bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Reslizumab; Saline
Intervention MeSH terms: Reslizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cinquil™; Reslizumab

Summary:

      The purpose of this study is to determine the effectiveness and safety of reslizumab in the
      treatment of subjects with poorly controlled asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  written informed consent

          -  male or female subjects aged ≥ 18 to 75 years at time of screening

          -  female if she is of non-childbearing potential, or of childbearing potential and
             willing to use specific barrier methods specified in protocol

          -  confirmation of asthma

          -  symptoms consistent with a diagnosis of asthma that is poorly controlled with an
             inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥
             1.5

          -  requirement for treatment with high dose daily fluticasone and at least one other
             agent for the treatment of asthma not specifically excluded in the protocol

          -  requirement for >/= 3% eosinophils in induced sputum at Screening

        Exclusion Criteria:

          -  a clinically important event that would interfere with study schedule or procedure or
             compromise subject safety

          -  a diagnosis of hypereosinophilic syndrome

          -  an underlying lung disorder

          -  a current smoker

          -  use of systemic immunosuppressive agents within 6 months of study

          -  current use of systemic corticosteroids

          -  received attenuated live attenuated vaccines within three months prior to study entry

          -  expected to be poorly compliant with study drug, procedures, visits

          -  aggravating factors that are inadequately controlled

          -  participation in any investigational drug or device study within 30 days prior to
             study entry

          -  participation in biologics study within 3 months prior to study entry

          -  receipt of anti-human interleukin-5 (hIL-5) antibody within 6 months of study entry

          -  female subjects who are pregnant or nursing

          -  concurrent infection or disease that may preclude assessment of eosinophilic
             esophagitis

          -  concurrent immunodeficiency (human immunodeficiency [HIV], or acquired
             immunodeficiency syndrome [AIDS] or congenital immunodeficiency).

          -  current suspected drug and/or alcohol abuse
A Study of OV101 in Individuals With Fragile X Syndrome
Condition: Fragile X Syndrome (FXS)
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: OV101 (gaboxadol)
Intervention description: OV101 (gaboxadol)
Intervention MeSH terms: Gaboxadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: Male
Minimum age: 13 Years
Maximum age: 22 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101
      (gaboxadol) in subjects with Fragile X syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is male and 13 to 22 years old (inclusive) at the time of informed consent.

          -  Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).

        Exclusion Criteria:

          -  Concomitant disease or condition that are clinically significant and would limit study
             participation

          -  Clinically significant lab abnormalities or vital signs at the time of screening

          -  History of uncontrollable seizure disorder or seizure episodes within 6 months of
             screening or change in the anticonvulsant pharmacotherapy in the past 3 months.

          -  Unable or does not have a caregiver able to comply with study requirements.

          -  Enrolled in any clinical trial within the 30 days before screening.
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
Condition: HSV-2
Intervention: AIC316; AIC316; AIC316; AIC316; Placebo
Intervention description: Oral administration; Oral administration; Oral administration; Oral administration; Oral administration
Intervention MeSH terms: Pritelivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention
      of reactivation of genital herpes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, Immunocompetent men and women in good health of any ethnic group

          -  History of recurrent episodes of genital herpes for at least 12 months

          -  Seropositive for Herpes Simplex Virus HSV Type 2

          -  Body Mass Index (BMI) between 18 and 35 kg/m2

        Exclusion Criteria:

          -  Present episode of genital herpes

          -  Intake of systemic drug against HSV or any topical application against HSV within 7
             days before randomization for the trial

          -  Intake of systemic corticosteroids, other immunomodulating agents or any
             investigational agent within 3 months before randomization for the trial

          -  Positive results in any of the virology tests for human immunodeficiency virus
             antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg)
             or hepatitis B core antibody (HBc-Ab)
Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Clofarabine; Ara-C
Intervention description: 1-hour IV infusion 30 mg/m^2 daily times 5 days (Days 1-5); 20 mg/m^2 subcutaneously daily times 14 days (Days 1-14). On Days 1 to 5 of each course, clofarabine will precede injection of ara-C by approximately 4 hours (+/- 1 hour).
Intervention MeSH terms: Cytarabine; Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute Myeloid Leukemia; AML; High-Risk Myelodysplastic Syndrome; MDS; Clofarabine; Cytarabine; ara-C

Summary:

      The goal of this clinical research study is to study how effective treatments with
      clofarabine alone and clofarabine given in combination with ara-C are in the treatment of
      leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older.
      The safety of these treatments will also be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated AML and high-risk MDS ( > 10% blasts, or International Prognostic
             Scoring System (IPSS) intermediate-2). Prior therapy with hydroxyurea, single agent
             chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted"
             therapies are allowed.

          -  Age > 60 years.

          -  Eastern Cooperative Oncology Group (ECOG) performance status </= 2.

          -  Sign a written informed consent form.

          -  Adequate liver function (total bilirubin < 2mg/dL,serum glutamic pyruvic transaminase
             (SGPT) or Serum glutamic oxaloacetic transaminase (SGOT) < x 4 upper limit of normal
             (ULN)) and renal function (serum creatinine < 2mg/dL).

        Exclusion Criteria:

          -  Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed
             by history and/or physical examination.
TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Condition: Retinal Vein Occlusion; Macula Edema
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: TLC399 (ProDex)
Intervention description: 2-vial system: TLC399-DSP and TLC399-Lipid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in
      subjects with macular edema due to CRVO or BRVO.
    

