tape; -Kinesiotape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: low back pain; kinesio taping
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This four-period, single-center, open-label, single-dose, randomized, cross-over study will
      assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a
      Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four
      sequences in which they will receive the treatment under fed and under fasted conditions.
    


Intervention name(s): ribavirin [Copegus]; ribavirin [Copegus]; ribavirin [Copegus]; ribavirin [Copegus]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablet under fed condition; tablet under fasted condition; oral solution under fed condition; oral solution under fasted condition
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this study is to efficiently evaluate the clinical efficacy and
      safety of different investigational therapeutics among adults who have COVID-19 but are not
      yet sick enough to require hospitalization. The overall hypothesis is that through an
      adaptive trial design, potential effective therapies (single and combination) may be
      identified for this group of patients.

      COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol
      designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding
      (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the
      platform, every investigational product will collect data for both Domain primary endpoints.
      Individual treatments to be evaluated in the platform will be described in separate
      sub-protocols.
    

Detailed description: 
      The platform study allows investigational products with objectives either: evaluating viral
      shedding (Virology Domain); and COVID-19 related Clinical Outcomes (Clinical Domain).

      The primary objective for investigational products within the Viral Domain is:

      A. To evaluate the efficacy of each therapeutic intervention in addition to standard
      supportive care (SSC) compared with SSC in reducing viral shedding of SARS-CoV-2 virus in
      outpatients with COVID-19 disease.

      The primary objective for investigational products within for the Clinical Domain is:

      B. To evaluate the efficacy of each therapeutic intervention in addition to SSC as compared
      to SSC in improving sustained clinical outcomes in outpatients with COVID-19 disease.

      Secondary objectives are:

        1. The objective of the non-assigned domain an investigational product is under.

             1. If under Clinical Domain, reduction in viral shedding.

             2. If under Viral Domain, time to resolution of symptoms.

        2. To evaluate the efficacy of each therapeutic intervention in reducing SARS-CoV-2 related
           hospitalizations, ED visits, or death in outpatients with COVID-19 disease.

        3. To assess the development of antibodies against SARS-CoV-2

        4. To evaluate the safety and tolerability of each therapeutic intervention compared with
           placebo (supportive care).
    

Intervention name(s): Acebilustat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg capsule administered orally once daily; Placebo to match acebilustat administered orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Outpatient
Effects of Nutraperf Consumption in Runners
Condition: Nutrition Processes
Study type: Interventional

Summary: 
      Exercise has numerous health benefits. Nevertheless, when exercise duration is ~45 min or
      longer and intensity moderate to intense, it may induce different troubles, for example:
      hypoglycemia, peripheral and central fatigue, muscle damages, osteoarticular injuries,
      inflammation, cardiovascular dysfunctions. Nutritional loading during exercise may prevent
      and and/or reduce some of these troubles.

      In regard of recent data, we proposed a novel energy drink (NUTRAPERF®) to limit deleterious
      effects of long time exercise in neutral environment (outside temperature between 4 and 25°C)
      and to improve performance. If performance may be increased by this energy drink during long
      time exercise, we proposed that it consumption may also improve performance in short and
      sub-maximal exercise.

      So, the purpose of this study is to investigate the effects of the consumption of this novel
      energy drink on performance during long and short time exercise. Moreover, we studied the
      effects of this consumption on different metabolic parameters (heart rate, oxygen
      consumption, respiratory quotient, ventilation, glycemia, lactatemia), on central and
      peripheral fatigue and on cognitive parameters.
    


Intervention name(s): Carbohydrate drink
Intervention type(s): Dietary Supplement
Intervention description(s): Maltodextrins, dextrose, fructose, amino acids (leucine, isoleucine, valine), natural flavors, sodium chloride, magnesium citrate, zinc, lactate, acid: malic acid, anti-caking agent: silicon dioxide; Curcumin (turmeric extract) , Thickener: xanthan gum, caffeine, vitamin C (Acerola extract), vitamin E - B1 - B2 - B3; piperine (black pepper extract).
Other intervention name(s): NUTRAPERF
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: energy drink; exercise; BCAA; peripheral and central fatigue
Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes
Condition: Branched-chain Amino Acid Metabolism; Insulin Sensitivity
MeSH terms: Insulin Resistance; Prediabetic State; Hypersensitivity
Study type: Interventional

Summary: 
      Elevated circulating levels of certain amino acids (the building blocks of protein) are
      strongly associated with insulin resistance. This study will investigate the metabolism of
      these amino acids in individuals with normal glucose metabolism compared to overweight or
      obese pre-diabetic individuals. The purpose of this study is to determine how elevated levels
      of the branched-chain amino acids may contribute to the development of insulin resistance and
      ultimately diabetes. An additional purpose is to determine whether exercise or gastric bypass
      (GBP) surgery intervention can correct aberrations in branched-chain amino acid metabolism as
      insulin sensitivity improves. This information will be used to further our understanding of
      the development of insulin resistance and type 2 diabetes in at-risk populations and
      potentially improve clinical treatment of such conditions.
    


Intervention name(s): Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training; GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Branched-chain Amino Acids; Insulin Sensitivity; Exercise; Leucine
Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension
Condition: Menopause
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I pharmacokinetic study

      Main objective:

      To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone
      on each of the formulations studied, after multiple-dose administration

      Study design:

      Randomized, controlled, open-label, parallel, pharmacokinetic study

      Sites: 1

      Subjects: 30 postmenopausal women
    

Detailed description: 
      Sites: 1

      Phase: 1

      Main objective:

      To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone
      on each of the formulations studied, after multiple-dose administration.

