bioihbjkbjnl/mcl2 huggingface dataset:
My MediHealth: A Paradigm for Children-centered Medication Management
Condition: Asthma
Study type: Observational

Summary: 
      The last mile of the medication use system requires tools to help patients comply with
      medication administration rules and monitor for side effects. Personal health records (PHR)
      and emerging user-adopted communication tools promise to change the landscape of medication
      management. The overarching goal of the MyMediHealth project is to investigate ways in which
      PHRs and supported applications can improve the safety and quality of medication delivery.
      Preliminary work in this area by a team of parents, patients and school/clinic health
      providers created a vision for MyMediHealth, a next-generation medication management system.
      MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure
      safe and effective medication delivery. This vision featured just-in-time medication
      reminders to children with special health care needs, two-way communication to log when doses
      have been administered or when side effects have occurred, and mechanisms to warn caregivers
      about side effects and drug interactions. However, much of this work was done using
      prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried
      out without significant changes in processes and policies, the purpose of this proposed study
      is to evaluate the impact of medication management tools such as MyMediHealth on medication
      adherence for children with chronic illnesses. Specifically, the investigators hypothesize
      that compared with usual practice, children using mymedihealth will have improved medication
      adherence and will report improved (decreased) asthma symptoms.
    


Intervention name(s): MyMediHealth access
Intervention type(s): Other
Intervention description(s): Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents between the ages of 12 and 17 with a diagnosis of asthma and on at
        least one daily medication.
AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess
      the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose
      administration to healthy male Japanese volunteers.
    


Intervention name(s): AZD7325; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule for oral, single dose; Placebo capsule for oral, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AZD7325; Japanese Healthy Volunteers; Phase I study; Single Ascending Dose
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
Condition: Hepatitis C; Oxidative Stress
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional

Summary: 
      The objective of the present study is to evaluate the antioxidant status in the blood of HCV
      patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin
      (1000 to 1250 mg) before and after supplementation of vitamins E, C and the mineral zinc (800
      mg,500 mg and 40 mg; respectively) during six months.
    

Detailed description: 
      The WHO estimated that around 170 million people are infected by HCV, about 3% of the world
      population. HCV is the leading cause of acute hepatitis and chronic liver disease, which may
      lead to cirrhosis and hepatocellular carcinoma.

      The combined therapy with interferon with or without pegylation associated with ribavirin has
      shown greater sustained virological response than monotherapy with interferon-alpha, however
      this response still represents around 60% of cases. The mechanisms by which HCV causes
      cellular damage are not yet well understood, however immune liver damage, direct cytotoxic
      damage mediated by different viral products and also oxidative stress have been implicated in
      the pathogenesis of chronic hepatitis C. Several studies support that reactive oxygen species
      (ROS) and oxidative stress are involved in the pathogenesis of hepatitis C, despite that
      increased ROS levels in HCV patients might be beneficial by suppressing HCV replication. ROS
      are involved in several diseases and cause oxidative damage to lipids, DNA, proteins and
      carbohydrates.
    

Intervention name(s): Antioxidant Supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: antiviral therapy; antioxidant therapy; hepatitis C virus; oxidative stress; vitamin E
Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a short yoga program practiced daily
      at home on blood pressure, quality of Life and stress. The subjects of the study are primary
      health care patients diagnosed with hypertension, with or without current medication.
    

Detailed description: 
      Hypertension is one of the most common diseases in the world, affecting approximately 26% of
      the adult population. Persistent hypertension increases the risk of developing coronary heart
      disease, stroke and other cardiovascular diseases, such as heart failure. Hypertension is a
      common diagnosis in primary health care and the societal costs of examination and treatment
      of hypertension and its consequences are considerable.

      The YHIP-study (The Impact of Yoga on Blood Pressure and Quality of Life in Patients With
      Hypertension), that investigated yoga as additional treatment for hypertension on primary
      care patients, showed that a short yoga program practiced daily at home had a blood pressure
      lowering effect as well as a positive effect on self-rated quality of life compared to
      control.

      Other previous studies have demonstrated positive effects of yoga on blood pressure, quality
      of life, subjective well-being and stress. However, these studies are relatively few and we
      need to further investigate the possibility of using yoga as a treatment in primary health
      care.

      If the yoga intervention shows to be effective, yoga exercises may be useful as a
      supplementary BP therapy in addition to medical treatment when prescribed by primary care
      physicians. It is to be hoped that patients will also experience a higher quality of life and
      less stress if they perform yoga on a regular basis.
    

Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): The participants in the Yoga group will get a private doctors appointment (20 minutes) where they get instructions for two yoga exercises to perform at home 15 minutes twice a day.
The two yoga exercises were:
"Left nostril breathing" - deep breaths in and out through the left nostril while sitting or lying down, with the right nostril closed off by the right thumb or an earplug (about 11 minutes); and
"Spinal flex" - movement that alternates between flexing the spine forwards (arching) and relaxing the spine back in time with deep breaths while sitting in a chair (about 4 minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Yoga; Hypertension; Quality of Life; Primary Health Care; Stress; Anxiety; Depression
Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fed condition in normal,
      healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Risperidone Tablet 1 mg of Ipca Laboratories Limited, India and the corresponding Reference
      Product: Risperdal® (Risperidone) Tablets 25 mg of Janssen Pharmaceutica Products, USA, under
      fed condition in normal, healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single 1 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 16 days including washout period of at
      least 10 days between administrations of study drug in each study period.
    