Eligibility criteria:

        Inclusion Criteria:

          1. male or female, at least 18 years of age

          2. macular edema due to CRVO or BRVO

          3. best-corrected visual acuity (BCVA) score of 20/40 to 20/400

          4. mean central subfield thickness (CST) ≥350 um

          5. willing and able to comply with the study procedure and sign a written informed
             consent

          6. agree to use a medically acceptable form of birth control

        Exclusion Criteria:

          1. poorly controlled diabetes

          2. history of significant intraocular pressure (IOP) elevation to steroid treatment

          3. history of ocular hypertension and glaucoma

          4. cataract surgery in the study eye within 3 months, or intraocular surgery within 6
             months prior to screening

          5. use of hemodilution for the treatment of RVO

          6. use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to
             screening; or IVT aflibercept within 8 weeks prior to screening

          7. IVT Ozurdex to the study eye within 6 months prior to screening

          8. prior use of Retisert or Iluvien

          9. use of systemic steroids or heparin within 1 month prior to screening
Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Exemestane; Celecoxib + Exemestane
Intervention description: Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.; Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.
Intervention MeSH terms: Celecoxib; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either
      exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on
      tamoxifen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal female patient with histologically or cytologically confirmed breast
             cancer having progressed on Tamoxifen.

          -  Advanced disease: patients with advanced breast carcinoma with disease progression who
             had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced
             disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending
             on receptor status; or progressed within 12 months from completion of adjuvant
             treatment with Tamoxifen.

          -  at least one measurable lesion

        Exclusion Criteria:

          -  More than one previous chemotherapy and/or more than one hormonotherapy for advanced
             disease.

          -  Previous hormonotherapy for advanced disease other than Tamoxifen.

          -  Myocardial infarction within previous 6 mo
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Antidepressant + placebo; Antidepressant + cariprazine (0.1-0.3 mg/day); Antidepressant + cariprazine (1-2 mg/d)
Intervention description: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.; Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.; Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Adjunctive; Depression; Major Depressive Disorder (MDD)

Summary:

      This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on
      therapy to standard antidepressants in patients who did not respond to previous
      antidepressant therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-65 years old

          -  Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic
             features.

          -  Previous failure to respond to adequate trials of one or two ADTs with less than 50%
             reduction in depressive symptoms during the present episode.

        Exclusion Criteria:

          -  DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I
             disorder other than MDD that was the primary focus of treatment within 6 months before
             Visit 1
Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine
Intervention description: Decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts).
Intervention MeSH terms: Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Dacogen; Decitabine

Summary:

      The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia
      (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the
      DACO-018 study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must sign an Institutional Review Board (IRB) -approved informed consent form,
             indicating his/her awareness of the investigational nature of decitabine and its
             potential hazards prior to initiation of any study-specific procedures or treatment.

          2. Must have had one of the following:

             MDS (de novo or secondary) fitting any of the recognized French-American-British
             classifications

             OR

             chronic myelomonocytic leukemia (with WBC <12,000/μL)

             AND

             an International Prognostic Scoring System score of ≥1.5 as determined by complete
             blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of
             study entry OR AML (≥ 30 % bone marrow blasts), except M3 or acute promyelocytic
             leukemia.

          3. Must be age 18 years or older.

          4. Must have completed participation per protocol in the MGI PHARMA DACO-018 decitabine
             trial.

          5. Must enroll in this trial no more than 8 weeks after discontinuation from the MGI
             PHARMA DACO-018 trial.

          6. Must have recovered from all toxic effects of all prior therapy.

        Exclusion Criteria:

          1. Must not have any other active malignancy, other than basal or squamous cell skin
             carcinoma.

          2. Must not have received in the period after discontinuation from DACO-018 and
             enrollment into this trial any other chemotherapy agent, including investigational
             agents, for their disease.

          3. Must not have evidence of any other significant clinical disorder or laboratory
             finding that makes it undesirable for the patient to participate in the trial, at the
             discretion of the principal investigator.

          4. Must not be pregnant or lactating.
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab [Avastin]; docetaxel; capecitabine [Xeloda]
Intervention description: 15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles; 75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles; 950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks
Intervention MeSH terms: Bevacizumab; Docetaxel; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and
      Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will
      be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time
      on study treatment is 3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, 18-70years of age;

          -  histologically-proven invasive breast cancer;

          -  no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of
             the cervix;

          -  no distant disease/secondary cancer.

        Exclusion Criteria:

          -  pregnant or lactating women;

          -  pre-operative local treatment for breast cancer;

          -  prior or concurrent systemic antitumor therapy;

          -  clinically significant cardiac disease.
Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Doxil; Carboplatin; Bevacizumab
Intervention description: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.; Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.; Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Intervention MeSH terms: Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: negative for a protein called HER2/neu; negative for estrogen receptors (ER) and progesterone receptors (PR).; breast cancer

Summary:

      The purpose of this research study is to look at the effectiveness of a combination of doxil,
      carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being
      studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and
      progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on
      both cancer and normal cells. This family of receptors is important for cell growth and is
      found in many tumor types.This study is being conducted for the following research purposes:·
      To find out what effects, if any, the study drug has on metastatic breast cancer. For
      instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the
      safety of the study drugs and to see what affects it has. For instance, are there any side
      effects? If so, what kind of side effects does the study drug cause? How severe are the side
      effects, and how often do they occur?· To see if the study drugs have any effect on keeping
      the disease from getting worse.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women with previously untreated metastatic breast cancer, ER/PR/HER2/neu negative.

          2. Age >= 18

          3. ECOG performance status <= 2

          4. Normal organ and marrow function

          5. Normal cardiac function as evidenced by LVEF within institutional normal limits

        Exclusion Criteria:

          1. History of hypersensitivity reactions to doxil or bevacizumab

          2. Myocardial infarct or unstable angina within 6 months before enrollment

          3. Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720
             mg/m2 for epirubicin.

          4. Proteinuria