bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve
      Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2
      parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800
      to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034)
      800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus
      standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG)
      and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000
      mg/day) plus boceprevir for 48 weeks.
    

Detailed description: 
      The study was conducted in 2 parts.

      Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mg/day and compared:

        -  PegIntron and ribavirin for 48 weeks (Arm 1 - Control)

        -  PegIntron, ribavirin, and boceprevir for 28 weeks (Arm 2)

        -  Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron, ribavirin and
           boceprevir for 24 weeks (Arm 3)

        -  PegIntron, ribavirin and boceprevir for 48 weeks (Arm 4)

        -  Lead-in with PegIntron and ribavirin for 4 weeks, followed by PegIntron, ribavirin and
           boceprevir for 44 weeks (Arm 5)

      Participants from Arm 1 receiving PegIntron and ribavirin that were HCV positive after 24
      weeks of treatment had the option to receive boceprevir in combination with PegIntron and
      ribavirin for an additional 24 weeks. All participants from Arm 1 that started boceprevir
      after Week 24 formed the crossover arm (Arm 8).

      Part 2 of the study assessed the safety and efficacy of low dose ribavirin (400-1000 mg/day)
      and compared:

        -  PegIntron, ribavirin (800-1400 mg/day) and boceprevir for 48 weeks (Arm 6)

        -  PegIntron, low-dose ribavirin (400-1000 mg/day) and boceprevir for 48 weeks (Arm 7)

      Follow-up for all participants was up to 72 weeks after randomization.
    

Intervention name(s): boceprevir (SCH 503034); peginterferon-alfa 2b (PegIntron); ribavirin; ribavirin (low-dose)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg capsules taken as 800 mg orally three times daily (TID); 1.5 μg/kg subcutaneously (SC) once weekly (QW); 200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily; 200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily
Other intervention name(s): Boceprevir, Victrelis, SCH 503034
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
Condition: Healthy; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Traumatic brain injury (TBI) is a health issue impacting athletes and no clinical treatment
      protocol, other than rest, is yet established. The efficacy of a treatment protocol relies on
      objective, physiological measures of brain function and ultimately a quantification of injury
      severity.

      The present study aims to assess neurophysiological markers of auditory and visual measures
      of brain function using the NeuroCatch Platform and eye-tracking technology, respectively.
      The current gold standard of TBI evaluation, including cognitive and balance assessments,
      will also be captured.
    


Intervention name(s): NeuroCatch Platform (NCP)
Intervention type(s): Device
Intervention description(s): The NCP plays a proprietary 6-minute auditory stimulus sequence of tones and words that elicit involuntary evoked responses in the brain. Tone stimuli elicit N100 and P300 responses, and spoken word pairs elicit N400 responses. The NCP proprietary software identifies the latency and amplitude (timing and size) of three selected ERPs. Latency and amplitude values are reported as empirical (measured) values.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Up to 70 hockey players aged 14-25 years will be included in the study.
Evaluation of the Effectiveness of Aromatherapy on Anxiety, Vital Signs, and Postoperative Complications in Lower Impacted Wisdom Tooth Surgery
Condition: Tooth, Impacted; Dental Anxiety
MeSH terms: Tooth, Impacted; Postoperative Complications; Anxiety Disorders
Study type: Interventional

Summary: 
      Dental anxiety is considered to be one of the fears and concerns associated with dental
      treatment. Lavender has a relaxing and anxiolytic aroma. The aim of this study was to
      evaluate the effects of aromatherapy on dental anxiety in bilateral impacted wisdom tooth
      surgery.
    


Intervention name(s): Lavander Aromatherapy
Intervention type(s): Other
Intervention description(s): Aromatherapy is one of the potential non-pharmacological methods. Lavender oil has been known to have calming properties and is one of the most effective aromatherapy oils. It reduces blood pressure and anxiety by stimulating the parasympathetic system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: aromatherapy; lavender oil; wisdom tooth extraction
A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects
Condition: Healthy; Pharmacokinetics of ASP0456
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition,
      pre-prandial and postprandial administrations, is compared.
    


Intervention name(s): ASP0456; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): linaclotide
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: ASP0456; Pharmacokinetics; safety; tolerability; food effect
Dopaminergic Effects on Brown Adipose Tissue
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In this study the investigators will investigate the effect of dopamine (bromocriptine) on
      Brown Adipose Tissue in lean, young, healthy males.

      The investigators will also examine energy expenditure, body temperature and insulin
      sensitivity as measurements of Brown Adipose Tissue activity.
    

Detailed description: 
      In this study the investigators will investigate whether bromocriptine influences the
      metabolic activity of BAT, as assessed with a 18F-fluorodeoxyglucose (18F-FDG) Positron
      Emission Tomography (PET)-CT scan

      This is an observational, prospective design with invasive measurements. The investigators
      will include 16 healthy lean male volunteers (aged 18-30 years, BMI 19-25 kg/m2) The
      volunteers will be recruited by advertisement in local paper and internet (via social media),
      covering the direct surroundings of our clinic (Amsterdam) and by advertisement at the
      medical faculty of the Academic Medical Center (AMC).

