bioihbjkbjnl/mcl2 huggingface dataset:
BDNF Levels After Bacopa
Condition: Memory
Study type: Interventional

Summary: 
      Brain-derived neurotrophic factor (BDNF) is a well-known neurotrophic factor important for
      learning, memory, and synaptogenesis. Healthy activities such as exercise are believed to
      raise BDNF, while stress is associated with lower BDNF. What is not well understood is if
      there are certain supplements that may raise BDNF over time. Bacopa monnieri is well
      characterized nutraceutical. Animal and pre-clinical data support multiple beneficial
      mechanisms, including raising BDNF and increasing synaptogenesis. Additionally, small studies
      have shown Bacopa enhances cognition and improves mood. We would like to investigate if BDNF
      level changes in people after starting Bacopa.
    

Detailed description: 
      This is a single site two-visit, 12-week, open label, trial to evaluate the safety,
      tolerability, and potential effects of Bacopa on BDNF, MoCA and GDS. Potentially eligible
      subjects will be invited to screening (Visit 1) at the study site. Subjects will sign an
      informed consent followed by collection of medical history and history of current
      medications, have their height, weight, vital signs (blood pressure, pulse, and temperature)
      measured, complete study assessments (MoCA , BDS and LEC) Routine clinical laboratory tests
      (hematology and chemistry) will be performed. Blood samples will be taken for analysis of
      BDNF and genetics (APOE, BDNF).

      Subjects will be instructed to orally self-administer the provided supplement (Bacopa)
      preferably with food with no dietary restrictions once a day in the morning.

      Subjects will be contacted by phone at 1 week (+/- 3 days) to be reminded to go to two pills
      per day, 1 month (+/-1 week) to check on compliance or any AE's and 2 months (+/- 1 week) to
      report any Adverse events for review by the Principal Investigator.

      Subjects will return to the study site for Visit 2 at the end of 12 weeks (+/- 1 week). Study
      staff will question subjects about any changes in the subject's health since the first visit.
      They will be asked about their exercise activity and if there have been any changes to their
      LEC-5. Subjects will have their weight and vital signs measured. Routine clinical laboratory
      tests (hematology and chemistry) will be performed, and blood samples will be saved for
      analysis of Bacopa and other biomarkers
    

Intervention name(s): Bacopa Monnieri
Intervention type(s): Dietary Supplement
Intervention description(s): subjects will take Bacopa Monnieri daily for 3 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Web-based Resource for Children and Adolescents About Clinical Research
Condition: Healthy; Chronic Illnesses, Multiple
MeSH terms: Chronic Disease; Multiple Chronic Conditions
Study type: Interventional

Summary: 
      The overall aims of this project are to: 1) create a developmentally appropriate interactive
      educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the
      feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.
    

Detailed description: 
      Youth (N=30) will be recruited to participate in the feasibility study. Parent permission and
      youth assent will be sought. Participants will be randomized into one of two study arms:
      intervention and wait-list control. All participants will complete a web-based pre-test
      questionnaire. Youth in the intervention group will then receive access to DigiKnowIt News:
      Teen for one week. Approximately one week after completing the pre-test questionnaire, all
      participants will complete a web-based post-test questionnaire (the post-test for youth in
      the intervention group will also include Consumer Satisfaction Questions). Youth in the
      wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After
      one week, they will complete a Consumer Satisfaction Questionnaire.
    

Intervention name(s): DigiKnowIt News: Teen
Intervention type(s): Behavioral
Intervention description(s): Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Bioavailability Study for New Atorvastatin Formulation
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to estimate the relative bioavailability of the commercial
      tablet with one prototype extemporaneous preparation suspension formulation, to assist with
      internal decision making on formulation development.
    

