bioihbjkbjnl/mcl2 huggingface dataset:
Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ruxolitinib
Intervention description: Ruxolitinib 25 mg tablets taken with water twice a day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer

Summary:

      This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose
      disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens
      or ketoconazole) for metastatic, androgen-independent prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with radiographically-documented metastatic prostate cancer that has
             progressed while receiving androgen-suppressive therapy in the form of a bilateral
             orchiectomy or Gonadotropin-Releasing Hormone (GnRH) agonist (eg, leuprolide,
             goserelin).

          -  Patients must demonstrate evidence of progressive disease based on 1 of the following
             criteria: 1) Progressive measurable disease, or 2) Progressive rise in
             prostate-specific antigen (PSA) level (2 consecutive rises from a prior reference
             level), or 3) Development of new lesions on bone scan.

          -  If receiving a GnRH agonist as primary hormonal therapy, the serum testosterone level
             must be ≤ 50 ng/mL.

          -  Must have received and progressed during or following 1 prior chemotherapy regimen for
             metastatic disease (not including an anti-androgen or ketoconazole); or, must have
             discontinued prior systemic therapy because of poor tolerance or other adverse
             effects; or, must have refused chemotherapy treatment. Patients having undergone more
             than 1 prior chemotherapy regimen may be admitted at the discretion of the sponsor.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

          -  Baseline serum PSA level of ≥ 10 ng/mL

        Exclusion Criteria:

          -  Received any anti-cancer medications in the 30 days before receiving their first dose
             of study medication except for GnRH agonists and bisphosphonates.

          -  Any unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer
             therapy, except for stable chronic toxicities not expected to resolve, such as
             peripheral neurotoxicity.
Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Gemcitabine
Intervention description: A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles
B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles; A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles
B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine
      Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in
      patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity
      respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is
      reasonable to investigate the most optimal schedule for this combination, and which
      combination is associated with the most anti-tumor activity in the phase II arena.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologic or cytologic diagnosis of NSCLC Stage IIIB or IV

          -  no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer

          -  Prior radiotherapy must be completed at least 4 weeks before study enrollment.

        Exclusion Criteria:

          -  estimated life expectancy of 12 weeks

          -  a serious cardiac condition, such as myocardial infarction within 6 months, angina, or
             heart disease

          -  documented brain metastases unless the patient has completed successful local therapy
             for central nervous system metastases and has been off of corticosteroids for at least
             2 weeks before enrollment

          -  significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.
Use of Cone Beam Kilovoltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: PTV Reduction
Intervention description: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kilovoltage Imaging; Cone-beam CT; CBCT; radiation therapy; head and neck neoplasms

Summary:

      To evaluate the use of cone beam computed tomography in treating head and neck to hopefully
      reduce side effects
    

Eligibility criteria:

        Inclusion Criteria:

          -  any patient receiving radiation therapy for a head and neck tumor assigned to the new
             Elekta Synergy Linare Accelerator

        Exclusion Criteria:

          -  NA
Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Brolucizumab 3 mg/50 μL; Brolucizumab 6 mg/50 μL
Intervention description: Administered as an intravitreal injection; Administered as an intravitreal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; nAMD; wetAMD; Age-Related Macular Degeneration

Summary:

      The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2
      different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when
      administered at 4-week intervals for a total of 3 intravitreal injections in subjects with
      neovascular age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent;

          -  Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the
             central subfield in the study eye;

          -  Best Corrected Visual Acuity (BCVA) > 23 letters in the study eye at Baseline;

          -  50 years of age or older at the time of Screening.

