bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Condition: Unruptured Wide-neck Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Intervention: PulseRider® Aneurysm Neck Reconstruction Device
Intervention description: Neck Reconstruction Device
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Unruptured; intracranial aneurysms; Endovascular

Summary:

      This is a prospective, multi-center, non-randomized clinical evaluation utilizing the
      PulseRider® Aneurysm Neck Reconstruction Device.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject with wide neck intracranial aneurysm located at a bifurcation

          2. The subject is between 18 and 80 years of age the time of consent

          3. Informed consent is obtained and the subject signs the IRB approved consent prior to
             beginning any study procedures

          4. In the opinion of the treating physician, placement of the PulseRider® device is
             technically feasible and clinically indicated

        Exclusion Criteria:

          1. Unstable neurological deficit (condition worsening within the last 90 days)

          2. Subarachnoid Hemorrhage (SAH) within the last 60 days

          3. Irreversible bleeding disorder

          4. Patient has another intracranial aneurysm that in the Investigator's opinion, may
             require treatment within the 1 year follow up period

          5. A history of contrast allergy that cannot be medically controlled

          6. Known allergy to nickel

          7. Relative contraindication to angiography

          8. Woman of child-bearing potential who cannot provide a negative pregnancy test

          9. Current involvement in a study for another investigational product

         10. Patient and / or family considering a move from this geographical location at the time
             of consent

         11. Categorized as a vulnerable population and require special treatment with respect to
             safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)
Targeted Retreatment of COPD Exacerbations
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Ciprofloxacin; Placebo
Intervention description: 500 mg, twice daily for 1 week (oral); One capsule, twice daily for 1 week
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD)

Summary:

      This study investigates the effects of targeted re-treatment of patients who do not recover
      from an exacerbation of COPD. Half of the patients will receive ciprofloxacin while the other
      half will receive a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of COPD confirmed spirometrically at screening

          2. COPD exacerbation with treatment commenced 14 days prior to study enrolment and
             treated with 5-14 days of a non-quinolone antibiotic.

          3. Exacerbation here will be defined as an episode of symptomatic worsening of COPD that
             was treated by the patient's attending clinician. Confirmation of the initial
             exacerbation diagnosis will be provided from the case notes, referral letter, or
             directly from the treating clinician, and will be documented in the CRF.

          4. Age: ≥ 45 years of age at screening.

          5. Persistent symptoms and/or a CRP≥8mg/L when assessed 2 weeks after exacerbation onset

          6. Able to complete questionnaires for health status and symptoms and keep written diary
             cards

          7. Severity of disease: Patients with a measured FEV1<80% of predicted normal values at 2
             weeks post exacerbation

          8. Able and willing to give signed and dated written informed consent to participate.

        Exclusion Criteria:

          1. Other clinically predominant chronic respiratory disease.

          2. Intubated and receiving mechanical ventilation

          3. Patients with known hypersensitivity to the antibiotic under evaluation, to other
             quinolones or any excipients of the IMP/placebo.

          4. Patients with a prior history of tendonopathy or tendon rupture

          5. Elderly patients taking long term systemic corticosteroids

          6. Patients on long term antibiotics for other conditions

          7. Patient too unwell for randomisation, i.e. requiring retreatment in the judgment of
             the study doctor

          8. Female patients who are pregnant or planning on becoming pregnant during the study, or
             are breastfeeding.

          9. Patient taking clinically significant contraindicated medication as per the SmPC s,
             such as use of concomitant tizanidine or methotrexate.
A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing spondylitis

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in
      Chinese participants with radiographic axial spondyloarthritis (r-axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have an established diagnosis of radiographic axial spondyloarthritis (r-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.

          -  Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF)
             inhibitor.

          -  Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range
             for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.

          -  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 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.

          -  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.
Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin 1% Gel; Placebo
Intervention description: Topical gel; Topical Placebo gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1125.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,
      designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the
      marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.
    

Eligibility criteria:

        IInclusion Criteria:

          -  Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical
             diagnosis of acne vulgaris.

          -  Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25
             non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions
             (nodules and cysts) and have an IGA score of 2, 3 or 4.

        Exclusion Criteria:

          -  Subject has more than 2 facial nodular lesions; any nodules present will be documented
             but not included in the inflammatory lesion count for analysis.

          -  Subject has active cystic acne.

          -  Subject has acne conglobata.

