bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Prednisone; Intetumumab; Placebo
Intervention description: Docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks.; Prednisone 5 mg orally twice daily.; Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.; Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
Intervention MeSH terms: Prednisone; Docetaxel; Intetumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostatic neoplasms; CNTO 95; Intetumumab; Docetaxel; Prednisone

Summary:

      The purpose of this study is to assess the effects of intetumumab when given in combination
      with docetaxel and prednisone to participants with metastatic (spread of cancer cells from
      one part of the body to another) hormone-refractory (not responding to treatment) prostate
      cancer (abnormal tissue that grows and spreads in the body until it kills).
    

Eligibility criteria:

        Inclusion Criteria

          -  Confirmed cancer of the prostate

          -  Evidence of metastatic disease

          -  Have a life expectancy greater than 12 weeks

          -  Have at least 4 weeks from previous major surgery to date of first study agent given

          -  Have progressive hormone-refractory disease after orchiectomy or
             gonadotropin-releasing hormone analog and/or antiandrogen treatment within 6 months
             prior to the first study agent administration Exclusion Criteria

          -  Have known Central Nervous System metastases (cancerous tumors that have spread to the
             brain from somewhere else in the body)

          -  Had prior systemic non-hormonal therapy for hormone refractory prostate cancer

          -  Have known Human Immunodeficiency Virus (HIV, a life-threatening infection which you
             can get from an infected person's blood or from having sex with an infected person)
             seropositivity or known hepatitis B or C infection

          -  Have planned major surgery during the study

          -  Have taken any over-the-counter (medicine that can be bought without a prescription)
             or herbal treatment for prostate cancer within 4 weeks prior to the first study
             treatment administration
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
Condition: Hematologic Diseases; Leukemia; Lymphoma; Myeloma
MeSH terms: Hematologic Diseases; Graft vs Host Disease
Intervention: Busulfan; Fludarabine; Cyclophosphamide
Intervention description: Starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.; Dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.; Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
Intervention MeSH terms: Cyclophosphamide; Busulfan; Fludarabine; Fludarabine phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 6 Months
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Post-allogeneic transplantation; Graft-versus-Host Disease Prophylaxis; Graft-versus-Host Disease; GVHD; Hematologic malignancies; Leukemia; Lymphoma; Myeloma; Human Leukocyte Antigen; HLA; Busulfan; Cyclophosphamide; Fludarabine; Mesna; Cytoxan®; Neosar®; Busulfex; Myleran®; Fludarabine Phosphate

Summary:

      The goal of this clinical research study is to learn if cyclophosphamide given after busulfan
      and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which
      transplanted tissue attacks the body into which it is transplanted) in patients receiving a
      stem cell transplant. The safety of this drug combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with high risk hematological malignancies, including those with induction
             failure and after treated or untreated relapse.

          2. HLA-identical sibling or matched unrelated donor transplants not eligible for
             protocols of higher priority.

          3. Age 6 months to 75 years.

          4. Bilirubin </= 1.5 mg/dl, serum glutamate pyruvate transaminase (SGPT) </= 200 IU/ml
             (unless Gilbert's syndrome).

          5. Calculated creatinine clearance of >50mL/min using the Cockcroft-Gault equation for
             adult patients 18 to 70 years old, and the Schwartz equation for pediatric patients 6
             months to 17 years old.

          6. Diffusing capacity for carbon monoxide (DLCO) >45% predicted corrected for hemoglobin
             (as reported by the Pulmonary Function Laboratory at MDACC). For most children </= 6
             years of age who are unable to perform pulmonary function test (PFT), pulse oximetry
             >/= 92% on room air.

          7. left ventricular ejection fraction (LVEF) >/= 35%.

        Exclusion Criteria:

          1. HIV seropositivity

          2. Uncontrolled infections.

          3. Positive Beta human chorionic gonadotropin (HCG) test in a woman with child bearing
             potential defined as not post-menopausal for 12 months or no previous surgical
             sterilization

          4. Inability to sign consent
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: ATI-50002
Intervention description: ATI-50002 Topical Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female
      subjects with androgenetic alopecia.
    

Eligibility criteria:

        Inclusion Criteria:

        Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a
        clinical diagnosis of androgenetic alopecia.

        Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length
        on their balding spot.

        Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the
        center of the identified target area.

        Subjects must agree to maintain the same hair style and hair care regimen during the study.

        Exclusion Criteria:

        Females who are nursing, pregnant, or planning to become pregnant for the duration of the
        study and up to 30 days after the last application of study medication.

        Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss
        on the treatment area, due to disease, injury or medical therapy.

        Active skin disease of the scalp (such as psoriasis or seborrheic dermatitis) or a history
        of skin disease on the scalp that in the opinion of the investigator would interfere with
        the study assessments or efficacy or safety.
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
Condition: Chronic Kidney Disease; End Stage Renal Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia
Intervention: Roxadustat
Intervention description: Oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney; ESRD; End Stage Renal Disease; Anemia; Oral anemia treatment; Hemoglobin levels; Hemodialysis; CKD; Chronic Kidney Disease; Peritoneal; HD; PD; Hb; Erythropoietin; Blood count

Summary:

      The purpose of this open-label extension study is to evaluate long-term efficacy and safety
      of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis
      chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat
      FibroGen-sponsored anemia study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Minimum age 18 years

          2. Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia
             study in the United States.

        Exclusion Criteria

          1. Participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study

          2. Pregnant or breastfeeding females

          3. Females of childbearing potential, unless using adequate contraception; male
             participants with sexual partners of childbearing potential who are not on birth
             control unless the male participant agrees to use adequate contraception

          4. Participants who received roxadustat in a previous study that did not demonstrate
             adequate hemoglobin response per the investigator's clinical judgment

          5. Any medical condition that in the opinion of the investigator may pose a safety risk
             to a participant in this study or which may interfere with study participation
Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BCT197; Placebo
Intervention description: Capsules will be taken orally with fluids over a 5 day period after randomization; Capsules will be taken orally with fluids over a 5 day period after randomization
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 282.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of BCT197 when added on to
      standard of care in adult subjects with acute respiratory exacerbations of chronic
      obstructive pulmonary disease requiring hospitalization. Additionally, the study will
      characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the
      study will be 26 weeks. Subjects will receive study treatment administration over a period of
      5 days after randomization. It is expected that approximately 255 subjects will complete the
      study and follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults

          -  Presence of an active exacerbation of the ongoing COPD requiring hospitalization for
             treatment

          -  Subjects with a documented diagnosis of COPD C or D

          -  Current smokers or ex-smokers

          -  A documented history of at least one moderate or severe COPD exacerbation in the 12
             months preceding the Screening Visit that required antibiotics and/or systemic
             corticosteroid.

          -  Current regular treatment for COPD (for at least 2 months prior to the Screening
             Visit.

        Exclusion Criteria:

          -  Age less than 40 years old

          -  Current diagnosis of asthma

          -  Subjects who have already completed treatment for the current exacerbation of COPD

          -  Subjects currently requiring intensive care unit (ICU) and/or mechanical ventilation

          -  Received a course of PDE4, p38 or PDE3/4 inhibitors within their respective defined
             washout periods.
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
Condition: Myelodysplastic Syndrome; Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Ara-C; Mitoxantrone; Etoposide
Intervention description: Induction: 3000mg/m2 IV infusion for day 1 and day 5
Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total); Induction: 30mg/m2 after the end of HiDAC day 1 and day 5; Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days
Intervention MeSH terms: Cytarabine; Etoposide; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia; Myelodysplastic syndrome; Acute myeloid leukemia

Summary:

      The purpose of this study is to determine the effectiveness of a particular combination of
      drugs used to treat cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect
             the properties of DNA or cell growth for some condition other than acute myeloid
             leukemia prior to diagnosis.

          -  Patients must have t-MDS/t-AML

          -  To be eligible for allogeneic transplantation, patients must have a suitable donor who
             is HLA compatible.

          -  Patients must be over the age of 10.

          -  Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of
             the Section of Hematology/Oncology.

        Exclusion Criteria:

          -  Patients must not have any other serious medical condition(e.g.uncontrolled or severe
             cardiovascular disease, diabetes, pulmonary disease, or infection)

          -  Psychiatric condition which would prevent compliance or possibly be worsened by
             treatment
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: LGX818; Cetuximab; BYL719
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-label dose escalation; BRAF inhibitor; LGX818; PI3K inhibitor; BYL719; EGFR; cetuximab; metastatic colorectal cancer; KRAS; BRAF; V600

Summary:

      This study will assess the safety and efficacy of LGX818 when combined with cetuximab or
      combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic colorectal cancer

          -  Progression after at least one prior standard of care regimen or be intolerant to
             irinotecan-based regimens

          -  Life expectancy ≥ 3 months

          -  ECOG performance status ≤ 2

        Exclusion Criteria:

