bioihbjkbjnl/mcl2 huggingface dataset:
Study of Ambrisentan in Participants With Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Ambrisentan
Intervention description: Tablet administered orally once daily
Intervention MeSH terms: Ambrisentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to monitor the long-term safety of ambrisentan in
      adult participants with pulmonary hypertension. The available ambrisentan doses for this
      study are 2.5, 5, or 10 mg administered orally once daily. Investigators will be able to
      adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose
      adjustments is required. Participants receiving other therapies for pulmonary hypertension
      that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in
      this study and continue to receive such therapies. Participants enrolled in this study will
      receive treatment with ambrisentan until such time as the investigator or participant chooses
      to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor
      stops the study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men and women with pulmonary hypertension who are discontinuing a clinical study of
             ambrisentan due to study closure by the sponsor. Eligible participants are those
             participating in countries where ambrisentan is not yet commercially available.
             Participants participating in countries where ambrisentan is commercially available
             may be eligible if they do not qualify for treatment per the current prescribing
             information of that country.

        Key Exclusion Criteria:

          -  Participants who have discontinued an ambrisentan clinical study for any other reason
             than sponsor-initiated study closure are not eligible.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Add on Lacosamide Versus High Dose Monotherapy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: lacosamide; levetiracetam
Intervention description: Lacosamide maximum of 200 mg/day, to be titrated as follows:
Week 1: 50 mg twice a day
Beginning Week 2: 100 mg twice a day.; Low dose ≤1500 mg/day, High dose >1500 mg/day
Intervention MeSH terms: Lacosamide; Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epilepsy; antiepileptic drug; polytherapy

Summary:

      This is a study to determine whether a combination of low dose lacosamide and levetiracetam
      is more effective than high dose levetiracetam in patients who have failed low dose
      levetiracetam.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults age 18 or older

          2. Determined to have had at least two partial seizures by an epilepsy specialist, or to
             have had a single partial seizure with clinical and/or laboratory evidence of a high
             seizure recurrence risk

          3. Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks

          4. Breakthrough seizure while on stable dose (>5 days) of levetiracetam monotherapy
             regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed
             medications)

        Exclusion Criteria:

          1. Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized
             epilepsy

          2. Pregnant, child-bearing age not using contraception, or breast feeding

          3. Medical contraindication to adding lacosamide

          4. History of antiepileptic drug (AED) polytherapy

          5. Presence of a vagus nerve stimulator

          6. Creatinine clearance of less than 50 mL/min

          7. Blood pressure instability: pulse <50 or >100, systolic blood pressure (SBP) <50 or
             >180, clinically significant electrocardiogram (EKG) abnormality

          8. History of significant drug rash or anaphylactic reaction with antiepileptic drug

          9. Patients with progressive lesions (e.g. brain tumors)
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
Condition: Impotence
MeSH terms: Erectile Dysfunction
Intervention: tadalafil; Placebo
Intervention description: 5 mg tadalafil tablet taken by mouth once a day for 12 weeks; placebo tablet taken by mouth once a day for 12 weeks
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 342.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves
      getting and maintaining an erection in men with erectile dysfunction and if there are
      improvements in the sexual quality of life of the man and his female study partner
    

Eligibility criteria:

        Inclusion Criteria:

        Male

          -  History of erectile dysfunction (ED) for at least 3 months duration

          -  Anticipate having the same female partner willing to participate throughout the study

          -  At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts
             during the early phase of the study

          -  Adequate partner sexual function as determined by a Female Sexual Function Index

          -  Willing to record responses to efficacy questionnaires, sexual quality of life
             questionnaires and other instruments used in the study

        Exclusion Criteria:

          -  May not participate in the study if you have taken tadalafil previously.

          -  History of cardiac conditions including angina requiring treatment with nitrates,
             heart disease of coronary conditions including myocardial infarction, bypass surgery,
             angioplasty or stent placement for specified time before starting the study.

          -  Have sexual partner not willing to complete the scales.

          -  Use of nitrates.
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
Condition: Behcet's Disease; Behcet Syndrome; Neuro-Behcet's Disease
MeSH terms: Behcet Syndrome
Intervention: TA-650
Intervention description: TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Behcet's disease; intestinal Behcet's disease; neuro-Behcet's disease; vascular Behcet's disease

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650
      in patients with Behcet's disease ( BD ) with special lesions after the administration of
      TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to
      week 46.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who were diagnosed with the complete or incomplete type of Behcet's disease
             according to "The criteria for a diagnosis of Behcet's disease, Ministry of Health,
             Labour and Welfare in Japan (partially revised in 2010)"

          -  Patients who have special lesions despite having received conventional treatments for
             special lesions, or patients who cannot receive conventional treatments due to
             intolerability.

          -  Patients who have clinical symptoms associated with each special lesions.

        Exclusion Criteria:

          -  Patients with intestinal, neuro-, vascular Behcet's disease in whom a differential
             diagnosis of each Behcet's disease from other conditions．

          -  Patients who have received treatment with infliximab within 1 year before enrollment
             for another purpose than treating special lesions; or patients whose previous
             treatment with infliximab was discontinued due to adverse events.

          -  Patients who had participated in another clinical study and had received a study drug
             within 12 weeks before giving acquirement.
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: Bosutinib; imatinib
Intervention description: 500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.; 400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 502.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bosutinib; imatinib; CML

Summary:

      Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of
      bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase
      Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one
      year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.

