bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: ubenimex
Intervention MeSH terms: Ubenimex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World
      Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening.

      This study is a Phase 2, open-label, extension study to evaluate long-term safety and
      efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have completed Study EIG-UBX-001 through Week 24.

          -  In the opinion of the Principal Investigator, has been generally compliant with study
             requirements during Study EIG-UBX-001.

          -  Agrees to use a medically acceptable method of contraception throughout the entire
             study period.

          -  Willing and able to comply with scheduled visits, treatment plans, and laboratory
             tests and other study procedures.

        Exclusion Criteria:

          -  Is pregnant or lactating.

          -  Concurrent regular use of another leukotriene pathway inhibitor.

          -  Any reason that, in the opinion of the investigator, precludes the patient from
             participating in the study.

               1. Any condition that is unstable or that could jeopardize the safety of the patient
                  and his/her compliance in the study

               2. A serious uncontrolled medical disorder/condition that in the opinion of the
                  investigator would impair the ability of the patient to receive protocol therapy

          -  An ongoing, drug-related, serious adverse event (SAE).

          -  Significant/chronic renal insufficiency.

          -  Transaminases (alanine transaminase, aspartate transaminase) levels >3 × upper limit
             of normal (ULN) and/or bilirubin level >2 × ULN.

          -  Absolute neutrophil count <1500 mm3.

          -  Hemoglobin concentration <9 g/dL at Screening.
Ranolazine Among Unrevascularized Chronic Stable Angina Patients
Condition: Angina
MeSH terms: Angina Pectoris
Intervention: Ranolazine; Sugar pill
Intervention description: Ranolazine 500mg tablet
500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks; 500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: deferred percutaneous coronary intervention; fractional flow reserve

Summary:

      This is a prospective, double-blind, placebo-controlled, randomized, single-center (North
      Florida- South Georgia VA Medical Center) study. The study objective is to determine if
      ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary
      artery disease patients who have demonstrable myocardial ischemia, but who do not undergo
      revascularization
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >= 18 years of age referred for cardiac catheterization for evaluation
             of cardiac symptoms ( angina, fatigue, or shortness of breath)

          -  At least 1 indeterminate stenosis (20-80%),

          -  Fractional flow reserve (FFR) <=0.8 and PCI deferred

        Exclusion Criteria:

          -  Coronary revascularization (percutaneous coronary intervention or coronary artery
             bypass grafting) during the index procedure or anticipated within the next month

          -  acute coronary syndrome or cardiogenic shock

          -  QTc > 500 milliseconds

          -  use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole,
             clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)

          -  use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital,
             phenytoin, carbamazepine, and St. John's wort)

          -  liver cirrhosis

          -  sever renal insufficiency (i.e. creatinine clearance < 30mL/min/1.73 m2)
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 812.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades
      3-4), treatment-related, select adverse events in patients with advanced or metastatic
      Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or
      after at least 1 systemic therapy.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  ECOG Status: PS 0-1 & PS 2

          -  Subjects with histologically or cytologically-documented SqNSCLC

          -  Subjects must have experienced disease progression or recurrence during or after one
             prior platinum doublet-based chemotherapy regimen

          -  Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria

          -  Subjects with treated or asymptomatic CNS metastases

          -  Prior palliative radiotherapy must have been completed at least 14 days prior to study
             drug administration

          -  Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy,
             immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or
             standard or investigational agents for treatment of NSCLC, must be completed 28 days
             prior to the first dose of nivolumab

          -  Males and Females, ages 18 or older

        Exclusion Criteria:

          -  Subjects with untreated, symptomatic CNS metastases

          -  Subjects with carcinomatous meningitis

          -  Subjects with active, known or suspected autoimmune disease.

          -  Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,
             anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or
             drug specifically targeting T-cell costimulation or checkpoint pathways) or who have
             previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Condition: Obesity
Intervention: JNJ-64565111 Dose Level 1; JNJ-64565111 Dose Level 2; JNJ-64565111 Dose Level 3; Liraglutide; Placebo
Intervention description: Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.; Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.; Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.; Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.; Participants will receive matching placebo SC once-weekly until Week 26.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 474.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo
      after 26 weeks of treatment on the percent change in body weight from baseline and to assess
      the safety and tolerability, in non-diabetic severely obese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) greater than or equal to (>=) 35 to less than or equal to (<=)
             50 kilogram per square meter (kg/m^2) at the screening visit

          -  Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening
             based on medical history)

          -  Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise
             be incapable of pregnancy, or (c) Heterosexually active and practicing a highly
             effective method of birth control, or (d) Not heterosexually active

          -  Woman of childbearing potential have a negative pregnancy test at screening

          -  Willing and able to adhere to specific the prohibitions and restrictions

        Exclusion Criteria:

          -  History of obesity with a known secondary cause (for example, Cushing's
             disease/syndrome)

          -  History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic
             ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to
             pancreatitis or pancreatectomy

          -  Has a Hemoglobin A1c (HbA1c) of >= 6.5% or fasting plasma glucose (FPG) >= 126
             milligrams per deciliter (mg/dL) (>= 7.0 millimoles per liter [mmol/L]) at screening

          -  Screening calcitonin of >= 50 picograms per milliliter (pg/mL) personal history or
             family history of medullary thyroid cancer, or of multiple endocrine neoplasia
             syndrome type 2 (MEN 2), regardless of time prior to screening

          -  History of glucagonoma
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
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Condition: Heavy Uterine Bleeding; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Menorrhagia; Hemorrhage
Intervention: Elagolix placebo; Elagolix; 0.5 mg estradiol / 0.1 mg norethindrone acetate; 1 mg estradiol / 0.5 mg norethindrone acetate; E2/NETA placebo
Intervention description: oral coated tablet; oral coated tablet; oral hard capsule; oral hard capsule; oral hard capsule
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 571.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Uterine Fibroids; Leiomyomata; Elagolix; Menorrhagia; Elagolix sodium; Heavy Uterine Bleeding; ABT-620

Summary:

      This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety
      and efficacy of elagolix alone and in combination with add-back therapy versus placebo on
      heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is pre-menopausal female 18 to 51 years of age at Screening.