Detailed description: 
      Estimation of Relative Bioavailability
    

Intervention name(s): Atorvastatin suspension; Lipitor
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 80 mg Atorvastatin suspension; A single dose of 80 mg Lipitor tablet
Other intervention name(s): Atorvastatin
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cardiovascular Diseases
Influence of Bag Volume Variation on the Reproducibility of Inert Gas Rebreathing
Condition: Chronic Obstructive Pulmonary Disease; Bronchial Asthma; Restrictive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma
Study type: Observational

Summary: 
      Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising results
      in the determination of pulmonary blood flow (PBF). The volume of the rebreathing bag (Vbag)
      is proposed by the system, however, elderly patients or those suffering from high grade
      pulmonary diseases might be unable to entirely rebreathe this volume and therefore fail to
      completely mix the test gases. The aim of our study is to evaluate the effect of adapting
      Vbag on the reproducibility of IGR measurements in patients with obstruction (group A),
      restriction (group B) and pulmonary healthy controls (group C).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        inpatients and outpatients, internal medicine, university hospital
Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
Condition: Depression; Anxiety
MeSH terms: Rumination Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility and efficacy of real-time fMRI
      neurofeedback for rumination.
    

Detailed description: 
      Neuroimaging MRI techniques for measuring brain structure, tissue composition, and Blood
      Oxygenation Level Dependent functional Magnetic Resonance imaging (BOLD fMRI) will be used to
      measure task-dependent and task-independent brain hemodynamic and electrophysiological
      changes in human subjects with major depressive disorders (MDD).

      After being informed about the study and potential risks, all participants giving written
      informed consent will undergo one session of the cognitive process-based fMRI neurofeedback
      (CNF) targeting the rumination-related brain functional connectivity, and a one-week
      follow-up. Participants will be randomized in a double-blind manner (participant and
      investigator) in a 1:1 ratio to Active (receiving feedback from their own brain activity) or
      Sham (receiving artificially generated feedback).
    

Intervention name(s): Active neurofeedback; Sham neurofeedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.; The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to a cognitive process-based real-time fMRI neurofeedback (CNF) or a sham condition.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: neurofeedback; real-time fMRI; rumination
Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is intended to compare whether bone marrow aspirate concentrate or platelet rich
      plasma injections is more effective in treating knee osteoarthritis.
    

Detailed description: 
      While PRP shows promise in helping restore function to these patients, there are still
      concerns with PRP's long term outcomes. Another option that has become more popular for
      physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA),
      which use's undifferentiated cells found in the bone marrow to promote healing and tissue
      regeneration. These cells have the ability to replicate into a multiple different tissue
      types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and
      aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown
      the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage
      and bone grafts.

      Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative
      medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical
      efficacy platelet rich plasma has been documented to alleviate symptoms related to knee
      osteoarthritis. However, randomized, prospective comparison of the two techniques has not
      been reported in the literature and long term follow-up for both treatments is limited, and
      especially limited in the use of BMA for osteoarthritis treatment.
    

Intervention name(s): Pure PRP II; PureBMC
Intervention type(s): Combination Product; Combination Product
Intervention description(s): The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.; The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.
Other intervention name(s): GS60-PURE-II; BC60-PURE
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to either a PRP intervention group or the BMC intervention group. Knee pain and function outcomes of enrolled patients in the two groups will be compared to determine which treatment is more effective in treating knee osteoarthritis.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee; osteoarthritis; platelet rich plasma (PRP); bone marrow concentrate (BMC)
Evaluation of the Safety and Outcomes of Outpatient Management With Mild to Moderate COVID-19 Pneumonia
Condition: Covid19; Pneumonia
MeSH terms: COVID-19; Pneumonia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the strategy of investigators for outpatients
      SARS-CoV-2 moderate pneumonia management in terms of efficacy and patient safety. The
      investigators ultimate goal is to validate first wave management strategy in order to support
      the investigators future approach in the event of a second wave, and spare the hospital
      resources by safely keeping at home as many patients as possible.
    

