bioihbjkbjnl/mcl2 huggingface dataset:
Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies
Condition: Pancreatic Cancer; Unresectable Biliary-pancreatic Malignancies
MeSH terms: Neoplasms
Intervention: ERCP with SEMS plus radiofrequency ablation; ERCP with SEMS alone (standard of care)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stent Placement; Biliary Obstruction; 14-260

Summary:

      The purpose of this study is to compare the effects good and/or bad of combining
      radiofrequency ablation with placement of a second stent, versus a second stent alone. The
      investigators will also look at the safety of the combination treatment, and see which
      treatment is better. In either case, the second stent will be placed inside the existing
      stent as is done in standard practice when treating a blocked stent for the first time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with any tumor obstructing the distal bile duct and causing an indwelling
             biliary SEMS

          -  Patients with jaundice or clinical cholangitis, with new elevation of alkaline
             phosphatase, total bilirubin, and imaging findings supportive of stent occlusion (loss
             of stent patency, debris within stent, loss of or excessive pneumobilia)

          -  Age ≥ 18 years

        Exclusion Criteria:

          -  Have altered gastro-duodenal or hepatobiliary anatomy such that ERCP is felt to be
             unacceptably technically difficult or unsafe

          -  Have additional sites of biliary strictures (intrahepatic/hilar) such that ERCP
             stenting is felt to be unlikely to provide adequate clinical benefit

          -  Have cardiac pacemakers

          -  Have Child B/C cirrhosis

          -  Are pregnant

          -  Are unsuitable for endoscopy (either because of hemodynamic instability, respiratory
             distress or unsafe hematological parameters such as refractory anemia <7g/dL,
             thrombocytopenia <50K/mcL, or coagulopathy with INR >2.0)

          -  Have biliary strictures not technically amenable to endoscopic therapy
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
Condition: CKD Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Roxadustat; Placebo
Intervention description: Oral tablets; Oral tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 922.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease (CKD); non-dialysis; Hemoglobin (Hb); End-Stage Renal Disease; erythropoeitin; ASP1517; erythropoeisis stimulating-agent; AZD9941

Summary:

      The purpose of this study is to determine whether roxadustat is safe and effective in the
      treatment of anemia in participants with chronic kidney disease and not on dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis

          -  Anemia qualified by measurements of hemoglobin values during screening

          -  Additional blood work must be in a safe range for study entry

          -  Body weight 45 to 160 kilograms (kg)

          -  Willingness to use contraception if of child-bearing potential

        Exclusion Criteria:

          -  Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to
             study participation

          -  More than 1 dose of intravenous iron within 12 weeks prior to study participation

          -  Blood transfusion within 8 weeks prior to study participation

          -  Active infection

          -  Chronic liver disease

          -  Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot

          -  Uncontrolled blood pressure within 2 weeks prior to study participation

          -  Renal cell carcinoma

          -  History of malignancy, including multiple myeloma or other myelodysplastic syndrome

          -  Chronic inflammatory disease that could impact red blood cell production

          -  Any prior organ transplant or a scheduled organ transplantation

          -  Anticipated elective surgery that is expected to lead to significant blood loss or
             anticipated elective heart procedure

          -  Gastrointestinal bleeding

          -  Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase
             inhibitor (HIF-PHI)

          -  Recent use of an investigational drug or treatment, or participation in an
             investigational study
Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
Condition: Anesthesia
Intervention: Normal Saline; Lactated Ringer; Normosol-R Inj
Intervention description: IV infusion of 0.9% NaCl throughout surgery.; IV infusion of lactated ringer throughout surgery.; IV infusion of Normosol throughout surgery.
Intervention MeSH terms: Plasma-lyte 148
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 10 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      During major surgical procedures, intravascular volume is maintained with the administration
      of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three
      of these fluids are in common clinical use for this purpose. As large volumes of NS may
      result in a dilutional acidosis and an increasing base deficit, it may cloud clinical
      decision making when resuscitative efforts are guided by acid-base status on routine arterial
      blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base
      and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids
      for intraoperative resuscitation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major surgical procedure requiring arterial access

        Exclusion Criteria:

