bioihbjkbjnl/mcl2 huggingface dataset:
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Intervention: ZD4054 15 mg; Placebo; ZD4054 10 mg
Intervention description: 15 mg oral tablet once daily; 10mg oral tablet once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 447.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rising PSA; bone metastases; Clinical study; pain-free or mildly symptomatic

Summary:

      This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating
      prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo
      (sugar pill). The study will also provide further information on the safety of ZD4054
      (Zibotentan).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Surgically or medically castrated

          -  Bone metastasis

          -  Rising PSA

        Exclusion Criteria:

          -  Opiate use

          -  Prior chemotherapy
Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: eculizumab; Placebo
Intervention description: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses; Placebo IV weekly for 4 doses then every two weeks for 7 doses
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether eculizumab is safe and effective in the
      treatment of patients with generalized myasthenia gravis despite treatment with various
      immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and
      cyclophosphamide, that are currently available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generalized MG

          -  MGFA Clinical Classification Class II, III or IVa.

          -  QMG total score ≥12

          -  Minimum score of two (2) in four (4) or more test items in the QMG

          -  Able to give informed consent.

          -  Have failed at least two immunosuppressants after one year of treatment

          -  A positive serologic test for binding anti-acetylcholine receptor Abs at Screening and
             one of the following a) history of abnormal neuromuscular transmission test
             demonstrated by single-fiber electromyography or repetitive nerve stimulation, or b)
             history of positive anticholinesterase test, eg, edrophonium chloride test, or c)
             patient has demonstrated improvement in MG signs on acetylcholinesterase inhibitors as
             assessed by treating physician.

        Exclusion Criteria:

          -  History of thymoma or other neoplasms of the thymus.

          -  History of thymectomy within 12 months prior to screening.

          -  Pregnancy or lactation

          -  Current or chronic use of plasmapheresis/plasma exchange

          -  IVIG treatment within 8 weeks prior to screening.

          -  Use of etanercept within 2 months prior to screening.

          -  Use of rituximab (RITUXAN®) within 6 months prior to screening.

          -  MGFA Class I, IVb, and V

          -  Crisis or impending crisis
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
Condition: Vulvodynia
MeSH terms: Vulvodynia
Intervention: Lidocaine/Diphenhydramine; lidocaine; placebo
Intervention description: semi solid, twice weekly, 4 months; semi solid, twice weekly for 4 months; semi solid, twice weekly for 4 months
Intervention MeSH terms: Diphenhydramine; Promethazine; Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of two vaginal products compared with that
      of placebo to determine if the two products are better than placebo in the relief of vaginal
      discomfort.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have sought doctor's care for this condition.

          -  Patients must be having menstrual cycles.

        Exclusion Criteria:

          -  Patients must not have any vaginal infections.

          -  Patients must not be pregnant or nursing.

          -  Must not be receiving any other medicinal therapies or any medications that would
             interfere with the outcome of the study.
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
Condition: Esophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Matuzumab; Epirubicin; Cisplatin; Capecitabine
Intervention description: Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.; Participants will receive epirubicin 50 milligrams per square meter (mg/m^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles.; Participants will receive cisplatin 60 mg/m^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.; Participants will receive capecitabine 1250 mg/m^2 daily in a 21-day cycles up to a maximum of 8 cycles.
Intervention MeSH terms: Capecitabine; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esophagus; Gastric; Adenocarcinoma; EGFR; matuzumab; EMD 72000; randomized; Epirubicin; cisplatin; capecitabine; Metastatic Esophago-Gastric cancer

Summary:

      The purpose of this study is to compare the effectiveness and safety of experimental
      treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take
      part have metastatic cancer of the esophagus (gullet) or stomach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third
             of the esophagus

          -  Metastatic disease

          -  Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from
             archived tissues

          -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1

          -  At least 1 measurable lesion (modified World Health Organization criteria)

        Exclusion Criteria:

          -  Previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed greater than
             (>) 12 months prior to study treatment

          -  Radiotherapy or major surgery within 4 weeks prior to treatment

          -  Brain metastases

          -  Peripheral neuropathy or ototoxicity greater than or equal to (>/=) Grade 2 (National
             Cancer Institute Common Terminology Criteria for Adverse Events Version 3 [NCICTC V3])

