bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Condition: Uncontrolled Asthma
MeSH terms: Asthma
Intervention: Tralokinumab; Placebo
Intervention description: Subcutaneous injection; Subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1207.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Reactive Airways; Respiratory Tract Disease; Obstructive Lung Disease; Lung Diseases

Summary:

      A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3
      Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with
      Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12 -75

          2. Documented physician-diagnosed asthma.

          3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg
             fluticasone propionate dry powder formulation equivalents) and a LABA

          4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of
             age) of their PNV.

          5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1

          6. ACQ-6 score ≥1.5

        Exclusion Criteria:

          1. Pulmonary disease other than asthma

          2. History of anaphylaxis following any biologic therapy

          3. Hepatitis B, C or HIV

          4. Pregnant or breastfeeding

          5. History of cancer

          6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years

          7. Previous receipt of tralokinumab
Management of Etonogestrel Subdermal Implant-related Bleeding
Condition: ESI-related Bleeding
MeSH terms: Hemorrhage
Intervention: Doxycycline; Placebo
Intervention description: Doxycycline 100 mg oral capsules twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.; Placebo, one capsule orally twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.
Intervention MeSH terms: Doxycycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Implanon; Etonogestrel subdermal implant; Nexplanon; Contraception; Irregular Bleeding; Menometrorrhagia

Summary:

      This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be
      conducted within the Mayo Clinic and the Mayo Clinic Health System.

      The goal of the research study is to gather information to determine whether Doxycycline is
      effective for the treatment of unacceptable bleeding associated with the etonogestrel
      subdermal implant (ESI), as compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women, aged 18-51 years

          -  Expressed desire for compliance-independent contraception

          -  No current pregnancy or anticipated desire for childbearing within 3 years of study
             enrollment and Implanon insertion

          -  Agreement to participate in all study related procedures and evaluations as documented
             by a signed informed consent

        Exclusion Criteria:

          -  Current or prior use of Implanon

          -  Current long-term use of Doxycycline for other indications

          -  Known structural uterine abnormalities such as polyp, submucosal leiomyoma

          -  Prior permanent sterilization or endometrial ablation

          -  Pregnancy or desire for childbearing within 3 years

          -  Contraindications to or intolerance of etonogestrel

          -  Allergy to or intolerance of Doxycycline

          -  Inability or unwillingness to complete study related procedures and evaluations
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: Oteseconazole (VT-1161); Placebo
Intervention description: Oteseconazole (VT-1161) 150mg capsule; matching placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 438.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is
      defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of
      oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for
      RVVC than other oral anti-fungal medicines.

      This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the
      treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for
      the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd
      part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg
      or a placebo (according to a random assignment), and then a 36-week follow-up period.

      In addition, at participating sites, an amendment to the study allows US patients who
      complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a
      48-week observational extension period designed to evaluate the continued effectiveness of
      oteseconazole (VT-1161).

      This study is identical to VMT-VT-1161-CL-012 (NCT03561701).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  3 or more episodes of acute VVC in the past 12 months

          -  Positive KOH or Gram stain

          -  Total vulvovaginal signs and symptoms score of ≥3 at screening visit

          -  Total vulvovaginal signs and symptoms score of <3 at baseline visit

          -  Must be able to swallow pills

        Key Exclusion Criteria:

          -  Presence or a history of another vaginal or vulvar condition(s)

          -  Evidence of major organ system disease

          -  History of cervical cancer

          -  Poorly controlled diabetes mellitus

          -  Pregnant

          -  Recent use of topical or systemic antifungal or antibacterial drugs

          -  Recent use of immunosuppressive or systemic corticosteroid therapies
Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants
Condition: Pneumonia, Pneumococcal
MeSH terms: Pneumonia, Pneumococcal
Intervention: Pneumosil; Prevenar 13; Synflorix
Intervention description: One single dose contains 2 μg of polysaccharide for serotypes 1, 5, 6A, 7F, 9V, 14, 19A, 19F and 23F, and 4 μg for serotype 6B formulated with aluminium phosphate as an adjuvant in an appropriate buffer; One single dose contains 2.2 µg of the following pneumococcal polysaccharides serotypes - 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - and 4.4 µg of pneumococcal polysaccharide serotype 6B, all conjugated to CRM197 and absorbed onto aluminum phosphate; One single dose contains 1 μg of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14, and 23F, and 3μg of serotypes 4, 18C, and 19F formulated with aluminum phosphate as an adjuvant.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 660.0
Sex: All
Minimum age: 42 Days
Maximum age: 56 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objectives of this study are to evaluate the immunogenicity (antibody response)
      and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of
      Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants based on medical history and clinical assessment.