Intervention name(s): Risperidone Tablet 1 mg; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg tablet once a day; 1 mg tablet once a day
Other intervention name(s): Test Product; Risperdal®
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pelvic Examination in Pregnancy
Condition: Early Pregnancy Bleeding; Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      This study is designed to determine whether the pelvic examination (including bimanual and
      speculum examination) is necessary in patients with first trimester vaginal bleeding/ lower
      abdominal pain when an intra-uterine pregnancy (IUP) is seen on ultrasound. Patients with the
      chief complaint of vaginal bleeding or lower abdominal pain less than 16 weeks and positive
      HCG will be considered for this non-inferiority-designed clinical trial. All patients who
      present to the BMC Emergency Department (ED) Mon - Fri from 8am to 11pm and have had serum or
      urine HCG testing and a formal ultrasound by a credentialed emergency physician or radiology
      technician as part of standard of care will be screened for further eligibility. Those
      patients with intra-uterine pregnancies < 16 weeks gestation seen on ultrasound and meet
      inclusion criteria will then be asked to provide informed consent to participate in the
      study. Randomization will occur after consent has been obtained. Half of the patients will be
      randomized to receive pelvic examinations and the other half will not. Further care will be
      determined by the treating attending physician. The primary outcome will be a composite
      morbidity endpoint at 30 days, including return visits to the ED, emergency surgery, need for
      transfusion, infection, or other missed source of bleeding/ pain. Secondary outcomes of
      interest include ED throughput time, and patient satisfaction.
    


Intervention name(s): No Pelvic Exam; Pelvic Examination
Intervention type(s): Procedure; Procedure
Intervention description(s): Will not receive pelvic examination.; Pelvic examination will be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
tDCS to Enhance Cognitive Training in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary aim for the study is to determine whether transcranial direct current stimulation
      (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to
      determine whether tDCS combined with CT causes larger transferable improvements on
      non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are
      maintained over time (i.e., maintenance effects).

      Specific hypotheses are:

        1. CT combined with active tDCS will produce greater training gains on CT tasks compared to
           a similar control group receiving CT with sham tDCS.

        2. CT combined with active tDCS will produce greater generalisation effects on non-trained
           cognitive tasks compared to CT with sham tDCS.

        3. The cognitive improvements gained by patients from both interventions will be maintained
           over 1 month follow-up.
    


Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this pilot study is to test whether 6 months of supervised weekly Kundalini
      yoga classes and a brief daily meditation homework assignment can improve memory and thinking
      in older adults with mild memory complaints when compared to weekly classes of memory
      training with daily homework assignments.
    

Detailed description: 
      The purpose of this pilot study intervention is to investigate brain mechanisms of response
      to memory enhancement training (MET) compared to Kundalini yoga and "Kirtan Kriya" meditation
      using functional magnetic resonance imaging (fMRI) that will be acquired from each subject at
      baseline and at 12 weeks (post-randomization).

      Overall, the investigators anticipate recruiting 66 adults with memory complaints and
      diagnosed with MCI for adults 55 years old and older. Subjects will either receive: (1) MET
      class for 60 minutes per week; or (2) Kundalini yoga and "Kirtan Kriya" meditation class for
      60 minutes per week. All assessments will be completed immediately after the interventions
      for a total of 10 visits in 12 weeks and a follow-up visit at 6 months (24 weeks)to monitor
      the overall benefit of the intervention.
    

Intervention name(s): Kundalini yoga and meditation; Memory Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks.; Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Memory impairment; Meditation; Yoga; memory training; Mild cognitive impairment; MCI; geriatric; fMRI
A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
Condition: Cognition
Study type: Interventional

Summary: 
      There is some evidence that polyphenols can affect cognitive function. Therefore, consumption
      of polyphenols has the potential to prevent cognitive impairment or even enhance cognitive
      performance. The objective of this study is to investigate the effect of polyphenol
      consumption served in the form of Concord Grape Juice (CGJ) on cognitive performance and
      driving performance in Mums.

      The study design will be a repeated measures, double-blind, randomised, placebo controlled,
      crossover study. There will be 2 conditions; CGJ and a placebo drink. 20 participants will
      undergo two 12 week dietary interventions which will entail daily consumption of a 12oz
      serving of CGJ or placebo in a counterbalanced manner. There will be a 4 week washout period
      between conditions. At baseline, 6, and 12 weeks of each 12-week treatment arm cognitive
      performance and driving performance will be assessed (using the driving simulator at the
      Institute for Transport Studies). CGJ is a common ingredient in commercially available
      products.

