bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: RSLV-132; Placebo
Intervention description: RNase-Fc fusion protein; Saline placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the
      cutaneous manifestations in subjects with systemic lupus erythematosus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CLASI score greater than or equal to 10 at Baseline

          -  Positive for one or more RNA autoantibodies

        Exclusion Criteria:

          1. severe, active central nervous system (CNS) involvement at Screening;

          2. severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol,
             or an estimated creatinine clearance of <30 mL/min);

          3. use of cyclophosphamide within 3 months of the Baseline visit;

          4. use of rituximab within 6 months of the Baseline visit;

          5. use of belimumab within 3 months of the Baseline visit;

          6. use of background medications within 1 month of Baseline in excess of: i.
             mycophenolate mofetil > 3 g/day; ii. azathioprine > 200 mg/day; iii. methotrexate > 25
             mg/day; iv. hydroxychloroquine > 400 mg/day; v. prednisone (or equivalent) > 15
             mg/day;

          7. use of an intravenous steroid "pulse" within 2 months of Baseline;

          8. use of an intramuscular steroid injection within 1 month of Baseline;

          9. change in SLE medications within 1 month of Baseline;

         10. the presence of a clinically significant infection in the judgement of the
             Investigator within seven days prior to the receipt of the first dose of study drug;

         11. positive viral load test for hepatitis B, C, or HIV at Screening;

         12. participation in another clinical trial with receipt of an investigational product
             within 3 months or 5 half- lives, of last administration (whichever is longer) from
             Baseline;

         13. positive pregnancy test at Screening or at Baseline;

         14. female subjects currently breast feeding at Baseline;

         15. inability or unwillingness to comply with protocol-specified procedures which, in the
             opinion of the Investigator, would make the subject unsuitable for study
             participation.
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
Condition: Cushing's Syndrome
MeSH terms: Cushing Syndrome; Syndrome
Intervention: CORT125134
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cushing's Syndrome; Cushing's Disease; Cushing's; Hypercortisolemia; Cushingoid; Type 2 Diabetes; Impaired Glucose Intolerance; Hypertension; Adrenal Corticotrophic Hormone (ACTH); Adrenocortical Carcinoma; Primary Pigmented Nodular Adrenal Disease (PPNAD); Moon Facies; Dorsocervical Fat Pad; Adrenal Adenoma; Adrenal Carcinoma; Adrenal Autonomy; Cortisol

Summary:

      Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels
      of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated
      endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from
      cortisol overproduction by the adrenal glands is the subject of this protocol.

      Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic
      administration of high doses of glucocorticoids, were not eligible for enrollment in this
      study.

      The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment
      of endogenous Cushing's syndrome. The multicenter study was conducted in the United States
      and in Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a confirmed diagnosis of endogenous Cushing's syndrome.

          2. Requires medical treatment of hypercortisolemia.

          3. Meets at least one of the following criteria:

               1. Has type 2 diabetes mellitus.

               2. Has impaired glucose tolerance.

               3. Has hypertension.

        Exclusion Criteria:

          1. Has non-endogenous source of hypercortisolemia

          2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

          3. Has poorly controlled hypertension

          4. Has Stage ≥ 4 renal failure
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: tirzepatide; Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide; Tirzepatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 318.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in
      participants with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had type 2 diabetes (T2D) for ≥6 months according to the World Health
             Organization (WHO) classification.

          -  Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.

          -  If on metformin, have been treated with stable doses of metformin for at least 3
             months.

          -  Have a body mass index (BMI) ≥23 and <50 kilograms per square meter.

        Exclusion Criteria:

          -  Have type 1 diabetes (T1D).

          -  Have used any glucose-lowering medication other than metformin within 3 months prior
             to study entry or during screening/lead-in period or have used any glucagon-like
             peptide-1 receptor agonists (GLP-1 RAs) at any time in the past.

          -  Have had any of the following cardiovascular conditions: acute myocardial infarction
             (MI), New York Heart Association Class III or Class IV heart failure, or
             cerebrovascular accident (stroke).

