bioihbjkbjnl/mcl2 huggingface dataset:
Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pegilodecakin; Pembrolizumab
Intervention description: Pegilodecakin plus Pembrolizumab; Pembrolizumab Alone
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of pegilodecakin in combination with pembrolizumab versus
      pembrolizumab alone in participants with metastatic non-small cell lung cancer as measured by
      objective response rate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must have histologically or cytologically confirmed WT NSCLC that is
             stage IV / metastatic or recurrent

          2. Participants with tumor tissue high expression of PD-L1 as defined by Tumor Proportion
             Score (TPS) ≥ 50%

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          4. Participants with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria.

          5. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks
             prior to randomization.

          6. Participants must be naïve to therapy for the advanced stage of the disease. Previous
             neoadjuvant or adjuvant therapy is allowed for participants who successfully underwent
             complete radical surgery and ONLY if the last treatment was administered more than 12
             months prior to the start of the trial treatment

        Exclusion Criteria:

          1. Participants with active central nervous system (CNS) metastases or carcinomatous
             meningitis

          2. Participants with any serious or uncontrolled medical disorder or active infection
             with the hepatitis virus or the human immunodeficiency virus (HIV)

          3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior
             anti-cancer therapy other than alopecia and fatigue prior to randomization

          4. Participants that have received pembrolizumab

          5. Participants with a history of severe hypersensitivity reactions to monoclonal
             antibodies

          6. Pregnant or lactating women

          7. Participants receiving any investigational agent within 28 days of first
             administration of trial treatment

          8. Participants that have received therapy with anti-tumor vaccines or other
             immunostimulatory antitumor agents

          9. Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2,
             anti-CD-137, and/or anti CTLA-4 antibodies
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Intervention: Cenicriviroc
Intervention description: Cenicriviroc immediate release tablets
Intervention MeSH terms: Cenicriviroc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This rollover study will provide open-label treatment with cenicriviroc and will assess the
      long-term safety of continued treatment with cenicriviroc in participants who participated in
      either the CENTAUR study 652-2-203 [NCT02217475] or the AURORA study [NCT03028740].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of both Treatment Period 1 and Treatment Period 2, of the
             CENTAUR Study (652-2-203), including a Year 2 liver biopsy.

          -  Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated
             liver-related clinical outcome in Part 1 or Part 2 of the study of:

          -  Histopathological progression to cirrhosis

          -  Model for end-stage liver disease (MELD) score ≥ 15

          -  Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a
             diuretic)

          -  Hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed,
             hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial
             peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid
             bacterial culture).

        Exclusion Criteria:

          -  Prior or planned liver transplantation

          -  Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary
             biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's
             disease, hemochromatosis, or iron overload, or Alpha-1 antitrypsin (A1AT) deficiency.
Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Intervention: PLN-74809; Knottin tracer
Intervention description: PLN-74809; Radiotracer
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Open label, incomplete crossover, up to 2 single doses administered at two different times
Masking: None (Open Label)
Masking description: No masking
Enrollment: 9.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of IPF, within 5 years prior to Screening,

          -  FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1
             month of screening.

          -  DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted
             if within 1 month of screening.

          -  Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if
             on a stable dose for at least 3 months

        Exclusion Criteria:

          -  Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents
             not approved for that indication by the FDA

          -  Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC
             ratio <0.7

          -  Clinical evidence of active infection, including but not limited to bronchitis,
             pneumonia, sinusitis that can affect FVC measurement or IPF progression

          -  Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months
             of Screening

          -  Smoking of any kind within 3 months of Screening
Placebo Controlled Trial of Bosentan in Scleroderma Patients
Condition: Systemic Scleroderma; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Intervention: Bosentan; Placebo
Intervention description: 62.5 mg by mouth (PO) twice daily (Bid) for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks; 62.5 mg PO Bid for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
Intervention MeSH terms: Bosentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: scleroderma; systemic sclerosis; bosentan; pulmonary hypertension; PHAROS; PHROS; exercise echocardiogram

Summary:

      The purpose of this study is to determine whether the drug Bosentan improves exercise
      tolerance in scleroderma patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  SSc patients > 18 with NYHA functional Class I/II symptoms, informed consent, and who
             are willing to participate in the Pulmonary Hypertension Assessment and Recognition of
             Outcomes in Scleroderma (PHAROS) long term study (Georgetown IRB 04-227)

