bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Joint Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study
      with repeated doses of AP1189. The study population will consist of newly diagnosed subjects
      with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score
      (CDAI) > 22, who are to start up-titration with methotrexate.
    

Detailed description: 
      A multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with
      repeated doses of AP1189. The study population will consist of newly diagnosed subjects with
      severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) >
      22, who are to start up-titration with methotrexate.

      The study will be conducted in two parts separated by an interim analysis.

      Part 1: The subjects will be randomized in a 1:1:1 ratio into: .

        -  AP1189 dose 50 mg

        -  AP1189 dose 100 mg

        -  placebo

      INTERIM ANALYSIS

      Part 2: All subjects will be randomized into either design 1, 2 or 3 based on data from the
      interim analysis.

        -  Design 1: AP1189 dose 50 mg or placebo in a 2:1 ratio

        -  Design 2: AP1189 dose 100 mg or placebo in a 2:1 ratio

        -  Design 3: Continue with the same doses as in Part 1

      The purpose of this study is to determine the safety and efficacy of 2 doses of AP1189
      compared with placebo after 4 weeks of treatment.
    

Intervention name(s): 50 mg AP1189; AP1189; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg AP1189 powder in bottle; 100 mg AP1189 powder in bottle; Placebo powder in bottle
Other intervention name(s): AP1189
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, two-part, randomized, double-blind, placebo-controlled 4-week study with repeated doses of AP1189
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered
      once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis
      B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to
      ETV will be verified using the antiviral effect as the index.
    

Detailed description: 
      This study is a multicenter, randomized, active comparator-controlled, double-blind,
      parallel-group comparison study in Japanese patients with compensated chronic hepatitis B
      untreated with any nucleic acid analogue and its subsequent open-label study. Efficacy and
      safety will be compared between once-daily dosing of GSK548470 300 mg and once-daily dosing
      of ETV 0.5 mg, and subsequently the efficacy and safety of GSK548470 administered long term
      will be investigated. A total of 165 subjects will be assigned to the GSK548470 group or the
      ETV group at a ratio of 2:1. The subjects will be assigned by stratified randomization in
      terms of HBe antigen and serum HBV-DNA level. The primary purpose is to verify the
      non-inferiority of GSK548470 to ETV using as an index the change amount of HBV-DNA level at
      Week 24 from the baseline level. The secondary purpose is to investigate the efficacy and
      safety of GSK548470 300 mg administered once daily for a long term.
    

Intervention name(s): GSK548470 300 mg tablet; ETV 0.5 mg capsule
Intervention type(s): Drug; Drug
Intervention description(s): Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate; Brown capsules, each capsule containing 0.53 mg of entecavir hydrate
Other intervention name(s): GSK548470; ETV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tenofovir Disoproxil Fumarate; Chronic Hepatitis B
Driving After Cervical Spine Surgery
Condition: Cervical Disc Disease
Study type: Interventional

Summary: 
      This is a single-center, prospective controlled simulation study designed comparing and
      evaluating the driving performance of subjects who have had cervical spine surgery and the
      use of a validated driving simulator. To date, there haven't been evidence-based
      recommendations to determine a patient's "fitness to drive" in the peri-operative or
      postoperative state. The objective of this study is to delineate the effect cervical spine
      procedures have on driving performance in the peri-operative time period. The study will take
      place at New York University Langone Medical Center - Hospital for Joint Diseases which will
      include the surgeries. The follow up visits will be at the NYU Center for Musculoskeletal
      Care.
    


Intervention name(s): STISIM driving simulator
Intervention type(s): Device
Intervention description(s): This simulator is complete with computerized driving scenarios and driving hardware, has been validated in numerous studies and allows for a more comprehensive investigation of driving performance. The simulated course recreates standard turns, traffic intersections, pedestrian crosswalks, lane changes and several hazardous conditions routinely encountered during driving situations.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cervical Spine Surgery; Simulation
Colchicine in Percutaneous Coronary Intervention
Condition: Coronary Artery Disease; Acute Coronary Syndrome
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Inflammation in the arteries of the heart may increase the risk of cardiac death. The
      proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory
      medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of
      the heart. With its quick onset of action and excellent safety profile, colchicine may have
      the potential to reduce risk of major adverse events related to the heart. This research also
      seeks to better understand the role of neutrophils, the most common type of inflammatory
      white blood cell in the body, when there is damage to the heart.
    