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
             than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level
             >2.5 times the upper limit of the reference range, as determined by the central
             laboratory at study entry; participants with NAFLD are eligible for participation in
             this trial.

          -  Have had chronic or acute pancreatitis any time prior to study entry.

          -  Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square
             meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.

          -  Have serum calcitonin ≥20 picograms per milliliter, as determined by the central
             laboratory at study entry.

          -  Have any condition that is a contraindication for use of the GLP-1 RA class (per
             country-specific labels) at study entry or develop such condition between study entry
             and randomization.
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Intervention: Serelaxin
Intervention description: Serelaxin was administered intravenously for up to 48 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Acute heart failure; RELAX-AHF-PEDIATRIC PK; AHF

Summary:

      The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an
      intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients
      with acute heart failure (AHF)
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Body weight ≥2.5 kg to ≤120 kg

          -  Hospitalized in an intensive care unit or step-down unit with the following:

          -  - Signs and symptoms of acute heart failure of any etiology

          -  - Stable dose of vasoactive and/or inotropic drugs

          -  - For non-surgical patients echocardiographic evidence of reduced ventricular function
             (ejection fraction <50% or fractional shortening <28%)

          -  Systolic blood pressure (SBP) ≥25th percentile SBP for age and gender.

        Key Exclusion criteria:

          -  Moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch
             obstruction

          -  Single ventricle physiology

          -  Fixed pulmonary hypertension

          -  Blood lactate levels >5 mmol/L at screening

          -  Birth < 36 weeks post-conceptual age (for patients <1year old)

          -  Confirmed or clinically suspected systemic infection or severe localized infection

          -  Dyspnea or acute lung injury primarily due to non-cardiac causes

          -  Patients with severe renal impairment, those known to have significant renal disease
             and those having renal replacement therapy

          -  High use of inotropic and/or vasoactive agents at screening

          -  Electrocardiographic abnormalities

          -  Solid organ transplant recipient within 1 year of transplantation or one who presents
             with severe organ rejection
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
Condition: GVHD, Chronic
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: BN101
Intervention description: BN101 is an orally ROCK2 selective inhibitor
Intervention MeSH terms: Belumosudil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 2, open-label, multicenter trial to evaluate the efficacy and safety of BN101
      in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least First Line of
      systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects at least 18 years of age who have had allogenic hematopoietic
             cell transplant (HCT).

          -  Previously received at least 1 and not more than 5 lines of systemic therapy for cGVHD

          -  Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to
             screening;

          -  Have persistent cGVHD manifestations and systemic therapy is indicated

        Exclusion Criteria:

          -  Subject has not been on a stable dose / regimen of systemic cGVHD treatments for at
             least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin
             inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis
             (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).

          -  Histological relapse of the underlying cancer or post-transplant lymphoproliferative
             disease at the time of screening.

          -  Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a
             washout of at least 28 days prior to treatment.
Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Intervention: Cantharidin
Intervention description: Application of topical cantharidin
Intervention MeSH terms: Cantharidin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment
      option. Treatment is often available in private practice offices, where a prescribing
      physician may offer a non-FDA approved treatment on an individualized basis. The situation is
      different in many hospital and academic settings, such as our own for example, where the
      formulary is defined through a FDA-approved indication. The absence of an indication
      precludes its addition to many hospital formularies, thus limiting the options available to a
      prescribing physician and denying patient access to a treatment offered in the private
      practice setting. An indication and formulary status require controlled clinical trials on
      the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this
      commercially-viable cantharidin formulation has a comparable safety and efficacy profile as
      formulations previously studied under conditions which most closely match the what has been
      historically done in the clinic.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of MC by the Principal Investigator.

        Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left
        or right leg, hands, feet, buttocks, and groin.

        Execution of Informed Consent and or assent forms

        Exclusion Criteria:

        Patients with immunosuppression, including organ transplantation, HIV infection.