          -  Between 6 and 8 weeks (ie 42 to 56 days) old, inclusive.

          -  Subject's parent must provide voluntary written/thumb-printed informed consent and be
             willing to comply with study requirements and procedures.

          -  Subjects must have been born full-term, have a weight-to-height Z score of ≥ -2 at the
             time of enrollment (WHO child growth standard), and be ≥ 3.5 kg at randomization.

          -  Subject's parents must be available for the duration of trial participation

        Exclusion Criteria:

          -  Use of any investigational medicinal product prior to randomization.

          -  Previous vaccination against or infection with S. pneumoniae.

          -  History of anaphylactic shock or an allergic reaction to any prior vaccination.

          -  Any fever, illness (including malaria).

          -  Receipt of another study vaccine within 30 days of study start.

          -  Chronic administration of an immunosuppressant or administration of immunoglobulins

          -  History of blood disorder, primary immunodeficiency, or a sibling who has such a
             diagnosis or who died suddenly without apparent cause.

          -  History of meningitis, seizures or any neurological disorder.

          -  Exposure to human immunodeficiency virus (HIV) by history.
The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
Condition: Familial Chylomicronemia Syndrome; Lipoprotein Lipase Deficiency; Hyperlipoproteinemia Type 1
MeSH terms: Hyperlipoproteinemia Type I; Hyperlipoproteinemias; Hyperlipidemias; Syndrome
Intervention: Volanesorsen
Intervention description: 300 mg volanesorsen administered via SC injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants
      with FCS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must give written informed consent to participate in the study (signed and dated) and
             any authorization required by law.

          -  Able and willing to participate in a 65-week study.

        Group 1 and 2:

          -  Satisfactory completion of ISIS 304801-CS6 (NCT02211209) or ISIS 304801-CS16
             (NCT02300233) index studies with an acceptable safety profile, per Sponsor and
             Investigator judgment.

        Group 3:

          -  Participants who did not participate in the CS6 or CS16 index studies and meet
             additional inclusion criteria of FCS may enroll in the study.

          -  History of chylomicronemia.

          -  A diagnosis of FCS (Type 1 Hyperlipoproteinemia.)

          -  Fasting triglycerides greater than or equal to (≥)750 milligrams per deciliter [mg/dL]
             (8.4 millimoles per liter [mmol/L]) at Screening.

        Exclusion Criteria:

          -  Unwilling to comply with lifestyle requirements for the duration of the study.

        Group 1 and 2:

          -  Have any new condition or worsening of existing condition which in the opinion of the
             Investigator would make the participant unsuitable for enrollment, or could interfere
             with the participant participating in or completing the study.

        Group 3:

          -  Diabetes mellitus if newly diagnosed or if hemoglobin A1c (HbA1c)≥ 9.0%.

          -  Active pancreatitis within 4 weeks of screening.

          -  Acute Coronary Syndrome within 6 months of screening.

          -  Major surgery within 3 months of screening.

          -  Treatment with Glybera therapy within 2 years of screening.

          -  Have any other conditions in the opinion of the investigator which could interfere
             with the participant participating in or completing the study.
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
Condition: Skin Structures and Soft Tissue Infections
MeSH terms: Soft Tissue Infections
Intervention: Iclaprim; Vancomycin
Intervention description: Experimental treatment; Active comparator
Intervention MeSH terms: Vancomycin; Iclaprim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 613.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim
      compared to vancomycin for the treatment of skin and skin structure infections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. written informed consent;

          2. ≥18 years of age;

          3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;

          4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;

          5. the presence of purulent or seropurulent drainage or at least three signs and symptoms
             of infection (discharge, erythema, swelling, warmth, or pain).

