bioihbjkbjnl/mcl2 huggingface dataset:
Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Condition: Leukaemia, Lymphocytic, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: chlorambucil, tablets; ofatumumab (GSK1841157) infusion
Intervention description: 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles; iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;
Intervention MeSH terms: Ofatumumab; Chlorambucil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 447.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Safety; Untreated; Efficacy; Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia (CLL), untreated; Ofatumumab; Oncology

Summary:

      The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to
      chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmed CLL diagnosis and active CLL requiring treatment

          -  considered inappropriate for fludarabine-based therapy

          -  not been treated for CLL before

          -  fully active at a minimum or fully capable of selfcare and up and about more than 50%
             of waking hours

          -  age 18yrs or older

          -  signed written informed consent

        Exclusion Criteria:

          -  prior CLL therapy

          -  abnormal/inadequate blood values, liver, and kidney function

          -  certain heart problems, active or chronic infections, serious significant diseases,
             active autoimmune hemolytic anemia (AIHA) requiring treatment, other current cancer or
             within last 5 years

          -  CLL transformation

          -  CLL central nervous system involvement

          -  current participation in other clinical study

          -  inability to comply with the protocol activities

          -  lactating or pregnant women or female patients of child-bearing potential (or male
             patients with such partners) not willing to use adequate contraception
A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to compare PFS (progression-free survival) rate at 6
      months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab
      240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and
      Sq).
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically or cytologically documented Squamous or non-Squamous Non-small cell
             lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following
             multimodal therapy

          -  Patients must have received pre-study nivolumab for up to 12 months and have 2
             consecutive tumor assessments confirming Complete response (CR), Partial response
             (PR), or Stable disease (SD)

          -  Measurable disease before start of pre-study nivolumab treatment

          -  Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

        Exclusion Criteria:

          -  Carcinomatous meningitis

          -  Untreated, symptomatic Central nervous system (CNS) metastases

          -  Symptomatic interstitial lung disease

        Other protocol defined inclusion/exclusion criteria could apply
Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
Condition: Long QT Syndrome Type 3
MeSH terms: Long QT Syndrome; Syndrome
Intervention: Eleclazine; Eleclazine placebo
Intervention description: Tablets administered orally; Tablets administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 3 long QT syndrome (LQT3); Long QT syndrome; Congenital long QT; Sudden cardiac death

Summary:

      The primary objective of this study is to evaluate the effect of oral eleclazine on mean
      daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long
      QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will
      receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period,
      participants who have not permanently discontinued study drug will be eligible, at the
      discretion of the investigator, to continue receiving eleclazine during an open-label
      extension (OLE) phase.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals with an established diagnosis of LQT3 (by genotype testing)

          -  Mean (of triplicate) QTc interval ≥ 480 msec (or ≥ 460 msec, for individuals who are
             currently taking ranolazine or Class I antiarrhythmic drugs such as mexiletine) at 3
             or more time points, determined by standard 12-lead ECG, at screening

        Key Exclusion Criteria:

          -  Known mutations associated with type 1 long QT syndrome (LQT1) or type 2 long QT
             syndrome (LQT2)

          -  Known or suspected history of seizures or epilepsy

          -  History of heart failure defined as New York Heart Association (NYHA) Class IV and/or
             known left ventricular ejection fraction (EF) ≤ 45%

          -  Body mass index (BMI) ≥ 40 kg/m^2 at screening

          -  Severe renal impairment at screening (defined as an estimated glomerular filtration
             rate (eGFR) < 30 mL/min/1.73m^2, using the 4 Variable Modification of Diet in Renal
             Disease (MDRD) equation, as determined by the study center)

          -  Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT)
             or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN), or total
             bilirubin > 1.5 x ULN

          -  An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD)
             implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to
             screening

          -  Any other condition or circumstance that in the opinion of the investigator would
             preclude compliance with the study protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Buprenorphine Treatment for Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine
Intervention MeSH terms: Buprenorphine; Naloxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid Dependence; Buprenorphine

Summary:

      Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription
      opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this
      patient population. The goal of this study is to determine if there are differences in
      clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high
      dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will
      be treatment retention, use of opioids, and the use of other drugs of abuse.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between the ages of 18 to 65, current dependence on prescription
             opioids as evidenced by documented prior treatment for opioid dependence, signs of
             opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or
             greater, self-reported history of opioid dependence, and a positive urine toxicology
             for opiates;

          2. willingness to be detoxified from opioids for buprenorphine maintenance ;

          3. for women of childbearing age, a negative pregnancy test at screening with agreement
             to use adequate contraception to prevent pregnancy, with monthly pregnancy tests
             obtained during study participation.

        Exclusion Criteria:

          1. use of heroin for more than 4 days in the past month;

          2. lifetime history of opioid dependence due to heroin alone;

          3. ever used heroin intravenously;

          4. requirement for current ongoing opioid treatment for adequate pain management;

          5. current alcohol, benzodiazepine, barbiturate use with physiologic dependence as
             determined during screening history and physical,

          6. serious unstable medical illness including bradycardia or other arrhythmias, major
             cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine
             treatment is contraindicated or which at the determination of the MD is medically
             dangerous;

          7. serious psychiatric illness including psychosis, bipolar disorder with psychosis:

          8. or significant current suicidal or homicidal thoughts necessitating a higher level or
             care;

          9. known allergy or intolerance to buprenorphine.
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY2963016; Lantus®; Insulin Lispro
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin Glargine

Summary:

      The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus®
      in combination with mealtime insulin lispro in adult Chinese participants with Type 1
      Diabetes Mellitus (T1DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO]
             Classification).

