bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo; ABT-494
Intervention description: Oral Dosing; Oral Dosing
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately
      to severely active Crohn's Disease with a history of inadequate response to or intolerance to
      Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of Crohn's disease (CD) for at least 90 days.

          2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
             equal to 450.

          3. Subject inadequately responded to or experienced intolerance to previous treatment
             with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or
             anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

        Exclusion Criteria:

          1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.

          2. Subject who has had surgical bowel resections in the past 6 months or is planning
             resection.

          3. Subjects with an ostomy or ileoanal pouch.

          4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

          5. Subject who has short bowel syndrome.

          6. Subject with recurring infections or active Tuberculosis (TB).
Ruxolitinib in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ruxolitinib
Phase: Phase 2
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
Healthy volunteers: No
Keywords: pSTAT3+

Summary:

      Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is
      thought that this pathway might be important in certain types of breast cancer, and that
      blocking this pathway might lead to anti-cancer effects. This study is testing the effects of
      ruxolitinib in patients with breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed invasive breast cancer

          -  Must have known ER, PR and HER2 status

          -  Either, Triple Negative Metastatic Breast Cancer or

          -  Inflammatory Breast Cancer with any ER, PR HER2 status

          -  Availability of archival tissue specimen suitable for pStat3 testing

          -  Life expectancy of greater than 3 months

          -  Measurable disease by RECIST

          -  At least one prior chemotherapy regimen for treatment of metastatic breast cancer
             and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy
             or

          -  For patients with inflammatory breast cancer but no distant metastases, progression
             through standard neoadjuvant chemotherapy is required

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Active brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ruxolitinib

          -  Clinically significant malabsorption syndrome

          -  Concurrent use of medications/substances that are strong inhibitors of CY3A4

          -  No uncontrolled intercurrent illness
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
Condition: Osteomyelitis
MeSH terms: Osteomyelitis
Intervention: daptomycin; daptomycin; vancomycin; teicoplanin; nafcillin; oxacillin; flucloxacillin
Intervention description: 6 mg/kg; 8 mg/kg; 1 gram; 6 mg/kg; used only at UK sites; 1-2 gram; 1-2 gram; 1-2 mg
Intervention MeSH terms: Vancomycin; Daptomycin; Teicoplanin; Floxacillin; Oxacillin; Nafcillin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteomyelitis; Prosthetic Hip; Prosthetic Knee; MRSA; Osteomyelitis Associated with an Infected Prosthetic Hip or Knee Joint; Staphylococci

Summary:

      This is a research study designed to look at the efficacy and safety of daptomycin given at a
      dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections
      caused by Staphylococci. These types of bacteria are among the most common types of bacteria
      causing infections of prosthetic joints.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be between the ages of 18 and 80, inclusive

          -  Subject must have a diagnosis of prosthetic joint infection (PJI) in a hip or knee
             joint which has never previously been totally revised because of an infection and for
             which they are anticipated to undergo a two-stage replacement surgery

          -  Subject must have a positive microbiological identifier of staphylococci.

          -  If Subject is female of childbearing potential, must be willing to practice reliable
             birth control

        Exclusion Criteria:

          -  Subject has permanent intravascular prosthetic material such as heart valves or
             pacemakers

          -  Subject has a creatinine clearance (CLCR) <30 mL/min as determined by the
             Cockcroft-Gault equation using actual body weight.

          -  Subject has significant hepatic dysfunction

          -  Subject has a fungal or mycobacterial PJI

          -  Subject is known to be HIV-infected with CD4 count ≤ 200 cells/ mm3

          -  Subject has an abnormal creatine phosphokinase (CPK) (elevated CPK level ≥ 2x ULN) at
             baseline as measured by central laboratory

          -  Subject is currently under treatment with chemotherapeutic agents excluding chronic
             maintenance therapy (e.g. tamoxifen to prevent relapse of primary breast cancer)

          -  Subject is pregnant, nursing, or lactating.

          -  Subject is receiving or is expected to receive chronic immunosuppressive therapy
             during the study.
Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
Condition: Breast Neoplasms; Neoplasm Metastasis
MeSH terms: Breast Neoplasms; Neoplasms; Neoplasm Metastasis
Intervention: SKI-606 (Bosutinib)
Intervention description: SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Breast Cancer

Summary:

      The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the
      treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB,
      IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIB, IIIC or IV breast cancer not curable with available therapy.

