bioihbjkbjnl/mcl2 huggingface dataset:
A Phase IIa Repeat Dose AXP1275 vs Placebo Cross-over Trial With Pulmonary Allergen Challenge in Adults With Asthma
Condition: Atopic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is the first study in human patients with asthma that the sponsor is conducting in order
      to evaluate if there are signals that the investigational medication, AXP1275, may be a safe
      and effective treatment for asthma. The results of this study may help the sponsor to design
      additional studies.
    

Detailed description: 
      This 2-way, randomized, double-blind crossover study in subjects with mild to moderate atopic
      asthma is designed to compare the responses to allergen and methacholine challenges within
      the same subject after approximately 2 weeks of treatment with AXP1275 50 mg or placebo. A
      total of 20 subjects with asthma with a dual (early and late) asthmatic response to an
      inhaled aeroallergen will be randomized to 1 of 2 treatment sequences (placebo then AXP1275
      or AXP1275 then placebo) in a double-blind fashion to receive either oral AXP1275 or matching
      placebo, once-daily, for 14 days. The washout period between the 2 treatment periods will be
      14 to 21 days.

      A post-treatment follow-up visit will occur 14 ± 3 days after completion of the second
      treatment period.
    

Intervention name(s): AXP1275; AXP1275 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): AXP1275 50 mg (2 × 25-mg capsules); AXP1275 matching placebo (2 capsules)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma
A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Condition: Multiple Sclerosis; Walking Impairment
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and
      walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102
      in subjects with MS (ADS-AMT-301).
    

Detailed description: 
      This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules
      in subjects with MS and walking impairment who completed study drug treatment for 16 weeks
      and completed a Week 16 visit in Study ADS-AMT-MS301.

      All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the
      second week, and 274 mg for the remainder of the 52-week open-label treatment period.

      Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52.
      In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38.
      Subjects who withdrew from the study prior to completion of the Week 52 visit had an early
      termination (ET) visit that included safety and efficacy assessments. Subjects who completed
      52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and
      efficacy assessment at Week 54.

      All study visits and efficacy assessments were to be scheduled to occur at approximately the
      same time of day for each individual subject. Each subject's efficacy assessment was to be
      performed by the same clinical rater, if possible.
    

Intervention name(s): ADS-5102, 274 mg
Intervention type(s): Drug
Intervention description(s): Oral capsules
Other intervention name(s): amantadine extended release
Intervention MeSH terms: Amantadine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Examining the Effects of a Job Entry Intervention
Condition: Autism Spectrum Disorder; Autism; ASD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The current study will examine the efficacy of a virtual reality (VR) intervention as well as
      a newly developed Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE)
      with adolescents diagnosed with autism spectrum disorder.
    

Detailed description: 
      The current study will examine the efficacy of a virtual reality (VR) intervention entitled
      "IMPRoving Expression of Skills and Strengths In Interviewing in a Virtual Environment"
      (IMPRESSIVE) which targets social competency skills needed for successful job interviewing.
      Specifically, 2 VR tools are utilized in the IMPRESSIVE intervention. The first tool is
      VR-Job Interview Training, a VR program which offers the opportunity for repeated practice
      with a virtual human interviewer. Preliminary evidence suggests that the VRprogram is
      successful in adults with ASD and schizophrenia in improving interview abilities. However,
      the efficacy of it has not been evaluated in adolescents with ASD. This represents a
      significant void in our knowledge, as we do not know whether this program is effective for
      youth. In addition to VR training, a newly developed tool is included in the currently
      proposed intervention: the Kessler Foundation STRength IDentification and Expression tool
      (VR-STRIDE). KF-STRIDE is focused on improving the ability to express personal strengths
      during the job interview, a skill that is not taught with VR training. The proposed
      IMPRESSIVE intervention, which combines the learning of 2 critical abilities (social skills
      and strength identification), has never been examined in individuals with ASD. Thus, the
      current proposal will be the first to examine the efficacy of these 2 combined tools in this
      at-risk population.
    