        Exclusion Criteria:

          -  Any active ocular infection or inflammation;

          -  Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®), ranibizumab (LUCENTIS®),
             brolucizumab, or an investigational drug for neovascular AMD prior to enrollment in
             the study, as specified in protocol;

          -  Ocular surgery in the study eye, as specified in protocol;

          -  Uncontrolled glaucoma in the study eye, as specified in protocol;

          -  Use of steroids in the study eye, as specified in protocol;

          -  Medical conditions that may prevent study completion;

          -  Pregnant or nursing (lactating) women;

          -  Women of child-bearing potential unless using contraception;

          -  Uncontrolled blood pressure, as specified in protocol;

          -  Other protocol-specified exclusion criteria may apply.
AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
Condition: Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: AG-013736 (Axitinib)
Intervention description: patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study tests the safety and efficacy of axitinib in patients who have the hematologic
      disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who
      have poor prognosis before entering the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Poor prognosis AML or MDS

          -  Histological confirmation of diagnosis

          -  White blood cell count less than or equal to 30,000/mm3

          -  Adequate hepatic and renal function documented within 14 days prior to registration

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  No evidence of preexisting uncontrolled hypertension

          -  Not a suitable candidate for chemotherapy

          -  No prior systemic chemotherapy treatment for AML or MDS or treatment with an
             anti-angiogenesis agent

        Exclusion Criteria:

          -  Patients must not have exclusion criteria.

          -  Candidate for chemotherapy

          -  Patients with AML M3 (acute promyelocytic leukemia)

          -  Conditions that might confound the evaluation of safety or efficacy or increase
             patient risk.
Esmolol vs. Labetalol in Endoscopic Sinus Surgery
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Intervention: Labetalol; Esmolol
Intervention description: Aliquots of 20mg of Labetol
• Maximum Dose - 300mg total for case; Infusion - 0.1mg/kg/min
• Maximum Dose - after 30 minutes, 0.3mg/kg/min
Intervention MeSH terms: Labetalol; Esmolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative
      visibility scores in functional endoscopic sinus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of CRS with or without nasal polyps

          -  Undergoing FESS for CRS

          -  American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient
             with mild systemic disease).

        Exclusion Criteria:

          -  Pregnancy

          -  Asthma

          -  COPD

          -  Bradycardia

          -  Heart failure

          -  End stage renal disease

          -  Cerebrovascular accident

          -  Diabetes mellitus

          -  Preoperative use of NSAIDs, aspirin, or beta-blockers

          -  Body mass index (BMI) greater than 40 kg/m2.
Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
Condition: Idiopathic Small Fiber Neuropathy
MeSH terms: Neuralgia; Small Fiber Neuropathy
Intervention: Pregabalin; Placebo
Intervention description: Pregabalin will be given to the patients, starting at 75 mg BID and increased weekly to reach 225 mg BID for 8 weeks. During withdrawal phase, dose of pregabalin will be kept the same for patients who are randomized to the pregabalin withdrawal group.; Placebo will be given to the patients that are randomized to placebo during withdrawal phase.
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess safety and efficacy of treatment with pregabalin in
      patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched
      enrollment randomized withdrawal study that comprises 4 phases: a screening and selection
      phase, a washout period from previous pain medication for enriched enrollment, an 8 week
      single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with idiopathic predominate-small fiber neuropathy

          -  Subject must have chronic peripheral neuropathic pain for more than 3 months

          -  A score >3 and <8 on Pain intensity scale for pain in prior week at first visit;

          -  Show increase in pain intensity scores during the wash off period;

          -  Age older than 18 years;

        Exclusion Criteria:

          -  Subjects with large-fiber predominant neuropathy

          -  Subjects with HIV infection, trigeminal neuralgia (TGN), toxic neuropathy (e.g.
             chemotherapy exposure), paraneoplastic neuropathy, mono-gammopathy, inflammatory
             neuropathy, celiac disease, systemic lupus, peripheral vascular disease, connective
             tissue disorders, hepatitis C, Fabry disease, and diabetes;

          -  Subjects with uncontrolled thyroid or B12 disorders

          -  Subjects with Complex Regional Pain Syndrome

          -  Allergy to Pregabalin

          -  Subjects at risk of suicide or self harm

          -  Subjects with any clinically unstable cardiovascular, hematological, autoimmune,
             endocrine, renal, hepatic, renal, respiratory, or gastrointestinal disease; epilepsy,
             symptomatic peripheral vascular disease including intermittent claudication,
             pernicious anemia, untreated hypothyroidism, venous insufficiency, or spinal stenosis.