          -  Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that
             would interfere with the diagnosis or assessment of acne.
PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)
Condition: Newly Diagnosed, Previously Untreated Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone; Elotuzumab
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Elotuzumab; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and
      Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma
      cells at the time of progression than those who receive Lenalidomide and Dexamethasone
      without Elotuzumab
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

        Subjects who are newly diagnosed with symptomatic MM and who:

          -  Have not received any prior systemic anti-myeloma therapy

          -  Have measurable disease

          -  And are not candidates for high-dose therapy plus stem-cell transplantation (SCT)
             because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose
             therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject <65 years
             old. There must be a comorbidity that prevents SCT for a subject <65 years old

        Exclusion Criteria:

          -  Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

          -  Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

          -  Monoclonal Gammopathy of Undetermined Significance (MGUS)

          -  Active plasma cell leukemia

          -  Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: TAS-102; Placebo
Intervention description: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.; Placebo orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer
      refractory or intolerable to standard chemotherapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has provided written informed consent

          -  Has adenocarcinoma of the colon or rectum

          -  Has failed at least 2 prior regimens of standard chemotherapies for metastatic
             colorectal cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Is able to take medication orally

          -  Has adequate organ function (bone marrow, kidney and liver)

          -  Women of childbearing potential must have a negative pregnancy test and must agree to
             adequate birth control if conception is possible. Males must agree to adequate birth
             control.
Evaluation of Efficacy and Safety of SDN-037
Condition: Inflammation and Pain Associated With Ocular Surgery
MeSH terms: Inflammation
Intervention: SDN-037; Placebo
Intervention description: twice daily; twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle
      for the treatment of inflammation and pain associated with ocular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be at least 2 years of age on the date of assent or 18 years of age at the date of
             consent

          2. Be able and willing to follow study instructions and complete all required visits

          3. Females of childbearing potential must not be pregnant (as confirmed by a negative
             urine pregnancy test

          4. Able to self-instill the IP or have a caregiver available to instil all doses of the
             IP

        Exclusion Criteria:

          1. Any known allergy or hypersensitivity to difluprednate therapy

          2. An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation
             in the study eye

          3. Any active corneal pathology noted in the study eye

          4. Currently suffering from alcohol and/or drug abuse
Apixaban in Patients With Sickle Cell Disease
Condition: Vaso-occlusive Crisis; Reduction in Hospitalizations; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Apixaban; Placebo
Intervention description: Drug is taken by mouth twice a day for 6 months
Intervention MeSH terms: Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vaso-occlusive crisis; Reduction in hospitalizations; Sickle Cell Disease

Summary:

      In patients with SCD, the use of low dose anticoagulation as an outpatient may lead to a
      significant decrease in morbidity and as a result, decrease healthcare utilization and costs.
      This study attempts to critically avoid admissions by reducing daily pain scores and pain
      crisis as an outpatient by use of a novel oral anticoagulant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  documented HgbSS, SC or HgbS-beta0 thalassemia,

          -  age ≥18 years old and ≤80,

          -  seen in outpatient clinic ≥2 times in past year

          -  seen for an acute care visit (hospitalization, emergency department, or day hospital
             visit) for pain >2 times in the past year.

        Exclusion Criteria:

          -  Hospitalization or day hospital visit for pain crisis within the past 2 weeks

          -  Patients with ≥10 acute care visits within the past year will be excluded

          -  Creatinine >3.0 mg/dL

          -  creatinine ≥1.5 mg/dL AND weight ≤60 kg

          -  chronic use of antiplatelet or anticoagulation medication

          -  Patients with known vasculopathy or Moya-Moya

          -  platelet count <100 X 109/L

          -  AST or ALT >3 times normal

          -  chronic red blood cell transfusions (scheduled transfusions)

          -  packed red blood cell transfusion within the past 2 months

          -  Use of CYP3A4 and P-gp inhibitor medications
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo; Risankizumab
Intervention description: Placebo for risankizumab administered by subcutaneous injection; Risankizumab administered by subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 964.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the safety and efficacy of risankizumab versus
      placebo in participants with moderately to severely active psoriatic arthritis (PsA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening
             Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening
             Visit.

          -  Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68
             joint counts) and ≥ 5 swollen joints (based on 66 joint counts)

          -  Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 cm
             diameter or nail changes consistent with psoriasis at Screening Visit.

          -  Participant has demonstrated an inadequate response or intolerance to or
             contraindication for conventional synthetic disease modifying anti-rheumatic drugs
             (csDMARD) therapy(ies).

          -  Presence of either at Screening:

               -  ≥ 1 erosion on radiograph as determined by central imaging review or;

               -  High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.

        Exclusion Criteria:

          -  Participant is considered by investigator, for any reason, to be an unsuitable
             candidate for the study.

          -  Participant has a known hypersensitivity to risankizumab.

          -  Participant has previous treatment with biologic agent.
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Condition: Rosacea
MeSH terms: Rosacea
Intervention: CLS001 (Omiganan); Vehicle
Intervention description: Topical gel; Vehicle Gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel
      compared to vehicle gel in subjects with severe papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, male and non-pregnant female subjects, 18 years of age or older.

          2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at
             Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.

          3. Subjects with the presence of telangiectasia at Baseline.

          4. Subjects with an erythema score of at least 2 on the Investigator Assessment of
             Erythema scale at Baseline.

          5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

        Exclusion Criteria:

          1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

          2. Subjects with nodular rosacea.

          3. Standard exclusion criteria.
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 429.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams
      (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major
      depressive disorder (MDD) who have a partial response to ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Visit 1

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study

               5. Dissociative disorder

               6. Posttraumatic stress disorder

               7. MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.