        Exclusion Criteria:

          1. severely impaired arterial blood supply such that amputation of the infected
             anatomical site is likely;

          2. infected diabetic foot ulcers;

          3. infected decubitus ulcers;

          4. necrotizing fasciitis or gangrene;

          5. uncomplicated skin or skin structure infection;

          6. infections associated with a prosthetic device;

          7. suspected or confirmed osteomyelitis;

          8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression
             therapy.
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: SAR153191 (REGN88)
Intervention description: Pharmaceutical form: solution
Route of administration: subcutaneous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2023.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Main Study:

      Primary Objective:

      Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA).

      Secondary Objective:

      Assess the long term efficacy of sarilumab in participants with RA.

      Sub-Study:

      This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by
      participants with moderate or severe RA, or their professional or non-professional healthcare
      providers in an unsupervised real-world situation. To mimic the real-world practice, the
      sub-study was incorporated into the LTS11210 study without additional visits compared to the
      scheduled visits in the main study. The duration of this sub-study was 12 weeks.
    

Eligibility criteria:

        Inclusion criteria :

        Main study:

        Participants with RA who were previously randomized in the sarilumab RA clinical program:
        e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study.

        Sub-study:

        Participants enrolled in the LTS11210 study who were receiving either sarilumab 200mg q2w
        PFS or sarilumab 150mg q2w PFS and who were able and willing to participate in this
        sub-study.

        Participants who had been enrolled in the main study for at least 24 weeks. Participants
        must sign a sub-study written informed consent prior to any sub-study related procedure.

        Exclusion criteria:

        Main study:

        Participants with any adverse event (AE) led to permanent study drug discontinuation from a
        prior study.

        Participants with an abnormality(ies) or AEs that per investigator judgment would adversely
        affect participation of the participant in the study.

        Sub-study: There are no additional exclusion criteria to those defined in main study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Methotrexate; Abatacept Placebo; Methotrexate Placebo
Intervention MeSH terms: Methotrexate; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 994.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if abatacept is effective in the treatment of early
      rheumatoid arthritis.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Rheumatoid arthritis (RA) diagnosis less than 6 months

          -  CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h

          -  At least 3 swollen and 3 tender joints

          -  Anti-citrullinated protein antibodies (ACPA) positive

        Exclusion Criteria:

          -  At risk for tuberculosis

          -  Have acute infection

          -  Have chronic or recurrent bacterial or serious latent viral infection

          -  History of malignancies in the last 5 years except squamous skin, basal skin or
             cervical carcinoma

          -  Previous treatment with any conventional or biologic Disease-modifying anti rheumatic
             drugs (DMARD)
Vitamin D and Omega-3 Trial (VITAL)
Condition: Cancer; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: vitamin D3; omega-3 fatty acids (fish oil); Vitamin D3 placebo; Fish oil placebo
Intervention description: Vitamin D3 (cholecalciferol), 2000 IU per day.; Omacor, one 1-gram capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).; Vitamin D placebo; Fish oil placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25871.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin D3; omega-3 fatty acids; fish oil; cardiovascular disease; cancer; primary prevention

Summary:

      The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and
      women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or
      omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart
      disease, and stroke in people who do not have a prior history of these illnesses. The 5-year
      intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention
      observational follow-up of study participants is ongoing.
    

Eligibility criteria:

        To be eligible for the study, respondents had to, at study entry,:

          1. be men aged 50 or older or women aged 55 or older;

          2. have no history of cancer (except non-melanoma skin cancer), heart attack, stroke,
             transient ischemic attack, angina pectoris, coronary-artery bypass grafting, or
             percutaneous coronary intervention;

          3. have none of the following safety exclusions: history of renal failure or dialysis,
             hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or
             sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or
             granulomatosis with polyangiitis (Wegener's);

          4. have no allergy to fish or soy;

          5. have no other serious illness that would preclude participation;

          6. be consuming no more than 800 IU of vitamin D from all supplemental sources combined
             (individual vitamin D supplements, calcium+vitamin D supplements, medications with
             vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to
             decrease or forego such use during the trial;

          7. be consuming no more than 1200 mg/d of calcium from all supplemental sources combined,
             or, if taking, willing to decrease or forego such use during the trial;

          8. not be taking fish oil supplements, or, if taking, willing to forego their use during
             the trial