          -  Abnormal electrocardiogram (ECG)
A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
Condition: Lower Urinary Tract Symptoms; Bladder Outlet Obstruction
MeSH terms: Urinary Bladder Neck Obstruction; Lower Urinary Tract Symptoms
Intervention: Mirabegron; Placebo
Intervention description: oral; oral
Intervention MeSH terms: Mirabegron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Beta-3 Receptor Agonist; YM178; Men; Lower Urinary Tract Symptoms; Bladder Outlet Obstruction

Summary:

      This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 45 years of age or older

          -  Documented bladder outlet obstruction

        Exclusion Criteria:

          -  History of urinary retention

          -  Symptomatic and recurrent urinary tract infection (UTI)
Explorative Study of AZD1305 in Atrial Fibrillation Patients
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AZD1305; AZD1305; Placebo
Intervention description: AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2; AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2; Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at
      initiation of treatment and at steady state
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28
             days.

          -  Sinus rhythm at randomisation

        Exclusion Criteria:

          -  Haemodynamically unstable condition as judged by the Investigator, systolic BP <100
             mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation

          -  Personal or family history of Torsades de Pointes (TdP), any other polymorphic
             ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome
             and/or Brugada syndrome

          -  Sinus bradycardia (<50 beats per minute (bpm)) at randomisation

          -  QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,

          -  Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above
             5.0 mmol/L

          -  QRS duration >120 ms at randomisation

          -  Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging
             drug and/or drug that inhibits CYP3A4, as well as St John's Worth
Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Galantamine; CDP-choline; Placebo; risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole
Intervention description: Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.; CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.; The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.; All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Ziprasidone; Choline; Galantamine; Cytidine Diphosphate Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Schizoaffective Disorder; Acetylcholine; Nicotinic Receptors; Nicotine; Galantamine; negative symptoms

Summary:

      This study will evaluate the effectiveness of galantamine and CDP-choline in improving
      symptoms associated with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for schizophrenia or schizoaffective disorder

          -  Eligible for care within the Veterans Affairs Medical system

          -  Taking risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole (oral or
             injection)

        Exclusion Criteria:

          -  Significant liver, kidney, lung, endocrine, active peptic ulcer, or cardiovascular
             disease

          -  Seizure disorder and/or head injury

          -  Substance use or abuse within 3 months of study entry

          -  Pregnant
Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms
Condition: Vasomotor Symptoms (VMS)
Intervention: MT-8554
Intervention description: MT-8554 Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label, long term extension study of MT-8554 in postmenopausal women experiencing
      moderate to severe vasomotor symptoms who completed Study MT-8554-A01
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent to participate in this study.

          -  Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.

        Exclusion Criteria:

          -  Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)
Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy
Condition: Breast Cancer
Intervention: Glutamine; Placebo
Intervention description: Oral glutamine for subjects undergoing breast conserving therapy; For subjects undergoing breast conserving therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast

Summary:

      This study is a single-centered, double-blind, two-arm randomized study to determine if oral
      glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving
      Therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject have been diagnosed with Stage I or II invasive breast cancer

          -  Subject will undergo Accelerated Partial Breast Irradiation (APBI) as part of Breast
             Conserving Therapy (BCT)

          -  Subject is eligible for APBI based on American Society of Therapeutic Radiation
             Oncology (ASTRO) criteria

          -  Subject is 18 years of age or older

          -  Subject is female

        Exclusion Criteria:

          -  History of uncontrolled, clinically significant lung, heart, endocrine, liver, or
             renal disease

          -  Subject has been diagnosed with any other cancer

          -  Subject has a known hypersensitivity reaction to the following: oral glutamine (GLN),
             glutamate, monosodium glutamate (MSG) (i.e., Chinese restaurant syndrome)

          -  Subject has history of collagen vascular disease

          -  Subject has been diagnosed with Diabetes mellitus I or II

          -  Subject has had any prior breast radiation

          -  Subject is pregnant or breastfeeding
Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
Condition: Chronic Myeloid Leukemia; Blast Crisis
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis
Intervention: Dasatinib
Intervention description: Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myeloid blast phase Chronic Myeloid Leukemia (CML)