Intervention name(s): VR-JIT/KF-STRIDE
Intervention type(s): Behavioral
Intervention description(s): Treatment group will receive 12 sessions of job interview training protocol.
Other intervention name(s): Virtual Interview Training for Transition Age Youth (VIT-TAY); Kessler Foundation STRength IDentification and Expression tool (KF-STRIDE)
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Virtual Reality Job Interview Training & character strength training (KF-STRIDE)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; ASD; Job reentry; Employment intervention; Virtual reality; VR
Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine immune system function following vaccination in
      HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior
      vaccination, patients in this study will receive booster shots of one of two pneumococcal
      vaccines, a hepatitis B vaccine, and a measles vaccine.
    

Detailed description: 
      With their immunocompromised status, HIV-infected children are at especially high risk for
      opportunistic infections, including infection by Streptococcus pneumoniae, hepatitis B, and
      measles. In PACTG P1024, HIV-infected children taking highly active antiretroviral therapy
      (HAART) received 2 doses of the pneumococcal conjugate vaccine (PCV), 1 dose of the
      pneumococcal polysaccharide vaccine (PPV), and booster shots of the hepatitis B vaccine (HBV)
      and measles, mumps, and rubella vaccine (MMR). Early responses to these vaccinations were
      favorable, but with declining antibody responses within the 18 months after vaccination. It
      is unknown if additional booster vaccinations in these children will result in a protective
      immunologic memory upon re-exposure to these pathogens. This study will determine whether
      HIV-infected children on HAART have evidence of specific immunologic memory 3 to 4 years
      after vaccination in PACTG P1024.

      Patients will be randomly assigned to receive PCV or PPV at study entry. All eligible
      patients will also receive HBV and MMR at study entry. Patients will be monitored in the
      clinic for 1 hour after vaccination for any adverse effects. Study staff will contact
      patients by phone around Day 3 after study entry to ask patients if they have experienced any
      adverse effects to the vaccinations; patients who received MMR at study entry will be
      contacted again around Day 21. Some patients may be asked to return to the clinic for further
      evaluation if they experience side effects.

      There will be study visits at study entry and Days 7 and 28. Medical history, a physical
      exam, blood collection, and an assessment of HIV-related symptoms will occur at all visits.
      HAART will not be provided by this study.
    

Intervention name(s): Pneumococcal 7-valent conjugate vaccine; Pneumococcal polysaccharide vaccine; Hepatitis B vaccine; Measles, mumps, and rubella virus vaccine, live
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL administered intramuscularly; 0.5 mL administered intramuscularly; 0.5 mL administered intramuscularly; 0.5 mL administered subcutaneously
Other intervention name(s): PCV; PPV; HBV; MMR
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaccination
Obesity, Physical Inactivity or Dietary Fat ?
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is the consequence of a chronic disequilibrium of fat balance. Genetic factors
      determine predisposition to obesity, but the most often mentioned idea is that environmental
      factors, such as a high-fat diet and a sedentary lifestyle, join to favour weight gain and
      explain the increased prevalence of obesity in our westernized societies. Since lipogenesis
      is negligible in humans, obesity represents the consequence of altered fat partitioning
      between oxidation and storage, likely due to a preferential directing of dietary fat towards
      adipose tissue and away from muscle. Interventions that favour partitioning of dietary fat
      towards muscle for oxidation might thus protect against weight gain. Exercise may be one kind
      of such intervention but the scant data on dietary fat metabolism does not allow clear
      conclusions, in particular in obese subjects. One question concerns the impact of the type of
      fat eaten: the effects of physical inactivity may vary according to the length and saturation
      degree of the fatty acids. We hypothesize that 1) physical activity of moderate intensity,
      independently of its effect on energy balance, will favor a preferential trafficking towards
      adipose tissue, will modify the expression of genes implicated in fat oxidation and storage
      and partly correct the abnormalities observed in obese subjects, 2) effects of physical
      activity vary according to the saturation degree of fat. Twelve obese subjects, aged 18 to
      55, will undergo tests before and after 2 months of training at current recommendations to
      ascertain dietary fat partitioning using stable isotopes and to determine changes in gene
      expression with muscle and adipose tissue microbiopsies.
    


Intervention name(s): Physical training
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Exercise; Fat oxidation; Overweigh (IMC>25 and IMC<30)
Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease
Condition: Ocular Surface Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Ocular surface disease is a common adverse effect of systemic isotretinoin therapy.