        Patients utilizing immunosuppressive agents (including oral corticosteroids) will be
        excluded except for patients using inhaled corticosteroids, such as those utilized for
        asthma or allergic rhinitis.

        Females who have reached menarche and are sexually active as well as pregnant patients will
        be excluded as the effects of this drug have not been evaluated in pregnancy.

        Patients who have greater than 50 MC lesions will also be excluded from the study.
A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Elsubrutinib; Upadacitinib; Placebo for elsubrutinib; Placebo for upadacitinib
Intervention description: Elsubrutinib capsule will be administered orally.; Upadacitinib tablet will be administered orally.; Placebo capsule for elsubrutinib will be administered orally.; Upadacitinib placebo tablet will be administered orally.
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: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Elsubrutinib; ABBV-105; Upadacitinib; ABBV-599; Rheumatoid Arthritis (RA); Long-term extension (LTE)

Summary:

      This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy
      of ABBV-105 (elsubrutinib [ELS]) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in
      participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has completed Study M16-063

          -  Participant has not developed any laboratory or clinical discontinuation criteria as
             defined in the Study M16-063 protocol

          -  Participant is willing and/or able to comply with procedures required in the current
             study protocol

        Exclusion Criteria:

          -  Participant is currently enrolled or planning to enroll in another interventional
             clinical study while participating in this study (except the preceding study M16-063)

          -  Participant requires vaccination with any live vaccine during study participation,
             including at least 30 days after the last dose of study drug
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: nivolumab; nivolumab; nivolumab
Intervention description: Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons; Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons; Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced/Metastatic; clear cell component

Summary:

      The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal
      Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response
      relationship exists.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component

          -  Previous treatment with at least one anti-angiogenic agent

          -  Progressed within 6 months of study enrollment

          -  Subjects should not have had more than 3 prior treatments for locally advanced or
             metastatic disease

          -  Must have available tumor tissue for submission

          -  Subjects must also meet various laboratory parameters for inclusion

        Exclusion Criteria:

          -  Subjects with any active autoimmune disease or a history of known autoimmune disease

        Other protocol-defined inclusion/exclusion criteria apply
Saracatinib and Alcohol Drinking
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: Saracatinib; Placebos
Intervention description: Saracatinib 125 mg once per day for 8 days; Placebo once per day for 8 days
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effects of the study medication,
      saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory
      setting in which participants are given an initial drink of alcohol followed by the choice to
      drink up to 12 more drinks over a three-hour period. The investigators hypothesize that
      saracatinib will reduce craving and number of drinks consumed prior to and after exposure to
      the initial drink of alcohol and during the three hour drinking period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21-50

          -  Able to read English at 6th grade level or higher and to complete study evaluations

          -  Regular alcohol drinker

        Exclusion Criteria:

          -  Individuals who are seeking alcohol treatment

          -  Medical conditions that would contraindicate the use of saracatinib

          -  Regular use of other substances
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: SHP674
Intervention description: SHP674: powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m^2: 2500 IU/m^2 every 14 days if BSA <0.6 m^2: 82.5 IU/kg every 14 days
Intervention MeSH terms: Pegaspargase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: The intervention study model is sequential in results section of record.
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 1 Year
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia

Summary:

      The objectives of the study are to assess the safety and tolerability of a single dose of
      SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of
      Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2
      (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute
      lymphoblastic leukemia (ALL) in Japanese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 1 to ≤21 years at the time of informed consent;

          -  Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2;

          -  Newly diagnosed, untreated precursor B-cell ALL

          -  No prior therapy for malignant tumor such as chemotherapy and radiation therapy before
             signing the informed consent;

          -  Life expectancy of at least 6 months from the date of enrollment;

        Exclusion Criteria:

          -  Mature B-cell ALL ; Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL

          -  Preexisting known coagulopathy ;

          -  History of pancreatitis;

          -  Continuous use of corticosteroids;

          -  Prior treatment or possible prior treatment with an L-asparaginase preparation;

          -  History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs;

          -  Pregnant