bioihbjkbjnl/mcl2 huggingface dataset:
Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to evaluate whether the efficacy of 1PC111 is superior to pitavastatin and
      ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week
      treatment period.
    


Intervention name(s): Pitavastatin; Ezetimibe; 1PC111
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pitavastatin, QD; Ezetimibe, QD; 1PC111, QD
Intervention MeSH terms: Ezetimibe; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary Hypercholesterolemia; Mixed Dyslipidemias
Bioavailability of Nasal Epinephrine
Condition: Anaphylaxis
MeSH terms: Anaphylaxis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of
      FMXIN002 Microspheres Powder with Epinephrine 0.3 mg Intramuscular Injection in Adult
      Subjects with Seasonal Allergic Rhinitis with and without Nasal Allergen Challenge
    

Detailed description: 
      Study Design: Open-label, single-dose, two-period, three-treatment, fixed-sequence,
      comparative bioavailability study Study Population: Non-smoking, male and female subjects,
      from 18 to 55 years of age with known history of hay fever, seasonal allergies, or rhinitis
      during the last year.
    

Intervention name(s): Epinephrine Nasal Product, 1.6 mg; Epinephrine nasal product, 1.6 mg + allergen; Epinephrine Injection 0.3 mg; Epinephrine Nasal Product, 3.2 mg; Epinephrine Nasal Product, 3.2 mg + allergen
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose Nasal powder spray without allergen challenge; Single dose Nasal powder spray with allergen challenge; Intramuscular injection; Twice dose Nasal powder spray without allergen challenge; Twice dose Nasal powder spray with allergen challenge
Other intervention name(s): FMXIN002 Microspheres Powder; FMXIN002 Microspheres Powder; EpiPen; FMXIN002 Microspheres Powder, double dose; FMXIN002 Microspheres Powder, double dose
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Intervention model: Sequential Assignment
Intervention model description: Open-label, single-dose, two-period, three-treatment, fixed-sequence, comparative bioavailability study
Masking: None (Open Label)
Primary purpose: Treatment
Role of Liver and Visceral Fat in Glucose and Lipid Metabolism During Pregnancy
Condition: Pregnancy; Gestational Diabetes; Obesity; Liver Fat
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be
      associated with adverse maternal and fetal pregnancy outcomes. This study will examine how
      fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to
      metabolize glucose (sugar) during pregnancy.
    

Detailed description: 
      This study aims to serially evaluate liver and visceral fat stores during pregnancy and their
      relationship with glucose and lipid metabolism, placental function, and newborn size. To do
      this we will conduct both a prospective cohort study of pregnant women without
      pre-gestational or early gestational diabetes assessed at both 12-16 weeks gestation and at
      32-36 weeks gestation and a case-control study of women with normal and impaired glucose
      tolerance in the early third trimester. Physical assessments will be performed by the Oregon
      Health and Science University bio-nutrition unit and will include the use of magnetic
      resonance imaging, ultrasound, and blood draws.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women ages 18-40 years and actively enrolled in Kaiser Permanente Northwest
        (KPNW).
Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic
Condition: COVID19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The SARS-CoV-2 pandemic has resulted in an international shortage of the nasopharyngeal (NP)
      swabs used to collect sample for virological testing. This shortage has become a crisis as
      testing capacity is growing, and threatens to become the bottleneck at University of Virginia
      Health System and in the Commonwealth of Virginia, as it already is in other testing centers.
      To resolve this crisis, a team in the Clinical Microbiology Laboratories at University of
      Virginia Medical Center has been working closely with biomedical engineers in the University
      of Virginia (UVA), School of Engineering and with high volume domestic manufacturers
      developing injection molded polypropylene flocked nylon NP swab.

      This prototype will be tested for non-inferiority relative to existing, already validated NP
      swabs ("control swab") for purposes of molecular microbiology: i.e. the polymerase chain
      reaction (PCR) tests used for virological testing for SARS-CoV-2. Specifically, the
      nasopharynx of patients with Covid-19 and patients under investigation (PUI) for Covid-19,
      the disease caused by SARS-CoV-2, will be swabbed using a prototype swab and a control swab
      (the standard of care swab), and test for concordance of SARS-CoV-2. In all cases the swab
      will be transported in validated FDA cleared viral transport medium (VTM) as per standard
      operating procedure at University of Virginia Medical Center.
    


Intervention name(s): Control swab; Prototype swab
Intervention type(s): Device; Device
Intervention description(s): FDA-cleared nasopharyngeal swab; Injection molded polypropylene flocked nylon nasopharyngeal swab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The primary objective of this study is to determine whether the newly designed nasopharyngeal swabs perform acceptably compared to standard swabs.
Masking: None (Open Label)
Primary purpose: Other
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese
      Infants
    


Intervention name(s): 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this research study is to learn how best to use patient portals to help
      improve the treatment of mood disorders.
    