      The investigators consider that punctal plugs and Omega 3 is a good line for treatment of
      ocular surface disease associated with systemic isotretinoin therapy
    

Detailed description: 
      Subjective and objective evaluation of ocular surface disease was done at baseline ,1 and 3
      months of the study .
    

Intervention name(s): Omega 3; punctal plug
Intervention type(s): Drug; Device
Intervention description(s): daily intake of 250 mg; punctal plug will be inserted in inferior punctum
Other intervention name(s): docosahexaenoic acid; OASIS SOFT PLUG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Anti-snoring Bed
Condition: Snoring
MeSH terms: Snoring
Study type: Interventional

Summary: 
      Habitual snoring is a widespread complication. Most snorers snore predominately when sleeping
      in supine position. Therefore, therapeutic interventions force snorers to avoid supine
      position. Devices that restrict the sleeping position or raise alarms when the user obtains
      the supine position cause discomfort or disrupt sleep resulting in low compliance. Therefore,
      anti-snoring mechanisms, which lift the trunk of the user without disturbing sleep, have been
      proposed.

      We set out to investigate whether individual interventions provided by beds with lifting
      mechanisms are able to stop snoring within three minutes (success rate) and whether the bed
      reduces the snoring index (number of total snores divided by total time in bed). In addition,
      we investigat whether the trunk elevation provided by the bed is interfering with the
      subjective sleep quality assessed using the Groningen Sleep Quality Score.

      Subjects are observed for four nights (adaptation, baseline, and two intervention nights).
      During intervention nights, the bed lifts the trunk of the user in closed-loop manner.
      Subjects are divided in three groups (non-snorers, snorer group one, and snorer group two).
      Non-snorers are lifted by the bed at random time points during the night. In snorer group
      one, a stepwise increase of the bed inclination is compared with going directly to a randomly
      selected angle. In snorer group two, the influence of a small inclination angle (10°) and a
      big inclination angle (20°) is compared..
    


Intervention name(s): Anti-snoring bed
Intervention type(s): Device
Intervention description(s): The mattress shape is adjusted using a custom made intelligent anti-snoring bed, which is able to detect snoring sound and change the position of the user whenever snoring occurs.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Dietary Nitrate on the Oral Microbiome
Condition: Cardiovascular Health; Identify Oral Bacteria Responsible for Nitrate Reduction
Study type: Interventional

Summary: 
      This study evaluates whether dietary manipulation of the oral microbiota modulates
      cardiovascular health through effects on nitric oxide bioavailability.
    

Detailed description: 
      Nitric oxide is an important molecule for human health because it controls blood flow and
      blood pressure. With aging, our ability to make nitric oxide gets worse and our blood
      pressure tends to increase. We can help the body produce more nitric oxide by supplementing
      the diet with vegetables, such as beetroot juice, which contains high amounts of nitrate.
      This has been shown to improve blood flow and blood pressure. The bacteria inside our mouths
      play an important role in helping convert the ingested nitrate to nitric oxide. The reason
      for this study is to find out whether there are differences in oral bacteria between young
      and older adults, and how the oral bacterial community and blood flow and blood pressure
      might change when diet is supplemented with natural, nitrate-rich beetroot juice and when we
      use antibacterial mouthwash. This study will help us understand how the bacteria inside our
      mouths might be useful for keeping us healthy.
    

Intervention name(s): Nitrate-rich beetroot juice; Nitrate-depleted beetroot juice; Mouthwash
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): concentrated beetroot juice; concentrated beetroot juice; 2 x 10 mL antibacterial mouthwash per day for 14 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Cytokine Production and Immunity to Varicella Zoster Virus (VZV) in Elderly Recipients of Zoster Vaccine
Condition: Immunity; Defect Due to Antibody or Cell Mediated Immune Defect
MeSH terms: Herpes Zoster; Chickenpox
Study type: Observational

Summary: 
      After immunization, particularly in older persons, some people are protected from disease by
      a vaccine and others are not. The investigators believe that this variable response may be
      due to overproduction of molecules that suppress development of immunity (antibodies and cell
      mediated immunity). Normally, these molecules are produced to make sure that immunity is
      regulated in just the right way for the body as a whole, and to prevent autoimmune disease.

