bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Vinorelbine; Vandetanib
Intervention description: once daily oral dose
Intervention MeSH terms: Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mesothelioma; inoperable; relapsed

Summary:

      A clinical study to assess if a new investigational drug is effective in treating malignant
      mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients
      will be assigned by chance to receive either the new drug or a chemotherapy treatment
      (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient
      wishes to continue in the study. The study will recruit approximately 66 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with mesothelioma

          -  Previously treated with only one course of chemotherapy for mesothelioma

          -  No previous treatment with vinorelbine

          -  No serious heart problems within the last 3 months

        Exclusion Criteria:

          -  Serious abnormal laboratory values

          -  Severe or uncontrolled disease or condition as judged by the Investigator

          -  Pregnant or breast-feeding women

          -  Other cancers within the last 5 years

          -  Major surgery or radiation therapy within 4 weeks prior to starting study therapy

          -  Receipt of any investigational agents within 30 days prior to commencing study
             treatment.
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Inarigivir Soproxil; TAF
Intervention description: Administered orally once daily one hour before or one hour after a meal; Administered orally once daily with food
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety and tolerability of the 12
      week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or
      commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB),
      to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF
      alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of
      12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB
      participants (Group 4).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Groups 1-3 and 5:

               -  Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment

          -  Group 4:

               -  HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.

               -  Have been on a commercially available HBV NUC treatment(s)

        Key Exclusion Criteria:

          -  Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or
             hepatitis D virus (HDV).

          -  Extensive bridging fibrosis or cirrhosis

          -  Evidence of hepatocellular carcinoma on imaging

          -  Any history of, or current evidence of, clinical hepatic decompensation (e.g.,
             ascites, encephalopathy or variceal hemorrhage).

          -  Chronic liver disease of a non-HBV etiology

          -  Current alcohol or substance abuse

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
Condition: Cancer
MeSH terms: Neoplasm Metastasis
Intervention: Bone scan; 99mTc-methyl diphosphonate; Positron Emission Tomography (PET) scan; 18F-Fludeoxyglucose (18F-FDG); Computed Tomography (CT) scan; 18F-Sodium Fluoride (18F-NaF); Whole Body Magnetic Resonance Imaging (WB-MRI) scan; Gadopentetate dimeglumine; Gadofosveset; Gadobutrol
Intervention description: Scan to diagnose a number of bone conditions including cancer or metastasis; Radiolabel for bone scan procedures; Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F; Radiolabel for positron emission tomography scan procedures; Scan to detect & analyze X-rays; Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.; Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.; A gadolinium-based contrast agent for MRI; A gadolinium-based contrast agent for MRI; A gadolinium-based contrast agent for MRI
Intervention MeSH terms: Diphosphonates; Methylene diphosphonate; Listerine; Deoxyglucose; Fluorides; Sodium Fluoride; Fluorodeoxyglucose F18; Technetium Tc 99m Medronate
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F)
      fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance
      imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or
      stage II-IV prostate cancer.
    

Eligibility criteria:

        All patients were enrolled after receiving a regular medical care bone scan using the
        radiolabel 99mTc-methyl diphosphonate (t99-MDP).

        INCLUSION CRITERIA

          -  ≥ 18 years old at the time of the drug administration

          -  ≥ Stage 3 breast cancer OR ≥ stage 2 prostate cancer OR prostate-specific antigen
             (PSA) > 10 micrograms/L OR recurrent breast or prostate cancer

          -  Capable of complying with study procedures

          -  Able to remain still for duration of imaging procedure (about one hour)

          -  Written informed consent

        EXCLUSION CRITERIA

          -  Pregnant or nursing

          -  Metallic implants that contraindicate MRI

          -  Renal function impairment that contraindicates MRI
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]
Intervention description: 150 mg orally daily
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients
      with locally advanced, metastatic or recurrent non-small cell lung cancer who have not
      received previous chemotherapy for their disease and who present epidermal growth factor
      receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease
      progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung
             cancer with mutations in the tyrosine kinase domain of the epidermal growth factor
             receptor (EGFR)

