bioihbjkbjnl/mcl2 huggingface dataset:
A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain
Condition: Pain; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral
      dose administration in participants with pain after tooth-extraction of mandibular impacted
      wisdom tooth.
    

Detailed description: 
      This is a multi-center (conducted in more than one center), double-blind (neither Physician
      nor participant knows the name of the assigned drug), randomized (study drug assigned by
      chance), parallel-group (each group of participant will be treated at the same time) and
      comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on
      visual analog scale, score ranging from 0 mm [no pain] to 100 mm [worst possible pain]),
      following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts:
      Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of
      single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and
      placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible
      participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the
      participants will primarily be evaluated through total pain relief, which will be evaluated
      on numerical rating scale. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Tramadol Hydrochloride; Acetaminophen; Placebo; Tramadol plus Acetaminophen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).; Acetaminophen two oral capsules will be administered once as 650 mg.; Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.; Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively.
Other intervention name(s): JNS013
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Tooth extraction; Oral surgery; Postoperative pain; JNS013; Tramadol hydrochloride; Acetaminophen
Combination Of PAXIL Tablet And Benzodiazepines
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to assess the efficacy and safety of combination therapy of PAXIL and
      benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or
      depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in
      the symptoms of depression will be evaluated by use of the rate and extent of decrease in
      Hamilton Rating Scale for Depression (HAM-D).
    


Intervention name(s): paroxetine
Intervention type(s): Drug
Intervention description(s): 1 or 2 tablets once a day
Intervention MeSH terms: Paroxetine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depressive episodes; paroxetine; PAXIL; depression; benzodiazepine; combination
Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall objective of the study is to assess the efficacy, safety, tolerability, and
      pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to
      enhance the response rate seen with pegloticase alone in adults with uncontrolled gout.
    

Detailed description: 
      The study design will include: 1) up to a 2-week Screening Period (screening should be
      complete within 2 weeks prior to Week -4), 2) a 4-week MTX Run in Period (Week - 4 through
      Day 1); 3) a 52-week Pegloticase + IMM (immunomodulator), (Pegloticase + MTX) Period 4) a
      Safety Follow-up (Phone/Email/Site Visit) and 5) a 3 and 6 month Post Treatment Follow-up.
    

Intervention name(s): Pegloticase; Methotrexate (MTX); Standard Gout Flare Prophylaxis; Infusion Reaction (IR) Prophylaxis; Folic Acid
Intervention type(s): Biological; Drug; Drug; Drug; Dietary Supplement
Intervention description(s): pegloticase administered intravenously (IV); oral MTX; It is required that before a subject begins the Pegloticase + IMM Period, he or she has been taking at least one protocol standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤10 mg/day) for ≥1 week before the first dose of pegloticase and continues flare prophylaxis per American College of Rheumatology guidelines [Khanna D et al.2012] for the greater of 1) 6 months, 2) 3 months after achieving target serum urate (sUA < 6 mg/dL) for patients with no tophi detected on physical exam, or 3) 6 months after achieving target serum urate (sUA < 5 mg/dL) for patients with one or more tophi detected on initial physical exam that have since resolved.; For IR prophylaxis, fexofenadine (60 mg or 180 mg orally based on the Principal Investigator's discretion) will be taken the day before each infusion; fexofenadine (60 mg or 180 mg orally based on the Principal Investigator's discretion) and acetaminophen (1000 mg orally) will be taken the morning of each infusion; and methylprednisolone (125 mg IV) given over the infusion duration 10-30 minutes (recommended) or hydrocortisone (200 mg IV) will be administered immediately prior to each infusion.; Subjects will also take folic acid 1 mg orally every day beginning at Week -4 (the start of MTX) and continuing until prior to the Week 52 Visit.
Intervention MeSH terms: Folic Acid; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gout; uncontrolled gout
The Cognitive Resilience Study
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The purpose of this study is to test whether two new cognitive "stress tests" may help
      distinguish between people at lower or higher genetic risk of Alzheimer's Disease. The
      investigators are trying to understand how these cognitive "stress tests" work in people who
      have not been diagnosed with Alzheimer's Disease and are not exhibiting symptoms of
      Alzheimer's Disease. Study subjects will undergo testing of memory and executive function
      during functional magnetic resonance image (fMRI) of the brain and also during a walking
      test.
    

