bioihbjkbjnl/mcl2 huggingface dataset:
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIII (BAY81-8973) on demand; rFVIII (BAY81-8973) prophylaxis low-dose; rFVIII (BAY81-8973) prophylaxis high-dose
Intervention description: Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization; Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.; Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Male
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Haemophilia treatment; rFVIII

Summary:

      The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with
      BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe
      Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, aged 12 to 65 years

          -  Severe hemophilia A

          -  History of more than 150 exposure days (ED) with clotting factor concentrates

          -  Currently receiving episodic treatment with FVIII; no regular prophylaxis for more
             than 6 consecutive months in the past 5 years

          -  No current Factor VIII inhibitor or history of inhibitor

          -  Willing to use electronic patient diary

        Exclusion Criteria:

          -  Presence of another bleeding disease that is different from hemophilia A

          -  Thrombocytopenia

          -  Abnormal renal function

          -  Presence of active liver disease

          -  Known hypersensitivity to FVIII
Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
Condition: Asthma
MeSH terms: Inflammation
Intervention: Benralizumab; Placebo
Intervention description: Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive; Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive
Intervention MeSH terms: Benralizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: asthma

Summary:

      This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4
      weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an
      inhaled allergen.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures

          2. Female or male aged 18 to 65 years, inclusively, at the time of enrolment.

          3. General good health

          4. Mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta
             2 agonists (not more than twice weekly)

          5. Positive skin-prick test to at least one common aeroallergen

        Exclusion Criteria:

          1. Current lung disease other than mild allergic asthma

          2. Any history or symptoms of disease, including, but not limited to, cardiovascular,
             neurologic, autoimmune or haematologic

          3. Any clinically significant abnormal findings in laboratory test results in complete
             blood count, coagulation, chemistry panel and urinalysis at enrolment and during
             screening period

          4. History of anaphylaxis to any biologic therapy or vaccine
Treatment of Erectile Dysfunction I
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Udenafil; Placebo
Intervention description: Tablets via oral administration before an attempt at sexual intercourse.; Tablets via oral administration before an attempt at sexual intercourse.
Intervention MeSH terms: Udenafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 618.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the
      safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of
      PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, at least 19 years of age

          -  Stable monogamous relationship for at least 6 months with a consenting female partner
             who is at least 19 years of age, vaginal intercourse is a required study activity

          -  History of ED (clinically defined as the inability to attain and maintain an erection
             of the penis sufficient to permit satisfactory sexual intercourse) of at least 3
             months duration

          -  Partner is not pregnant or lactating

        Exclusion Criteria:

          -  History of new-onset symptomatic coronary artery disease within the last 3 months or a
             history of myocardial infarction or cardiac surgical procedure within six months

          -  Cardiac arrhythmias requiring antiarrhythmic treatment

          -  Symptomatic congestive heart failure

          -  Taking nitrate medication in any form

          -  Uncontrolled diabetes (HbA1c ≥ 13%)

          -  Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors such as Viagra®,
             Cialis® or Levitra®

          -  Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®
Tiotropium / Respimat One Year Study in COPD.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: Respimat; Tiotropium
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 3991.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the long-term (one year) efficacy and safety of
      tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study
      will examine the effect of treatment on COPD exacerbations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female

          2. At least 40 years old

          3. Smoker or ex-smoker

          4. Smoking history > 10 pack-years

          5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

        Exclusion Criteria:

          1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or
             hospitalisation for cardiac failure

          2. History of asthma or allergic conditions.

          3. Malignancy requiring treatment within past 5 years

          4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident
             bronchiectasis

          5. Known active tuberculosis

          6. Known hypersensitivity to anticholinergic drugs.
A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: VELCADE Administered by subcutaneous injection; VELCADE Administered by intravenous infusion
Intervention description: Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle; Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.
Intervention MeSH terms: Bortezomib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized, open-label, international, multi-center, Phase 3 study in which patients are
      randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects 18 years or older

