bioihbjkbjnl/mcl2 huggingface dataset:
Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study
Condition: Influenza Virus Vaccine
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Some people experience symptoms just after receiving the seasonal inactivated influenza
      vaccine. The cause of some of these symptoms is likely to be an immune response to the
      vaccine. The investigators would like to look at the earliest immune responses to the
      inactivated influenza vaccine. This pilot study will help us to determine at what time points
      we should look.
    


Intervention name(s): Trivalent Inactivated Influenza vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 ml IM once only
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: influenza vaccine; cytokines; chemokines; symptoms
Bioequivalence Study of Aripiprazole in Healthy Adult Subjects Under Fasting Condition
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence
      of two different immediate release products each containing Aripiprazole 10 mg, after
      administering a single oral dose, to healthy adult subjects under fasting conditions.
    

Detailed description: 
      Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive
      a single dose of the test product (T) or the reference product (R) at each phase, under
      fasting conditions, with a wash-out period of 21 days.

      Aripiprazole plasma concentration was determined using a validated LC-MS-MS method, followed
      by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine
      the average bioequivalence.
    

Intervention name(s): Aripiprazole 10 mg tablet; Abilify® 10 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): an immediate-release tablet containing 10 mg Aripiprazole; an immediate-release tablet containing 10 mg Aripiprazole
Other intervention name(s): Test product (T); Reference product (R)
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Bioequivalence; Randomized; Crossover; Aripiprazole
Tideglusib vs. Placebo in the Treatment of Adolescents With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the safety and efficacy of tideglusib vs. placebo for the treatment
      of core symptom domains in adolescents with Autism Spectrum Disorders
    

Detailed description: 
      There are no pharmacologic treatments available for social function deficits in individuals
      with Autism Spectrum Disorders (ASD). The data for pharmacologic treatment of repetitive
      behaviours in this disorder has also become difficult to interpret given that the last two
      large multisite trials of selective serotonin re-uptake inhibitors (SSRIs) in autism are
      reported to be negative for the treatment of repetitive behaviours. Only the associated
      symptom of irritability has 2 drugs with Food and Drug Administration (FDA) indications,
      whereas no systematic data exists on the pharmacologic treatment of anxiety in ASD, and
      response rates to stimulants for hyperactivity are lower than what is seen in Attention
      Deficit Hyperactivity Disorder (ADHD). In addition, there are no biological markers of
      treatment response identified in this population at this point. This study will examine the
      potential efficacy and safety of tideglusib for core and associated symptom domains of
      autism, and will explore biological markers of safety and treatment response. As there is no
      juvenile toxicity published in the animal model, we will limit the age range to 12 years of
      age and older.
    

Intervention name(s): Tideglusib; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administered orally after dispersion in approximately 100 ml of water at dose levels of 400 to 1000 mg; Administered orally after dispersion in approximately 100 ml of water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASD; Autism
Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for
      14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™
      System including how to use the bolus calculator using manual entry of blood glucose values
      or by using the CGM-informed bolus calculator.
    

Detailed description: 
      The study schedule consists of two outpatient phases:

        1. 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry
           of BG values to deliver boluses (Phase 1) followed by;

        2. 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the
           CGM-informed bolus calculator to deliver boluses (Phase 2)

      Following subject screening, system training and enrollment, subjects will commence the first
      7-day Manual Mode phase of the study.

      Subjects will be trained to use the Manual Mode feature of the system including how to use
      the bolus calculator using manual entry of BG values or by using the CGM-informed bolus
      calculator.

      After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™
      without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase
      using the system with a connected CGM using the CGM-informed bolus calculator to deliver
      boluses.
    

Intervention name(s): Omnipod Horizon™ Automated Glucose Control System
Intervention type(s): Device
Intervention description(s): Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
Intervention model: Single Group Assignment
Intervention model description: This is a single-arm, multi-center, prospective clinical study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T1D; Omnipod
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either
      alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol
      (LDL-C).

      Secondary Objectives:

        -  To assess the pharmacodynamic profile of alirocumab administered either alone or on top
           of ezetimibe or fenofibrate, based on other lipid parameters.

        -  To assess the pharmacokinetic profile of alirocumab administered either alone or on top
           of ezetimibe or fenofibrate.
    

Detailed description: 
      Total duration of the study per subject (excluding screening) is about 22 weeks.
    

Intervention name(s): Alirocumab; Ezetimibe; Ezetimibe Placebo; Fenofibrate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: overencapsulated tablet
Route of administration: oral; Pharmaceutical form: capsule
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Other intervention name(s): SAR236553; REGN727
Intervention MeSH terms: Ezetimibe; Alirocumab; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the study is to determine the effects of low-dose oral theophylline
      added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid
      (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of
      exacerbations defined as increase of symptoms that requires a change of medication
      (antibiotics and/or systemic glucocorticoid) or hospitalisation.

      DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel,
      prospective study. Patient will be recruited during an hospitalisation due to COPD
      exacerbation and randomised at the time of discharge to receive theophylline 100 mg or
      placebo on top of combination therapy with inhaled corticosteroids and long-acting beta
      agonist. The rate of exacerbations will be determined every three months up to one year
      follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of
      them, the following information will be obtained:

        -  Number/severity of exacerbations or hospitalisation since last clinic visit

        -  Compliance and side effects

        -  Blood sample

        -  Plasma levels of theophylline

        -  Sputum (induced)

        -  MMRC

        -  SGRQ

        -  Forced spirometry + inspiratory capacity

           - At the beginning and at the end of the study

        -  6MWT

        -  BMI

        -  BODE
    


Intervention name(s): theophylline; placebo
Intervention type(s): Drug; Other
Intervention description(s): theophylline 100 mg, twice at day; Placebo
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD
Steady State Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate
      Tablets 300 mg.

      Study Design:

      Randomized, Two-Way, Crossover, multiple Dose, and Open-Label
    


Intervention name(s): Torrent's Quetiapine Fumarate Tablets
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric
      participants with moderate-to-severe plaque psoriasis.
    


Intervention name(s): Ixekizumab; Placebo; Etanercept
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Other intervention name(s): LY2439821
Intervention MeSH terms: Etanercept; Ixekizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: children; psoriasis treatment; adolescents
Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG)
      lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a
      two weeks treatment on top of metformin.
    


Intervention name(s): Vildagliptin; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): 50mg vildagliptin bid; 100mg sitagliptin po qd
Intervention MeSH terms: Sitagliptin Phosphate; Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus Type two; T2DM; vildagliptin; sitagliptin; FPG; DPP-4
Effect Of Obesity On Ozone-Induced Airway Inflammation
Condition: Obesity
MeSH terms: Obesity; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of ozone exposure on airway reactivity and
      inflammation in obese vs. non-obese adults.
    

Detailed description: 
      Obesity has been shown to be associated with initial onset of asthma in children and
      increased airway hyperresponsiveness in adults (1,2). An important aspect of these
      epidemiologic data is that the impact of obesity on asthma is much stronger in females than
      males. For example, the incidence of asthma after the age of 11 years is five- to sevenfold
      higher in female children who become obese versus those who remain lean, whereas no such
      relationship exists for males (3). Recent mouse models of obesity suggest that this condition
      enhances airway responses to ozone air pollution (4). These mice eat excessively due to a
      defect in the gene encoding leptin, a satiety hormone produced in adipocytes. Shore et al (4)
      showed that these leptin-deficient obese mice had greater airway hyperreactivity to i.v.
      methacholine following ozone exposure compared to lean, wild-type mice. Furthermore,
      administration of exogenous leptin (which is actually increased in the serum of obese
      individuals (4)) was shown to enhance ozone-induced cytokine and protein release into BAL
      fluid of lean, wild type mice (4). Reduced lung volumes and altered breathing patterns in the
      obese may also contribute to enhanced airway reactivity in these patients (5). Stretch of
      airway smooth muscle during tidal breathing and especially during deep breaths, i.e. sighs,
      acts as a potent bronchodilator that might ameliorate ozone-induced bronchoconstriction. The
      increased chest load associated with obesity may also diminish tidal breathing volumes and
      frequency of sighs during ozone exposure.
    

Intervention name(s): ozone, 0.4 ppm
Intervention type(s): Other
Intervention description(s): 2 hour ozone exposure, 0.40 ppm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ozone; clean air
Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
Condition: Environmental Enteric Dysfunction; Zinc Deficiency; Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Observational

Summary: 
      The overall objective is to determine the impact of EED on zinc absorption and homeostasis,
      and its impact on the absorptive capacity of vitamin A absorption of young children (18-24
      months of age) in an austere setting with high rates of diarrhea, stunting, and
      micro-nutrient deficiencies.
    

Detailed description: 
      Participating children are screened for EED using the lactulose:mannitol ratio test and
      assigned to one of two groups: +EED or -EED. All participants will be given standard,
      physiological dose of 3 mg zinc sulfate with a zinc stable isotope tracer on study day 8.

      On study day 11, 0.5 mg of 13C10-retinyl-acetate will be administered orally to all
      participants.

      Spot urine samples will be collected twice daily from study days 11-14. Complete fecal
      collections will be obtained for days 11-14. Duplicate diets of all foods consumed will be
      collected on days 11-14. On study day 14, a blood sample will be taken for analysis of
      vitamin A isotope status.
    