Detailed description: 
      The objective is to establish the feasibility and evaluate the role of two novel tests of
      cognitive resilience for use in identification of early Alzheimer's Disease. The
      investigators hypothesize that exposure to the controlled stressor of increased cognitive
      task demand will evoke measurable phenotypes of poor resilience, which will be associated
      with Alzheimer's Disease risk. The study will include 30 volunteer participants from the Duke
      Alzheimer's Disease Prevention Registry (ADPR). The ADPR cohort has been characterized
      according to genetic risk based on genotype at loci associated with Alzheimer's Disease. The
      investigators will recruit a sample from the ADPR that includes 15 people in the "genetic
      high risk" group and 15 people, matched by age, in the "genetic low risk" group.
      Investigators and experimenters are masked to the genetic profile of all participants. All
      participants will undergo two cognitive stress test protocols. Both protocols include memory
      and executive function components, one done during functional MRI and one while ambulating on
      a force sensor mat. Both cognitive stress tests are minimal risk; the primary risk of this
      study is loss of confidentiality. Genetic testing is not performed as part of this protocol;
      the sampling strategy will make use of prior genetic testing results, which are not revealed
      to the primary investigators. In addition to determining whether scores on the two novel
      tests statistically differ by AD risk groups, the project will establish the tests'
      feasibility and characteristics for use in future study.
    

Intervention name(s): Cognitive stress tests during functional MRI; Cognitive stress tests during gait task
Intervention type(s): Other; Other
Intervention description(s): Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function while undergoing fMRI.; Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function both in sitting and while ambulating on a force sensor mat.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Worksite Program to Prevent Weight Gain Among Bus Drivers
Condition: Obesity; Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to implement and evaluate a two-year multi-component
      environmental intervention to prevent weight gain among city bus drivers at four bus garages.

      It is hypothesized that transit employees in the intervention garages will gain less weight
      compared to the transit employees in the control garages.
    

Detailed description: 
      BACKGROUND:

      Environmental influences that support less healthful food choices and sedentary behaviors
      have contributed to the epidemic increase in overweight and obesity among U.S. adults.
      Worksite settings are an effective channel through which to reach adults with interventions
      designed to prevent excess weight gain and obesity.

      DESIGN NARRATIVE:

      This study will implement and evaluate a multi-component environmental intervention to
      prevent excess weight gain among 1200 bus drivers working in four garages in a major
      metropolitan area. Four garages will be randomized to the intervention or control group for a
      two-year period. The environmental interventions are based on a social ecological framework
      and target four worksite environmental areas: 1) food availability and incentives; 2)
      physical activity opportunities and incentives; 3) the social environment; and 4)
      media/promotion related to health food choices, physical activity, and body weight.
    

Intervention name(s): Healthful eating and food choices behavior change programs and changes in worksite food availability and prices; Physical Activity; Environment
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Food choices and eating behavior programs and environmental changes will be implemented for 18 months in intervention garages.; Physical activity programs are offered at the intervention garages for an 18 month period.; Changes in the food and physical activity environment are made for an 18 month period in intervention garages. These include improving the healthfulness of the foods available in vending machines, and improving the fitness rooms at the garages.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome
Condition: Functional Dyspepsia; Joint Hypermobility Syndrome
MeSH terms: Joint Instability; Syndrome; Dyspepsia
Study type: Observational

Summary: 
      Functional dyspepsia (FD) is defined as the presence of gastroduodenal symptoms in the
      absence of organic disease that is likely to explain the symptoms. Joint hypermobility (JH)
      refers to the increased passive or active movement of a joint beyond its normal range. Recent
      reports have highlighted the co-existence of FD with Ehlers-Danlos syndrome type III or
      hypermobility type (EDSIII). The association between FD and EDS III, and the underlying
      pathophysiological alterations, are poorly understood. We hypothesised that EDS III might
      influence gastroduodenal sensorimotor function, resulting in dyspeptic symptoms. Therefore,
      the aim of this study is to explore the impact of EDS III on gastric motility, nutrient
      tolerance and dyspeptic symptoms in patients with functional dyspepsia.Our aim is to study
      the prevalence of EDSIII in FD compared to healthy subjects (HS) and to study the impact of
      co-existing EDSIII on gastric motility, nutrient tolerance and dyspeptic symptoms in FD.
    


Intervention name(s): No intervention: assessment of GI function
Intervention type(s): Other
Intervention description(s): Gastrointestinal function is assessed by the intragastric pressure measurement by a high resolution manometry. This is an examination test considered standard of care for the diagnosis of functional dyspepsia in the university hospital of leuven.
The joint hypermobility syndrome is assess by means of the Brighton criteria.
Other intervention name(s): No intervention: assessment of JHS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with PDS diagnosis as per Rome III by Rome III questionnaire and healthy subjects
        with out gastrointestinal symptoms
A Trial of a Walter Reed Army Institute of Research (WRAIR) Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      This descriptive study will evaluate the safety and immunogenicity of 5 different
      formulations of the WRAIR dengue vaccine compared to a placebo.
    

Detailed description: 
      Subjects will be randomized into one of 6 groups. One group will receive a placebo vaccine
      and the others will receive one of 5 different dengue vaccine formations. Each subject will
      receive two doses six months apart. Study subjects who elect to participate in a mosquito
      transmissibility component of the study will undergo mosquito feedings during each of the two
      assigned follow-up visits after vaccine dose 1. All subjects will have 11 venipunctures
      during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.
    