          -  At least one measurable lesion according to RECIST criteria

          -  European Cooperative Oncology Group (ECOG) performance status 0-2

          -  Adequate hematological, liver and renal function

          -  Patients with stable cerebral metastases who have received surgical or radiotherapy
             will be eligible

        Exclusion Criteria:

          -  Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or
             adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before
             entering the study)

          -  History of another neoplasm except for carcinoma in situ of the cervix, adequately
             treated basal cell skin carcinoma, radically treated prostate carcinoma with good
             prognosis (Gleason </= 6), or another curatively treated neoplasm without evidence of
             disease in the last 5 years

          -  Symptomatic cerebral metastases

          -  Any significant ophthalmologic abnormality

          -  Use of coumarins

          -  Pregnant or breast-feeding women

          -  Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and
             carcinomatosis (if this is the only presence of the disease)
Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas
Condition: Glioblastoma; Glioma
MeSH terms: Glioblastoma; Glioma
Intervention: Selinexor
Intervention description: One cycle is 28 days (4 weeks).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GBM; Glioblastoma; selinexor; KPT-330; Karyopharm; brain tumor; brain cancer; Glioma; Astrocytoma; Oligodendrogliomas; Oligo-astrocytomas

Summary:

      This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral
      selinexor in participants with recurrent gliomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed GBM (including all histologic variants) at first diagnosis
             with radiographic evidence of recurrent disease after treatment with radiotherapy and
             temozolomide;

          -  18 years of age or older

          -  Participants enrolling in the medical arm (Arms B, C and D) must be on a stable or
             decreasing dose of corticosteroids (or none) for at least 5 days prior to the baseline
             MRI;

          -  Measurable disease (according to RANO guidelines)

          -  Surgical arm (Arm A) must be predicted pre-operatively to have sufficiently sized
             tumor to be resected and provide tissue samples for exploratory assessments.

        Exclusion Criteria:

          -  Markedly decreased visual acuity if attributed to other causes than GBM.

          -  Known active hepatitis A, B, or C

          -  Participants with coagulation problems and medically significant bleeding in the month
             prior to start of treatment (e.g., peptic ulcer, epistaxis, spontaneous bleeding).
             Prior history of DVT or PE is not exclusionary.

          -  Participants must not have significantly diseased or obstructed gastrointestinal
             tract, malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral
             medications.

          -  Prior treatment with bevacizumab or other direct VEGF/ VEGFR inhibitors. For any
             question of the definition of a direct VEGF/VEGFR inhibitor, consult Sponsor.

          -  Arms C and D only: body surface area < 1.2 m².

          -  < 24 days from prior temozolomide, < 6 weeks from nitrosourea, < 4 weeks from other
             chemotherapy or investigational agents prior to start of treatment within study.
A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-0893; Sitagliptin; Metformin; Placebo for MK-0893; Placebo for Sitagliptin; Placebo for Metformin
Intervention description: Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).; Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).; Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).; Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.; Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).; Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 146.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will test the effectiveness and safety of treatment with MK-0893 in combination
      with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while
             either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose
             combination therapy

        Exclusion Criteria:

          -  Participants have a history of Type 1 Diabetes Mellitus

          -  Participants taking insulin or thiazolidinediones (TZDs: peroxisome
             proliferator-activated receptor [PPAR]-gamma agonists)

          -  Participants who have a contraindication to metformin or sitagliptin
ESBA105 in Patients With Severe Dry Eye
Condition: Eyes Dry Chronic
MeSH terms: Dry Eye Syndromes
Intervention: ESBA105 ophthalmic solution; ESBA105 vehicle
Intervention description: Inactive ingredients used as Run-In and placebo comparator
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular discomfort

Summary:

      The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing
      the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale
      (VAS) discomfort score.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ongoing physician diagnosis of dry eye for at least 6 months.

