bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
Condition: Idiopathic Pulmonary Fibrosis; Hypoxemia
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Hypoxia
Intervention: GBT440; Placebo
Intervention description: Capsules which contain GBT440 drug substance in Swedish orange; Placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF
      subjects will be randomized to receive GBT440 or Placebo orally daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of IPF.

          -  Oxygen desaturation with exercise.

          -  Completion of the baseline 6MWT

          -  Weight ≥ 50 kg

          -  Male or female of child bearing potential willing and able to use highly effective
             methods of contraception from study start to 3 months after the last dose of study
             drug.

        Exclusion Criteria:

          -  FEV1/FVC < 70%.

          -  Subjects on supplemental oxygen therapy at rest.

          -  History of other interstitial lung diseases.

          -  Significant polycythemia.

          -  Female who is breast-feeding or pregnant.

          -  Known current malignancy or history of malignancy within the last 2 years prior to
             screening.

          -  Use of cytotoxic and/or immunosuppressant medications within 30 days screening.

          -  Hospitalization due to an exacerbation of IPF within 30 days of screening

          -  Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of
             screening

          -  Corticosteroids (> 10 mg per day of prednisone or an equivalent) within 30 days of
             screening.

          -  Current smoker or history of smoking within 3 months of screening.

          -  Currently or, in the opinion of the investigator, soon to be listed for lung
             transplant.

          -  History of unstable or deteriorating cardiac or pulmonary disease (other than IPF)
             within 6 months of screening.

          -  Any condition possibly affecting drug absorption.

          -  Participated in another clinical trial of an investigational drug (or medical device)
             within 30 days or 5-half-lives, whichever is longer, prior to screening, or is
             currently participating in another trial of an investigational drug (or medical
             device).

          -  Subject who, for any reason, is deemed by the investigator to be inappropriate for
             this study.
Efficacy and Safety of CD5024 1% in Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: CD5024 1% cream; CD5024 cream placebo; CD0271/CD1579 gel; CD0271/CD1579 gel placebo
Intervention description: 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using
      intra-individual comparison involving subjects with acne vulgaris on face to evaluate the
      efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is a male or a female aged from 18 to 35 years old at screening visit.

          2. The subject has a medical diagnosis of acne vulgaris :

             2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred)
             non-inflammatory lesions (nose is excluded for the lesion count) at Baseline

             2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as
             compared to the other side at Baseline

          3. If the subject is a female of childbearing potential, she must agree to use an
             effective contraceptive method for the duration of the study

        Exclusion Criteria:

          1. The subject has an underlying known disease surgical or medical condition, in the
             opinion of the investigator might interfere with interpretation of the study results
             or put the subject at risk (e.g., other dermatological diseases affecting the
             treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or
             serious diseases which would normally prevent participation in any clinical study,
             such as a cancer, leukemia or severe hepatic impairment), (Screening).

          2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne,
             drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.

          3. The subject has a known or suspected allergies or sensitivities to any components of
             any of the study drugs (see Investigator's Brochure/Product label).

          4. The subject is a male with beard or facial hair, which would interfere with clinical
             evaluation or clinical procedure (Screening and Baseline).
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Pamrevlumab; Placebo
Intervention description: Sterile liquid for injection; Sterile liquid for injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Proof-of-concept
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Severe Acute Respiratory Syndrome coronavirus; SARS-COV-2 infection

Summary:

      This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab
      when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed SARS-CoV-2 infection

          2. Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by
             at least one (or more) of the following criteria:

               -  Interstitial pneumonia on chest x-ray or high-resolution computed tomography
                  (findings of consolidation or ground glass opacities), OR

               -  Peripheral capillary oxygen saturation < 94% on room air, OR

               -  Requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to
                  maintain SpO2

          3. Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO)
             use at time of randomization

          4. Not participating in another clinical trial for the treatment of COVID-19 disease
             through Day 28

        Exclusion Criteria:

          1. Female participants who are pregnant or nursing

          2. Participation in a clinical trial with another investigational drug for COVID-19
             disease

          3. Anticipated discharge from the hospital or transfer to another hospital or long-term
             care facility which is not a study site within 72 hours of randomization

          4. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
             monoclonal antibodies
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis; Lupus Erythematosus, Systemic
Intervention: Laquinimod; Mycophenolate Mofetil; Prednisolone/Prednisone; Placebo; Methylprednisolone
Intervention description: Laquinimod will be administered per dose and schedule specified in the arm description.; Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.; Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.; Placebo matching to laquinimod will be administered per schedule specified in the arm description.; Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus (SLE); Lupus Nephritis; Laquinimod

Summary:

      The study aims to evaluate the safety and clinical effect of daily oral treatment with
      laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod
      doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment
      (mycophenolate mofetil [MMF] and corticosteroids). Laquinimod is a novel immunomodulating
      drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for
      Multiple Sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with SLE

          -  Kidney biopsy within 12 months prior to baseline with a histological diagnosis of
             proliferative or membranous Lupus Nephritis (LN)

          -  Clinically active Lupus Nephritis as evident by urine protein-to-creatinine ratio
             (UPCR) of 1 or higher, for LN classes III, IV, or class V in combination with classes
             III or IV, or a UPCR of 2 or higher for LN class V, at screening or any time between
             screening and baseline.

