bioihbjkbjnl/mcl2 huggingface dataset:
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
Condition: Femoral Neck Fractures
MeSH terms: Fractures, Bone; Hip Fractures; Femoral Neck Fractures
Intervention: Sliding Hip Screw; Cancellous Screws; Vitamin D; Vitamin D Placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the impact of surgical fixation (cancellous screws
      versus sliding hip screws) and biologic intervention (Vitamin D versus placebo) on patient
      important outcomes.
    

Eligibility criteria:

        Inclusion Criteria

          1. Adult men or women ages 18 to 60 years.

          2. Fracture of the femoral neck.

          3. Fracture amenable to both surgical treatments (SHS and cancellous screws).

          4. Operative treatment within 7 days of injury.

          5. Provision of informed consent by patient or substitute decision maker.

        Exclusion Criteria

          1. Patients with previously diagnosed osteoporosis.

          2. Fracture-dislocation of the femoral neck and hip joint.

          3. Planned antegrade nailing of an ipsilateral femoral shaft fracture (if present).

          4. Current infection around the hip (i.e. soft tissue or bone).

          5. Stress fracture of the femoral neck.

          6. Pathologic fractures secondary to neoplasm or other bone lesion.

          7. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's
             disease, osteomalacia, osteopetrosis, osteogenesis imperfect, etc.

          8. Patients with hyperhomocysteinemia.

          9. Patient has an allergy to vitamin D or another contraindication to being prescribed
             vitamin D.

         10. Patient is currently taking an over counter drug and/or food supplement that contains
             vitamin D and is unable or unwilling to discontinue its use for this study.

         11. Likely problems, in the judgment of the attending surgeon, with maintaining follow up
             (e.g. patients with no fixed address, plans to move out of town). This may include
             patients with severe mental disorders and drug addictions without adequate support.

         12. Pregnancy.

         13. Patient is incarcerated.

         14. Patient is not expected to survive injuries.

         15. The attending surgeon believes the patient should be excluded because they are
             involved in a conflicting clinical trial.
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Baricitinib; Placebo
Intervention description: Administered orally.; Administered orally.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE

Summary:

      The reason for this long term study is to see how safe and effective the study drug known as
      baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the
      final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the final treatment study visit of an originating study, such as study
             JAHZ (NCT03616912) or Study JAIA (NCT03616964).
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Ocrelizumab
Intervention description: Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Intervention MeSH terms: Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 681.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to
      assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting
      Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a
      Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4
      weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72),
      and a Follow-up period of at least 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria

          -  Have a length of disease duration, from first symptom, of less than (<) 10 years

          -  Have received no more than two prior DMTs, and the discontinuation of the most recent
             DMT was due to lack of efficacy

          -  Suboptimal disease control while on a DMT

          -  Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening

          -  For women of childbearing potential: agreement to use an acceptable birth control
             method during the treatment period and for at least 6 months after the last dose of
             study drug

        Exclusion Criteria:

          -  Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or
             progressive relapsing multiple sclerosis (MS)

          -  Inability to complete an Magnetic Resonance Imaging (MRI) procedure

          -  Known presence of other neurological disorders

          -  Any concomitant disease that may require chronic treatment with systemic
             corticosteroids or immunosuppressants during the course of the study

          -  History or currently active primary or secondary immunodeficiency

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies

          -  History of opportunistic infections

          -  History or known presence of recurrent or chronic infection

          -  History of malignancy

          -  Congestive heart failure

          -  Known active bacterial, viral, fungal, mycobacterial infection or other infection,
             excluding fungal infection of nail beds
StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
Condition: Deep Partial-thickness Burn
Intervention: StrataGraft skin tissue
Intervention description: StrataGraft skin tissue was delivered as a single topical application to no more than 3 separate burn sites, totaling up to approximately 2000 cm^2 of treatment area using no more than 20 tissues.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alternative to Autograft

Summary:

      An autograft is a piece of skin taken from a healthy area of the body to be used to treat
      severe burns on another part of the same body.

      StrataGraft skin tissue was an investigational tissue that could be used as an alternative to
      an autograft.

