bioihbjkbjnl/mcl2 huggingface dataset:
Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma
Condition: Adult Brain Tumor
MeSH terms: Astrocytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit
      to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may
      prove beneficial in the treatment of adults with anaplastic astrocytoma.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with anaplastic astrocytoma.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in adults with anaplastic
           astrocytoma as measured by an objective response to therapy (complete response, partial
           response) or stable disease.

        -  To determine the safety and tolerance of Antineoplaston therapy in adults with
           anaplastic astrocytoma.

      OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma
      receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal +
      Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12
      months in the absence of disease progression or unacceptable toxicity. After 12 months,
      patients with a complete or partial response or with stable disease may continue treatment.

      To determine objective response, tumor size is measured utilizing MRI scans, which are
      performed every 8 weeks for the first two years, every 3 months for the third and fourth
      years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult anaplastic astrocytoma
Covid-19 Pandemic and Use of Video Laryngoscopy
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a highly contagious
      infection with the highest viral load in the upper respiratory secretions. Despite using
      personal protective equipment, SARS-CoV-2 contamination to the healthcare personnel is
      possible during the airway management of infected patients. Direct laryngoscopy remains as
      the most common method for endotracheal intubation. Our study aimed to compare the use of
      video laryngoscopy with direct laryngoscopy for tracheal intubation in adult patients
      receiving general anesthesia for elective surgery during the COVID-19 pandemic.
    


Intervention name(s): Videolaryngoscope; Macintosh Laryngoscope
Intervention type(s): Device; Device
Intervention description(s): C-MAC PM-Karl Storz; Laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Vitamin D Enriched Meat Project (Acute Study)
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The importance of achieving an adequate vitamin D status is widely recognised, with public
      health and research communities heightening their interest over recent years.

      Whilst vitamin D can be synthesised following skin exposure to UV light, due to public health
      concerns regarding sun safety, and modern indoor lifestyles, it has become evident that
      endogenous synthesis may not be an effective means of maintaining an adequate vitamin D
      status across the year. Given the marked variation in seasonally-induced cutaneous synthesis,
      habitually low dietary vitamin D intakes of 2-4µg/day typically reported within nationally
      represented population surveys, and the generally low uptake of supplementation at the
      population level, it is warranted to identify alternative food-based strategies to yield
      greater adherence to the 10µg DRV, particularly during winter months where sunlight exposure
      is negligible. Commodity-based biofortification may provide an innovative and viable
      additional food-based approach to suboptimal vitamin D status, in combination with safe sun
      exposure, inclusion of natural and fortified dietary sources and/or supplementation.

      Meat naturally contains vitamin D3 and 25(OH)D3, yet by manipulating feeding regimes and/ or
      housing environments, it is possible to improve the concentration of both metabolites in
      animal products. Eggs, beef and pork provide viable opportunities for the enhancement of
      vitamin D3 and 25(OH)D3 which contribute to an increase in total vitamin D activity (vitamin
      D3 + [25(OH)D3 x 5]), and therefore would be expected to positively impact vitamin D status.
      Albeit whilst much biofortification research has been established, less is known regarding
      its effectiveness at raising circulating serum 25(OH)D concentrations amongst apparently
      healthy adults, with the exception of some plant-based foods.

      Therefore, an opportunity exists to understand the bioavailability of vitamin D-enriched pork
      and vitamin D-enriched chicken to increase 25(OH)D concentration.
    


Intervention name(s): Pork arm; Chicken arm
Intervention type(s): Other; Other
Intervention description(s): The effect of 1 portion of vitamin D-enriched pork on 25(OH)D concentration in comparison to a vitamin D supplement and control pork.; The effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vitamin D; Pork; Chicken; Bioavailability; 25 hydroxyvitamin D; Adults; RCT; Crossover
Empirical Mode Decomposition in the Electroencephalogram
Condition: Depth of Anesthesia
Study type: Observational

Summary: 
      Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious
      level, is a noninvasive medical technique for monitoring and recording the electrical
      activity of brain.
    

Detailed description: 
      The electroencephalogram and BIS data have lots of information. Fourier transformation to
      decompose EEG was first applied on the EEG signaling until now. The disadvantages of Fourier
      transformation is hard to deal with physical signals, which was modulated by autonomic system
      and factors. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into
      intrinsic mode functions (IMF) since 2004. HHT can obtain instantaneous frequency data and
      work well for data that is nonstationary and nonlinear. HHT have been applied for wild
      ranges, not only in the analysis of arrhythmia for medical and public health fields, but also
      in the earthquake detection and earth physics detection…etc.