Detailed description: 
      The investigators focused on participants consulting in the emergency department at the HUG
      who remained in an outpatient setting, with pneumonia and moderate illness, defined by
      individuals who have evidence of lower respiratory disease by clinical assessment or imaging
      and a saturation of oxygen (SaO2) >93% on room air and no other hospitalization criteria
      (CURB 65 score below 2points).

      For patients' follow-up, the investigators have created an aftercare ambulatory unit, open
      5/7 days. The investigators were able to conduct 64 consultations between April 2 and May 5,
      2020. Every participant had suspected or confirmed SARS-CoV-2 pulmonary tract infection.

      The follow-up data was entered into DPI (patient's medical record at HUG) on a specific
      consultation form. Patients followed in the investigators consultation were contacted between
      30 and 60 days after diagnosis by the Covicare team. The Covicare team is call-center
      composed of medical students and primary care physicians who remotely followed patients with
      COVID-19 by calling them by phone or telemedicine every day or every other day depending on
      patients' needs and health status. The investigators will export data from RedCap concerning
      post-hospitalization, satisfaction survey on our care and oral consent for use of data (ARGOS
      study CCER number 2020-01273).
    

Intervention name(s): management strategy of outpatient with mild to moderate SARS-CoV-2 pneumonia
Intervention type(s): Other
Intervention description(s): Data collected with a cohorte of SARS-CoV-2 pneumonia in an outpatient basis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with SARS-CoV-2 pneumonia without hospitalization criteria at primary consultation
Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam
Condition: Typhoid; Paratyphoid Fever
MeSH terms: Typhoid Fever; Paratyphoid Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is part of International Vaccine Institutes (IVI)'s typhoid Vi demonstration
      project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic
      countries. The primary objectives of the study are to evaluate the logistic feasibility of a
      mass typhoid fever immunization campaign program targeting school age children in Hue City,
      Vietnam and to assess the knowledge, attitudes, beliefs, and practices of parents and
      healthcare providers in Hue City regarding typhoid fever prevention and treatment.
    

Detailed description: 
      Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects
      school-aged children, is more prevalent in urban areas, may last for several weeks and can
      lead to serious complications. Management of this disease is further complicated by the
      emergence of multi-drug resistant strains. Vaccination of high risk populations is considered
      the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine
      has been targeted for accelerated introduction into public health programs due to the
      following reasons: it has been shown to have consistent efficacy results even in areas of
      high typhoid incidence, is given as a single dose, lacks patent protection and requires less
      strict cold chain requirements. A cluster-randomized trial involving the Vi polysaccharide
      vaccine and an active control (Hepatitis A) was designed to determine the logistic
      feasibility of providing Vi vaccine under actual programmatic conditions among school
      students in Hue City. The vaccines used in this study are internationally produced and
      locally licensed.

      Secondary objectives of this trial are:

        -  To estimate the cost-effectiveness (cost of illness, willingness to pay, vaccine
           delivery costs, private vaccine costs, etc) of Vi vaccination

        -  To determine the effectiveness of the Vi polysaccharide vaccine following routine
           administration of a 1-dose schedule to school students (aged >=6 years)

        -  To determine the safety and immunogenicity of the Vi vaccine

        -  To study typhoid risk factors among students

      A nested, prospective matched case-control study is included in the trial in order to study
      typhoid risk factors among children in Hue City.
    

Intervention name(s): Typhoid Vi vaccine; Hepatitis A (control)
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Salmonella; typhoid vaccine; enteric fever; socioeconomic costs
Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921
      administered as a single subcutaneous dose in healthy volunteers.
    

Detailed description: 
      Tolerability and Pharmacokinetics of subcutaneously administered dose of PF-04236921 in
      healthy volunteers
    

Intervention name(s): PF-04236921
Intervention type(s): Drug
Intervention description(s): single subcutaneous dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Safety and tolerability; Pharmacokinetics; PF-04236921; Rheumatoid Arthritis
Chronic Muscle Disuse in the Elderly
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to define the effects of chronic disuse on skeletal muscle
      structure and function in elderly individuals at the cellular and molecular level by
      examining elderly characterized by chronic muscle disuse (patients with knee osteoarthritis)
      and healthy elderly no evidence of knee osteoarthritis and normal physical activity levels.
    