          -  History of known analgesic, alcohol or illicit drug abuse within 12 months of first
             visit;

          -  Pregnant females; breastfeeding females.
A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease; Mild to Moderate Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: GRF6019
Intervention description: GRF6019 for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study is evaluating the safety, tolerability, and feasibility of GRF6019, a
      plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild
      to moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable AD based upon the National Institute on Aging-Alzheimer's
             Association (NIA-AA) Criteria

          -  MMSE Score 12-24 inclusive

          -  Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4

          -  Provided a signed and dated informed consent form (either the subject and/or subject's
             legal representative as well as the trial partner)

        Exclusion Criteria:

          -  Evidence of clinically relevant neurological disorder(s) other than probable AD

          -  History of blood coagulation disorders or hypercoagulability; any concurrent use of an
             anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa
             inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.

          -  Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine,
             Axona, vitamin E supplementation or selegiline within 3 months prior to screening.

          -  Heart disease (or history thereof), as evidenced by myocardial infarction, unstable,
             new onset or severe angina, or congestive heart failure (New York Association Class
             II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure
             (systolic blood pressure of 160 mmHg or higher and/or diastolic blood

          -  Prior hypersensitivity reaction to any human blood product or intravenous infusion;
             any known clinically significant drug allergy.

          -  Treatment with any human blood product, including transfusions and intravenous
             immunoglobulin, during the 6 months prior to screening.

          -  History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke,
             anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.

          -  Hemoglobin <10 g/dL in women; and <11 g/dL in men.
A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Intervention: Pramlintide+Metreleptin; Placebo
Intervention description: Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks.; Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.
Intervention MeSH terms: Pramlintide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pramlintide; Metreleptin; Obesity; Amylin; Takeda

Summary:

      Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD)
      lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week
      LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or
      placebo) to begin a 16-week treatment period during which the effect on body weight of
      treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week
      blinded core treatment period, subjects will discontinue study medication for a period of 12
      weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate
      a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week
      off-drug and 12 week open label treatment periods, subjects will continue to participate in a
      Lifestyle Intervention (LSI) program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is obese with a BMI ≥35 to ≤45 kg/m2.

          -  Has stable body weight (not varying by >5% within 3 months prior to study start).

          -  Meets certain requirements with respect to concomitant medications.

          -  Has not smoked or used nicotine-containing products for at least 12 months prior to
             study start.

        Exclusion Criteria:

          -  Has not been enrolled in a weight loss program within 2 months prior to study start.
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Condition: Non-Small Cell Lung Cancer; NSCLC; Adenocarcinoma; Heregulin
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MM-121; Docetaxel
Intervention description: Investigational, fully human antibody targeting and inhibiting ErbB3; approved chemotherapy treatment for NSCLC
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Randomized, open-label, international, multi-center, Phase 2 study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; Non-Small Cell Lung Cancer; heregulin; ErbB3; docetaxel

Summary:

      The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is
      more effective than docetaxel alone in regards to PFS in patients with heregulin-positive
      NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of cytologically or histologically documented adenocarcinoma
             of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC
             disease not amenable to surgery with curative intent

          -  Not received more than 2 prior systemic therapies- one of which must have been a
             platinum based regimen- for primary or recurrent disease

          -  Tissue submitted for HRG-biomarker testing

          -  ECOG performance status (PS) of 0 or 1

        Exclusion Criteria:

          -  Known ALK mutation

          -  Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene

          -  Received >2 prior systemic anti-cancer drug regimen for locally advanced disease

          -  Prior treatment with an anti-ErbB3 antibody

          -  CTCAE grade 3 or higher peripheral neuropathy

          -  Symptomatic CNS metastases or CNS metastases requiring steroids

          -  Any other active malignancy requiring systemic therapy

          -  Clinically significant cardiac disease