          -  Symptomatic or untreated leptomeningeal disease

          -  Symptomatic brain metastasis

          -  Patients with clinically manifested diabetes

          -  Acute or chronic pancreatitis

          -  Clinically significant cardiac disease

        Other protocol-defined inclusion/exclusion criteria may apply.
Treatment of Patients With RAD001 With Progressive Sarcoma
Condition: Progressive Sarcoma
MeSH terms: Sarcoma
Intervention: Everolimus
Intervention description: 2.5 and 5 mg tablets taken orally and starting dose was 10 mg daily for all patients
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: progressive GIST; progressive sarcoma

Summary:

      The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to
      determine the preliminary efficacy and safety of RAD001 in patients with histological
      evidence of progressive or metastatic bone or soft tissue sarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

        Histological evidence of progressive or metastatic bone or soft tissue sarcoma.

        The following tumor types are included:

          -  malignant fibrous histiocytoma

          -  liposarcoma

          -  synovial sarcoma

          -  malignant paraganglioma

          -  fibrosarcoma

          -  leiomyosarcoma

          -  angiosarcoma including haemangiopericytoma

          -  malignant peripheral nerve sheath tumor

          -  STS, not otherwise specified

          -  miscellaneous sarcoma including mixed mesodermal tumors of the uterus

          -  osteosarcoma

          -  Ewing's sarcoma

          -  rhabdomyosarcoma

          -  gastrointestinal stromal tumor (only after failure or intolerance of imatinib or
             sunitinib in 1st and 2nd line)

          -  alveolar soft part sarcoma (ASPS)

               -  Objective progression of disease may be documented by RECIST criteria. Any of the
                  following would be sufficient according to RECIST:

          -  a 20% increase in the sum of unidimensionally measured target lesions

          -  a new lesion

          -  unequivocal increase in non-measurable disease.

               -  Patients must have disease not amenable to surgery, radiation, or combined
                  modality therapy with curative intent.

               -  ECOG performance status 0 - 2.

        Exclusion Criteria:

        Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy,
        immunotherapy, or radiotherapy.

          -  The following tumor types will not be included:

               -  gastrointestinal stromal tumor (except for patients after treatment with imatinib
                  or sunitinib in 1st and 2nd line)

               -  chondrosarcoma

               -  malignant mesothelioma

               -  neuroblastoma.

          -  Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).

          -  Neurotoxicity > grade 2 CTC.

          -  Radiation of the lung.

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer Stage IV
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Abemaciclib; Docetaxel
Intervention description: Administered orally; Administered IV
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: patient reported outcomes (PRO); patient focused outcomes (PFO); biomarkers; CDK 4 and 6

Summary:

      The main purpose of this study is to evaluate the effectiveness of the study drug known as
      abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung
      cancer (NSCLC) previously treated with platinum-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of stage IV NSCLC.

          -  Have progressed during or after platinum-based chemotherapy for advanced disease.

          -  Have not received prior treatment with docetaxel.

          -  Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived
             material.

          -  Have adequate organ function including hematology, renal, and liver.

          -  Have good performance score (0-1).

          -  Have measurable disease per RECIST 1.1.

          -  Agree to use a reliable medically approved method of birth control.

        Exclusion Criteria:

          -  Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor
             or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment
             administered is not known.

          -  Are currently receiving treatment in a clinical trial involving an investigational
             product or non-approved use of a drug or device.

          -  Have the presence of unstable central nervous system (CNS) metastasis.

          -  Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab; Placebo for adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection.; Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind.
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Crohn's Disease; Pharmacokinetics

Summary:

      The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of
      adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese
      subjects with Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of Chinese descent with full Chinese parentage.

          2. Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0 confirmed by
             endoscopy, radiologic evaluation, and/or histology during the Screening Period.

          3. Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450 despite treatment with oral
             corticosteroids and/or immunosuppressants.

          4. Subject has a negative Tuberculosis (TB) Screening Assessment.

        Exclusion Criteria:

          1. Subject with ulcerative colitis or indeterminate colitis.

          2. Subject who has had a surgical bowel resection within the past 6 months or who is
             planning any resection at any time point in the future.

          3. Subject with an ostomy or ileoanal pouch.

          4. Subject who has short bowel syndrome.

          5. Subject with symptomatic known obstructive strictures.

          6. Subject with an internal or external fistula (with the exception of an anal fistula
             without abscess).

          7. Chronic recurring infections or active TB.