Intervention name(s): Live attenuated tetravalent dengue vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated tetravalent dengue vaccine; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: Dengue infection
Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone
      sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The
      developmental objective for this combination product is an expansion of therapeutic options
      for the treatment of opiate dependence.
    

Detailed description: 
      This multicenter pivotal clinical trial was comprised of two phases. The first phase, which
      was four weeks in length, was double-blind placebo controlled and was primarily used to
      evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was
      primarily conducted to determine the safety of buprenorphine/naloxone.
    

Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Primary purpose: Treatment
Keywords: opioid dependence
Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom,
      e.g. spasticity and pain, management. Unfortunately not much is known about its effects
      outside the treatment for these 2 symptoms. Several previous studies have suggested people
      with MS using medical marijuana have lower levels of physical disability and improved walking
      abilities. A major limitation of these previous studies is that the investigators used
      subjective measures of motor function. In this proposed observational case-control study the
      investigators plan to objectively measure multiple domains of motor function, such as:
      fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to
      participants.
    

Detailed description: 
      To investigate the effects of medical marijuana usage on physical function the investigators
      will employ an observational case-control design. Cases (MS medical marijuana users) will be
      compared to age, sex, and disease duration matched controls (MS non-cannabis users).
    

Intervention name(s): Medical Marijuana
Intervention type(s): Behavioral
Intervention description(s): To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults diagnosed with Multiple Sclerosis.
Clinical Study on Diagnostics and Outcome of Ruptures of the Subscapularis After Arthroscopic Refixation
Condition: Subscapularis Tendon Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      The purpose of the trial is to optimize the diagnostics of subscapularis tendon tears and as
      the circumstances require to found a new classification.

      The prime objective is a comparison of the conclusive of the clinic check-up, the sonographic
      and magnetic resonance tomography findings.

      The secondary objective is to detect the correlation of the outcome with the age , the
      gender, the pathogenesis and attendant injuries.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of the patients, who got the operative therapy (refixaton of
        the subscapularis tendon) inclusive the post- treatment and satisfy the criteria .
Saccharomyces Cerevisiae for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to see the response of saccharomyces cerevisiae for symptomatic
      improvement of patients with IBS
    


Intervention name(s): Saccharomyces cerevisiae
Intervention type(s): Drug
Intervention description(s): Saccharomyces cerevisiae, which is a pro-biotic, was given in capsule form, 500mg twice daily for 1 month
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose of Hepatitis B Vaccines in Non/Low-response Populations
Condition: Vaccination; Complications, Reaction, Serum
MeSH terms: Hepatitis B
Study type: Interventional

Summary: 
      An interventional study will be performed in subjects aged 1-65 years old to evaluate effects
      of different doses of hepatitis B vaccines in low or non-response population.
    

Detailed description: 
      A randomized clinical study will be conducted to evaluate effects of different doses of
      hepatitis B vaccines in low or non-response population in China. 650 low or non-response
      subjects after hepatitis B vaccination will be enrolled under the premise of informed
      consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged
      18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day
      0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine
      with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an
      interval of at least 28 days. All vaccinations will be done by specific study personnel, who
      do not take part in the assessment of safety or immunogenicity. Adverse events will be
      recorded after vaccination and blood samples were collected at day 30 after each vaccination
      for antibody detection.

      The clinical program approved by the ethics committee will be performed by the researchers
      independently. Inspectors designated by the sponsor will take meticulous on-site audits to
      ensure the safety specifications during the whole process of research.
    

Intervention name(s): hepatitis B vaccine
Intervention type(s): Biological
Intervention description(s): hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
Other intervention name(s): HepB 10ug: Hansenula Polymorpha Yeast; HepB 60ug: Saccharomyces cerevisiae
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: response vaccination
Comparing Active and Passive Ankle-foot Prostheses
Condition: Trans-tibial Amputation
Study type: Observational

Summary: 
      The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot
      and evaluate if it provides a physiological generation of power at the ankle in transtibial
      amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e.
      robotic system).
    

Detailed description: 
      Subjects will be studied during level-ground walking. A camera-based motion capture system
      will be used to study the biomechanics of motion and evaluate if the pattern of ankle power
      generation by the prosthetic foot is physiological. In addition, the metabolic cost of
      ambulation will be monitored during walking at constant speed over a period of several
      minutes. The data will allow us to assess if the prosthetic foot leads to a decreased
      metabolic cost of ambulation compared to passive prosthetic feet.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults with history of traumatic unilateral transtibial amputation
      
Keywords: prosthesis; amputees; gait
Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are:

        -  To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge
           10/160mg after a single oral administration in healthy male volunteers

        -  To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis
           Exforge 10/160mg after a single oral administration in healthy male volunteers
    


Intervention name(s): CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg
Intervention type(s): Drug
Intervention description(s): single dose
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Pharmacokinetics