          -  Right heart catheterization with

               1. Normal Mean Pulmonary Arterial Pressure (PAP) at rest

               2. Mean PAP > 30 with exercise

               3. Wedge Pressure < 18

          -  Entry criteria for participating in the exercise echocardiogram study (Georegtown IRB
             03-363)

               1. Diffusing Capacity (DLCO) <60 with a Forced Vital Capacity (FVC) >60%, or

               2. FVC/DLCO > 1.6, or

               3. a resting Pulmonary Arterial Systolic Pressure (PASP)> 40mmHg

        Exclusion Criteria:

          -  Established resting pulmonary hypertension

          -  Congestive heart failure

          -  Diastolic dysfunction

          -  Pregnancy

          -  Inability to adequately walk/exercise

          -  Severe liver disease
Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Dacarbazine
Intervention MeSH terms: Ipilimumab; Dacarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the survival rate after 1 year of treatment with
      ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or
      Stage IV melanoma.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Japanese patients with histologic diagnosis of malignant melanoma

          -  Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma

          -  Prior adjuvant melanoma therapy permitted

          -  Eastern Cooperative Oncology Group performance status of 0 or 1

          -  Life expectancy of at least 16 weeks in this study

          -  Adequate bone marrow and renal and hepatic function, specifically:

               -  white blood cell count ≥2500/uL, absolute neutrophil count ≥1000/uL, platelet
                  count ≥75,000/uL, hemoglobin level ≥9.0 g/dL, creatinine level ≤2.5*upper limit
                  of normal (ULN), aspartate transaminase/alanine transaminase level <2.5*ULN for
                  patients without liver metastasis and <5*ULN for patients with liver metastasis,
                  total bilirubin level <1.5*ULN (for those with Gilbert's Syndrome, lower than 3.0
                  mg/dL)

        Key exclusion criteria:

          -  Evidence of brain metastases on brain imaging

          -  Active brain metastases with symptoms or requiring corticosteroid treatment; patients
             with any other malignancy from which they have been disease-free for fewer than 5
             years, with the exception of adequately treated and cured basal or squamous cell skin
             cancer, superficial bladder cancer, or carcinoma in situ of the cervix

          -  Primary ocular or mucosal melanoma

          -  History of or current active autoimmune disease

          -  History or concurrent disease of gastrointestinal perforations

          -  HIV infection; active Hepatitis B or C or human T-lymphotropic virus type1 infection,
             based on testing performed during the screening period of this study

          -  Prior or concomitant therapy with any anticancer agent for melanoma, or other
             investigational anticancer therapies

          -  Prior adjuvant therapy <4 weeks prior to the start of study drug administration

          -  Concomitant therapy with immunosuppressive agents, surgery, or radiotherapy

          -  Prior treatment with CTLA-4 inhibitors/agonists or other experimental immunotherapy
             drugs

          -  Treatment with other investigational products within 4 weeks prior to initial
             treatment of study drug
Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
Condition: Bulimia Nervosa; Eating Disorders
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Intervention: Erythromycin; Placebo
Intervention description: Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks; Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Binge-Eating Disorder

Summary:

      This study will determine the effectiveness of the antibiotic erythromycin in enhancing
      gastrointestinal function and decreasing the frequency of binge eating in people with bulimia
      nervosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets criteria for bulimia nervosa

          -  Duration of illness is greater than 1 year

          -  Self-induces vomiting

          -  Weighs 80%-120 % of ideal weight

        Exclusion Criteria:

          -  Significant medical illness

          -  Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic
             disorder, as defined by American Psychiatric Association criteria

          -  Moderate to severe depression, as defined by a score greater than 18 on the Hamilton
             Depression Scales

          -  Current diagnosis of organic mental disorder, factitious disorder, or malingering

          -  History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that
             might interfere with assessment or compliance with the study procedures

          -  At risk for suicide

          -  Current psychotropic medications and current medications that affect GI function or
             that inhibit or induce cytochrome three A gene expression

          -  Currently pregnant, lactating, or planning to become pregnant

          -  Drug or alcohol abuse within the 3 months prior to study entry

          -  Abnormal EKG at baseline or 1 week following each upward dosage adjustment

          -  Anemia

          -  Known intolerance to erythromycin, or related antibiotics

          -  Abnormal results on liver function tests

          -  Electrolyte abnormalities
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
Condition: Nausea; Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Intervention: Decadron®; Benadryl®; Ativan®; ondansetron hydrochloride
Intervention description: Given IV; Given IV; Given IV; Given IV
Intervention MeSH terms: Diphenhydramine; Promethazine; Dexamethasone; Lorazepam; Ondansetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: nausea; vomiting; emetic chemotherapy; unspecified childhood solid tumor, protocol specific

Summary:

      RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea
      and vomiting in patients treated with chemotherapy. It is not yet known whether
      diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in
      treating nausea and vomiting caused by chemotherapy.

      PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and
      dexamethasone to see how well they work compared with standard therapy in treating nausea and
      vomiting caused by chemotherapy in young patients with newly diagnosed cancer.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  ≥ 8 years of age and < 19 years of age at the time of registration

          -  Newly diagnosed with cancer

          -  Chemotherapy naive

          -  Scheduled to receive moderately or highly emetogenic chemotherapy (non-steroid
             containing regimen) as an in-patient. (Refer to Appendix IV. In multiple agent
             regimens, select the agent with the highest emetic potential.)

          -  Scheduled for placement of IV accesses device(s) for treatment purposes (allowing a
             dedicated line for continuous infusion of study agent)

          -  Not pregnant or lactating

        EXCLUSION CRITERIA:

          -  Prior chemotherapy

          -  Central Nervous System disease

          -  Stem cell transplant while on-study

          -  Out-patient chemotherapy

          -  Steroids are included in their chemotherapy regimen

          -  Contraindication to the use of dexamethasone (e.g. diabetes)

          -  Hepatic and/or renal failure

          -  Allergic to any of the study medications

          -  Pregnant or lactating
Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
Condition: Non Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Stereotactic Radiosurgery; Erlotinib
Intervention description: 21 Gy daily for 5 days; 150mg once daily
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: For all patients, all sites of progressive disease will be treated with local ablation (primarily stereotactic radiosurgery) followed by the EGFR-TKI erlotinib until disease progression.
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non small cell lung cancer; EGFR mutant; Phase II; erlotinib; tarceva; cyberknife; Lineberger

Summary:

      - Progression free survival after locally ablative therapy and erlotinib in EGFR patients
      progressed after EGFR-TKI therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  18 years of age or older

          -  Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC

          -  History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria

          -  Progressive disease following EGFR-TKI therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Adequate organ and marrow function

          -  Negative urine or serum pregnancy test for female patients

          -  Patients who can have children must agree to adequate contraception

        Exclusion Criteria:

          -  Unresolved chronic toxicities greater than 2, measured by CTCAE v4

          -  Treatment with any FDA approved or experimental cancer treatment following progression
             on EGFR-TKI

          -  Any history of previous greater than grade 3 toxicity attributable to erlotinib

          -  Pregnant or lactating female

          -  Any previous radiation to sites of planned Stereostatic Radiosurgery

          -  History of another malignancy

          -  Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)

          -  Evidence of severe or uncontrolled systemic diseases

          -  Known hypersensitivity reaction or idiosyncrasy to erlotinib

          -  Psychological, familial, sociological, or geographical conditions

          -  Any other condition in investigator's opinion jeopardize compliance with protocol
A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
Condition: Breast Neoplasms; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation
MeSH terms: Breast Neoplasms
Intervention: talazoparib
Intervention MeSH terms: Talazoparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; BRCA mutation; PARP inhibitor; BRCA 1; BRCA 2

Summary:

      The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of
      talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast
      cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to
      either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

        -  Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for
           metastatic disease with disease progression > 8 weeks following the last dose of
           platinum; or

        -  Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic
           disease and who have had no prior platinum therapy for metastatic disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed carcinoma of the breast

          -  Locally advanced and/or metastatic disease

          -  Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation

          -  Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for
             metastatic disease with disease progression > 8 weeks following the last dose of
             platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no
             prior platinum for metastatic disease

          -  ECOG performance status ≤ 1

          -  Have adequate organ function

        Exclusion Criteria:

          -  Prior enrollment into a clinical trial of a PARP inhibitor

          -  CNS metastasis except adequately treated brain metastasis documented by baseline CT or
             MRI scan that has not progressed since previous scans and that does not require
             corticosteroids for management of CNS symptoms

          -  Prior malignancy except for prior BRCA-associated cancer as long as there is no
             current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma
             skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study
             enrollment with no subsequent evidence of recurrence

          -  Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus

          -  Known hypersensitivity to any of the components of talazoparib