          -  Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.

          -  Life expectancy of at least 16 weeks.

          -  Ability to swallow whole capsules.

        Exclusion Criteria:

          -  Use of or requirement for bisphosphonates within 8 weeks prior to screening.

          -  Any other cancer within 5 years of screening, except for basal cell carcinoma or
             cervical carcinoma in situ

          -  Uncontrolled cardiac disease including congestive heart failure, angina, heart attack,
             etc.

          -  Recent or ongoing significant gastrointestinal disorder
Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Cyclophosphamide (CTX); Vincristine; Doxorubicin; Decadron; G-CSF; Methotrexate (MTX); Ara-C; Pegaspargase
Intervention description: 300 mg/m^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of; 2 mg by vein (IV) weekly for 3: Days 1, 8, 15; 50 mg/m^2 by vein (IV) over 24 hours; 80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18; 10 mcg/kg/day (rounded) by vein (IV) or under the skin (subcutaneously) within 72 ± 48 hours; 200 mg/m2 by vein (IV) over 2 hours followed by 800 mg/m2 over 22 hours on day 1; 3 gm/m^2 by vein (IV) over 2 hours every 12 hours for 4 doses on days 2 and 3.; 2,500 units/m2 by vein (IV) on day 1 of odd courses and day 5 of even courses
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Doxorubicin; Methotrexate; Vincristine; Asparaginase; Pegaspargase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia; ALL; Leukemia; Hyper-CVAD

Summary:

      The goal of this clinical research study is to learn if a special combination of chemotherapy
      drugs called "augmented hyper-CVAD chemotherapy" given over 6 to 8 months followed by monthly
      maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or
      lymphoblastic lymphoma. The safety of this therapy will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously treated acute lymphoblastic leukemia (ALL) (including Burkitt's lymphoma)
             or lymphoblastic lymphoma in relapse or primary refractory;

          -  No age restrictions;

          -  Zubrod performance status </= 3;

          -  Adequate liver (bilirubin </= 3mg/dl unless considered due to tumor) and renal
             function (creatinine </= 3mg/dl unless considered due to tumor);

          -  Adequate cardiac function (New York Heart Association (NYHA) < III as assessed by
             history and physical examination)

        Exclusion Criteria:

          -  Not Applicable
Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis
Condition: Focal Segmental Glomerulosclerosis
MeSH terms: Glomerulosclerosis, Focal Segmental
Intervention: Voclosporin
Intervention description: Voclosporin softgel capsules. Up to 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID).
The dose of voclosporin for Cohort 2 (at least 10 subjects) will be determined by analysis of efficacy and safety data at Week 12 from the first 5 or 6 subjects in Cohort 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: calcineurin inhibitors; Focal Segmental Glomerulosclerosis

Summary:

      Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission
      of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Primary FSGS diagnosed by renal biopsy.

          2. Urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≤3.2 g/dL and can be
             immunosuppressant treatment-naïve, or receiving treatment with steroids.

          3. Stable proteinuria, renal function, and BP.

        Exclusion Criteria:

          1. Clinical or histologic evidence of secondary FSGS.

          2. Histologic evidence of collapsing variant FSGS.

          3. eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
             equation of ≤30 mL/minute/1.73 m2 at initial screening assessment or ≤45
             mL/minute/1.73 m2 at last qualifying assessment.

          4. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected
             to require dialysis during the study period.

          5. Current or medical history of:

               -  Congenital or acquired immunodeficiency.

               -  In the opinion of the Investigator, clinically significant drug or alcohol abuse
                  within 2 years prior to screening.

               -  Malignancy within 5 years of screening, with the exception of basal and squamous
                  cell carcinomas treated by complete excision.

               -  Current or past lymphoproliferative disease or previous total lymphoid
                  irradiation.

               -  Severe viral infection within 3 months of screening, or known HIV infection.
                  Severe viral infection is defined as active disease requiring antiviral therapy.

               -  Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking
                  prophylaxis with isoniazid.
Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
Condition: Cesarean Section
Intervention: ketorolac; Chewing Gum; Enhanced Recovery Protocol
Intervention description: Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.; Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for a duration of 30 minutes at each time, based on a metanalysis and systematic review. Patient's will be encouraged on its use for return of bowel function.; enhanced recovery protocol (detailed previously) will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing and standing ketorolac for 24 hours postoperatively.
Intervention MeSH terms: Ketorolac
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 118.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Enhanced Recovery

Summary:

      To determine whether women randomized to an enhanced recovery program will have improved
      postoperative outcomes including improved breastfeeding initiation and continuation,
      reduction in hospital length of stay without compromising patient satisfaction in comparison
      to standard postoperative recovery interventions.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation

        Exclusion Criteria:

          1. Women undergoing an urgent or emergent cesarean birth

          2. Women less than 18 years old

          3. Patients receiving general anesthesia

          4. Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss
             (Placenta accreta)

          5. Pre-existing essential hypertension or hypertensive disorders of pregnancy
             (preeclampsia, eclampsia, HELLP)

          6. Chronic or acute renal impairment

          7. Bleeding disorders or platelet dysfunction

          8. Peptic ulcer disease or gastrointestinal bleeding

          9. Known hypersensitivity to ketorolac (toradol)

         10. Active infection at the time of cesarean

         11. Cesarean birth prior to 37 weeks

         12. Women in significant pain in labor
Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)
Condition: Geographic Atrophy; Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: LFG316; Sham; LFG316 Lower dose
Intervention description: LFG316 5 mg/50 μL solution for IVT injection,; Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given); LFG316 5 mg/50 μL solution for IVT Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 158.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: AMD; Age-related Macular Degeneration; geographic atrophy; GA; Dry AMD; Blindness; Drusen; GA lesion

Summary:

      This study was conducted in two parts; Part A and Part B: Part B was initially planned to
      include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in
      Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred
      to again and part B cohort 1 is referred to as part B alone in the remainder of the document
      and is the subject of this report.

      Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT)
      LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed
      a multicenter, randomized, sham - controlled, single masked design. Eight patients with
      advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of
      LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated
      the same as those assigned to LFG316, except that the hub of an empty syringe (without
      needle) was placed against the eye instead of the IVT injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AMD if enrolled in Part B of study

          -  Geographic atrophy in at least one eye if enrolled in Part A of study

          -  ETDRS best corrected visual acuity of 60 letters or worse (~≤ 20/63)

        Exclusion Criteria:

          -  Retinal disease other than AMD

          -  History of choroidal neovascularization

          -  Severe cataract

          -  History of infectious uveitis or endophthalmitis

          -  Eye surgery in the non-study eye within 30 days prior to study

          -  Eye surgery or IVT injection in the study eye within 90 days prior to study

          -  Other protocol-defined inclusion/exclusion criteria may apply
A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis
Condition: Erosive Hand Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: ABT-981; Placebo for ABT-981
Intervention description: ABT-981 administered by subcutaneous injection; Placebo for ABT-981 administered by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Joint diseases; Musculoskeletal diseases; Rheumatic diseases; Arthritis; Osteoarthritis, Hand

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled study to compare the
      safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female between the ages of 35 to 80.

          2. Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA)
             criteria

          3. Must have radiographic evidence of erosive hand OA

          4. Have one or more clinical signs and symptoms of active inflammation in at least three
             hand joints

          5. Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6.

        Exclusion Criteria:

          1. Previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1
             month prior to Screening, to intra-articular hyaluronic acid injection into hand
             joint(s) within 6 months prior to Screening, to any immunosuppressive biologic therapy
             within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study
             drug, OR current use of immunosuppressive oral medications within 3 months or 5
             half-lives (whichever is longer) prior to the first dose of study drug.

          2. Absolute neutrophil count < 2,000 per mm3

          3. Diagnosis of one or more of the following:

               -  Fibromyalgia,

               -  Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative
                  spondyloarthropathy,

               -  Psoriatic arthritis, psoriasis,

               -  Microcrystalline (including gout and pseudo gout) arthritis affecting the hands,

               -  Any OA of the hands due to an infectious origin or acute traumatic episode,
                  secondary OA or OA linked to cartilage and bone dysplasia,

               -  Other chronic painful syndromes that could interfere with assessment of pain at
                  the hand(s).

          4. Any uncontrolled medical illness or an unstable treatment or therapy.

          5. Any reason that prohibits a subject to undergo an MRI.