bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3502970; Dulaglutide; Placebo; Placebo
Intervention description: Administered orally; Administered subcutaneously; Administered orally; Administered subcutaneously
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in
      participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on
      diet and exercise alone or on a stable dose of metformin. This study will last about 30
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of
             metformin

          -  Have a stable body weight for the 3 months prior to randomization

          -  Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)

          -  Males must agree to use highly effective methods of contraception

          -  Women not of childbearing potential (WNOCBP) may participate in this trial

          -  Note: Hormone replacement therapy in post-menopausal women is allowed but women must
             be on stable therapy for 3 months prior to day 1.

        Exclusion Criteria:

          -  Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma

          -  Have a history of diabetic retinopathy, diabetic maculopathy, or severe
             non-proliferative diabetic retinopathy that requires immediate treatment intervention

          -  Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms

          -  Have acute or chronic pancreatitis

          -  Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi
             syndrome)

          -  Have gastric emptying abnormality or chronically take medications impacting GI
             motility

          -  Have poorly controlled hypertension

          -  Have the following heart conditions within the last 6 months: myocardial infarction
             (MI), unstable angina, coronary artery bypass graft, percutaneous coronary
             intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA),
             cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV
             heart failure

          -  Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease
             (NAFLD)

          -  Have HIV, or Hepatitis B or Hepatitis C
Arginine Therapy for Sickle Cell Disease Pain
Condition: Sickle Cell Disease; Vaso-occlusive Pain Episode
MeSH terms: Anemia, Sickle Cell
Intervention: L-arginine; L-arginine Loading Dose; Placebo
Intervention description: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.; One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg; Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Arginine Therapy

Summary:

      The aim of this study is to determine whether giving extra arginine, a simple amino acid, to
      patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful
      events (VOE) will decrease pain scores, decrease the need for pain medications or decrease
      length of hospital stay or emergency department visit. Funding Source - FDA OOPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of sickle cell disease (SCD); all genotypes

          -  Pain requiring medical care in an acute care setting (such as the emergency department
             or ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell
             causes, that is moderate-to-severe requiring parenteral opioids

        Exclusion Criteria:

          -  Decision to discharge home from the acute care setting

          -  Hemoglobin less than 5 gm/dL or immediate need for red cell transfusion anticipated
             within next 12 hours

          -  Hepatic dysfunction of SGPT greater than 3 times the upper value

          -  Renal dysfunction of creatinine greater than 1.0

          -  Mental status or neurological changes

          -  Acute stroke or clinical concern for stroke

          -  Pregnancy

          -  Allergy to arginine

          -  Two (2) or more ED visits for VOE within the last 7 days prior to CURRENT ED visit

          -  Hospitalization within 14 days

          -  Previous randomization in this arginine RCT (patient consented and screen failed
             before receiving study drug or placebo remains eligible for future participation).

          -  Use of inhaled nitric oxide, sildenafil or arginine within the last month

          -  PICU admission from the emergency department

          -  Hypotension requiring treatment with clinical intervention

          -  Acidosis with Co2≤ 16

          -  Newly started on HU for <3 months

          -  Not an appropriate candidate in the investigator's judgment

          -  Patient refusal
A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Ravagalimab 600 mg; Ravagalimab 300 mg
Intervention description: Ravagalimab 600 mg was administered intravenously (IV).; Ravagalimab 300 mg was administered subcutaneously (SC).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis (UC); ABBV-323; Ravagalimab

Summary:

      Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab
      (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must voluntarily sign and date an informed consent, approved by an
             independent ethics committee (IEC)/institutional review board (IRB), prior to the
             initiation of any screening or study-specific procedures.

          -  Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of
             biopsy results consistent with the diagnosis of UC in the assessment of the
             Investigator, must be available.

          -  Participant meets the following disease activity criteria: Active UC with an Adapted
             Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central
             review).

          -  History of inadequate response, loss of response, or intolerance to one or more of the
             approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or
             tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have
             received open-label drug).

        Exclusion Criteria:

          -  Participant having an active, chronic, or recurrent infection that based on
             Investigator's clinical assessment makes the participant an unsuitable candidate for
             the study.

