bioihbjkbjnl/mcl2 huggingface dataset:
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
Condition: Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Recurrent
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      1. Trial design: Prospective observational study

        2. Target population: 200 NSCLC patients with histologically or cytologically confirmed
           stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who
           consent for study participation and meet the study selection criteria

        3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations
           in NSCLC patients treated with Erlotinib

             -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR

        4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome
           (Overall Response Rate, Progression Free survival )

        5. Duration of Trial Recruitment: 2 years
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who
        have progressive disease after 1st line chemotherapy who consent for study participation
        and meet the study selection criteria
      
Biospecimen description: 
      NSCLC tumor tissue for c-MET expression by immuohistochemistry c-MET amplification by silver
      in situ hybridization EGFR mutation by realtime PCR
Drug-Drug Interaction Study in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effects of cyclosporine on the
      pharmacokinetics of K-877 in healthy adult subjects.
    


Intervention name(s): K-877; Cyclosporine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Adult Volunteers
Coping Strategies and Responsiveness to a Brief Online Intervention During COVID-19 Pandemic
Condition: Behavior, Social; Autonomic Imbalance
Study type: Interventional

Summary: 
      The present study investigates the efficacy of a brief and cost-effective video-intervention
      that combines bottom-up elements of deep breathing and third-wave cognitive behavioral
      therapy techniques (i.e., mindfulness and compassion) on coping strategies during the
      COVID-19 pandemic.
    


Intervention name(s): Deep Breathing training; Compassion focused intervention
Intervention type(s): Other; Other
Intervention description(s): The intervention will comprise a psychoeducational part on the theorethical background underlying this technique and a pratical session in which partecipant will be instructed to inhale air with his/her nose and exhale with his/her mouth for a period of 3 seconds of inhalation and 7 seconds of exhalation (i.e., 6 cycles of breaths per minute;). During the session, the participant will be encouraged to put one hand over his/her chest and the other over the abdomen in order to see the difference between normal breathing and deep breathing. To help the subjects in the training, an online pacer will give the rhythm of respiration and will be used as visual feedback.; The short compassion focused intervention will begin with a short psychoeducation on the evolved nature and difficulties of the human mind, such as tendencies for negativity bias, negative rumination, and self-criticism. Participants will then be offered insights into how humans can work with their 'tricky brains' using body-based and psychological-based practices aimed at increasing a grounding and soothing compassionate attitude towards ourselves and others. In particular, participants will be instructed to pratice a mindfulness technique designed to help them to become more aware of their present moment-to-moment and more compassionate towards their own emotions. They will then be guided to create an image conveying warmth and compassion to them. Lastly, participants will be guided to bring the image to mind and then write write a brief "self-compassionate letter" to themselves from that point of view.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: wait-list control design
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
The Effect of Simulation-based Training on Nursing Students
Condition: Simulation; Education; Learning; Clinical Skills; Child
Study type: Interventional

Summary: 
      This research will be carried out with the aim of making this practice practical with
      simulation-based training and improving cognitive, affective and psychomotor skills, and then
      applying it in the clinic, before applying the nasogastric tube placement application, which
      is included in enteral nutrition, to the child in the clinic.
    

Detailed description: 
      The fact that children react according to their age and cannot be considered separately from
      their families makes it difficult for nurse students to apply to the child group. When it
      comes to interventions that may cause stress/pain/discomfort, it can be even more difficult
      to manage the reactions of the child and family. By using the simulation method, the problems
      that make this type of teaching difficult can be reduced.For this reason, the aim of this
      study is for student nurses to make this practice practical with simulation-based training
      and to develop cognitive, affective and psychomotor skills before applying nasogastric tube
      placement, which is included in enteral nutrition, to a real child in the clinic, and then to
      apply it in the clinic.
    

Intervention name(s): Simulated group
Intervention type(s): Other
Intervention description(s): Students will be given training on nasogastic tube insertion and practice will be demonstrated in the laboratory based on the demonstration method and checklists, and will continue until students learn. Forms will be applied to students as a pre-test. A pilot scenario will be applied to two volunteer fourth year students.
Prebriefing: Students will be informed. Students will implement the scenario in the simulation laboratory and will wear uniforms. The student will be given 5 minutes for preparation, the application will be taken one by one and 15 minutes will be given for practice. Researchers will only observe during this time. During the application, the student will be scored according to the checklist. Students will be recorded with video.
Debriefing: Immediately after the end of the scenario, a debriefing session will be held with groups of 5 people. Feedback will be given on students' performance. Each session will last 20-30 minutes. Students will be given a post-test.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Simulation; Nursing student; Clinical skills; Child
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
Condition: Influenza Caused by the Novel Influenza A (H1N1) Virus
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for
      eliciting an immune response to H1N1 influenza in healthy adults.
    