Summary:

      The purpose of this study is to see what effect an investigational drug (BMS-354825) has on
      subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and
      who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study
      is to see what side effects this drug may have on subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with myeloid blast phase chronic myeloid leukemia

          -  Subjects who are either resistant or intolerant of imatinib mesylate

        Exclusion Criteria:

          -  Subjects who are eligible and willing to undergo transplantation

          -  Serious uncontrolled medical disorder or active infection

          -  Uncontrolled or significant heart problems, such as congestive heart failure, recent
             heart attack, etc

          -  Subjects receiving medications that may affect heart rhythm

          -  Other malignancy/cancer other than CML

          -  History of significant bleeding disorder unrelated to CML

          -  Pregnant or breastfeeding women (subjects must avoid becoming pregnant)

          -  Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a
             targeted anticancer medication within 14 days, an antineoplastic agent (other than
             hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28
             days

          -  Subject is receiving medications that affect platelet function or an anticoagulant
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
Condition: Herpes Simplex
MeSH terms: Infections; Herpes Simplex
Intervention: famciclovir
Intervention description: Administered orally as a single individualized dose between 25-200 mg based on body weight.
Intervention MeSH terms: Famciclovir
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: All
Minimum age: 1 Month
Maximum age: 1 Year
Healthy volunteers: No
Keywords: Infants, Herpes simplex infection

Summary:

      This study will evaluate the acceptability and safety of famciclovir in infants with herpes
      simplex infection
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients from 1 month up to 1 year of age with herpes simplex
             infection

        Exclusion Criteria:

          -  Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients
             with history of malabsorption or previous gastrointestinal surgery.

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis
Condition: Lymphangioleiomyomatosis
MeSH terms: Lymphangioleiomyomatosis
Intervention: Everolimus
Intervention description: Everolimus was formulated as tablets in strengths of 2.5mg, 5mg and 10mg.
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphangioleiomyomatosis,; High Resolution CT scan,; chest x-ray,; 6 minute walk test,; pulse oximetry,; renal MRI,; Pikometer

Summary:

      This was an exploratory study to determine whether escalating doses of RAD001 (everolimus)
      were safe and effective in patients with Lymphangioleiomyomatosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female aged >/= 18 years with a diagnosis of LAM

          -  Pulmonary function abnormalities as follows:

          -  FEV1 of ≤ 80% of the predicted value following administration of a standard dose of a
             short acting β2-agonist (*200 µg Salbutamol, measured between 10 and 15 minutes of
             inhalation) OR

          -  FEV1 < 90% of the predicted value of bronchodilator following administration of a
             standard dose of a short acting β2-agonist (*200 µg Salbutamol, measured between 10
             and 15 minutes of inhalation) and DLco (uncorrected) <80% predicted.

          -  Female patients including those of childbearing potential will be included in this
             study.

          -  Negative pregnancy test at screening and baseline

        Exclusion Criteria:

          -  FEV1<50% of predicted post-bronchodilator.

          -  Change in FVC (ml) > ± 15% of screening value at baseline visit (not less than 14d
             after screening visit).

          -  Use of any medicine containing estrogen in the 4 months prior to the screening visit
             and for the duration of the study

          -  Significant hematologic, renal, hepatic laboratory abnormality or amylase > 1.5x the
             upper limit of the normal range at the screening or baseline visits

          -  Fasting blood glucose > 126mg/dl or random blood glucose >200mg/dl at screening and/or
             baseline

          -  Recent surgery (involving entry into a body cavity or requiring sutures) within 2
             months of the screening visit or any evidence of unhealed surgical wound.

          -  Uncontrolled hyperlipidemia (defined as persistent elevation of total cholesterol or
             triglycerides >6.5nM/L) or a history of clinical atherosclerotic disease including
             heart attack, angina, peripheral vascular disease or stroke.

          -  Previous organ transplantation

          -  Inability to give informed consent

          -  Inability to perform pulmonary function or 6 minute walk tests and imaging assessments

        Other protocol-defined inclusion/exclusion criteria may apply