          2. Diagnosis of multiple myeloma

          3. Measurable, secretory multiple myeloma defined as serum monoclonal IgG of ≥10 g/L,
             serum monoclonal IgA or IgE ≥5 g/L, or serum monoclonal IgD ≥0.5g/L; or urine
             M-protein of ≥200 mg/24 hr

          4. Relapse or progression of myeloma following prior systemic antineoplastic therapy.

        Exclusion Criteria:

          1. Previous treatment with VELCADE

          2. More than 3 previous lines of therapy (separate lines of therapy are defined as single
             or combination therapies that are either separated by disease progression or by a
             greater than 6 month treatment-free interval)

          3. Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2

          4. Any of the following within 3 weeks prior to randomization:

             antineoplastic or experimental therapy, corticosteroid use above 10mg a day
             (prednisone or equivalent), or plasmapheresis

          5. Any of the following within 2 weeks prior to randomization:

             radiation therapy, major surgery (kyphoplasty is not considered major surgery)

          6. Prior malignancy other than multiple myeloma diagnosed or treated within the last 2
             years, with the exception of completely resected carcinoma in situ or basal/squamous
             carcinoma of the skin
Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Condition: Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)
MeSH terms: Neoplasm Metastasis; Vision Disorders; Vision, Low; Myopia; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab 0.5mg; Ranibizumab 0.5 mg; Verteporfin PDT
Intervention description: 0.5 mg ranibizumab (intravitreal injections); 0.5 mg ranibizumab (intravitreal injections); Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application
Intervention MeSH terms: Ranibizumab; Verteporfin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 457.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vision loss,PM,CNV,ranibizumab,verteporfinPDT,Brilliance

Summary:

      This study was designed to evaluate the efficacy and safety of two different dosing regimens
      of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in
      patients with visual impairment due to choroidal neovascularization secondary to pathologic
      myopia (PM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Visual impairment due to CNV secondary to PM.

          -  Best corrected visual acuity in the study eye > 24 and < 78 ETDRS letters.

          -  High myopia (> -6D),

          -  anterio-posterior elongation > 26 mm; posterior changes compatible with the pathologic
             myopia.

          -  Either CNV locations in the study eye: subfoveal, juxtafoveal, extrafoveal.

        Exclusion Criteria:

          -  Some preexisting eye disorders or systemic diseases;-Blood pressure > 150/90 mmHg

          -  Prior focal/grid laser to the macular area -History of treatment with any anti-VEGF or
             verteporfin PDT in the study eye

          -  Intravitreal treatment with corticosteroids or intraocular surgery within last 3
             months in the study eye
A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
Condition: Lip Augmentation
Intervention: PN40082
Intervention description: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 84.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., met all
             inclusion/exclusion criteria; received study device, completed Visit 5 within the
             specified window; had LFGS score by the Blinded Evaluating Investigator at Visit
             3/Month 2, and had no significant protocol violations that would affect the treatment
             evaluation.

          2. If female and of childbearing potential, a negative urine pregnancy test at Visit
             1/Day 1 and the subject agrees to use adequate contraception during the study period

          3. Willing to give written informed consent

        Exclusion Criteria:

        1. Women who are pregnant, lactating, or planning a pregnancy
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
Condition: Narcolepsy With Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Intervention: JZP-258; Placebo
Intervention description: JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate; Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial [United States Pharmacopeia/ National Formulary])
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the
      efficacy and safety of JZP-258.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 18 and 70 years of age, inclusive.

          2. Have a primary diagnosis of narcolepsy with cataplexy that meets ICSD-3 criteria or
             DSM-5 criteria, and currently untreated or treated with or without anticataplectics.

          3. If applicable, treated with a stimulant or alerting agent at unchanged doses for at
             least 2 months prior to dosing or not treated with a stimulant or alerting agent.