          -  Have duration of T1DM ≥1 year.

          -  Have HbA1c ≤11 %.

          -  Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90
             days prior to screening.

          -  Have a body mass index (BMI) ≤35 kilograms per meter squared.

        Exclusion Criteria:

          -  Exposure to an insulin glargine other than Lantus® within previous 30 days.

          -  Have had more than one episode of severe hypoglycemia within 6 months prior to entry
             into the study.

          -  Have had more than one episode of diabetic ketoacidosis or emergency room visits for
             uncontrolled diabetes leading to hospitalization within 6 months prior to entry into
             the study.

          -  Have known hypersensitivity or allergy to any of the study insulins (Lantus® or
             insulin lispro) or to excipients of the study insulins.

          -  Are pregnant, intend to become pregnant during the course of the study.

          -  Women who are breastfeeding.

          -  Are currently taking traditional medicine (herbal medicine or patent medicine) with
             known/specified content of anti-hyperglycemic effects within 3 months before
             screening.

          -  Have congestive heart failure Class III and IV.

          -  Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease.

          -  Have any active cancer.

          -  Have a history or diagnosis of human immunodeficiency virus (HIV) infection.

          -  Have presence of clinically significant gastrointestinal disease.

          -  Have a history of renal transplantation, or are currently receiving renal dialysis.

          -  Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response
Condition: Leukemia, Myeloid, Chronic-Phase
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Imatinib Mesylate 600 MG Oral Tablet; Imatinib Mesylate 400 MG Oral Tablet; Imatinib Mesylate
Intervention description: Imatinib Mesylate for CP CML; Imatinib Mesylate for CP CML; Imatinib Mesylate for CP CML
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: IM concentration < 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration >= 1000ng/mL Parallel Cohort: "standard strategy"
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic myeloid leukemia in chronic phase; residual plasma IM concentration; adapted strategy

Summary:

      The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with
      CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response
      and major molecular response rate) is dependent on the residual plasma Imatinib.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,

          2. Patients in complete cytogenetic response for at least 1 year

          3. Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)

          4. ECOG ≤ 2,

          5. Age ≥ 18 years

          6. Signed informed consent,

          7. Membership of a social security system

        Exclusion Criteria:

          1. Patients with CML-CP Philadelphia chromosome negative diagnosis.

          2. Patients previously treated with Imatinib Mesylate at doses above 400 mg / day

          3. Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg /
             d

          4. Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic
             or cardiac progressive uncontrolled by medical treatment

          5. Pregnant or breastfeeding women, women of childbearing potential not using a
             contraceptive method effective

          6. Known HIV positive

          7. Patients previously treated with another tyrosine kinase inhibitor

          8. Patient participating in another interventional clinical trial

          9. History of non-compliance to Imatinib Mesylate
Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Nivolumab; Cetuximab; Methotrexate; Docetaxel
Intervention MeSH terms: Docetaxel; Nivolumab; Methotrexate; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out whether Nivolumab will significantly improve overall
      survival as compared to therapy of investigator's choice in patients with recurrent or
      metastatic head and neck carcinoma.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG)
             performance status ≤ 1

          -  Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx),
             stage III/IV and not amenable to local therapy with curative intent (surgery or
             radiation therapy with or without chemotherapy)

          -  Tumor progression or recurrence within 6 months of last dose of platinum therapy in
             the adjuvant (ie with radiation after surgery), primary (ie, with radiation),
             recurrent, or metastatic setting

          -  Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per
             Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases are not allowed

          -  Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx,
             squamous cell carcinoma of unknown primary, and salivary gland or non-squamous
             histologies (eg: mucosal melanoma) are not allowed

          -  Subjects with active, known or suspected autoimmune disease
Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed dose combination granules for oral administration.; Granules for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and
      efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in
      CF subjects 2 through 5 years of age.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for the F508del mutation or heterozygous for F508del and a minimal function
             (MF) mutation (F/F or F/MF genotypes)

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers
Condition: Corneal Ulcer; Fungal Keratitis
MeSH terms: Corneal Ulcer; Keratitis; Ulcer
Intervention: Intrastromal voriconazole; Natamycin
Intervention description: Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.; Subjects will receive topical 5% natamycin drops hourly for 3 days.
Intervention MeSH terms: Voriconazole; Natamycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: cornea; ulcer; fungal; keratitis

Summary:

      Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical
      trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers.
      There is currently little evidence to guide the treatment of fungal keratitis beyond topical
      anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used
      as well. This study will provide evidence to guide the treatment of fungal keratitis in the
      future. The purpose of this study is to determine differences in microbiological cure for
      3-day repeat cultures between different antifungal treatments. For this study, there will be
      1:1 randomization to one of these two treatment groups: 1) topical natamycin plus
      intrastromal voriconazole injection or 2) topical natamycin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe corneal ulcer that is smear positive for filamentous fungus

          -  Pinhole visual acuity worse than 20/70 in affected eye

          -  Basic understanding of the study as determined by the physician

          -  Commitment to return for follow up visits

        Exclusion Criteria:

          -  Gram stain positive for bacteria or evidence of other concomitant infection (i.e.
             herpes, acanthamoeba)

          -  Impending or frank perforation at recruitment

          -  Involvement of sclera at presentation

          -  Non-infectious or autoimmune keratitis

          -  History of corneal transplantation or recent intraocular surgery

          -  No light perception in the affected eye

          -  Pinhole visual acuity worse than 20/200 in the unaffected eye

          -  Pregnant women

          -  Participants who are decisionally and/or cognitively impaired