          -  Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.

          -  Experience persistent ocular discomfort.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Contact lens wearers.

          -  Severe Sjogren's Syndrome.

          -  History of corneal surgery including refractive surgeries.

          -  Intraocular surgery within 6 months of Visit 1.

          -  Intraocular or periocular injection within 6 months of Visit 1.

          -  Lid function abnormalities.

          -  Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.

          -  Any acute infectious or non-infectious ocular condition of the anterior or posterior
             segments in either eye within 30 days of Visit 1.

          -  Diseases/conditions of ocular surface associated with clinically significant
             scarring/destruction of conjunctiva/cornea.

          -  Other protocol-defined exclusion criteria may apply.
Staccato Prochlorperazine in Migraine (in Clinic)
Condition: Migraine Headache, With or Without Aura
MeSH terms: Migraine Disorders; Headache
Intervention: Staccato Placebo; Staccato Prochlorperazine 5 mg; Staccato Prochlorperazine 10 mg
Intervention description: Inhaled Staccato Placebo; Inhaled Prochlorperazine 5 mg; Inhaled Prochlorperazine10 mg
Intervention MeSH terms: Prochlorperazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine, Staccato Prochlorperazine; Migraine headache with or without aura.

Summary:

      Development of Staccato Prochlorperazine for the treatment of migraine headache.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have migraine headache with or without aura (diagnosis according to
             International Headache Society guidelines) for at least 6 months, who have been pain
             free for at least 48 hours since the end of their last migraine attack, who have a
             pain rating of Moderate or Severe prior to dosing.

        Exclusion Criteria:

          -  Subjects who have taken any other migraine or pain medication within 48 hours of
             randomization, with a history of allergy or intolerance to phenothiazines and related
             drugs, or are considered by the investigator, for any reason, to be an unsuitable
             candidate for receiving prochlorperazine, or unable to use the inhalation device, must
             be excluded.
A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)
Condition: Hematologic Malignancy
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: Duvelisib
Intervention description: Administered as oral capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a long-term, continued treatment study that evaluated the long-term safety, clinical
      activity, and overall survival (OS) of duvelisib in individuals with hematologic malignancies
      that were previously treated with duvelisib in a previous sponsor-approved study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have participated in a previous study of duvelisib, and:

               -  Be actively receiving duvelisib monotherapy on the previous study (within 14 days
                  of study entry) and demonstrating clinical benefit (complete response [CR]/
                  partial response [PR]/ stable disease [SD]) of continued use, or

               -  Be in the survival follow-up phase of a previous duvelisib study

          -  Have completed the required components of the previous study and be appropriate for
             enrollment into this long-term continued treatment and follow-up study, as determined
             by the Sponsor

        Exclusion Criteria:

          -  Had any ongoing ≥ Grade 3 adverse event (AE) considered related to duvelisib treatment
             at screening

          -  Was pregnant or nursing
Early Intervention With Fluoxetine in Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Fluoxetine; Placebo
Intervention description: Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.; Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 30 Months
Maximum age: 58 Months
Healthy volunteers: No
Keywords: Autism

Summary:

      This study is a pilot study to evaluate the feasibility and safety of conducting a year long,
      double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance
      developmental processes in core areas impacted by autism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of autism

        Exclusion Criteria:

          -  Diagnosis of Asperger Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or
             Pervasive Development Disorder-Not Otherwise Specified

          -  Informed that treatment with a selective serotonin reuptake inhibitor (SSRI) is
             medically inadvisable

          -  Need for ongoing psychotropic medication (except for diphenhydramine, clonidine, or
             melatonin for sleep)

          -  Recent use of stimulants within 5 days prior to enrollment

          -  Ongoing need for or recent use of most psychotropic medications within 14 days of
             enrollment

          -  Recent initiation of specialized educational, behavioral, or diet intervention for
             autism in the month prior to enrollment