        -  StrataGraft skin tissue was in late-stage clinical development for the treatment of
           adults with deep partial-thickness (DPT) burns.

        -  There were no safety concerns reported to date. The sponsor submitted a treatment
           protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase
           3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it
           was commercially available.

      The main purpose of the study was to allow patients to receive StrataGraft during Biologics
      License Application review and prior to approval by the FDA for the treatment of DPT burns.
      The primary outcome measure was the number of participants with adverse events and safety
      concerns.
    

Eligibility criteria:

        Inclusion Criteria:

        To be considered for inclusion, a participant must:

          -  Provide written informed consent

          -  Have enough healthy skin to reserve as donor site(s), in case autografting becomes
             necessary

          -  Have protocol-defined thermal burn(s) on the torso, upper extremities and lower
             extremities:

               1. that are the right size for treatment areas,

               2. with intact dermal elements for which excision and autografting are clinically
                  indicated, and

               3. have not been previously excised and grafted.

        Exclusion Criteria:

        A participant must be excluded from participation if he/she:

          -  Is pregnant, a prisoner, or expected to live less than 3 months

          -  Has any other condition that, per protocol or in the opinion of the investigator, may
             compromise the participant's safety or the study objectives

          -  Has participated in an investigational study within 90 days before enrollment
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Intervention: Placebo; Relamorelin
Intervention description: Placebo injected twice daily; Relamorelin 10 μg injected twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetic gastroparesis; vomiting

Summary:

      A 46-week study to compare the efficacy of relamorelin with that of placebo in participants
      with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants
      will either continue on relamorelin or placebo for 6 additional weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are eligible to be included in the study only if all the following
             criteria apply:

          -  Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01
             (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study

          -  Able to provide written informed consent (IC) prior to any study procedures and
             willing and able to comply with study procedures

          -  In the opinion of the investigator, the participant demonstrated adequate compliance
             with the study procedures in Study RLM-MD-01 or RLM-MD-02

        Exclusion Criteria:

          -  Participants are excluded from the study if any of the following criteria apply:

          -  Participant is not willing or able to abide by the restrictions regarding concomitant
             medicine use

          -  Participant is planning to receive an investigational drug (other than study
             treatment) or investigational device at any time during Study RLM-MD-03

          -  Participant has an unresolved adverse event (AE) or a clinically significant finding
             on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG)
             that, in the investigator's opinion, would limit the participant's ability to
             participate in or complete the study

          -  Any other reason that, in the investigator's opinion, would confound proper
             interpretation of the study or expose a participant to unacceptable risk, including
             renal, hepatic or cardiopulmonary disease
A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo; Adalimumab
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Adalimumab; Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis

Summary:

      The main purpose of this study is to evaluate the safety and efficacy of the study drug known
      as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive
      participants with radiographic axial spondyloarthritis (rad-axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are ambulatory.

          -  Diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined
             radiographically according to the modified New York criteria.

          -  Participants have a history of back pain ≥3 months with age at onset <45 years.

          -  In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory
             drugs (for duration 4 weeks) or cannot tolerate NSAIDS.

          -  If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.

          -  Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

        Exclusion Criteria:

          -  Have total ankylosis of the spine.

          -  Have received any prior, or are currently receiving, treatment with biologics, tumor
             necrosis factor inhibitors or other immunomodulatory agents.

          -  Have recently received a live vaccine within 12 weeks or have had a vaccination with
             Bacillus Calmette-Guerin (BCG) within the past year.

          -  Have an ongoing or serious infection within the last 12 weeks or evidence of active
             tuberculosis.

          -  Have a compromised immune system.

          -  Have any other serious and/or uncontrolled diseases.

          -  Have either a current diagnosis or a recent history of malignant disease.

          -  Have had major surgery within 8 weeks of baseline, or will require surgery during the
             study.