      The relationship between frontal EEG patterns and general anesthesia remain poorly
      understood. It can only say that the increase in frontal EEG power and shift power to lower
      frequencies during general anesthesia from publications. The investigators are going to
      compare the EEG signal between generations, try to find the difference in aging using
      empirical mode decomposition method.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        20-40y/o patients or over 60y/o patients without severe systemic disease who were scheduled
        for general anesthesia.
Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.
Condition: Smoking
Study type: Interventional

Summary: 
      The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating
      System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels
      of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents
      (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).
    


Intervention name(s): Tobacco Heating System (THS 2.2); Smoking abstinence (SA); Conventional cigarette (CC)
Intervention type(s): Other; Other; Other
Intervention description(s): THS 2.2 ad libitum for 5 days in confinement; SA for 5 days in confinement; Subject's own preferred brand of CC ad libitum for 5 days in confinement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Smoking; Candidate Modified Risk Tobacco Product; Conventional cigarettes; Reduced exposure; Confinement
Short-term Effect of Intensive Insulin Therapy on Incretin Secretion
Condition: Type 2 Diabetes
Study type: Observational

Summary: 
      In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is
      observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced
      by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients.
      Various parameters such as the duration of diabetes, the amount of meal and their
      constitution, gastric bypass surgery, and some antidiabetic drugs affect the secretion of
      incretin. However, the secretion of GLP-1 and GIP in glucotoxic condition and whether they
      recover after improvement of glycemic status is not known. The investigators aim to study the
      effect of intensive insulin treatment in uncontrolled diabetic patients.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Subjects with normal glucose tolerance

          2. Early diabetic patients with disease duration of less than 5years

          3. Uncontrolled diabetic patients
      
Biospecimen description: 
      plasma serum
    
Keywords: incretin; GLP-1; GIP; intensive insulin therapy
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the superior efficacy of quetiapine
      extended release(XR) mono-therapy, administered once daily compared to placebo, in the
      treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder
    


Intervention name(s): Quetiapine Fumarate (SEROQUEL) Extended Release; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.; Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar Depression; Mental disease,
Improvement in Pain and Function Following a Physiotherapy Program in Older Adults With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study evaluates the combination of a therapeutic exercise program and dry needling in
      the treatment of knee osteoarthritis in older adults. Half of participants will receive
      therapeutic exercise program and dry needling in combination, while the other half will
      receive the same therapeutic exercise program and sham dry needling.
    

Detailed description: 
      Therapeutic exercise and dry needling each relieve pain and improve function, but they are
      different treatment tools.

      Therapeutic exercise takes a multitude of forms and results in numerous systemic and local
      effects, some of which have been investigate among people with knee osteoarthritis.
      Therapeutic exercise covers a range of targeted physical activities that directly aim to
      improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One
      of the main aims of this therapeutic approach is to improve muscle strength, given that
      weakness is common in knee osteoarthritis. Enhanced strength of the lower limb may lessen
      internal knee forces, reduce pain and improve physical function.

      Primary knee osteoarthritis provokes pain and disfunction is thought mediated by joint damage
      and changes in joint homeostasis. Recently, investigations focused in impaired neuromuscular
      system as a contribution to the above mentioned symptoms in the knee osteoarthritis syndrome
      explore the use of dry needling. Dry needling is a therapeutic approach for decreasing pain
      and improve function with high recommended evidence (grade A) effectiveness for upper-quarter
      myofascial pain, but poorly understood in knee osteoarthritis patients.
    

Intervention name(s): Therapeutic exercise; Dry needling; Sham dry needling
Intervention type(s): Other; Device; Device
Intervention description(s): 20-25 minutes aerobic exercise, 20-25 minutes strength exercise and 10-15 minutes stretch exercise.; Dry needling needle AGUPUNT®; Sham dry needling DONGBANG-ACUPRIME®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stiffness; Pain; Disfunction
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
Condition: RSV Bronchiolitis
MeSH terms: Bronchiolitis; Respiratory Sounds
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical
      effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial
      Virus (RSV) bronchiolitis.

      HYPOTHESES

      In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo)
      will result in:

        1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum
           and nasal wash measured on day 8 after randomization.

        2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks
           3-52 following randomization.
    


Intervention name(s): Azithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Improving Cognitive Health in COVID-19 Survivors
Condition: Cognitive Dysfunction; Covid19
MeSH terms: COVID-19; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate the efficacy of AKL-T01, a
      remotely-delivered digital cognitive intervention, relative to a waitlist control in
      improving cognitive functioning in COVID-19 survivors.
    

Detailed description: 
      Emerging evidence suggests a subgroup of survivors of COVID- 19 have residual difficulties
      with cognition and daily functioning. These deficits are pronounced in cognitive domains
      including attention, learning and executive skills, and may continue to impact quality of
      life after recovery from other COVID-19 symptoms. This study aims to investigate the efficacy
      of AKL-T01 (Akili Interactive), a remotely-delivered digital cognitive intervention, in
      targeting and improving cognition and functional outcomes in individuals recovering from
      COVID-19. The efficacy of the AKL-T01 intervention will be measured relative to a waitlist
      control group.
    

Intervention name(s): AKL-T01
Intervention type(s): Device
Intervention description(s): AKL-T01 will be administered as a 6-week intervention. It is an algorithmically delivered iPad-based video game designed to improve cognitive health by targeting attention and attentional control processes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized clinical trial designed to compare efficacy of the AKL-T01 intervention relative to a waitlist control in patients who were infected with COVID-19. Participants will be randomized to the AKL-T01 or a waitlist control. We will use a waitlist design; at the end of the intervention period, participants in the control group will have the option to receive the 6-week AKL-T01 intervention.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Covid19; Cognitive Dysfunction; Attention Disturbances; Cognitive Change
Evaluation of the Effectiveness of Vaccination With 2009 H1N1 Vaccines During Influenza Season 2010-11
Condition: Influenza Caused by the 2009 H1N1 Influenza Virus
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1
      vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the
      first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.
    

Detailed description: 
      In the beginning of the study, changes in the background information collected in the
      original study (conducted 2009-2010) are asked with a questionnaire. Information on influenza
      vaccinations is collected with vaccination cards and monthly short message service (SMS), and
      verified in registers, if needed. If an epidemic caused by the 2009 H1N1 virus starts in
      Finland, the participants are asked to actively report symptoms of influenza like illnesses
      (ILI). The symptoms are also monitored by weekly SMS. In case of ILI, nasal and oral swabs
      are collected to verify the 2009 H1N1 influenza cases. Paired serum samples are collected at
      the acute on convalescence phase of the disease. The occurrence of laboratory-confirmed 2009
      H1N1 influenza cases is compared between vaccinated and not (yet) vaccinated persons.
    

Intervention name(s): Follow-up; Follow-up
Intervention type(s): Other; Other
Intervention description(s): Questionnaires, interviews, nasal/oral and serum samples, register data; Questionnaires, interviews, nasal/oral and serum samples, register data
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participation in the study will be offered to all participants of the cohort study
        "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort
        study" AH1N1-483-09THL, who still live in the study area (city of Tampere) and who have
        complied to the SMS or phone follow-up. The eligibility criteria of the original study
        AH1N1-483-09THL were: full legal competence; community-dwelling; age 18 to 75 years,
        written informed consent obtained; able to communicate fluently in Finnish or Swedish and
        able to adhere to all protocol required study procedures without any special burden or
        risk. Originally, 3500 persons participated in the study
      
Biospecimen description: 
      nasal/oral swabs, serum samples
    
Keywords: 2009 H1N1 influenza; vaccination; pandemic; effectiveness
A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

        -  To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA
           during the first two years of life the percentage of subjects with an anti-HBs antibody
           titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10
           µg .

      Secondary objectives:

        -  Additional immunogenicity assessments

        -  Standard safety assessment.
    


Intervention name(s): HBVaxPRO® 5 µg / 0.5 mL; Engerix B® 10 µg / 0.5 mL
Intervention type(s): Biological; Biological
Intervention description(s): 5 µg / 0.5 mL; 10 µg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1 study is to evaluate the pharmacokinetics (PK), metabolism, routes and extent of
      elimination of a single oral dose of 400 mg [14C]LX4211 to healthy male subjects
    


Intervention name(s): [14C]-LX4211
Intervention type(s): Drug
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment