bioihbjkbjnl/mcl2 huggingface dataset:
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; PF-06651600
Intervention description: 200mg pill every day (QD) for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in
      seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate
      (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF
      biologic).
    

Eligibility criteria:

        Inclusion Criteria

          -  Subjects between the ages of 18 and 75 years, inclusive

          -  Must have moderate-to-severe, active Rheumatoid Arthritis

          -  Must have had an inadequate response to Methotrexate

          -  Subjects may have received one approved TNF inhibiting biologic agent that was
             inadequately effective and/or not tolerated

        Exclusion Criteria

          -  Subjects with any acute or chronic infections or infection history

          -  Have acute or active chronic dermatological disorders prior to study start

          -  Any major illness/condition(s) or evidence of an unstable clinical condition that in
             the judgment of the investigator would make the subject inappropriate for entry into
             this study

          -  Known immunodeficiency disorder or a first degree relative with hereditary
             immunodeficiency

          -  Any live (attenuated) vaccines or current routine household contact with anyone who
             has received live (attenuated) vaccine
MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Condition: Inherited Metabolic Disorders (IMD)
MeSH terms: Metabolic Diseases
Intervention: MGTA-456
Intervention description: Hematopoietic stem cell transplantation will be done with the cell therapy product MGTA-456.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 0 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: inherited metabolic disorders; cerebral adrenoleukodystrophy; Hurler syndrome; globoid cell leukodystrophy; Krabbe disease; metachromatic leukodystrophy; hematopoietic stem cells; hematopoietic stem cell transplant; umbilical cord blood; umbilical cord blood transplant; MGTA-456; myeloablative conditioning regimen; bone marrow transplant; mucopolysaccharidosis-1H

Summary:

      This study is designed to assess the safety and efficacy of using MGTA-456 in patients with
      Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 2.5 years with Hurler syndrome, age 2-17 years with cerebral
             adrenoleukodystrophy (cALD), age < 16 years with metachromatic leukodystrophy (MLD)
             and age ≤ 10 years with globoid cell leukodystrophy (GLD) (also referred to as Krabbe)

          -  Cord blood grafts require genetic testing and/or demonstration of enzyme activity for
             patients with Hurler syndrome, MLD or GLD and are tested for very long chain fatty
             acids (VLCFA) to confirm there is no evidence of VLCFA consistent with ALD

          -  Adequate organ function

          -  Availability of eligible donor material

        Exclusion Criteria:

          -  Availability of a matched-related donor who is not a carrier of the same genetic
             defect

          -  Active infection at screening

          -  Prior myeloablative conditioning

          -  History of human immunodeficiency virus (HIV) infection
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
Condition: Ependymoma
MeSH terms: Ependymoma
Intervention: Erlotinib
Intervention description: continuous oral Erlotinib 85 mg/m^2 per day
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 1 Year
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Pediatric Ependymoma; Ependymoma; Tarceva; Erlotinib

Summary:

      Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205
      and either progressed while on study or discontinued due to unacceptable toxicity related to
      etoposide were allowed to participate in this study to assess the safety profile of
      single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and
             either progressed while on study or discontinued due to unacceptable toxicity related
             to etoposide

          -  Performance status: Lansky ≥ 50% for patients ≤ 10 years of age or younger or
             Karnofsky ≥ 50% for patients greater than 10 years of age

          -  Patients must have recovered from any acute toxicity to any prior anti-cancer
             treatment

          -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic
             transaminase (SGPT) ALT ≤ 3 x ULN

          -  Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate (GFR)
             ≥ 70 mL/min/m2

          -  Patients must be neurologically stable for at least 7 days before registration

          -  Patients, both males and females, with reproductive potential must agree to practice
             effective contraceptive measures for the duration of study drug therapy and for at
             least 90 days after completion of study drug therapy

          -  Patients must be able to take erlotinib orally

        Exclusion Criteria:

          -  Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers ≤ 14 days before
             registration

          -  Have received any other chemotherapy or immunotherapy to treat ependymoma after
             discontinuation from OSI-774-205