          -  Are pregnant or breastfeeding.
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin, Onglyza; Dapagliflozin, Farxiga; Glargine insulin; Metformin
Intervention description: Tablets, Oral, 5mg , Once daily, 24 weeks; Tablets, Oral, 10mg , Once daily, 24 weeks; 100 Units/ml solution for injection in a prefilled SoloStar pen; Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks
Intervention MeSH terms: Metformin; Insulin Glargine; Dapagliflozin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 650.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM)
      will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin
      and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects
      receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a
      treatment period of 52 weeks.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  At least 18 years of age at screening

          -  HbA1c ≥ 8% and ≤ 12% at screening

          -  Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)

          -  Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea
             (defined as at least 50% maximal dose per local label) for at least 8 weeks

          -  estimated glomerular filtration rate (eGFR) &lt; 60 ml/ml/1.73m2

          -  Body Mass Index ≤ 45.0 kg/m2

        Exclusion Criteria:

          -  Clinical diagnosis of Type 1 diabetes

          -  History of ketoacidosis

          -  Renal, hepatic or pancreatic disease

          -  Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min

          -  Cardiovascular or vascular diseases identified within 3 months of
             participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60
             mL/min
Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
Condition: Neovascular Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: RTH258
Intervention description: 6 mg in prefilled syringe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: study with a single arm: brolucizumab 6 mg PFS
Masking: None (Open Label)
Masking description: open label study
Enrollment: 34.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: brolucizumab 6 mg prefilled syringe PFS; open label study; neovascular age related macular degeneration intravitreal injection IVT; observation

Summary:

      This was a multicenter, open label study that is designed to evaluate the safety of
      brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular
      degeneration and to support collection of observations of the prefilled syringe use for
      intravitreal injection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed.

          2. Study eye is diagnosed with neovascular age related macular degeneration and would
             need an intravitreal injection.

          3. Subjects >= 50 years of age.

        Exclusion Criteria:

          1. Active infection or inflammation in the eyes.

          2. Uncontrolled glaucoma.

          3. History of a medical, ocular or non-ocular conditions, resulting in that the study
             medication cannot be safely administered.

          4. Treatment with anti-VEGF intravitreal injection in the study eye within one month
             prior to enrollment.

          5. The use of intraocular corticosteroids in the study eye within the last three months
             prior to enrollment.

          6. Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug
             release device implantation.

          7. Uncontrolled hypertension.

        Other protocol defined inclusion and exclusion criteria may apply.
A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: SYM-1219; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical trial is to test the safety and efficacy of the oral
      investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are premenopausal adult females or post menarchal adolescent girls ≥12 years of age in
             good general health

          -  Have a clinical diagnosis of bacterial vaginosis, defined as having all of the
             following criteria:

          -  Off-white (milky or gray), thin, homogeneous vaginal discharge

          -  Vaginal pH ≥ 4.7

          -  Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic
             examination of the vaginal saline wet mount

          -  A positive 10% KOH Whiff test

          -  Have a Gram stain slide Nugent Score ≥ 4 at the Baseline Visit (Day 1)

        Exclusion Criteria:

          -  Are pregnant, lactating, or planning to become pregnant during the study

          -  Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1)

          -  Are suspected clinically (or confirmed diagnostically) of having alternative causes of
             vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis,
             Neisseria gonorrhoeae or Herpes simplex

          -  Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14
             days prior to the Baseline Visit (Day 1)
Second Open Label Extension to Bridging Study CTBM100C2303
Condition: Pulmonary Infections; Pseudomonas Aeruginosa
MeSH terms: Cystic Fibrosis
Intervention: Tobramycin inhalation powder
Intervention description: Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 6 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Tobramycin Inhalation Powder; Cystic fibrosis; Lung diseases; Anti-Bacterial Agents; Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis participants

Summary:

      This was an open-label, single arm (uncontrolled) study in participants suffering from cystic
      fibrosis, who have completed their study participation in CTBM100C2303 and extension study
      one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at
      enrollment into CTBM100C2303.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study
             CTBM100C2303E1 took place not more than 5 days before enrollment into this study.

          -  Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.

          -  Forced Expiratory Volume in one second (FEV1) at screening (at start of study
             CTBM100C2303) must be between 25% and 80% of normal predicted values.

        Exclusion Criteria:

          -  Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial
             CTMB100C2303E1 and the enrollment into this study.

          -  Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.