Detailed description: 
      This study is being done in 3 phases. First 2 phases were observational with total enrollment
      of 300 subjects. The final 3rd phase is interventional and we are anticipating to enroll 50
      subjects. It is described below.

      Patients being treated for depressive symptoms at the University of Iowa, Department of
      Psychiatry are invited to participate. Participants will complete a remote (phone or video)
      visit. After being informed about the study and potential risks, those who consent to being
      in the study will be assigned to one of two groups. They will complete an online survey and
      receive some basic training on patient portals. After the visit. both groups will be followed
      for 6 months. Depending on their group assignment, they will complete:

        -  two to five phone calls with a study team member and

        -  two to five online questionnaires
    

Intervention name(s): ConnectCare
Intervention type(s): Behavioral
Intervention description(s): increased monitoring between clinical mental health visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: patient portals; treatment adherence
Efficacy of TAK-085 in Participants With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the efficacy and safety of TAK-085, once daily
      (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily
      (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.
    

Detailed description: 
      TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085
      contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl
      docosahexaenoic acid (DHA-E)).

      This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of
      TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing
      lifestyle modification.

      The study period is a total of 20 weeks, comprised of an 8- week screening period and 12
      weeks of treatment.
    

Intervention name(s): Omega-3-acid ethyl esters 90 (TAK-085); Eicosapentaenoic acid-ethyl (EPA-E)
Intervention type(s): Drug; Drug
Intervention description(s): Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.; EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.
Other intervention name(s): LOVAZA; Omacor; Atheropan®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single-center, open-label, drug-drug interaction study in healthy male
      and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of
      itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be
      assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole
      or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the
      effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in
      approximately 18 subjects. In Part C, the effects of donepezil administered in combination
      with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in
      approximately 24 subjects.
    


Intervention name(s): E2609; itraconazole; rifampin; digoxin; donepezil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Itraconazole; Rifampin; Digoxin; Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects
Phase 2 Study of VGT-309 in Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in
      up to 40 subjects undergoing lung cancer surgery.
    

Detailed description: 
      A Phase 2, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted,
      activatable fluorescent imaging agent, to identify cancer in subjects undergoing lung cancer
      surgery. A total of 40 subjects will be enrolled to ensure at least 38 evaluable subjects
      with the option to expand enrollment by protocol amendment if deemed necessary to meet
      primary and/or secondary objectives.

      Following agreement with and signing of the informed consent, subjects will undergo screening
      measurements for the study. Assessments include the following, unless they have been done
      within 4 weeks prior to the anticipated dosing:

        1. Medical, surgical and medication history.

        2. Complete physical exam, including vital signs and weight.

        3. Standard pre-operative chemistry, hematology, coagulation and urinalysis clinical
           laboratory studies.

        4. 12-lead ECG.

        5. Serum pregnancy test for females of child-bearing potential.

      Following clearance of all enrollment criteria, each subject will receive an IV
      administration of 0.32 mg/kg VGT-309 at 12-36 hours prior to surgery (refer to section
      VGT-309 Dosing, below). Upon dosing, subjects will be observed for up to 2 hours and asked
      about possible treatment emergent adverse events.

      Subjects will undergo surgical resection as planned and within the time specified following
      VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the
      pathological examination of all surgical specimens.

      Following surgery, subjects will be monitored for safety during their hospitalization. After
      discharge from the hospital, and approximately 14 days post-surgery, the subjects will be
      contacted by telephone to assess their well-being. Between 19 to 39 days post-surgery,
      subjects will either return to the clinic or participate in a telehealth visit for final
      safety assessments. If there are no adverse events requiring further follow up, subjects will
      then be released from the study.
    

Intervention name(s): VGT-309
Intervention type(s): Drug
Intervention description(s): VGT-309 is an tumor-targeted, activatable fluorescent imaging agent which will be used with near infrared imaging during surgery to identify tumor.
Intervention model: Single Group Assignment
Intervention model description: All subjects to be dosed at the same dose level. This is open label and no randomization is required.
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain
Condition: Evaluation; Treatment
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study was to determine the validity, reliability and sensitivity of the
      Cognitive Exercise Therapy Approach Scale in patients with neck pain.
    

Detailed description: 
      According to the power analyzes 199 neck pain patients will be taken to the study.The study
      will be initiated after the approval of the Ethics Committee of the Eastern Mediterranean
      University Faculty of Health Sciences. After informing about the content of the study,
      individuals who want to participate in the study will be asked to sign the informed consent
      form. In order to evaluate the validity and reliability of the BETY scale in the study, the
      same individuals will be given a test-retest with 1 week intervals. In these tests, the Neck
      Disability Index (NDI), Arm Shoulder and Hand Problems Questionnaire (DASH), Short Form-36
      (SF-36), Hospital Anxiety and Depression Scale (HADS) and BETY scale will be applied.In order
      to assess the sensitivity to change, 44 individuals will be asked to re-fill the forms after
      the traditional physiotherapy program for neck pain, which will be administered 10 sessions.
      For 2 weeks, a routine exercise program consisting of 20 minutes of conventional TENS, 20
      minutes of hotpack, 8 minutes of therapeutic ultrasound and isotonic, isometric, stretching
      and relaxation exercises will be applied.
    