      The included subjects will visit the AMC hospital on 3 occasions. During visit 1 the
      investigators will obtain the Informed consent after oral and written information about the
      study. The investigators will obtain a medical history, vital signs and laboratory
      measurements.

      During visit 2 the investigators will measure body weight and the investigators will perform
      an energy expenditure measurement after 40 minutes of bed rest. The investigators will
      regularly measure temperature by a tympanic thermometer. The subjects will receive
      intravenous administration of the radioactive pharmacon 18F-FDG, 60 minutes after the
      administration of the 18F-FDG, and 18F-FDG PET-CT scan will be performed. After the 18F-FDG
      PET CT scans, the investigators will measure insulin sensitivity by performing an oral
      glucose tolerance test.

      After this visit, subjects will start using bromocriptine (1,25mg/day during the first week
      and 2,50mg/day during the second week) in the evening.

      Visit 3(2 weeks after visit 2) will be exactly the same as visit 2. In the three days before
      visit 2 and 3, subjects will record their eating behaviour.
    

Intervention name(s): Bromocriptine
Intervention type(s): Drug
Intervention description(s): The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself
Other intervention name(s): Parlodel
Intervention MeSH terms: Bromocriptine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Brown Adipose Tissue; Obesity; Insulin Sensitivity; Dopamine
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
Condition: Congenital Rubella Infection; Measles
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Thus study is a clinical trial for Measles and Rubella vaccine that will be used inIndonesian
      National Program of Immunization. The study design will be randomized, observer blind,
      prospective intervention study.
    

Detailed description: 
      The objectives of the study are:

        -  To assess the protectivity rate of Bio Farma's Measles/Rubella (MR) vaccine in infants

        -  To describe antibody response to Measles and Rubella after 1 dose of Bio Farma's MR
           vaccine as a primary dose in infants

        -  To assess the safety of Bio Farma's Measles/Rubella (MR) vaccine in infants

        -  To evaluate immunogenicity and safety one dose of Bio Farma's MR vaccine compare to
           registered MR vaccine.

        -  To evaluate immunogenicity and safety in three consecutive batches of Bio Farma's MR
           vaccine in infants .
    

Intervention name(s): Measles-Rubella vaccine Bio Farma; MR Vaccine SII
Intervention type(s): Biological; Biological
Intervention description(s): MR vaccine produced by Bio Frama with 3 consecutive batches; MR Vaccine produced by SII (Already registered in Indonesia)
Other intervention name(s): Vaksin Campak Rubella Bio Farma
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: healthy infants aged 9 - 12 months
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Measles; Rubella; Bio Farma
A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such
      as pain and swelling.
    


Intervention name(s): Celecoxib; Celecoxib; Naproxen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Higher dose, 6 mg/kg/dose BID; Active drug at lower dose; Control comparator, 15 mg/kg/dy target dose
Intervention MeSH terms: Celecoxib; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arthritis; juvenile
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Condition: Patent Ductus Arteriosus (PDA)
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      AGA-004 - The objective of the study is to determine safety, effectiveness and clinical
      utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 -
      The objective of this study is to evaluate the long term safety and effectiveness issues that
      may not have have been adequately addressed during AGA-004.
    


Intervention name(s): Device closure with AMPLATZER Duct Occluder; Objective Performance Criteria
Intervention type(s): Device; Other
Intervention description(s): Device closure with AMPLATZER Duct Occluder; Compare results of device closure to objective performance criteria
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patent ductus arteriosus (PDA)
A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effects of VX-702 in subjects with
      moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.
    


Intervention name(s): VX-702
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Pneumoperitoneum on the Continuous and Non-invasive Hemoglobin Monitoring
Condition: Gastric Cancer
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effect of pneumoperitoneum on the
      continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy
    


Intervention name(s): High end-tidal CO2; Low CO2 group
Intervention type(s): Other; Other
Intervention description(s): maintaining of end-tidal CO2 with the range of 40-45 mmHg; maintaining of end-tidal CO2 with the range of 30-35 mmHg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance
Condition: Altitude; Hypoxia; Environmental Sleep Disorder
MeSH terms: Sleep Wake Disorders; Dyssomnias; Hypoxia
Study type: Interventional

Summary: 
      Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure)
      caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with
      degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep
      and/or post-sleep performance are affected is not known. The study hypothesis is that sleep
      and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at
      altitudes of 8,000 or less.
    