          -  Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid
             solutions.
Progesterone vs Placebo Therapy for Women With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Progesterone Lozenges; Matched Placebo Lozenges
Intervention description: 200mg Progesterone Lozenges; Matched Placebo Lozenges
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Randomization was carried out separately for women with and without catamenial epilepsy, 2:1 to progesterone or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 294.0
Sex: Female
Minimum age: 13 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Epilepsy; Seizure; Hormone; Progesterone; Catamenial

Summary:

      The purpose of this investigation was to determine if cyclic adjunctive progesterone
      supplement is superior to placebo in the treatment of intractable seizures in women with and
      without catamenial epilepsy.
    

Eligibility criteria:

        INCLUSION:

          1. Subject must be between the ages of 13 and 45.

          2. Subject must have a history of seizures (documented by EEG).

          3. Subject must have had at least 2 seizures or auras per month during the past 3 months.

          4. Subject must be on stable antiepileptic drug therapy for at least 2 months.

          5. Subject must have cycle intervals between 21 and 35 days during 6 months prior to
             entry.

        EXCLUSION:

          1. Subject that is pregnant or lactating.

          2. Subject that is on major tranquilizers, antidepressant medications, or reproductive
             hormones.

          3. Subject that is unable to document seizures.

          4. Subject that has progressive neurological or systemic disorder or > 2-fold elevation
             in liver enzyme levels
APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
Condition: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
MeSH terms: Amyloid Neuropathies, Familial; Cardiomyopathies; Amyloidosis
Intervention: Placebo; Patisiran
Intervention description: Normal saline (0.9% NaCl) matching volume of patisiran doses will be administered intravenously.; Patisiran will be administered by intravenous (IV) infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic; Transthyretin; TTR; Amyloidosis; Cardiomyopathy; ATTR

Summary:

      The purpose of this study is to evaluate the efficacy and safety of patisiran in participants
      with ATTR amyloidosis with cardiomyopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either
             hereditary ATTR amyloidosis with cardiomyopathy or wild-type ATTR amyloidosis with
             cardiomyopathy

          -  Medical history of heart failure with at least 1 prior hospitalization for heart
             failure, or current clinical evidence (signs and symptoms of heart failure)

          -  Clinically stable with no cardiovascular related hospitalizations within 6 weeks of
             study start

          -  Has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥6
             months with evidence of disease progression while on tafamidis treatment

          -  Able to complete ≥150 m on the 6-minute walk test

          -  Screening N-terminal pro B-type natriuretic peptide (NT-proBNP), a blood marker of
             heart failure severity, >300 ng/L and <8500 ng/L; in participants with permanent or
             persistent atrial fibrillation, screening NT-proBNP> 600 ng/L and <8500 ng/L

        Exclusion Criteria:

          -  Known primary amyloidosis (AL) or leptomeningeal amyloidosis.

          -  Received prior TTR lowering treatment

          -  New York Heart Association heart failure classification of III and at high risk

          -  New York Heart Association heart failure classification of IV

          -  Neuropathy requiring cane or stick to walk, or is wheelchair bound

          -  Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2

          -  Abnormal liver function

          -  Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection

          -  Has non-amyloid disease that significantly affects ability to walk (e.g., severe
             chronic obstructive pulmonary disease, severe arthritis, or peripheral vascular
             disease affecting ambulation)

          -  Prior or planned heart, liver, or other organ transplant

          -  Other cardiomyopathy not related to ATTR amyloidosis
Study of Rapastinel as Monotherapy in Patients With MDD
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel (prefilled syringe, weekly intravenous IV administration); Placebo (prefilled syringe, weekly IV administration)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900
      milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive
      disorder (MDD).
    