        Exclusion Criteria:

          -  Participants with severe renal impairment or dialysis

          -  Participants with a clinically significant or unstable medical or surgical condition

          -  Women who are pregnant or nursing or who intend to be during the study period

          -  Women of child-bearing potential who do not practice an acceptable method of birth
             control NOTE: Other inclusion and exclusion criteria may apply.
Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis (MARINA)
Condition: Microvascular Angina
MeSH terms: Atherosclerosis; Microvascular Angina
Intervention: Ranolazine; Placebo
Intervention description: Ranolazine 1,000 mg twice daily; Placebo
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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: microvascular angina; coronary microvascular disease; coronary physiology; ranolazine

Summary:

      The purpose of this study is to look at the effects of the drug Ranolazine compared to
      Placebo on symptoms of chest pain or chest tightness (known as angina), exercise endurance
      and ability, and changes in blood flow to the very small arteries of the heart (known as
      coronary microvascular function) in patients who do not have significant blockages in their
      major heart arteries. Ranolazine is a drug that is already approved by the FDA for angina,
      but it may be particularly effective in people with disease in their tiny heart vessels
      (known as coronary microvascular disease).

      This trial aims to enroll 50 patients with angina who undergo baseline bicycle exercise
      testing with monitoring of the heart's electrical activity and oxygen consumption (known as
      cardiopulmonary exercise test) and coronary angiogram (taking pictures of the heart arteries
      through small hollow tubes placed through the wrist or groin). If severe blockages in the
      main arteries are not found then testing for coronary microvascular function will be
      performed. Subsequently, participants will then be randomized 50/50 to either Ranolazine or
      Placebo. After taking the study drug for 12 weeks, they will then repeat the cardiopulmonary
      exercise test and the coronary angiogram with testing for microvascular function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of typical angina or effort-induced anginal symptoms and are currently
             experiencing angina at least once per week

          -  Abnormal stress ECG, exercise stress imaging, or pharmacological stress imaging

          -  Non-obstructive coronary artery disease as defined by lesion stenosis ≤ 50% in any
             artery as visualized by diagnostic angiography

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  Active Myocardial Infarction

          -  History of coronary artery bypass grafting

          -  Diagnosis of other specific cardiac disease such as severe valvular heart disease,
             cardiomyopathy, or variant angina

          -  Left Ventricular Ejection Fraction (LVEF) < 30%

          -  Known renal insufficiency (CrCl < 30 mL/min) or on dialysis

          -  Contraindications to the use of Ranolazine
A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06882961
Intervention description: 4 matching placebo tablets taken twice a day (BID); Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 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: 412.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, double-blind, placebo controlled, parallel group study is being
      conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of
      multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM)
      inadequately controlled on metformin and/or diet and exercise. In addition, the study is
      intended to enable selection of efficacious doses for future clinical development of
      PF-06882961.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM who are treated with metformin and/or diet and exercise

          -  HbA1c greater than or equal to 7% and less than or equal to 10.5%

          -  Total body weight >50 kg (110 lb) with BMI 24.5 to 45.4 kg/m^2

        Exclusion Criteria:

          -  Any condition possibly affecting drug absorption

          -  Diagnosis of Type 1 diabetes

          -  History of myocardial infarction, unstable angina, arterial revascularization, stroke,
             heart failure, or transient ischemic attack within 6 months of screening

          -  Any malignancy not considered cured

          -  Personal or family history of MTC or MEN2, or participants with suspected MTC

          -  Acute pancreatitis or history of chronic pancreatitis

          -  Symptomatic gallbladder disease

          -  Known medical history of active proliferative retinopathy and/or macular edema

          -  Known medical history of active liver disease, including chronic active hepatitis B or
             C, or primary biliary cirrhosis

          -  Known history of HIV

          -  Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or
             equal to 100 mmHg (diastolic)

          -  Clinically relevant ECG abnormalities

          -  Positive urine drug test
IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Intervention: Ibuprofen; placebo
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: post-ERCP pancreatitis; pediatric; ibuprofen

Summary:

      Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique
      utilized to diagnose and treat pathologic conditions involving the ducts draining the liver
      and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and
      occurs in approximately 11% of children undergoing the procedure. By definition it leads to
      prolongation of hospital stay or delays in care and rarely can result in long-term morbidity
      or even death. Recent adult trials have demonstrated prevention of PEP with administration of
      rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed
      in children thus no "gold standard" or even commonly accepted method of preventing PEP in the
      pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages
      over rectally administered NSAIDs in the pediatric population in that it would allow for more
      consistent weight based dosing and would have more predictable absorption compared to
      suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV
      ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is
      a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls
      (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical
      Center Dallas over a two-year period. The primary outcome measurement will be development of
      PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be
      measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease
      rates of post-ERCP pancreatitis in pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age<=18 years

          -  Undergoing ERCP (defined as cannulation of the major or minor papilla) for any
             indication

        Exclusion Criteria:

          -  Age>18

          -  Pancreatitis within the 72 hours preceding ERCP

          -  Allergy or hypersensitivity to Aspirin or NSAID medications

          -  Pregnancy or breastfeeding mother

          -  Cr >1.4

          -  Gastrointestinal hemorrhage in preceding 72 hours

          -  Heart disease reliant upon a patient ductus arteriosis

          -  History of sickle cell disease
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Placebo
Intervention description: 5 mg orally once daily for 20 weeks; 10 mg orally once daily for 20 weeks; 20 mg orally once daily for 20 weeks; 30 mg orally once daily for 20 weeks; 40 mg orally once daily for 20 weeks; Orally once daily for 20 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: 305.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure; Heart Failure with Preserved Ejection Fraction

Summary:

      The objective of the study is to find the optimal dose of once daily oral neladenoson
      bialanate (BAY1067197) when given in addition to appropriate therapy for specific
      comorbidities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 45 years and older

          -  Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV,
             LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP

        Exclusion Criteria:

          -  Acute decompensated heart failure within the past 4 weeks

          -  Inability to exercise

          -  Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF <
             40%)