          -  Participant having any malignancy except for successfully treated non-metastatic
             cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the
             cervix.

          -  Participant with history of dysplasia of the gastrointestinal tract or evidence of
             dysplasia in any biopsy performed during the screening endoscopy other than completely
             removed low-grade dysplastic lesions.

          -  Laboratory values not meeting the following criteria : Serum aspartate transaminase
             (AST) and alanine transaminase (ALT) <= 2* upper limit of normal (ULN); Total white
             blood cell (WBC) count >= 3.0*10^9/L.
MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: MGTA-145; Plerixafor
Intervention description: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes.; An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study evaluates a new drug MGTA-145 in combination with plerixafor (Mozobil) to mobilize
      stem cells into the peripheral blood for collection by apheresis. The stem cells will be used
      for autologous stem cell transplant for treatment of multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma (MM) per the International Myeloma Working Group (IMWG)
             criteria

          -  Eligible for autologous stem cell transplantation (ASCT) per institutional guidelines

          -  Within 1 year of start of therapy for multiple myeloma

          -  Cardiac and pulmonary status sufficient to undergo apheresis and transplantation per
             institutional transplant guidelines

          -  Calculated creatinine clearance > 30 mL/min, according to the Modification of Diet in
             Renal Disease (MDRD) formula.

          -  Absolute neutrophil count (ANC) > 1500 x 10e6/L

          -  Platelet count > 100,000 x 10e6/L

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Agreement to use an approved form of contraception for male patients or female
             patients of childbearing potential.

        Exclusion Criteria:

          -  History of prior stem cell transplant for multiple myeloma or other indications

          -  Planned tandem stem cell transplant

          -  Prior history of failure to collect HSCs.

          -  Total bilirubin > 1.5x upper limit of normal (ULN) in the absence of a documented
             history of Gilbert's syndrome

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3x ULN

          -  Known allergy to MGTA-145 or plerixafor.

          -  Lifetime exposure to lenalidomide or another immunomodulatory drug greater than 6
             cumulative months of treatment, ie, > 6 cycles of 28 days or > 8cycles of 21 days

          -  Pregnant or lactating
Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Capmatinib; Spartalizumab; Docetaxel
Intervention description: Capmatinib 400 mg (tablets) orally taken twice daily; Spartalizumab 400 mg via intravenous infusion once every 28 days; Docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days
Intervention MeSH terms: Docetaxel; Spartalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Run-in part was single group. Randomized part (parallel design) was not opened.
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small-cell lung carcinoma; Non-small-cell lung cancer; NSCLC; epidermal growth factor receptor wild type; EGFRwt; Anaplastic lymphoma kinase negative; ALK-; INC280; capmatinib and spartalizumab; combination therapy; docetaxel

Summary:

      The purpose of this trial was to evaluate the safety and efficacy of capmatinib in
      combination with spartalizumab in adult participants with epidermal growth factor receptor
      (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic
      lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible
      for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC)
      after failure of platinum doublet and checkpoint inhibitor treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type,
             ALK rearrangement negative, non-small cell lung cancer

          -  Subject had demonstrated progression following one prior platinum doublet and one
             prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most recent
             treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)

          -  Subjects must be candidates for single agent docetaxel

          -  Subjects must have at least one lesion evaluable by RECIST 1.1

        Exclusion Criteria:

          -  Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor) targeting
             therapy

          -  Any untreated central nervous system (CNS) lesion

          -  Use of any live vaccines against infectious diseases within 12 weeks of initiation of
             study treatment.

        Other protocol-defined inclusion/exclusion criteria might apply.
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551
Intervention description: Applied twice daily for 2 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 122-0551; steroid; HPA

Summary:

      Adrenal suppression effects of corticosteroids are among the most important safety concerns
      for this group of products. This study is designed to determine the adrenal effects of the
      investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of
      the formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a clinical diagnosis of stable plaque psoriasis

        Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis

          -  Subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy
             within 30 days prior to initiation of treatment

          -  Subject has used systemic corticosteroids or topical, inhaled, intranasal
             corticosteroids within 30 days and 14 days, respectively, prior to study screening

          -  Subject has had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to initiation of treatment

          -  Subject has used topical psoriatic therapy including tar, anthralin, retinoids,
             vitamin D analogs (e.g., Dovonex®) within 14 days prior to initiation of treatment

          -  Subject has used emollients/moisturizers on areas to be treated within one day prior
             to initiation of treatment

          -  Subject is currently using lithium or Plaquenil (hydroxychloroquine)

          -  Subject is currently using a beta-blocking medication (e.g., propranolol) or
             angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has
             not been stabilized

          -  Subject is pregnant, nursing or planning a pregnancy during the study period

          -  Subject is currently enrolled in an investigational drug, biologic or device study

          -  Subject has received an investigational drug, biologic or an investigational device
             within 30 days prior to study start

          -  Subject has been previously enrolled in this study and treated with the test article

          -  Subject has an irregular sleep schedule or works night shifts
A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: fulvestrant; anastrozole
Intervention description: 500 mg intramuscular injection; 1 mg oral tablet
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: Female
Minimum age: 45 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: oncology; cancer; breast cancer

Summary:

      The purpose of this study is to compare the efficacy and tolerability of Faslodex
      (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor
      positive advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

        Exclusion Criteria:

          -  Previous treatment for advanced breast cancer (previous treatment for early breast
             cancer is allowed).
Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: GED-0507-34-Levo 80 mg; GED-0507-34-Levo 160 mg; Placebo
Intervention description: GED-0507-34-Levo 80 mg BID for 8 Weeks; GED-0507-34-Levo 160 mg BID for 8 Weeks; Placebo BID 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: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with
      active, mild-to-moderate UC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 and over at the time of signing the informed consent.

          -  Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.

          -  MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study

          -  Subjects are required to have a colonoscopy if one has not been performed within 12
             months prior to the Screening Visit.

          -  Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day

        Exclusion Criteria:

          -  Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic
             colitis, radiation colitis, or diverticular disease-associated colitis.

          -  UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).

          -  Subjects who have had surgery as a treatment for UC or who, in the opinion of the
             Investigator, are likely to require surgery for UC during the study.

          -  Clinical signs suggestive of fulminant colitis or toxic megacolon.

          -  Evidence of pathogenic enteric infection.

          -  History of colorectal cancer or colorectal dysplasia.

          -  Prior use of any TNF inhibitor (or any biologic agent).

          -  Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.

          -  Use of budesonide-MMx within the last 8 weeks.

          -  Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.

          -  Use of immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate
             [MTX]) within 8 weeks of the Screening Visit.
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: INCB054707; Placebo
Intervention description: INCB054707 tablet administered orally once daily at the protocol-defined dose.; Placebo tablet administered orally once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hidradenitis suppurativa; Janus kinase (JAK) inhibitor; skin disease

Summary:

      The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment
      period in men and women with moderate to severe hidradenitis suppurativa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6
             months before screening.

          -  Stable course of HS for at least 90 days before screening, as determined by the
             investigator.

          -  HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley
             Stage II or Hurley Stage III at screening.

          -  Total AN count of at least 3 at screening and baseline.

          -  Willingness to avoid pregnancy or fathering children.

        Exclusion Criteria:

          -  Women who are currently pregnant or lactating.

          -  Presence of > 20 draining fistulas at screening and baseline.

          -  Participants with protocol-defined concurrent conditions or history of other diseases.

          -  Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF),
             defined as ≥ 450 msec.

          -  Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB
             test at screening.

          -  A history of active tuberculosis (treated or untreated) or a history of untreated
             latent tuberculosis.

          -  Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus
             core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.

          -  Decreased blood cell counts at screening per protocol-defined criteria.

          -  Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or
             aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.

          -  Impaired renal function with serum creatinine > 1.5 mg/dL at screening.

          -  Use of protocol-prohibited medications.

          -  Known or suspected allergy to INCB054707 or any component of the study drug.

          -  Known history of clinically significant drug or alcohol abuse in the last year before
             baseline.