          -  Taking proton pump inhibitors ≤ 14 days before registration

          -  Participating in another investigational drug trial while on study

          -  Pregnant or breast-feeding
Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Sodium Nitrite Inhalation Solution; Placebo
Intervention description: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.; Normal saline will be administered (by inhalation) to participants prior to exercise.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Preserved Ejection Fraction

Summary:

      Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that
      has no proven effective treatment. This study will assess the effects of nebulized inhaled
      nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred
      to the catheterization lab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart Failure with preserved Ejection Fraction (HFpEF) is defined by clinical symptoms
             of dyspnea and fatigue

          -  Normal left ventricular ejection fraction (>/=50%)

          -  And elevated Left Ventricular (LV) filling pressure at cardiac catheterization
             (defined as resting Pulmonary Capillary Wedge Pressure (PCWP)>15 mmHg and/or PCWP
             >/=25 mmHg during exercise).

        Exclusion Criteria:

          -  Systolic Blood Pressure <120 mmHg (during catheterization)

          -  Prior nitrate therapy (within previous 2 weeks)

          -  Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency

          -  Other "non-HFpEF" specific causes of heart failure such as significant valvular
             disease (>moderate left-sided regurgitation, >mild stenosis)

          -  Severe pulmonary disease

          -  Unstable coronary disease or coronary spasm

          -  Primary renal or hepatic disease (end stage renal failure/on dialysis or clinical
             diagnosis of hepatitis or hepatic cirrhosis)

          -  Constrictive pericarditis, or infiltrative, restrictive, or hypertrophic
             cardiomyopathies

          -  Pregnant
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: MK-0873; Comparator: Placebo
Intervention description: MK-0873 1.25 mg twice daily for 12 weeks; Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
Intervention MeSH terms: MK 0873
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will look at whether this new drug is effective in the treatment of rheumatoid
      arthritis, and at whether it is safe and well-tolerated by participants with the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Rheumatoid arthritis, according to the American College of Rheumatology criteria, with
             active disease despite current medications

          -  Other criteria also apply

        Exclusion Criteria:

          -  Other major illnesses

          -  Past history of certain other disorders

          -  Certain prohibited medications
The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: HepQuant SHUNT Liver Diagnostic Kit
Intervention description: Serial testing over 48 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Sequential Assignment
Intervention model description: All subjects receive HepQuant SHUNT test and DSI measurement, but must first be enrolled into one of the three Gilead clinical trials listed above before they can be enrolled in the HepQuant study. Since the assigned intervention, the HepQuant SHUNT test, is the same for all participants in all three Gilead clinical trials, there is only one arm and intervention for the HepQuant study itself. Some analyses are conducted by grouping subjects into those who took the placebo in the parallel drug study versus those who were on active study drug in the parallel study.
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a
      minimally-invasive test of liver function and physiology which has been designated by the FDA
      as an investigational drug/device combination product.

      Enrollment into one of the 3 Gilead Selonsertib clinical trials (GS-US-416-2124,
      GS-US-384-1943/1944) is required for enrollment into the HepQuant study
    

Eligibility criteria:

        Inclusion Criteria:

        The key inclusion criteria for this HepQuant Parallel Study are the inclusion criteria into
        one of the Gilead selonsertib trials (GS-US-416-2124, GS-US-384-1943 or 1944). Once that
        has been met, subjects must:

          -  Be able to ingest liquid by mouth

          -  Have venous access to support a peripheral IV and 6 blood draws

        Exclusion Criteria:

        The key exclusion criteria for this HepQuant Parallel Study are the exclusion criteria for
        one of the Gilead selonsertib trials (GS-US-416-2124, GS-US-384-1943 or 1944). If this has
        been met, the subject is not eligible to participate in HepQuant. If no exclusion criteria
        has been met for the Gilead selonsertib trial, ADDITIONAL exclusions for HepQuant are:

          -  Subject should not have had first dose of selonsertib

          -  Subject cannot take anything by mouth

          -  Subject cannot be hypersensitive to eggs, albumin preparations, any ingredient in the
             formulation, or component of the container

          -  Subject cannot have intercurrent medical or surgical illness (eg: acute MI, acute
             cerebral hemorrhage, sepsis)

          -  subject cannot have had extensive resection of large segments of small intestine
             (short gut)

          -  Subject cannot have severe gastroparesis
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: High dose; Low dose; Placebo
Intervention description: 6 capsules of IBD98-M, twice a day; 4 capsules of IBD98-M; Placebo
Intervention MeSH terms: Mesalamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed
      Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the
      clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week
      treatment period and 2 weeks follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age ≥18 and <75 years, suffering from UC for at least 6 months prior
             to screening

          2. Female patients must be postmenopausal, sterile, or have a negative urine pregnancy
             test prior to entering the study and use adequate contraception during the study if of
             childbearing potential.

          3. Diagnosis of active UC with UCDAI ≥4 and ≤10, with endoscopy score of ≥1 in the UCDAI
             mucosal appearance subscore

        Exclusion Criteria:

          1. Patients diagnosed with Crohn's disease, indeterminate colitis, or ischemic colitis

          2. Female patients who are pregnant or breastfeeding

          3. Ulcerative proctitis with ≤15 cm of disease

          4. Patients with infectious colitis as determined by assessment for Clostridium difficile
             (C. difficile) and fecal pathogens at screening or treatment for C. difficile within
             30 days prior to screening

          5. History of or current evidence of toxic megacolon, fulminant colitis (e.g., Lichtiger
             score of ≥10), colonic perforation
Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Condition: Infections, Gram-positive Bacterial
MeSH terms: Infections; Communicable Diseases; Gram-Positive Bacterial Infections
Intervention: Telavancin; vancomycin or antistaphylococcal penicillin
Intervention description: Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days; Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
Intervention MeSH terms: Vancomycin; Penicillins; Telavancin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abscess; Burns; Cellulitis; Ulcer; Wound infections

Summary:

      Serious infections caused by resistant bacteria are becoming more of a medical problem
      throughout the world. This study will measure how well TD-6424 (Telavancin) can control
      infections and whether the drug is safe to give to patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of one of the following complicated skin and soft
             tissue infections and either a suspected or confirmed Gram positive organism

               -  major abscess requiring surgical incision and drainage

               -  infected burn (see exclusion criteria for important qualifications)

               -  deep/extensive cellulitis

               -  infected ulcer (see exclusion criteria for important qualifications)

               -  wound infection

          -  Patients must be expected to require at least 4 days of intravenous (IV) antibiotic
             treatment

        Exclusion Criteria:

          -  Previous systemic antibacterial therapy (with the exception of aztreonam and
             metronidazole) for > 24 hours within 7 days prior to the first dose of study drug
             unless the pathogen was resistant to prior treatment or the patient was a treatment
             failure (no clinical improvement after 3 days)

          -  Burns involving > 20% of body surface area or third degree/full thickness in nature,
             diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or
             mediastinitis
A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Standard chemotherapy; bevacizumab [Avastin]; trastuzumab [Herceptin]
Intervention description: As prescribed; 15mg/kg iv 3 weekly in cycles 1-8; 8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.
Intervention MeSH terms: Bevacizumab; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of preoperative treatment with
      Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory
      HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of
      pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is
      3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult females, >=18 years of age;

          -  inflammatory breast cancer;

          -  HER2-positive tumors;

          -  performance status 0-2.

        Exclusion Criteria:

          -  metastases;

          -  previous treatment with chemotherapy, radiation therapy or hormone therapy for a
             breast tumor;

          -  clinically significant cardiovascular disease, or history of thrombotic disorders.
Imaging Characteristics of a Follow-up 18F-AV-1451 Scan
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; Florbetapir F 18; Brain PET Scan
Intervention description: 370 megabecquerel (MBq) IV single-dose; 370 megabecquerel (MBq) IV single-dose; positron emission tomography (PET) scan of the brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the imaging characteristics of flortaucipir in subjects with a
      previous flortaucipir scan in order to assess the rate of change of tau deposition over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a previous 18F-AV-1451 brain scan

          -  Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a
             Magnetic Resonance Imaging (MRI) scan

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Current clinically significant psychiatric disease

          -  Are claustrophobic

          -  Current clinically significant cardiovascular disease or ECG abnormalities, or
             additional risk factors for Torsades de Pointes

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception

          -  Have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session