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

          -  Treatment naive in the current episode or have inadequate response to 1-3
             antidepressant therapies given at adequate dose and duration in the current episode

          -  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:

          -  Schizophrenia spectrum or other psychotic disorder

          -  Bipolar or related disorder

          -  Major neurocognitive disorder

          -  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

          -  Dissociative disorder

          -  Posttraumatic stress disorder

          -  MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Intervention: Histrelin Subcutaneous Implant
Intervention description: histrelin subcutaneous 50 mg implant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: puberty; precocious puberty; early puberty; early onset puberty; histrelin; histrelin subcutaneous implant; implant therapy

Summary:

      The purpose of this study is to follow and collect additional medical and developmental
      information on children after histrelin subcutaneous implant therapy is discontinued.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-treated or treatment naive patients with gonadotropin-dependent precocious puberty

          -  Pre-treatment pubertal type response of LH to a stndard GnRH stimulation test before
             initiation of treatment

        Exclusion Criteria:

          -  Children who are less than 2 years of age at enrollment

          -  Children whose chronological age is greater than 8 years (naive) and 10 years
             (pre-treated) for girls or 9 years (naive) and 11 years (pre-treated) for boys at the
             onset of the study
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Cariprazine; Placebo; Antidepressant Therapy (ADT)
Intervention description: Cariprazine capsules 1.5 to 4.5 mg/day; Dose-matched placebo capsule once per day; ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1022.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD; Major Depressive Disorder

Summary:

      The objective of this study is to evaluate the efficacy, safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided consent prior to any specific procedure

          -  Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text
             revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)

          -  Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at
             Visits 1 and 2

        Exclusion Criteria:

          -  Patients who do not meet DSM-IV-TR criteria for MDD
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
Condition: Chronic Obstructive Pulmonary Disorder
MeSH terms: Lung Diseases
Intervention: BFF MDI 320/9.6 μg; BFF MDI 160/9.6 μg; FF MDI 9.6 μg; BD MDI 320 μg; Symbicort® TBH 400/12 μg BID
Intervention description: Blinded Treatment; Blinded Treatment; Blinded Treatment; Blinded Treatment; Open Label
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2389.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung
      function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320
      μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Give their signed written informed consent to participate

          2. Are at least 40 years of age and no older than 80 years

          3. COPD patients who are symptomatic

          4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

        Exclusion Criteria:

          1. Current diagnosis of asthma,

          2. COPD due to α1-Antitrypsin Deficiency

          3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis,
             Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months

          4. Long-term-oxygen therapy (≥ 12 hours a day).
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: FMX-101, 4% minocycline foam; Vehicle Foam
Intervention description: FMX-101, 4% minocycline foam applied topically once daily for 12 weeks; Vehicle foam applied topically once daily for 12 weeks
Intervention MeSH terms: Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 466.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: acne

Summary:

      This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical
      administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne
      vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has facial acne vulgaris with:

               -  20 to 50 inflammatory lesions (papules, pustules, and nodules);

               -  25 to 100 noninflammatory lesions (open and closed comedones);

               -  no more than 2 nodules on the face; and

               -  IGA score of moderate (3) to severe (4)

          -  Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin
             Cleanser) and to refrain from use of any other acne medication, medicated cleanser,
             excessive sun exposure, and tanning booths for the duration of the study

        Exclusion Criteria:

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
             that could interfere with the clinical evaluations

          -  Sunburn on the face

          -  Severe systemic disease, which might interfere with the conduct of the study or the
             interpretation of the results.

          -  Abnormal baseline laboratory values that are considered clinically significant

          -  Allergy to tetracycline-class antibiotics or to any ingredient in the study drug

          -  Pseudomembranous colitis or antibiotic-associated colitis
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: E10030; ranibizumab; E10030 sham intravitreal injection
Intervention description: Pressure on the eye with a syringe with no needle
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 619.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; choroidal neovascularization; Fovista®; E10030; Lucentis®

Summary:

      The objectives of this study are to evaluate the safety and efficacy of intravitreal
      administration of Fovista® administered in combination with Lucentis® compared to Lucentis®
      monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related
      macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Active subfoveal choroidal neovascularization (CNV) secondary to AMD

          -  Presence of sub-retinal hyper-reflective material (SD-OCT)

        Exclusion Criteria:

          -  Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral
             supplements of vitamins and minerals

          -  Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless
             of indication (including intravitreal corticosteroids)

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication

          -  Subjects with subfoveal scar or subfoveal atrophy are excluded

          -  Diabetes mellitus