      Secondary objectives:

      To determine bioavailability of each of the formulations studied, after
      multiple-dose-administration. Describe tolerability of each of the formulations studied,
      after multiple-dose administration.

      Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study

      Investigational Products:

        -  Estradiol and progesterone microspheres aqueous suspension (1 mg/20 mg)

        -  Estradiol and progesterone microspheres aqueous suspension (0.5 mg/15 mg)

      Study subjects: 30 postmenopausal women 45 - 65 years old

      Brief description: After written informed consent, 30 eligible women will be randomized to
      study treatments (one IM injection each 28 days, for a total of 4 doses). Blood samples will
      be obtained for pharmacokinetic study.
    

Intervention name(s): Estradiol + Progesterone; Estradiol + Progesterone
Intervention type(s): Drug; Drug
Intervention description(s): Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.; Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Estrogen; Progesterone; Microspheres; Menopause; Pharmacokinetics
Integrative-omics of the Disordered COPD Small Airway Epithelium
Condition: Smoking; COPD
Study type: Observational

Summary: 
      We aim to use an integrated network systems approach to analyze certain existing small airway
      epithelium (SAE) omic data sets at the genetic, epigenetic (methylation), gene expression,
      microRNA and metabolomic levels, to develop an initial model of network connectivities and
      key network pressure points relevant to SAE biology in health and disease.
    

Detailed description: 
      Hypothesis: We hypothesize that the disordered differentiation of the SAE that characterizes
      COPD results from the complex interaction of cigarette smoke components with a hierarchy of
      genetic, epigenetic, gene expression and metabolomics network interactions as the BC
      differentiate into a mucociliary epithelium.

      Specific aim 1. Using an integrated network systems approach to analyze our extensive
      existing SAE omic data sets at the genetic, epigenetic (methylation), gene expression,
      microRNA and metabolomics levels, to develop an initial model of network connectivities and
      key network pressure points relevant to SAE biology in health and disease.

      Specific aim 2. To refine the model, a comprehensive omics data set will be collected at
      multiple time points as SAE BC of nonsmokers and COPD smokers differentiate to normal and
      disordered mucociliary epithelium (respectively) on air-liquid interface (ALI) culture, an in
      vitro model of SAE differentiation. The computational strategies from aim 1 will be used to
      improve the model with these data.

      Specific aim 3. To test and finalize the integrated network model, a parallel omics data set
      will be generated from BC from nonsmokers, and COPD smokers as they differentiate on ALI
      under conditions where key hubs will be up- or down-regulated and the differentiation process
      stressed under conditions mimicking the in vivo SAE environment. The end result will be an
      integrated systems model of SAE biology and how this is disordered in COPD.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        New York Metropolitan Area residents
      
Keywords: Smoking; COPD; Non-Smokers; Smokers
Study to Assess the Effect of "Eucerin AtopiControl" on Dermal Symptoms in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis; Allergy Pollen
MeSH terms: Rhinitis, Allergic, Seasonal; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The objective of this study is to assess the effect of 'Eucerin AtopiControl LOTION' and
      'Eucerin AtopiControl facial cream' on dermal symptoms in patients with Atopic Dermatitis
      (AD) after two 4 h challenges with grass pollen on two consecutive days. In addition, this
      clinical study with exposure of Dactyls glomerate-sensitized Patients with AD shall be used
      to compare the skin response with AD Patients not-sensitized to Dactylis glomerata to
      understand the specificity of the grass pollen exposure.
    

Detailed description: 
      After the screening assessments the subject's whole skin will be treated for a period of 12
      days with either 'Eucerin AtopiControl LOTION' or 'Eucerin AtopiControl facial cream' or will
      receive no treatment until Day 1 of the study. All patients will be challenged for 4 hours on
      two consecutive days (Day1 and 2) with 4000 pollen grains/m³ of Dactylis glomerata pollen. In
      this study approximately 9 subjects will be placed in the Environmental Exposure Chamber
      (ECC) at a time. At screening a blood sample will be taken for determination mutations of
      genes encoding for skin barrier proteins (e.g. filaggrin mutation). At day 1 and day 5 blood
      samples (serum) will be taken for biomarker assessments and lymphocyte proliferation assays
      (peripheral blood). The severity of atopic dermatitis will be rated (blinded observer,
      trained dermatologist) applying the 'SCORing Atopic Dermatitis (SCORAD) index, the objective
      SCORAD, local SCORAD and Investigator Global assessment (IGA). Assessment of itch and
      sleeplessness referring to the past 24 hous will be done by a blinded observer on each day
      including baseline assessments.
    

Intervention name(s): 'Eucerin AtopiControl Lotion' (for the body); Allergen challenge chamber
Intervention type(s): Drug; Other
Intervention description(s): Treatment with Eucerin AtopiControl Lotion; Exposure to Dactylis glomerata pollen in an environmental challenge chamber
Other intervention name(s): 'Eucerin AtopiControl facial cream' (for the face); Two 4h-challenges with grass pollen on two consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The working hypothesis fo this study is, that local treatment with 'Eucerin AtopiControl Lotion' and 'Eucerin AtopiControl Gesichtscreme' compared to no treatment signifixantly reduces the increase of SCORAD that is elicited during challenge in an environmental challenge chamber (ECC) with grass pollen.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone
      and placebo.
    


Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: rosiglitazone; vandia; Type 2 diabetes mellitus; diabetes;