      However, with aging, the immune system may have difficulty in proper immune regulation. Over
      production of immunosuppressive molecules after vaccination may interfere with the effects of
      a vaccine. For example when elderly individuals are immunized against zoster with a licensed
      vaccine, Zostavax, the vaccine is effective in only about 50 to 60%. The investigators will
      compare blood levels of antibodies, cellular immunity, and immunosuppressive molecules in
      recipients of Zostavax to see if there is a correlation between development low immunity and
      high levels of immunosuppressive molecules.
    

Detailed description: 
      In order to determine whether there is a relationship between production of immunosuppressive
      cytokines (such as IL-10) an lower levels of immunity to Varicella Zoster Virus (VZV) after
      vaccination, the investigators will obtain blood samples before and 3-5 times after
      immunization to determine the immunity to VZV and the levels of certain cytokines. The first
      blood samples will be obtained before the vaccine is given, as baseline values.

      The vaccine being used is the licensed vaccine, Zostavax, which is recommended by the Food
      and Drug Administration (FDA) and Center for Disease Control and Prevention (CDC) to be
      administered to all relatively healthy individuals over the age of 50. This study does not
      concern vaccine safety or effectiveness. As a benefit to vaccines, the vaccine is
      administered at no charge to the subject.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Relatively healthy people over age 60 who have not had Zostavax previously.
      
Biospecimen description: 
      Blood samples
    
Keywords: immune response; varicella zoster virus (VZV); cytokine levels; immunization
Incretin Effect in PCOS Women
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS)
      before and after removal of their insulin resistance by metformin.

      The investigators' hypothesis is that insulin resistant women with PCOS have a reduced
      incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance
      test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be
      improved when their insulin resistance is removed.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin, 2x 2 tablets a day, 500 mg tablets; Placebo (to metformin)
Other intervention name(s): 657-24-9
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: incretin effect; PCOS; insulin resistance; OGTT; IIGI
Meal Timing and Blood Pressure
Condition: Blood Pressure; Neurovascular Control
Study type: Interventional

Summary: 
      Brain blood flow, blood pressure, and neurovascular control mechanisms will be measured in
      middle-aged adults before and after a brief intervention period. The intervention will
      consist of changing the time in which the participant consumes food each day.
    

Detailed description: 
      Healthy adults experience a 10-20% decrease in night-time blood pressure, compared with
      day-time blood pressure. However, 20-40% of middle-aged adults do not demonstrate a decrease
      in blood pressure. Abnormal blood pressure patterns are linked to sleep disturbances,
      hypertension, and associated with elevated cardiovascular risk and mortality. Additionally,
      abnormal diurnal blood pressure patterns are associated with impaired neurovascular control
      of the circulation, contributing to an increased risk of hypertension, stroke, and
      cardiovascular disease. Importantly, midlife is the critical period for implementing
      interventions to prevent or delay future cardiovascular disease. Recent data demonstrates
      that time-restricted feeding may normalize blood pressure patterns. The overall goal of this
      study is to determine if time-restricted feeding normalizes blood pressure patterns and
      improves neurovascular control.

      The research aims are:

        1. To determine the effect of meal timing on blood pressure patterns in middle-aged adults.

        2. To determine the effect of meal timing on neurovascular control in middle-aged adults.
    

Intervention name(s): Time-Restricted Feeding
Intervention type(s): Behavioral
Intervention description(s): After baseline measurements have been completed, participants will enroll in a time-restricted feeding intervention. Participants will be asked to restrict the time in which they eat each day to 10 hours, fasting for the remaining 14 hours. Participants will also be asked to finish their last meal of the day at least 2 hours prior to bedtime.
Intervention model: Single Group Assignment
Intervention model description: The interventional study model used will consist of a time-restricted feeding intervention.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Meal Timing; Blood Pressure; Time-Restricted Feeding; Sympathetic Nerve Activity
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety
      and performance during total anterior cruciate ligament (ACL) reconstruction.
    


Intervention name(s): SeriACL Device ACL Reconstruction
Intervention type(s): Device
Intervention description(s): Long-term Bioresorbable ACL Scaffold
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL; Ligament