Detailed description: 
      The investigators will use colchicine as a tool to elucidate the role of neutrophil
      activation during acute vascular injury, and to explore the association between neutrophil
      activation and adverse cardiovascular outcomes. Colchicine reduces cell surface expression of
      selections, adhesion molecules key to neutrophil recruitment after vascular injury. Daily
      colchicine use is associated with reduced adverse cardiovascular events in stable
      atherosclerosis. Using a clinical percutaneous coronary intervention (PCI) model, the
      investigators evaluate whether pre-procedural colchicine (1.8 mg oral load over one hour)
      reduces the rate of post-PCI adverse cardiovascular outcomes in the context of a double-blind
      placebo-controlled randomized study. The investigators will also characterize neutrophil
      biology in acute vascular injury and the effects of colchicine on neutrophil biology in this
      setting.
    

Intervention name(s): Colchicine vs Placebo
Intervention type(s): Drug
Intervention description(s): Colchicine vs Placebo 1.8 mg PO over 1 hour
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inflammation; percutaneous coronary intervention; coronary artery disease; colchicine
D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents
Condition: Posttraumatic Stress Disorder; PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to show whether D-cycloserine in combination with cognitive
      behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of
      posttraumatic stress disorder (PTSD) in 13-18 year-old children.
    

Detailed description: 
      While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show
      improvement, they still have some enduring symptoms and functional impairment. Accordingly,
      there is a need for treatment advances. D-cycloserine (DCS), an antibiotic that has been used
      for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS
      was found to enhance learning and memory, and also facilitates extinction of fear reactions.
      However, DCS only produces an extinction effect when paired with behavioral training, not
      when simply given alone. Thus, the medication only needs to be given for seven doses in this
      research and youth do not need to take the medication long term. The research also includes a
      three-month follow-up.
    

Intervention name(s): D-cycloserine; Placebo pill; CBT
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.; Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol.; 12-session CBT protocol, called Youth PTSD Treatment.
Other intervention name(s): Seromycin; cognitive behavioral therapy
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavior Therapy; Children; Adolescents; Pharmacotherapy
Impact of Muscular Fatigability on Spastic Co-contractions After Stroke Patients
Condition: Stroke; Spasticity, Muscle; Muscle Fatigue; Gait, Hemiplegic
MeSH terms: Muscle Spasticity; Stroke; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      This study evaluates the effects of an isokinetic fatigue protocol of the quadriceps on the
      amount of co-contractions of this last with the hamstrings during a maximal isometric flexion
      movement in hemiparetic stroke patients.

      The effect of such a protocol on gait parameters and spasticity of the quadriceps will be
      evaluated also.
    


Intervention name(s): Muscle fatigue
Intervention type(s): Procedure
Intervention description(s): Isokinetic quadriceps muscle fatigue of the paretic lower limb
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Environment Analysis Inside an Investigational Prescription Bottle
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of the study is to test a research prescription bottle that will monitor the
      physical environment inside the bottle.
    

Detailed description: 
      The purpose of the study is to test a research prescription bottle that will monitor the
      physical environment inside the bottle. The participant will be asked to keep the medication
      in the bottle and to remove each pill immediately before taking it.

      The participant will not store medications in pill organizers, other pill bottles, pockets,
      purses, etc. The participant will keep a record of when the participant removes a pill from
      the bottle and takes it. Certain aspects of this study will be withheld from the participant
      to preserve the integrity of the study. This information will be revealed at the conclusion
      of the study.
    

Intervention name(s): Research Bottle; Regular prescription Bottle
Intervention type(s): Other; Other
Intervention description(s): The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.; This will test if the research bottle changes behavior relative to the research bottle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Denosumab and Osteoporotic Vertebral Compression Fracture
Condition: Osteoporotic Vertebral Compression Fracture
MeSH terms: Fractures, Bone; Fractures, Compression
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone
      turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in
      osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a
      12-month follow-up period.
    

Detailed description: 
      We performed a single-center, placebo-controlled, randomized clinical trial in the Department
      of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science
      and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and
      randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar,
      total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months
      post-operation. The visual analog scale (VAS) score for back pain, and function status
      questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire
      of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris
      Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in
      OVCF patients after vertebroplasty during a 12-month follow-up period.
    

Intervention name(s): Denosumab 60 mg/ml [Prolia]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): denosumab subcutaneously every 6 months (Q6M); placebo subcutaneously every 6 months (Q6M)
Other intervention name(s): Denosumab; equal volume of saline (0.9%)
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: denosumab; vertebroplasty
Playing AVI During Tennis Training Process
Condition: Learning, Spatial; Cognitive Change
Study type: Interventional

Summary: 
      Developing movement capabilities and efficiently acquiring and assimilating movement
      information and knowledge in middle childhood stages is of great importance for performing
      complex movement structures in later stages of life. Our study is directed to researching the
      influence of active video games (AVG) on assessment of tennis motor skills and visual
      capabilities in middle childhood, as a part of two separate sub-researches.
    