      Mums will be defined as mothers of pre-teen children (aged under 13 years) who are aged
      40-50. This population generally have hectic and stressful lifestyles and therefore there is
      potential for this population to receive cognitive benefit from polyphenol consumption.
    


Intervention name(s): Grape juice polyphenols
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Polyphenols; Cognition; Cognitive function; Driving performance; Stress
COVID-19 Surveillance Based on Smart Wearable Device
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      This is a prospective, multi-center cohort study. 200 subjects with COVID-19will be included
      . Wearable device's physiological parameters and clinical data will be continually collected
      , the investigators aim to explore whether using smart wearable devices is useful to early
      alerting deterioration of COVID-19.
    

Detailed description: 
      This is a prospective cohort study. 200 subjects aged 18～75y with asymptomatic, mild,
      general-type COVID-19 will be recruited. The physiological parameters of wearable devices,
      including heart rate, sleep, blood oxygen saturation, electrocardiogram and exercise records,
      will be continuously collected from the day of admission / isolation to 14 days after
      discharge or out of quarantine. The Department of Respiratory and Critical Care of Peking
      University First Hospital is responsible for this research. All clinical data of patients
      during hospitalization will be collected including demographic characteristics, onset time,
      visit time, hospitalization time, symptoms, physical examination, laboratory examination,
      imaging characteristics, disease severity, treatment and outcome. Primary outcome is the
      deterioration of disease, the correlation analysis between the change of wearable device
      physiological parameters and the deterioration of disease determined by the traditional
      disease evaluation system will be used to find it whether can early alert deterioration of
      COVID-19.

      The study protocol has been approved by the Peking University First Hospital Institutional
      Review Board (IRB) (2020-055). Any protocol modifications will be submitted for the IRB
      review and approval.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with novel coronavirus infection meeting the criteria of The New Coronavirus
        Pneumonia Diagnosis and Treatment Program (Seventh Edition)
      
Keywords: COVID-19 Surveillance Smart wearable device
Effect of Hyperbaric Oxygen Therapy on Microcirculation
Condition: Hyperbaric Oxygen Therapy
Study type: Interventional

Summary: 
      Previous studies shoes that hyperoxia alters microcirculation.The investigators hypothesize
      that hyperbaric may restore microcirculation integrity. This hypothesis is supported by a
      recent study in rabbits, but no data exists for humans.

      The study will expose fifteen healthy volunteers to a succession of different fraction of
      inspired oxygen and barometric pressure and assess microcirculatory and macrocirculatory
      changes via sidestream dark field videomicroscopy, near-infrared spectroscopy, Laser Doppler,
      transthoracic echocardiography and bio-impedancemetry at every step.
    

Detailed description: 
      Microcirculation alterations and hyperoxia are known to alter ICU-patients' prognostic.

      Studies have shown that hyperoxia alters healthy volunteers' microcirculation, whereas
      hyperbaric oxygen therapy is commonly used to facilitate cicatrization. There seems to be a
      paradox. A recent study in rabbits has given some evidences that hyperbaria may restore
      microcirculation integrity, but to date, there is no such evidences in human.

      To study hyperoxia and hyperbaric induced changes in micro and macrocirculation, fifteen
      healthy volunteers will be exposed to successive variations of inspired oxygen fraction and
      barometric pressure according to a predefine sequence so that only one parameter will change
      from a condition to the next one :

        1. FiO2 0.21 - 1 ATA

        2. FiO2 1 - 1 ATA

        3. FiO2 1 - 2.5 ATA

        4. FiO2 0.21 - 2.5 ATA

        5. FiO2 0.21 - 1 ATA

      At each time, and after a 30 minutes period of exposure, measures will be made using
      SDF-microscopy, Laser Doppler and NIRS to assess microcirculation.

      As previously described, macrocirculation can modify microcirculation due to a mechanism
      called hemodynamic coherence.

      Hence, the investigators planned to assess macrocirculation changes at every step of the
      protocol using bioimpedancemetry and transthoracic echocardiography.

      Each volunteer will be his own control, using the first measurements (condition 1. FiO2 0.21
      - 1 ATA) as reference.
    

Intervention name(s): Hyperbaric oxygen therapy
Intervention type(s): Procedure
Intervention description(s): FiO2 0.21 - 1 ATA
FiO2 1 - 1 ATA
FiO2 1 - 2.5 ATA
FiO2 0.21 - 2.5 ATA
FiO2 0.21 - 1 ATA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hyperbaric oxygen therapy; Normobaric oxygen therapy; Hyperoxia; Sidestream dark field videomicroscopy; Microcirculation
Perceived Barriers of Cervical Cancer Screening in Reunion Island and Key Levers for Improvment
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island
      and key levers for improvment.
    

Detailed description: 
      FOSFORE is a cross sectional KABP (Knowledge, Attitudes, Beliefs and Practices) telephone
      survey on cervical cancer screening from a sounding board of women aged between 25 and 65
      years and living in Reunion Island.

      Sample size was estimated from local datas on cervical cancer screening.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Telephone survey from a sounding board of women living in Reunion Island
      
Keywords: Cervical cancer; Screening; Barriers