Intervention name(s): 3 mg zinc sulfate supplement; 0.5 mg of 13C10-retinyl-acetate
Intervention type(s): Drug; Drug
Other intervention name(s): Vitamin A isotope
Intervention MeSH terms: Vitamin A; Acetic Acid; Retinol acetate; Zinc Sulfate
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Toddlers aged 18-24 mos living in Dhaka, Bangladesh
      
Biospecimen description: 
      Spot urine samples x 4 days; complete fecal collections x 4 days; blood sample
    
Keywords: environmental enteric dysfunction; environmental enteropathy; zinc; vitamin A; Bangladesh
Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to
      the tumor.

      PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7)
      in treating patients with metastatic or unresectable solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of therapeutic angiotensin-(1-7) in patients with
           metastatic or unresectable solid tumors.

        -  Determine the pharmacokinetics of this drug in these patients.

      Secondary

        -  Determine tumor response in patients treated with this drug.

      OUTLINE: This is a dose-escalation study.

      Patients receive therapeutic angiotensin-(1-7) subcutaneously on days 1-5. Courses repeat
      every 21 days in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of therapeutic angiotensin-(1-7) until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first 3 weeks of
      study therapy. At least 6 patients are treated at the MTD.

      Blood samples are collected from patients after the first and fifth doses of the study drug
      for pharmacokinetic correlative studies.

      PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
    

Intervention name(s): therapeutic angiotensin-(1-7)
Intervention type(s): Biological
Intervention description(s): sequentially increasing doses 50-1000 mcg/kg
Intervention MeSH terms: Angiotensin I (1-7)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes
Condition: Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of bariatric surgery on blood sugar
      control and underlying mechanisms that contribute to type 2 diabetes in men and women with a
      BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y
      gastric bypass operation or intensive medical, dietary and exercise management.
    

Detailed description: 
      Obesity and type 2 diabetes mellitus (T2DM) are two of the greatest public health problems of
      the 21st century. Lifestyle changes and pharmacotherapy, which are mainstay treatments for
      T2DM have had limited success. More intensive lifestyle weight management such as in the Look
      AHEAD trial reported an 8.6% weight loss after 1 year, while the Diabetes Prevention Program
      reported a 7% weight loss after 2 years, and a 58% decrease in the risk of developing T2DM.
      In contrast,we have observed a 31% weight loss together with 83% remission of T2DM in
      severely obese patients after Roux-en-Y gastric bypass (RYGB) surgery. However, direct
      evidence of the glycemic benefits of bariatric surgery from randomized control trials is
      lacking; there is no clear consensus that RYGB surgery is a good treatment option for
      moderately obese T2DM patients; and the mechanisms responsible for reversing T2DM after
      surgery remain unclear but may involve pancreatic insulin secretion and skeletal muscle and
      hepatic insulin resistance.

      The objective of this application is to evaluate the effects of RYGB surgery on glycemic
      control and underlying mechanisms that contribute to T2DM in obese subjects (BMI: 30-40
      kg/m2). Our central hypothesis is that RYGB surgery will reduce hyperglycemia via reversal of
      beta-cell dysfunction and decrease hepatic and peripheral insulin resistance. The approach
      requires a 12-month randomized controlled trial. The rationale is based on data showing that
      RYGB lowers fasting and postprandial glucose, and increases the GLP-1 response to a meal.
      However, the therapeutic efficacy of RYGB surgery in obesity-related T2DM needs to be
      demonstrated in a randomized trial.
    

Intervention name(s): laparoscopic roux en y gastric bypass operation; medical management
Intervention type(s): Procedure; Other
Intervention description(s): roux en y gastric bypass operation; latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen
Other intervention name(s): bariatric surgery; meal replacement; exercise; group support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; type 2 diabetes
99mTc Labeled Anti-PD-L1 sdAb SPECT/CT in Assessment of PD-L1 Expression in NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To evaluate the safety, dosimetry and efficacy of 99m-Tc labeled anti-PD-L1 single domian
      antibody (sdAb) (Product Code Name: 99mTc-NM-01)SPECT/CT in the diagnostic imaging PD-L1
      expression in Non-Small Cell Lung Cancer (NSCLC) and compare it with the existing gold
      standard "biopsy PD-L1 detection". It is also to establish a new clinical method of
      non-invasive PD-L1 expression detection in NSCLC using 99m-Tc labeled anti-PD-L1 sdAb.
    


Intervention name(s): Injection of 99m-Tc-NM-01
Intervention type(s): Procedure
Intervention description(s): Patient is injected with micro-dose of 99m-Tc-NM-01
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic