bioihbjkbjnl/mcl2 huggingface dataset:
Barrett's Esophagus in Olmsted County
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      To compare participation rates in screening for Barrett's Esophagus (BE) using sedated
      esophagogastroduodenoscopy (EGD), unsedated transnasal endoscopy and capsule endoscopy in a
      population based cohort. An age and gender stratified random sample of 300 patients from a
      previously defined (in terms of the presence or absence of symptoms of gastroesophageal
      reflux using a validated questionnaire) population based cohort from Olmsted County11, 12
      using the Rochester Epidemiology Project (REP), who have not undergone endoscopy, will be
      randomized to undergo screening using capsule endoscopy OR transnasal endoscopy OR
      conventional sedated endoscopy. The investigators will compare participation rates in the
      three arms.

      To identify factors associated with non-participation in population screening for BE. The
      investigators will compare demographic and clinical factors in participants and
      non-participants, to help predict non-participation using data from prior surveys (data has
      been collected on patient demographics, bowel and reflux symptoms, employment, education,
      somatization behavior, psychological profiles using the validated Gastroesophageal Reflux
      questionnaire [GERQ] and the Bowel Disease Questionnaire [BDQ]) which have been completed by
      all targeted subjects. This preliminary will allow us to identify barriers to screening and
      develop interventions to increase participation in future larger studies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Olmsted county residents
      
Biospecimen description: 
      Gastric, GE junction and esophagus tissue samples collected.
    
Keywords: probability of patient participation in each of the Groups 1, 2 and 3.; Identification of factors predicting poor participation in screening for Barrett's esophagus.
Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Sargramostim Administered Subcutaneously, Intravenously, or by Inhalation
Condition: Drug Kinetics; Drug Effects on Physiology
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, single ascending dose (SAD) and repeat dose study in healthy adults
      comprises 2 parts. Part 1 will consist of 6 SAD cohorts, in which different dose levels of
      sargramostim will be given by intravenous (IV) infusion, subcutaneous (SC) injection, or
      inhalation (IH) administration. Part 2 will consist of 1 repeat dose cohort in which
      sargramostim will begiven by SC administration.

      Blood samples for PK assessment will be collected before and over 24 hours after each study
      drug administration. Blood samples for PD assessment will be collected before and up to 14
      days after drug administration in Part 1, as well as before the first and up to 14 days after
      the second drug administration in Part 2. Safety and tolerability will be assessed throughout
      the study. For Cohort 5 of Part 1 only, 3 subjects will provide a CSF sample for PK assessmen
      tonce after SC drug administration.
    


Intervention name(s): sargramostim
Intervention type(s): Biological
Intervention description(s): Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
Other intervention name(s): Leukine®; rhu-GM-CSF
Intervention MeSH terms: Sargramostim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is assess the efficacy and safety of single and multiple
      applications of the FS-67 patch in the treatment of ankle sprain in pediatric population
      (ages 13-17).
    

Detailed description: 
      A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and
      Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
    

Intervention name(s): FS-67 Patch; Placebo Patch
Intervention type(s): Drug; Other
Intervention description(s): One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days); One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Other intervention name(s): Topical Patch; Sham treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ankle Sprain
Study of the Safety and Immunogenicity of H1N1 Vaccine
Condition: H1N1 Flu
Study type: Interventional
Phase: Phase 1

Summary: 
      The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1
      Vaccine In Healthy Adults
    

Detailed description: 
      This is a single center, placebo-controlled, single blinded dose escalation study to
      preliminarily assess the safety, reactogenicity, and immunogenicity of different HAC1 vaccine
      formulations. This study will assess a novel HAC1 vaccine, which is plant derived. This
      vaccine will be compared to Placebo of normal (0.9%) saline, and reference vaccine consisting
      of an approved monovalent vaccine containing an A/California (H1N1)-like strain.

      Subjects will receive 2 intramuscular injections of the experimental vaccine, placebo, or
      reference vaccine on Study Days 0 and 21
    

Intervention name(s): HAC1 Vaccine
Intervention type(s): Biological
Intervention description(s): Subjects will come to the Clinical Trials Center up to 7 days prior to each vaccine dose to have blood drawn for research assays. The first dose of vaccine will be given on Day 0 and the second dose will be given 21 days later (± 3 days). Dose escalation will be staggered by at least 7 days as shown in Figure 1. Subjects from Groups G and H will be vaccinated with each of the other 6 groups. Two subjects from group A will be immunized on study day -1. The immunizations will be performed one hour apart with close monitoring. The remaining eight subjects from Group A will be immunized on study day 0. All subsequent immunizations for each group will occur on the same day. The principal investigator and the medical monitor will review all adverse events and make a determination on whether it is safe to proceed to the next higher dosage group. The control and reference vaccine groups can be vaccinated starting anytime after screening.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HAC1, H1N1
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen
Condition: Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen
MeSH terms: Rhinitis; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to assess the clinical efficacy of a modified allergen extract
      of Olea europaea pollen in the treatment of patients affected by allergic
      rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to
      olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the
      medication.
    

Detailed description: 
      Immunotherapy is a specific treatment for allergic diseases. Unlike conventional
      pharmacological treatment, immunotherapy is the only treatment that could modify the natural
      course of allergic disease. This is a prospective double-blind placebo-controlled study with
      two arms of treatment: placebo and active.
    

Intervention name(s): Immunotherapy with modified extract of Olea europaea pollen; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.; Placebo for subcutaneous monthly administration
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Immunotherapy; Allergoid; Depigmented; Polymerized; Allergen-extract; Rhinoconjunctivitis
Age Gender Left Ventricular Mass and Cardiac Troponin T
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose of this study is to determine the influence of functional or anatomic cardiac
      parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals.
    

Detailed description: 
      We sought to investigate the relative contribution of functional or anatomic parameters as
      assessed by cardiac magnetic resonance tomography (cMRI, 1.5 Tesla), and clinical variables
      including increasing age and gender on high sensitivity cTnT (TnThs) levels in healthy
      individuals. Therefore we measured TnThs in serum samples of 120 healthy volunteers aged
      between 20 and 70 years. All individuals underwent cMRI including stress testing using
      dobutamine or adenosine.TnThs concentrations were related to cMRI and clinical findings.
      Partial correlation, as well as linear and hierarchical regression analyses were used to
      identify independent predictors and their relative contribution for prediction of TnThs
      values.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        residents of Heidelberg and urban hinterland
      
Keywords: Age Gender left ventricular mass high sensitive Troponin T
A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects (0000-108)(COMPLETED)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics
      of [13C3,4]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of
      Reverse Cholesterol Transport (RCT) measurements. The study will determine whether atom
      percent enrichment (% APE) at 18 hours can be extrapolated from the steady-state value and
      whether the mean difference in repeat Ra measurements is below is a prespecified level.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited for the study
      
Biospecimen description: 
      Plasma
Pharmacokinetics of NRL972 in Patients With Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-Alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of
      steatohepatitis using fatty liver disease as the comparator group. In addition, the
      sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared
      to results from the standard laboratory tests, elastography, tests of metabolic markers and
      serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD
      patients. Patients will be included if they have clinical evidence of fatty liver disease and
      have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood
      tests and scans of the liver.
    


Intervention name(s): NRL972
Intervention type(s): Drug
Intervention description(s): Single dose of 2 mg NRL972 administered intravenously. Total volume 5mL.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Stomach Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is
      rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric
      ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients
      receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or
      Naprosyn® 500mg (an approved treatment for OA).
    

Detailed description: 
      This is a double-blind, double-dummy, active-comparator study of LT-NS001 versus Naprosyn®
      for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for
      ongoing NSAID therapy. The percentage of patients with a gastric ulcer by endoscopy (EGD) at
      week 12 will be compared. EGD is performed at screening and months 1, 2, and 3. Secondary
      objectives include assessment of pain in the affected knee by WOMAC questionnaire to
      demonstrate non-inferior pain control using LT-NS001 as compared to Naprosyn®. Information
      about gastrointestinal pain and tolerability will be collected.

      The length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week
      treatment period and a 4 week post treatment monitoring period.
    