Intervention name(s): CSL425; CSL425
Intervention type(s): Biological; Biological
Intervention description(s): CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume); CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Adults with Crohn's disease that is clinically active despite conventional treatment will be
      eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental
      drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
    


Intervention name(s): PF-00547659 SC injection; PF-00547659 SC injection; PF-00547659 SC injection; PF-00547659 SC injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo delivered SC, 3 doses separated by 4 weeks; Drug dose level 1 delivered SC, 3 doses separated by 4 weeks; Drug dose level 2 delivered SC, 3 doses separated by 4 weeks; Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's disease Safety Efficacy Pharmacokinetics Pharmacodynamics Crohn's Disease Activity Index (CDAI)
Project Fit:a School- and Community-based Obesity Intervention
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Project FIT is a collaboration between the public school system, local health systems,
      physicians, neighborhood associations, businesses, faith-based leaders, community agencies
      and university researchers to develop a multi-faceted approach to promote physical activity
      and healthy eating toward the general goal of preventing and reducing childhood obesity among
      children in Grand Rapids, MI, USA. There are four overall components to Project FIT: school,
      community, social marketing, and school staff wellness - all that focus on: 1) increasing
      access to safe and affordable physical activity and nutrition education opportunities in the
      schools and surrounding neighborhoods; 2) improving the affordability and availability of
      nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge,
      self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school
      staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to
      incorporate healthful values; and 5) encouraging dialogue among all community partners to
      leverage existing programs and introduce new ones.
    


Intervention name(s): Project Fit
Intervention type(s): Behavioral
Intervention description(s): physical activity and nutrition education
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical inactivity; poor diet
Cohort Study on Internet Game and Smart Phone Addiction
Condition: Adolescent Problems; Addictive Behavior
MeSH terms: Behavior, Addictive; Internet Addiction Disorder
Study type: Observational

Summary: 
      The aim of this cohort study is to observe the prevalence, incidence, relapse, and remission
      rates of online and/or smartphone game addiction among elementary and secondary school
      students in Korea. In addition the investigators are going to identify risk and protective
      factors, to determine whether online and/or smart phone game addiction is a primary or
      secondary problem, and to identify outcomes for individuals who become or stop being online
      and smart phone game addiction.
    

Detailed description: 
      Participants:

      Total 3,000 children will be enrolled the cohort and followed up for 4 years.

      Procedures:

      These students will be surveyed annually between 2015 and 2019. Surveys were conducted in
      classrooms by trained interviewer who had been trained by the research team assisted by the
      teachers.

      Measurements

        -  usage and frequency of internet, internet game, and smartphone game etc.

        -  interpersional relationship; with family members, peer group, and teacher etc.

        -  personal characteristics; self esteem, social support, depression, anxiety,
           hyperactivity etc.

        -  Socio-demographic factors
    

Intervention name(s): refer to mental health specialists
Intervention type(s): Other
Intervention description(s): children who have diagnosed internet and/or smartphone disorder by psychiatrists referred to mental health specialists
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tatal 3,000 elementaty and sencondary school students
Impact of Flaxseed on the Syndrome Metabolic Inflammation
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study aims to evaluate the effects of enterolignanas of flaxseed on nutritional and
      inflammatory indicators in male workers of a food industry.
    


Intervention name(s): Flaxseed or rice raw powder ingestion
Intervention type(s): Other
Intervention description(s): The experimental groups received isocaloric diets and different proportions of carbohydrates, and the introduction of 60g of brown flaxseed or rice raw powder. Flaxseed and raw rice were crushed weekly by minimal particle type mill and appropriate sieves for fine grinding grain with a degree to 250 mm/micrometers. After crushing flaxseed and raw rice, they were weighed in semi-analytical balance. The addition of flaxseed or raw rice powder was made in the collation (40 g added to milk) and lunch (20 g added to baked beans). The volunteers received flaxseed or rice raw powder, portioned to be used for 42 days, including the weekends.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: flaxseed; lignans; inflammation; Nutrition; enterolactone; enterodiol
A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of
      the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune
      responses to the 13 serotypes in common Prevnar 13®
    


Intervention name(s): V114 Aluminum-adjuvanted; V114 Non-adjuvanted; Prevnar 13®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Invasive pneumococcal disease; Pneumonia; Pneumococcal conjugate vaccine
Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
Condition: Knee Prosthesis; Knee Arthroplasty
Study type: Observational

Summary: 
      The objectives of this study are four-fold:

        1. To determine the three-dimensional, in vivo kinematics for subjects having either a
           fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis,
           comparing the in vivo kinematics to determine if one implant type leads to a benefit for
           the patient.

        2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar
           III Prosthesis under in vivo, weight-bearing conditions during multiple activities
           (gait, stair descent, deep knee bend and chair rise).

        3. To determine if there is a correlation between in vivo kinematic data obtained using
           fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine
           if variability occurs between these two TKA types.

        4. To determine if a clinical benefit is either visibly detected (video camera) or
           quantifiably determined (questionnaire) for either TKA type.
    


Intervention name(s): DePuy fixed-bearing Total Condylar III (TC3) TKA; DePuy PFC Rotating Platform TC3 TKA
Intervention type(s): Device; Device
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects requiring total knee arthroplasty
Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals
      are to assess the safety, tolerability and blood levels of ascending doses of multiple
      formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on
      exposure, in healthy subjects.
    


Intervention name(s): PF-06650833; Placebo; PF-06650833; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive sequential single escalating doses of 1-1000 mg of Immediate Release of PF-06650833 (as solution/suspension) under fed and / or fasted conditions.; Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as solution/suspension) under fed and/ or fasted conditions.; Subjects will receive sequential single escalating doses of 10-500 mg of Modified Release of PF-06650833 (as capsule) under fed and / or fasted conditions.; Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as capsule) under fed and/ or fasted conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this study is to assess the safety and tolerability of ascending
      single and multiple oral doses of SAM-531 in healthy subjects
    


Intervention name(s): SAM-531; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study is to determine the relative performance of a new toric soft
      contact lens against a toric and a spherical contact lens currently available in market,
      specifically with regards to the fit and visual acuity as well as the comfort, vision and
      satisfaction while in the practitioner's office. Approximately 2 hours duration.
    

Detailed description: 
      Non-dispensing, single-masked (subject-masked), randomised, controlled study.
    

Intervention name(s): senofilcon A toric contact lens; alphafilcon A toric; etafilcon A sphere
Intervention type(s): Device; Device; Device
Intervention description(s): contact lens; contact lens; contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: astigmatism; visual acuity; fit; comfort; satisfaction; contact lens
The Effect of Perthes' Disease on Hip Cartilage
Condition: Perthes' Disease
MeSH terms: Legg-Calve-Perthes Disease
Study type: Observational

Summary: 
      The purpose of this study is to determine whether Perthes' disease has caused detectable hip
      cartilage damage in young people who have reached the healed stage of the disease.
    

Detailed description: 
      We will recruit 20 subjects from our healed Perthes' population. We will use dGEMRIC imaging
      to identify regions of cartilage degeneration in the femur and acetabulum. Both hips will be
      imaged so that we can use the unaffected side as a control. We will apply dGEMRIC imaging,
      which allows the composition of cartilage (specifically, the concentration of
      glycosaminoglycans [GAGs], important structural proteins in the cartilage) to be assessed.

      The MRI protocol consists of intravenous injection of 0.4 ml/kg dose of gadopentetate
      dimeglumine 2- [Gd-DTPA2-] contrast agent (Magnevist, Bayer) 90 minutes prior to imaging. Due
      to the need to image within a relatively narrow window of time, each hip of each subject must
      be imaged on separate days. The subject will be asked to walk for 10 minutes after receiving
      the contrast agent injection to facilitate equilibration of contrast agent into the hip
      joint.

      The scans will be performed at UBC's High Field Imaging Centre on the 3T Phillips Intera
      scanner. Dr. Wilson has access to this scanner for his research. The scanning protocol is as
      follows: 3D IR-TFE sequence with TR/TE/Flip of 4.7 ms/1.6 ms/30 o and seven inversion times;
      1600, 1200, 800, 400, 200, 300, and 100 ms. In-plane resolution is 0.7 mm with a slice
      thickness of 3 mm. Total imaging time is approximately 1 hour (at each visit). The T1
      calculated image will be obtained using validated, custom written software (IGOR). The
      resulting image provides a map approximating glycosaminoglycan concentration and,
      consequently, cartilage degeneration.

      The MRI will not be done under sedation. MRIs are performed under sedation at BCCH for
      children under age seven. Subjects in this study will be between the ages of 7 and 18. The
      contrast agent, Gd-DTPA2- is routinely used in children in the clinical setting.

      Radiographs used for comparison are obtained as part of standard of care follow-up protocol.
    

Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): MRI protocol consists of intravenous injection of 0.4 ml/kg dose of gadopentetate dimeglumine 2- [Gd-DTPA2-] contrast agent (Magnevist, Bayer) 90 minutes prior to imaging.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Volunteers with healed unilateral Perthes' disease between the ages of 7-18 years
      
Keywords: MRI; Perthes'disease; hip; cartilage
Observing the Morphology of Schlemm's Canal and Crystalline Lens in Different Age
Condition: Schlemm's Canal Occlusion
Study type: Interventional

Summary: 
      The aim of this study is to quantify and observe the morphology of trabecular meshwork (TM),
      Schlemm's canal (SC), ciliary body and crystalline lens before and after cycloplegia in
      patients with different ages using swept-source optical coherence tomography.
    


Intervention name(s): swept-source optical coherence tomography
Intervention type(s): Device
Intervention description(s): Aswe pt-source OCT (CASIA SS-1000; Tomey Corporation, Nagoya, Japan), which is specifically designed for anterior segment imaging using a 1310 nm wavelength with a scan speed of 30,000 A-scans per second and an axial resolution of <10 μm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention