bioihbjkbjnl/mcl2 huggingface dataset:
PF-06741086 Long-term Treatment in Severe Hemophilia
Condition: Hemophilia A or B
MeSH terms: Hemophilia A
Intervention: PF-06741086
Intervention description: PF-06741086 subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 12 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: hemophilia

Summary:

      This study is designed to evaluate the safety, tolerability and efficacy of long-term
      treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month
      Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%)

          -  Subjects enrolled as Factor VIII or Factor IX inhibitor patients must have a positive
             inhibitor test result (above the upper limit of normal) at the local laboratory and
             must receive a bypass agent as primary treatment for bleeding episodes.

          -  Episodic (on-demand) treatment regimen prior to screening

          -  At least 6 acute bleeding episodes during the 6-month period prior to screening

        Exclusion Criteria:

          -  Known coronary artery, thrombotic, or ischemic disease

          -  Concomitant treatment with activated prothrombin complex concentrate
Efficacy and Safety of TD-1473 in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo; TD-1473
Intervention description: Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.; TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TD-1473; Janus kinase inhibitor; JAK inhibitor; Inflammatory Bowel Disease; IBD; Crohn's Disease; Intestinal restriction

Summary:

      A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with
      moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is at least 18 years of age at screening

          -  Males and females with clinical evidence of Crohn's disease for at least 3 months
             duration at screening

          -  Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's
             Disease Activity Index (CDAI) score of 220-450 inclusive

          -  SES-CD score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of
             the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD]

          -  Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to
             conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as
             azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy,
             anti-IL-12/23 (anti-interleukin), anti-integrin).

          -  Additional inclusion criteria apply

        Exclusion Criteria:

          -  Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy

          -  Has a current bacterial, parasitic, fungal, or viral infection

          -  Has clinically significant abnormalities in laboratory evaluations

          -  Prior exposure or potential exposure to a JAK inhibitor that was stopped due to
             intolerance or lack of efficacy

          -  Subject has participated in another clinical trial of an investigational drug (or
             medical device) within 30 days prior to Screening or 5x the half-life of the
             investigational drug, whichever is longer, or is currently participating in another
             trial of an investigational drug (or medical device)

          -  Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e.,
             anti-TNF, anti-integrin, and anti-IL12/23)

          -  Additional exclusion criteria apply
Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis
Condition: Severe Sepsis
MeSH terms: Sepsis; Toxemia
Intervention: Acetaminophen; placebo
Intervention MeSH terms: Acetaminophen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia,
      hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free
      hemoglobin in these patient population has been associated with poor outcomes, including an
      association with an increased risk of death. Acetaminophen may have a protective effect in
      these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose
      of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults
      with severe sepsis and detectable cell-free hemoglobin.

      The primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation,
      as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis
      and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The
      secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin
      treated with acetaminophen will have better clinical outcomes, including decreased incidence
      of acute kidney injury and lower rates of hospital mortality, compared to those who receive
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Female >=18 years old

          -  Admitted to an Intensive Care Unit

          -  Severe Sepsis

          -  Detectable plasma cell-free hemoglobin

        Exclusion Criteria:

          -  patients who received acetaminophen in the past 48 hours prior to enrollment

          -  intolerance or allergy to acetaminophen

          -  measured AST/ALT >400 U/L in the 24 hours prior to enrollment

          -  chronic liver disease defined by a Child-Pugh score >4

          -  cannot swallow or have no enteral feeding access

          -  patients with no detectable cell-free hemoglobin

          -  patients transitioned to palliative care

          -  pregnant patients or women of childbearing potential without a documented pregnancy
             test
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Condition: Cervical Strain
MeSH terms: Sprains and Strains
Intervention: Cyclobenzaprine; Ibuprofen; Ibuprofen plus Cyclobenzaprine
Intervention description: 5 mg orally every 8 hours as needed; Ibuprofen 400 mg every 8 hours as needed; Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
Intervention MeSH terms: Ibuprofen; Amitriptyline; Cyclobenzaprine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cervical strain; whiplash; ibuprofen; cyclobenzaprine

Summary:

      The purpose of this study is to see whether the combination of a muscle relaxant and
      anti-inflammatory drug is more effective at relieving pain in patients with neck strains or
      whiplash than either of the two medications alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  neck pain within 24 hours of injury

        Exclusion Criteria:

          -  Children, allergy or contraindication to any of the study drugs
A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma
Intervention: rituximab
Intervention description: 1
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of MabThera in combination chemotherapy,
      followed by maintenance treatment with MabThera. The anticipated time on study treatment is
      1-2 years, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-65 years of age;

          -  previously untreated indolent nonfollicular non-Hodgkin's lymphoma;

          -  active disease;

          -  >=3 involved sites.

        Exclusion Criteria:

          -  typical chronic lymphocytic leukemia;

          -  other malignancies within 3 years before study, except basal or squamous cell skin
             cancer or cancer in situ of the cervix;

          -  systemic corticosteroid use for >1 month;

          -  significant cardiovascular disease;

          -  central nervous system involvement;

          -  hepatitis B or C virus infection, or HIV infection.
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Condition: Orthopoxviral Disease
Intervention: ST-246 400 mg; ST-246 600 mg; Placebo
Intervention description: Capsules, 400 mg daily for 14 days; Capsules, 600 mg daily for 14 days; Capsules, once daily for 14 days
Intervention MeSH terms: Tecovirimat
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Orthopoxvirus; Smallpox; This is a safety study only; ST-246 is being studied for treatment of Orthopoxviruses

Summary:

      The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two
      clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral
      dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose
      will be used in expanded pivotal safety trials.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 - 75 yrs

          2. Healthy volunteer

          3. Ability to consent

          4. Available for clinical follow-up for study

          5. Not taking other medications

          6. Adequate venous access

          7. Using adequate birth control; negative pregnancy test

          8. Able and willing to avoid alcohol for screening and study duration

        Exclusion Criteria:

          1. Inability to swallow study medication

          2. Pregnant or breast-feeding

          3. Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury
             other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures,
             cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C,
             HIV or AIDS, chronic microbial infection,

          4. History of drug allergy that contraindicates study participation

          5. Medical, psychiatric, social, occupational or other reason that jeopardizes the
             safety/rights of participant or renders he/she unable to comply with the protocol
             (including drug or alcohol abuse, or homelessness)

          6. Clinically abnormal ECG

          7. Has or will participate in a clinical trial or experimental treatment within 30 days
             of, or during, the study

          8. Cannot or will not do physical exercise 24 hrs before and after PK days

          9. Will not consume grapefruit/grapefruit juice during study

         10. Vaccination within 2 wks of screening, or planned before Day 42 of study

         11. Treatment with prednisone or equivalent immunosuppressant/modulatory drug <3 mths
             before screening

         12. Clinically significant physical exam and lab results <2weeks from 1st study drug dose
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
Condition: Lupus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: BMS-931699; Placebo matching BMS-931699
Intervention MeSH terms: Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 730.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic
      lupus erythematosus in male and female adults. Patients who qualify will be randomized to
      either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the
      initial 24 weeks of treatment and who are responding to therapy will have the option to
      continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and
      safety will be assessed over the course of the study through laboratory values, various
      rating scales accepted in systemic lupus erythematosus studies and patient self reporting.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male or female aged between 18 to 70 (included)

          -  Diagnosed with active systemic lupus erythematosus by a doctor

          -  Disease must be in patient's joints or on the skin at a minimum

          -  Taking other medications is allowed but some are excluded

        Exclusion Criteria:

          -  Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis

          -  Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Condition: Raynaud's Phenomenon Secondary to Systemic Sclerosis
MeSH terms: Neoplasm Metastasis; Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: Temanogrel; Placebo
Intervention description: Participants will receive a single oral dose of temanogrel during the treatment visit.; Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.
Intervention MeSH terms: APD791
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Raynaud's phenomenon; SSc-RP; Systemic sclerosis; SSc; Digital cold sensitivity; Digital blood flow; APD791; Temanogrel

Summary:

      The purpose of this study is to determine whether oral temanogrel improves digital blood flow
      in participants with Raynaud's phenomenon secondary to systemic sclerosis (SSc-RP) as a
      potential safe and effective treatment for symptoms associated with SSc-RP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Raynaud's phenomenon (defined as a history of digital cold sensitivity associated with
             color changes of cyanosis and pallor, with on average at least 5 attacks per week
             during the winter period) secondary to systemic sclerosis (SSc)

          -  Both men and women participants agree to use a highly effective method of birth
             control if the possibility of conception exists

          -  Body mass index 18.0 to 40.0 kilograms per square meter (kg/m^2), inclusive

        Exclusion Criteria:

          -  Active digital ulcer(s), recent history (within 3 months of Screening) of digital
             ulcers, or history of recurrent digital ulcerations that in the opinion of the
             Investigator increase the likelihood of developing a digital ulcer during the course
             of the study. Any history of gangrene, amputations, or other critical digital ischemic
             event

          -  Raynaud's phenomenon due to any cause other than SSc

          -  Severe gastrointestinal complications related to SSc that in the opinion of the
             Investigator could significantly affect study drug absorption

          -  History of gastrointestinal bleeding or active gastric or duodenal ulcers
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06835919; PF-06835919
Intervention description: Placebo; 150 mg once daily; 300 mg once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus

Summary:

      This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis
      and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be
      treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the
      effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males, or females of nonchildbearing potential

          -  18 to 70 years of age

          -  Type 2 Diabetes Mellitus

          -  Liver fat >/=8% by MRI-PDFF

          -  On stable dose of metformin monotherapy for at least 2 months (at a dose of at least
             500 mg daily)

        Exclusion Criteria:

          -  History of other liver disease

          -  Unable to have an MRI performed

          -  Significant weight loss in the previous month and/or participant in current weight
             loss program

          -  History of diabetic complications with end-organ damage
Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Quizartinib
Intervention description: Quizartinib was orally administered once daily every morning. Treatment with quizartinib was administered in 28-day cycles and continued until the discontinuation criteria for treatment were met.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: FLT3-ITD; Positive refractory or relapsed acute myeloid leukemia; Hematology malignancy; Developmental Phase II

Summary:

      This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and
      pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive
      refractory or relapsed acute myeloid leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AML patients in first relapse or refractory after all prior therapy

          -  Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

        Exclusion Criteria:

          -  Diagnosis of acute promyelocytic leukemia

          -  AML secondary to prior chemotherapy for other neoplasms.

          -  Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML
             therapy

          -  Prior treatment with a FLT3 targeted therapy

          -  Active infection not well controlled by antibacterial, antifungal and/or antiviral
             therapy
Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.
Condition: Down Syndrome; Amyloid Beta-protein
MeSH terms: Down Syndrome; Amyloidosis; Syndrome
Intervention: Florbetaben (BAY94-9172)
Intervention description: 300 megabecquerels (MBq) as single IV injection of 2 to 10 mL
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amyloid beta-protein; Down Syndrome

Summary:

      To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting
      cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals
      without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the
      age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
    

Eligibility criteria:

        Inclusion Criteria:

        Study participants were individuals with DS and healthy volunteers (HVs).

          -  Main inclusion criteria for individuals without DS

               -  >=21 and <= 40 years of age

               -  Mini-Mental State Examination (MMSE) >= 28

               -  Clinical Dementia Rating (CDR) of 0

          -  Main inclusion criteria for individuals with DS

               -  >= 40 years of age

        Exclusion Criteria:

          -  Main exclusion criteria for both groups

               -  Unstable medical or psychiatric condition, study specific screening procedures
                  with the understanding that the patient has the right to withdraw from the study
                  at any time