          4. Willing and able to comply with the study design schedule and other requirements.

          5. Willing and able to provide written informed consent.

        Exclusion Criteria:

          1. Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion)

          2. History or presence of any unstable or clinically significant medical condition,
             behavioral or psychiatric disorder (including active suicidal ideation), or history or
             presence of another neurological disorder or surgical history that might affect the
             subject's safety and/or interfere with the conduct of the study in the opinion of the
             Investigator.

          3. Treatment with any central nervous system sedating agents, including but not limited
             to benzodiazepines, nonbenzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics,
             opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, e.g. diclofenac,
             valproate, ibuprofen, within 2 weeks prior to enrollment (discontinuation for the
             purpose of study enrollment is permitted only if considered safe by the Investigator
             and approved by the Medical Monitor).

          4. Treatment with an antidepressant for cataplexy, if the withdrawal of the
             antidepressant during cross-titration with JZP-258 might be unsafe due to prior
             history of depression.

          5. Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the
             Investigator.
A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; CP-690,550; Placebo; Placebo
Intervention description: Film coated tablet, 5 mg PO BID, 1 year; Film coated tablet, 10 mg PO BID, 1 year; Film coated tablet, 1 tablet PO BID, 3-6 months; Film coated tablet, 1 tablet PO BID, 3-6 months
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 795.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis; Rheumatoid; Antirheumatic Agents; Clinical Trial

Summary:

      This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg
      BID is safe and effective when used in combination with a variety of traditional disease
      modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to
      confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that
      were observed in the Phase 2 rheumatoid arthritis studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a diagnosis of Rheumatoid Arthritis based on the American College of
             Rheumatology (ACR) 1987 Revised Criteria.

          -  The patient has active disease as defined by both >=4 tender or painful joints on
             motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) >
             28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.

          -  Patient had an inadequate response to at least one disease modifying antirheumatic
             drug (traditional or biologic) due to lack of efficacy or toxicity.

          -  Patient must remain on at least one background traditional disease modifying
             antirheumatic drug.

          -  No evidence of inadequately treated latent or active infection with Mycobacterium
             tuberculosis.

        Exclusion Criteria:

          -  Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
             blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count
             <100 x 109/L.

          -  History of any other rheumatic autoimmune disease other than Sjogren's syndrome.

          -  No malignancy or history of malignancy.

          -  History of infection requiring hospitalization, parenteral antimicrobial therapy, or
             as otherwise judged clinically significant by the investigator, within the 6 months
             prior to the first dose of study drug.
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Gabapentin; Acetaminophen; Celecoxib; Ketorolac; Paracervical block with ropivacaine; Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites; Hydromorphone; Oxycodone
Intervention description: 600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op; Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op; Celecoxib 200mg PO q 12h x 7d post op; 30mg IV once at end of hysterectomy procedure; 0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL; 0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total; 1mg IV PRN q3h, post op, while inpatient; To be discharged home with: 12 tabs of 5mg PRN q4h
Intervention MeSH terms: Acetaminophen; Celecoxib; Ketorolac; Oxycodone; Gabapentin; Hydromorphone; Ropivacaine; Anesthetics, Local; Anesthetics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Prospective cohort with retrospective controls
Masking: None (Open Label)
Enrollment: 68.0
Sex: Female
Minimum age: 25 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hysterectomy

Summary:

      Hysterectomy is the most common major gynecologic surgery performed in the US and is
      performed for a variety of indications including malignancy, pelvic mass, endometriosis,
      leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control
      post-operatively is opioid-based however in light of the opioid epidemic, a transition to
      non-opioid pain medication regimens is desired by both physicians and patients alike. The
      goal of this study is to develop a multimodal non-opioid pain medication regimen that
      minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy.
      Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm
      from November, 2020 to November, 2022. Included in our treatment protocol is paracervical
      block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and
      acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use
      will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering
      in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain
      scores will additionally be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without
             bilateral salpingo-oophorectomy

          -  Uterine weight ≤325 grams

        Exclusion Criteria:

          -  contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)

          -  current opioid prescription