Detailed description: 
      In the first sub-research, which included a sample of 55 children aged between 7 and 9, the
      investigators measured the physiological responses of bodies after acute and chronic exposure
      to playing AVG. The investigators established a significant difference in skin conductance
      before beginning the intervention between the virtual and actual game. After the
      intervention, the experimental group had a significantly higher average value of heart rate
      frequency and breathing frequency while playing AVG in comparison to the control group.

      In the second sub-research the investigators measured progress in tennis technique (TRSC
      test), development of gross motor skills and change in reaction time on the same group of
      children. In the TRSC test, the control group improved in all sub-groups with both strokes.
      The experimental group made no improvements in sub-group 3d with the ''forehand'', 1d and 3d
      with the ''backhand''. In the gross motor skill development test the investigators have not
      established a significant interaction effect. In the analogue reaction time measurement test,
      the investigators recorded a significant interaction between time x group. The same goes for
      Simon's test with incongruent stimuli, with congruent the interaction was of no relevance.

      The investigators established that the use of AVG can represent a new strategy for combining
      movement/sports activities and cognitively directed tasks aiming at effective assessment of
      tennis skills.
    

Intervention name(s): Active video games; tennis training process
Intervention type(s): Device; Other
Intervention description(s): Participants played the active video game Virtua tennis 4 on a playstation kinect device; Participants were involved in a regular tennis training process, performed two times a week for one hour per lesson.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke technique; psychophysiological body responses; visual perceptual skills; reaction time.
Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Morphine and Naloxone on Motivation (MBBAnalgesic)
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the current study is to examine the role of the opioïd system on the cognitive
      parameters of motivation. They are embedded in a conceptual framework of motivation that
      merges decision-making and reinforcement learning theories. Every action is conceived as path
      from one state to another. The different states are associated to different values (positive
      for rewards and negative for punishments), and the different actions to different costs
      (risk, effort and delay). The tasks are designed such that the sensitivity to the state and
      action parameters can be inferred by fitting computational models.The primary objective is to
      characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on cost accumulation slope,
      assessed in an effort management task, in which participants are asked to squeeze a hand grip
      during 30 seconds at varying level of effort in order to win monetary payoff. Secondary
      objectives are to characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on other
      cognitive parameters of motivation (assessed with a motivational battery that includes
      rating, choice and learning tasks).
    


Intervention name(s): 50 mL of sodium chloride (0,9%); Morphine 0,05mg/kg; Naloxone 10mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Morphine; Naloxone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: volunteers
A Trial of HRS4800 Tables in Healthy Male Subjects
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-site study to evaluate the safety, tolerability and pharmacokinetics (PK) of
      single dose administration of HRS4800, and the effect of food on the PK of HRS4800 in healthy
      male subjects.
    


Intervention name(s): HRS4800 tablets; Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): single oral administration; single oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consists of 2 parts: single dose escalation (Part 1) with four cohorts and food effect on HRS4800 PK (Part 2) with one cohort. All cohorts can enroll healthy male subjects
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel
Condition: CYP2C19 Genotypes
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate if the genetic variant CYP2C19*17 affects the
      pharmacokinetics of proguanil and clopidogrel.
    


Intervention name(s): Proguanil; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): 2x350 mg Malarone followed by 3 days of blood- and urine sampling; 2x300 mg Plavix followed by 7 hours days of blood sampling
Intervention MeSH terms: Proguanil; Clopidogrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CYP2C19*17; Pharmacokinetics; Pharmacodynamics
Cancer Screening; Access; Awareness; Navigation
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      To assess the feasibility and efficacy of community-based Colorectal Cancer (CRC) screening
      intervention in increasing CRC screening rates To evaluate individual-level knowledge related
      to CRC screening and risk factors To characterize individual -level facilitators and barriers
      to engaging in CRC screening and related diagnostic tests and treatment when applicable.
    

Detailed description: 
      To address the multiple determinants of health that impact CRC screening in the South Shore
      community in the University of Illinois Cancer Center's catchment area by conducting an
      experimental intervention to test the effectiveness of Fecal immunochemical test (FIT) tests
      dispensed by community stakeholders (community-dispensed) versus FIT tests dispensed using
      standard of care procedures by a clinic dispensed FIT test return rates. This study will
      follow American Cancer Society (ACS) guidelines for FIT testing, with the South Shore
      community area assigned to the intervention group (community-dispensed). CRC screening within
      the Mile Square Englewood Health Center, using standard of care, will serve as our control
      group to use for comparison (clinic-dispensed). The intervention will include a multifaceted
      approach to health education and community engagement focused on CRC led by a team of trusted
      health champions (community leaders, a barber, a hair salon, and community health workers) in
      the South Shore community area.
    

Intervention name(s): Community-Based (Intervention Arm)
Intervention type(s): Other
Intervention description(s): Community dispensed FIT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental and Standard of care arms
Masking: None (Open Label)
Primary purpose: Screening