Intervention name(s): LT-NS001; Naprosyn®
Intervention type(s): Drug; Drug
Intervention description(s): 1200 mg b.i.d. p.o. for 12 weeks; 500 mg b.i.d. p.o. for 12 weeks
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: LT-NS001; Gastric Ulcers; NSAID; Osteoarthritis; Naproxen
Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children
Condition: Demyelinating Disease
MeSH terms: Demyelinating Diseases
Study type: Observational

Summary: 
      The neural circuits in our brains require a layer of insulation in order to transmit signals
      in a rapid and efficient fashion. This insulation is called White Matter and is comprised of
      a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs
      following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and
      cognitive problems. Currently there are no effective medical therapies to promote brain
      repair and reduce disability following damage to white matter. In this project, we hope to
      change the situation by encouraging the brain itself to generate new oligodendrocytes and
      thus new white matter. Our first step is to find measures sensitive to white matter growth.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        There will be a total of 80 participants in this study. The study population consists of
        both patients (demyelinating disease) and non-patient participants (healthy volunteers).
Pharmacokinetic Evaluation of Testosterone Gel (1%)
Condition: Primary or Secondary Hypogonadism; Constitutional Delay in Growth and Puberty (CDGP)
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      Measure and evaluate the level of testosterone in blood, and determine the safety and
      tolerability following daily applications of testosterone gel. Subjects who complete this
      trial may participate in the extension part (UMD-01-080E).
    


Intervention name(s): Testosterone Gel (1%)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypogonadism
Translating Neuroscience to Population Health
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The current study will examine the relationship between brain responses and a guided imagery
      exercise in overweight and obese individuals. Results of this work are highly relevant to
      public health because they employ neuroimaging methods to understand food decision-making.
      Findings from this study will inform health decision making and holds great potential for
      future translation across multiple health behaviors and scalable interventions to impact
      population health
    

Detailed description: 
      Negative health behaviors (e.g. overeating, smoking) are associated with increased negative
      health outcomes. Engaging in healthy behaviors is not always rewarding (e.g. carrot vs.
      cake). Neural models of healthy behaviors focus on the balance between reward and regulation
      brain regions. The current pilot application examines the engagement of these regions during
      the evaluation of food and nonfood cues before and after a guided imagery exercise targeting
      positive associations with food and regulation.

      The long-term goal is to understand the interaction between positive associations with
      healthy foods and thinking about future rewards may influence healthy decision-making. The
      objective of the current study is to empirically test the combined effects of positive affect
      and positive episodic future thinking on brain activation.
    

Intervention name(s): Guided Imagery
Intervention type(s): Behavioral
Intervention description(s): The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves.
Intervention model: Single Group Assignment
Intervention model description: Participants will be assigned to a guided imagery exercise
Masking: None (Open Label)
Primary purpose: Basic Science
Bioequivalence of Two Formulations of Meropenem Intravenous Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two
      formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion
      in healthy volunteers.
    


Intervention name(s): Meropem; Mepem
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: volunteers
A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess whether an opioid antagonist has any impact on the release of a strong painkiller
      in the blood when it is given to healthy volunteers when they have eaten and also when they
      have fasted.
    

Detailed description: 
      This is an exploratory study to assess the influence of an opioid antagonist on the
      pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.

      Determination is by measurement of drug concentrations in the blood at serial collection time
      points pre-dose until 32 hours post-dose, following an administration of a single oral dose.
      Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.
    

Intervention name(s): 4 mg 12 hourly capsule - strong pain killer fasted; 4 mg 12 hourly capsule - strong pain killer fed; 12 hourly capsule strong painkiller with antagonist fasted); 4 mg 12 hourly capsule strong painkiller with antagonist fed
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): MR2XXX; MR2XXX; MR2XXX; MR2XXX
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteer; Pharmacokinetics
Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and
      numerous negative health consequences including depression. Advanced Medical Electronics, in
      partnership with researchers are the University of Pennsylvania, propose developing an
      innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for
      the treatment of insomnia.
    

Detailed description: 
      Open-label pilot study in 20 older adults with insomnia (sleep onset latency>30 minutes for
      at least 3 nights a week) with a two week intervention period.
    

Intervention name(s): MBAT
Intervention type(s): Behavioral
Intervention description(s): Breathing-based intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      In Spain, palbociclib was launched last November 1st, 2017. However, since February 2015 the
      on-going compassionate use programme of palbociclib has enabled drug access to patients with
      RH+/HER2- breast cancer previously treated with at least 4 treatment lines for advanced
      disease. During this period, approximately 400 patients have received treatment within this
      programme. Since this population of patients more pre-treated was not included in the studies
      for regulatory submission, the collection of efficacy and toxicity data in the clinical
      practice setting is of clinical interest.
    


Intervention name(s): Palbociclib
Intervention type(s): Drug
Intervention description(s): Palbociclib administration in breast cancer patients included in a compassionate use programme. Patients were treated according to the standard of care
Intervention MeSH terms: Palbociclib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with metastatic breast cancer included in a compassionate use programme