Intervention name(s): Assigned Interventions
Intervention type(s): Other
Intervention description(s): exercises, physical agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cognitive Exercise Therapy Approach Scale; validity; reliability; responsiveness; neck pain
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
Condition: Health Care Utilization; Vaccine Preventable Disease
MeSH terms: Vaccine-Preventable Diseases
Study type: Interventional

Summary: 
      Our objective is to determine the effectiveness of varied outreach methods to children age
      12-17 years old who are due for a well child check visit and don't have one scheduled in the
      next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt
      of the COVID-19 vaccination.
    


Intervention name(s): Low tailored message; No message; Low tailored message plus COVID-19 vaccine message
Intervention type(s): Other; Other; Other
Intervention description(s): 2 low tailored text or phone message reminders that child is overdue for well child check visit; No reminders are sent; 2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma
Condition: Dysplastic Nevus; Health Status Unknown; Melanoma; No Evidence of Disease
MeSH terms: Melanoma; Dysplastic Nevus Syndrome
Study type: Interventional

Summary: 
      This trial studies an internet-based intervention for skin self-examination (SSE) in
      participants at increased risk for melanoma. Early detection of suspicious growths on the
      skin can be done by performing regular SSE checks. Using an internet-based intervention, such
      as mySmartCheck, may help to promote regular, thorough checks on the skin in individuals at
      increased risk for melanoma.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To evaluate the impact of mySmartCheck versus usual care on skin-self-examination (SSE)
      behaviors among individuals at increased risk for developing melanoma.

      SECONDARY OBJECTIVES:

      I. To evaluate the impact of mySmartCheck versus usual care on patients barriers and benefits
      to conducting SSE, SSE self-efficacy (confidence), level of worry about developing melanoma,
      and number of health care consultations (visits, telephone calls, and emails).

      II. To evaluate whether mySmartCheck effects are moderated by the patient's Total Body
      Photography (TBP) status.

      III. To identify barriers and facilitators to using mySmartCheck.

      OUTLINE:

      PHASE I: Participants complete a telephone based usability testing of the online program.
      Participants complete between 1-5 user testing sessions of the mySmartCheck program (about
      45-60 minutes per session) to provide feedback on acceptability, satisfaction, comprehension,
      and usability.

      PHASE II: Participants are randomized to 1 of 2 groups. Both the intervention and control
      group complete a baseline survey as well as a 13 weeks post-baseline survey.

      GROUP I: After completing the baseline survey, participants receive access to the
      mySmartCheck program, and continue to receive standard of care. Participants are asked to
      complete another survey 13 weeks post-baseline.

      GROUP II: After completing the baseline survey, participants receive standard of care.
      Participants are asked to complete another survey 13 weeks post-baseline.

      Study duration is 13 weeks for all participants.
    

Intervention name(s): Best Practice; mySmartCheck; Survey Administration
Intervention type(s): Other; Behavioral; Other
Intervention description(s): Receive standard of care; Receive access to mySmartcheck program; Ancillary studies
Other intervention name(s): standard of care; standard therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS
Condition: Radiography; Emergencies; Diagnostic
MeSH terms: Emergencies
Study type: Observational

Summary: 
      This study assesses the performance of radiographers in detecting radiological anomalies of
      the appendicular skeleton in emergency department. This is a retrospective study comparing
      the radiographers' diagnostic performance before and after dedicated training, assisted or
      not by artificial intelligence software. All performances will be evaluated and compared.
    


Intervention name(s): Emergency radiography
Intervention type(s): Diagnostic Test
Intervention description(s): The intervention is to determine how the radiographer classify emergency radiography.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Radiographer : a health practionner with official autorisation to use X-ray imagery.
Uterocervical Angle in the Pregnancy Termination of Multiparous Women
Condition: Medical; Abortion, Fetus; Second Trimester Abortion
Study type: Observational

Summary: 
      To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination
      success of multiparous women.
    

Detailed description: 
      Medical termination of pregnancy is a common procedure in obstetrics. In recent years,
      uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor.
      Dziadosz et al concluded that the performance of UCA was even better than the cervical length
      in their cohort. A wide UCA during second trimester shown to have an increased risk of
      preterm labor and narrow angle was less likely to have labor.

      The investigators are aimed to investigate predictive role of both cervical length and UCA in
      the termination of second trimester pregnancy.The investigators focused on multiparous women
      who are taking Foley baloon for the cervical preparation and aim to measure their UCA.
    

Intervention name(s): uterocervical angle
Intervention type(s): Other
Intervention description(s): the angle between cervical canal and anterior uterine wall is measured sonographically.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiparous pregnant women undergoing medical abortion in the second trimester
      
Keywords: uterocervical angle; multiparous