Detailed description: 
      Skeletal muscle disuse is an important contributing factor to physical disability. Disuse is
      more frequent in the elderly and they are more susceptible to its debilitating effects
      because of their diminished physiological reserve. Despite these facts, the mechanisms
      whereby disuse promotes skeletal muscle contractile dysfunction in this population remain
      largely undetermined. Therefore, the investigators will systematically test for modifications
      of single skeletal muscle fiber structure and function that underlie contractile dysfunction.
      Elderly individuals characterized by chronic muscle disuse (patients with knee
      osteoarthritis) will be compared to carefully-matched controls with no clinical evidence of
      knee osteoarthritis and normal activity levels. Thereafter, elderly with chronic disuse will
      undergo an exercise intervention to remediate muscle disuse. The investigators hypothesize
      that muscle disuse impairs contractile function, in part, through alterations in myosin
      kinetics, myofilament protein content and the mechanical properties of the myofilament
      lattice and that exercise rehabilitation will counteract these deficits. The investigators
      will specifically examine the effect of disuse on mechanical, kinetic and structural
      properties and molecular composition of single muscle fibers in cases and controls, as well
      as determine how increasing muscle use in elderly with chronic disuse via exercise training
      affects muscle fiber mechanical, kinetic and structural properties and molecular composition.
      These translational studies will provide the first comprehensive evaluation of the cellular
      and molecular mechanisms through which muscle disuse alters skeletal muscle structure and
      contractile function in elderly humans. This knowledge can assist in the development and
      refinement of preventative and corrective therapies for disability by tailoring these
      approaches to address specific molecular defects.
    

Intervention name(s): Resistance exercise training
Intervention type(s): Behavioral
Intervention description(s): Lower extremity resistance exercise training 3x/wk
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: elderly; muscle; disuse; osteoarthritis; exercise
Effect of Fruit and Vegetable Intake on Markers of Fruit and Vegetable Consumption
Condition: Healthy
Study type: Interventional

Summary: 
      This study will examine what contribution of 'markers' of fruit and vegetable (FV) intake in
      blood and urine is most closely related to FV intake. 30 healthy volunteers will be fed
      either 2, 5 or 8 portions of FV per day for 4 weeks (ten participants per group, randomly
      assigned). Volunteers will have all their food provided during the study, and will consume
      two meals each weekday at the University. Volunteers will complete diet and lifestyle
      questionnaires at the start and end of the study and will have blood and urine samples
      collected at 0, 2 and 4 weeks.
    

Detailed description: 
      Single biomarkers of FV consumption, such as Vitamin C and certain carotenoids and
      flavonoids, have been proposed, but associations between these compounds and FV intake are
      relatively weak. The investigators propose that, given the complexity of FV, production of an
      algorithm based on a wide variety of bioactive compounds found in FV might better predict FV
      consumption. A controlled feeding study (30 volunteers randomised to 2, 5 or 8 portions of FV
      day for 4 weeks) will allow development of such an algorithm. Volunteers will be recruited by
      advertisement from QUB and the general public, and will have all their food provided for the
      4 week period (two meals per day during the week to be consumed under supervision at the
      University).
    

Intervention name(s): 2 portions of fruit and vegetables per day; 5 portions of fruit and vegetables per day; 8 portions of fruit and vegetables per day
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Consume 2 portions of fruit and vegetables per day; Consume 5 portions of fruit and vegetables per day; Consume 8 portions of fruit and vegetables per day
Other intervention name(s): 2 portions/day; 5 portions/day; 8 portions/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fruit; vegetables; biomarkers; randomised controlled feeding study; Fruit and vegetable intake biomarkers in healthy adults