          -  Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.

          -  Subject has heavy uterine bleeding associated with uterine fibroids.

        Exclusion Criteria:

          -  Subject has had a myomectomy, uterine artery embolization or high intensity focused
             ultrasound for fibroid destruction within 6 months prior to Screening or endometrial
             ablation within 5 years prior to Screening.

          -  Subject has a history of osteoporosis or other metabolic bone disease.

          -  Subject shows evidence of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including
             depression, schizophrenia, bipolar disorder), or neurologic diseases or any
             uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any
             history of attempted suicide.

          -  Subject has a history of clinically significant condition(s) including but not limited
             to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic
             kidney disease * Any cancer (except treated basal cell carcinoma of the skin),
             including breast or ovarian cancer or subject has taken any systemic cancer
             chemotherapy
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
Condition: Neuroendocrine Carcinoma of the Lung and Thymus
MeSH terms: Carcinoma; Carcinoma, Neuroendocrine; Lung Neoplasms
Intervention: Pasireotide LAR; Everolimus; Pasireotide LAR and Everolimus Combination
Intervention description: 60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1; 10 mg tables administered orally once a day; Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
Intervention MeSH terms: Everolimus; Pasireotide; Somatostatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus,adult,SOM230,carcinoma,lung cancer,

Summary:

      This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR
      alone or in combination in adult patients with advanced (unresectable or metastatic)
      neuroendocrine carcinoma of the lung and thymus
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmed advanced well differentiated typical and atypical carcinoid
             tumors of the lung or thymus

          -  Patients of all treatment lines including naive patients could have been enrolled

          -  At least one measurable lesion of disease on CT scan or MRI

          -  Radiological documentation of disease progression within 12 months prior to
             randomization

          -  Adequate liver, renal and bone marrow function

          -  WHO Performance Status 0-2

        Exclusion Criteria:

          -  Poorly differentiated neuroendocrine carcinoma

          -  Non-neuroendocrine thymoma

          -  Patients with severe functional disease who required symptomatic treatment with
             somatostatin analogs

          -  Prior therapy with mTOR inhibitors

          -  History of liver disease

          -  Baseline QTcF> 470 msec

          -  Uncontrolled diabetes mellitus despite adequate therapy
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Condition: Type I Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Exenatide (Bydureon®); Placebo
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The goal of the proposed pilot study is to determine whether glucose control can be improved
      with Bydureon treatment in patients with type I diabetes (T1D)
    

Eligibility criteria:

        Inclusion Criteria

          -  Male or female aged 18-65 years who meets the American Diabetes Association standard
             T1DM criteria.

          -  Diagnosis of T1DM at least 2 years from Visit 0

          -  Insulin Requirement of ≤ 0.90 units/kg

          -  Absence of ketoacidosis in the past 6 months

          -  HbA1c of ≥ 6.5% and ≤ 9.5%

          -  Menstruating women must have a negative pregnancy test and be willing to avoid
             pregnancy during the study period

          -  Signed informed consent

        Exclusion Criteria:

          -  Inability or unwillingness to give informed consent

          -  Current or prior use of immunomodulators or systemic steroids in the last 6 months
             that could potentially affect diabetes or immunologic status.

          -  Known hypersensitivity to Exenatide, Liraglutide or any product component.

          -  Participation in an investigational treatment trial within the last 6 weeks before
             enrollment.

          -  1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of
             others) within the last 6 months.

          -  Another condition that would, in the view of the investigator, affect the safety of
             using Bydureon. This might include, among others a history of MEN 2, a history of
             medullary carcinoma of the thyroid or pancreatitis.

          -  Known severe renal impairment, end-stage renal disease or renal transplantation.

          -  Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis,
             thyroid nodules or malignancy with the exclusion of a history of localized basal cell
             carcinoma.

          -  Uncompensated heart failure, fluid overload, myocardial infarction or liver disease
             within the last 6 weeks before enrollment.

          -  Clinically active serious infection.

          -  Positive pregnancy test in menstruating women or lactating females.

          -  Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes
             medications other than insulin.
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Placebo; OBE2109
Intervention description: Placebo tablets for oral administration once daily; OBE2109 tablets for oral administration once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 328.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Pelvic Pain; Endometriosis; Dysmenorrhea; Dyspareunia

Summary:

      The primary objective of this study is to assess the efficacy and safety of a range of oral
      doses of OBE2109 versus placebo, in reducing endometriosis associated pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The subject must have had her most recent surgical and - if available - histological,
             diagnosis of pelvic endometriosis up to 10 years before screening.

          -  The subject has moderate to severe endometriosis-associated pain during the screening
             period.

          -  The subject has regular menstrual cycles.

          -  The subject has a BMI ≥ 18 kg/m2 at the screening visit.

        Key Exclusion Criteria:

          -  The subject is pregnant or breast feeding or is planning a pregnancy within the
             duration of the treatment period of the study.

          -  The subject had an interventional surgery for endometriosis performed within a period
             of 60 days before screening.

          -  The subject did not respond to prior treatment with gonadotropin releasing hormone
             (GnRH) agonists or GnRH antagonists for endometriosis.

          -  The subject has a history of, or known osteoporosis or other metabolic bone disease.

          -  The subject has chronic pelvic pain that is not caused by endometriosis and requires
             chronic analgesic / therapy, or that would interfere with the assessment of
             endometriosis related pain.