Intervention name(s): altitude exposure in hypobaric chamber
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Basic Science
Keywords: high altitude; sleep; altitude illness; neurobehavioral manifestations; psychomotor performance; mood states
Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
Condition: Nonsuicidal Self-Injury
MeSH terms: Self-Injurious Behavior
Study type: Interventional

Summary: 
      The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy
      for Adolescents (ERITA) who self-harm.
    


Intervention name(s): Emotion Regulation Individual Therapy for Adolescents
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 60732 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics
      and pharmacodynamics of BI 60732
    


Intervention name(s): BI 60732; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Safety and Efficiency of γδ T Cell Against Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing
      surgery, for example, cryosurgery going to be investigated
    

Detailed description: 
      Lung tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the
      patient will be separated from peripheral blood. After making them potential cancer killer γδ
      T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

      NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to
      ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of
      majority of cancer patients could not be effectively expanded, including cell number, cell
      purity and cell function could not meet the requirements of reinfusion. Meanwhile, those
      patients could not tolerate 100ml of blood drawing for culture every 2 ~ 3 weeks.

      Therefore, we submitted new clinical study application to the ethical committee of the Fuda
      Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous
      protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted
      allogeneic cells instead of autologous in our subsequentially clinical study.
    

Intervention name(s): Cryosurgery or IRE surgery; γδ T cell; γδ T cells/ A Cryosurgery or IRE
Intervention type(s): Procedure; Biological; Other
Intervention description(s): Cryosurgery or IRE surgery will be used in local tumor; γδ T cells will be used against Lung Cancer; Combination γδ T cell and Cryosurgery or IRE surgery will be used in Lung Cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Immunotherapy, γδ T Cell, Lung Cancer
Acute Health Effects Due to Ultrafine Particles From Candles and Cooking
Condition: Candle Burning; Cooking; Lung Function Decreased; DNA Damage; Subjective Health; Asthma
Study type: Interventional

Summary: 
      People spend up to 90% of their life indoor, and the way we live and behave in our homes has
      substantial effects on our health and well-being. Particle contamination is suggested to have
      substantial negative effects on health, with candles and cooking emitting the largest amount
      of particles, thus being the largest contributors to indoor air pollution.

      The overall aim of the present project is to contribute to increased understanding of the
      association between indoor particulate air pollution and health and well-being.
    

Detailed description: 
      Introduction: People spend up to 90% of their life indoor, and the way we live and behave in
      our homes has substantial effects on our health and well-being. Particle contamination is
      suggested to have substantial negative effects on health, with candles and cooking emitting
      the largest amount of particles, thus being the largest contributors to indoor air pollution.
      Little is known about the potential adverse health effects of candles and cooking, and people
      with asthma may be more susceptible.

      Aim: To investigate local and systemic effects of short-term exposure to lit candles and
      cooking among young asthmatics.

      Design: In a randomised double-blinded cross-over study non-smoking asthmatics (18-25 years)
      were exposed for five hours at three different exposure conditions separated by 14 days; A)
      clean filtered air, B) lit candles and C) cooking emissions under controlled environmental
      conditions.

      Measurements: TSI P-TRAK Ultrafine Particle Counter was used for particle counts. Health
      effects, including lung function (FEV1/FVC) and fraction of exhaled nitric oxide (FeNO) were
      evaluated in relation to local and systemic effects prior to, right after and 24 h. after
      exposure.

      Analysis: Mixed methods approach taking both time and exposure into account.
    

Intervention name(s): Particles from candles; Particles from cooking; Clean Air
Intervention type(s): Other; Other; Other
Intervention description(s): Generating fine and ultrafine particles from lit candles; Generating fine and ultrafine particles from frying pork in an oven; Nothing but clean air
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomised double-blinded crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Particle contamination; Indoor air; Acute health effects; RCT; Asthma
Minocycline for Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate minocycline as a potential treatment for bipolar
      depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is
      approved for the treatment of infections and acne. Participation in this research study is
      expected to last 8 weeks, and includes five outpatient visits.
    

Detailed description: 
      Bipolar depression remains the great unmet need in the treatment of bipolar disorder. Only
      two treatments have been FDA-approved for the management of acute bipolar depression (the
      combination of olanzapine and fluoxetine and quetiapine). Early pilot data suggests the drug
      minocycline has potent antidepressant effects. Minocycline is approved by the Food and Drug
      Administration (FDA) (for acne and bacterial infections), is inexpensive and readily
      available in generic formulation, and is generally well-tolerated. This study will examine
      whether administering the drug minocycline to individuals with bipolar depression over 8
      weeks will improve their depressive symptoms. This study will also offer an option to
      participate in proton magnetic resonance spectroscopy (1H-MRS) to measure N-Acetylaspartate
      (NAA) levels in the brain, which are thought to be decreased in bipolar disorder.
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): Minocycline 100 to 300mg per day for 8 weeks
Other intervention name(s): Minocin
Intervention MeSH terms: Minocycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar disorder; depression; minocycline; mood disorders; bipolar depression