          -  Diagnosis of CML chronic phase confirmed.

          -  Adequate hepatic and renal function.

          -  Able to take oral tablets.

        Exclusion Criteria:

          -  Exclusions include Philadelphia negative CML.

          -  Prior anti-leukemia treatment.

          -  Prior stem cell transplant.
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
Condition: Carcinoma, Non-Small-Cell Lung; Adenocarcinoma
MeSH terms: Adenocarcinoma; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; BIBW 2992; Cisplatin
Intervention description: Pemetrexed IV given once every 3 weeks for up to 6 cycles; BIBW 2992 once daily until progression; Cisplatin IV given once every 3 weeks for up to 6 cycles
Intervention MeSH terms: Pemetrexed; Afatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomised, open label phase III trial will be performed in patients with adenocarcinoma
      of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation.
      The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A,
      with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of
      patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural
             effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients
             with mixed histology are eligible if adenocarcinoma is the predominant histology.

          -  Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of
             tumour biopsy material.

          -  Measurable disease according to RECIST 1.1.

          -  Eastern Cooperative Oncology Group score of 0 or 1.

          -  Age >/= 18 years.

          -  Life expectancy of at least three months.

          -  Written informed consent that is consistent with International Conference on
             Harmonisation-Good Clinical Practice guidelines.

        Exclusion criteria:

          -  Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant
             chemotherapy is permitted if at least 12 months has elapsed between the end of
             chemotherapy and randomisation.

          -  Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or
             antibodies.

          -  Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.

          -  Active brain metastases

          -  Any other current malignancy or malignancy diagnosed within the past five years

          -  Known pre-existing interstitial lung disease.

          -  Significant or recent acute gastrointestinal disorders with diarrhoea as a major
             symptom.

          -  History or presence of clinically relevant cardiovascular abnormalities.

          -  Any other concomitant serious illness or organ system dysfunction.

          -  Adequate absolute neutrophil count and platelet count

          -  Adequate liver and kidney function

          -  Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Carboxymethylcellulose Based Eye Drop; Carboxymethylcellulose Sodium 0.5%
Intervention description: Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.; Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of a new eye drop formulation in patients
      with dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Used artificial tears for dry eye

          -  Visual acuity of at least 20/32 (while wearing glasses, if necessary).

        Exclusion Criteria:

          -  Use of contact lenses in the last 3 months, or anticipated use of contact lenses
             during the study

          -  Herpes keratitis in the last 6 months

          -  Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive
             keratectomy, within the last 6 months
Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Flutemetamol (18F) Injection
Intervention description: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
Intervention MeSH terms: Flutemetamol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Mild Cognitive Impairment; Positron Emission Tomography; National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association; Assess Prognostic Usefulness of Flutemetamol Injection for Identifying Subjects who will Convert to Clinically Probable Alzheimer's Disease

Summary:

      This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in
      identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from
      aMCI to a b-amyloid associated clinically probable Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is 60 years old or older.

          -  The subject meets the Petersen criteria for amnestic MCI.

          -  The subject has a score of less than or equal to 4 on the Modified Hachinski Ischemic
             Scale.

          -  The subject has a MMSE score of 24-30.

          -  The subject has a non-contrast MRI examination as part of the screening visit that
             excludes aMCI arising from structural causes.

          -  The subject and/or the subject's legally acceptable representative, if applicable, in
             accordance with local regulations, has signed and dated an informed consent.

        Exclusion Criteria:

          -  The subject has any significant neurologic disease other than suspected aMCI; such as
             Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor,
             supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or
             history of significant head trauma followed by persistent neurologic deficits, or
             known structural brain abnormalities.

          -  The subject has one or more aneurysm clips, artificial heart valves, metal implants,
             embedded metal fragments or pacemakers that would pose a risk during an MRI.

          -  The subject has major depression, bipolar disorder, as described in the DSM-IV within
             the past year.

          -  The subject has history of schizophrenia (DSM-IV criteria).

          -  The subject has had, within the prior 3 months, psychotic features, agitation or
             behavioral problems that could lead to protocol compliance issues.
Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: rF.VIII
Intervention description: 40 IU/kg recombinant factor VIII will be given once-weekly or thrice-weekly by intravenous injection for 26 weeks. At 26 weeks after a 72 hour washout period, 40 IU/kg recombinant factor VIII will be given thrice-weekly or once-weekly, respectively, by intravenous injection until week 52, with up to two rescue doses per week for bleeds
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemophilia; Prophylaxis; Recombinant factor VIII

Summary:

      The purpose of this pilot R34 trial is to determine the feasibility of a large single dose
      Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly
      recombinant factor VIII. Efficacy will measured by bleeding frequency, factor usage, joint
      range of motion, cost, quality-of-life, F.VIII level, and inter-dose hypocoagulability by
      thrombin generation. Safety will be measured by inhibitor formation and bleeding events
      unresponsive to up to two rescue doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males 18 years or older

          -  Severe hemophilia A (F.VIII < 0.01 U/ml)

          -  At least 150 exposure days to F.VIII products

          -  No detectable inhibitor

          -  No history of allergic reaction

          -  Platelets at least 150,000/ul

          -  If HIV(+), CD4 at least 200/ul, HIV-VL <48 copies/ml,and cART compliant

          -  If HCV(+), no splenomegaly,varices,GI bleed,ascites,edema,encephalopathy

          -  Willingness to comply with cross-over design, randomization schema

          -  Willingness to keep a personal diary of bleeding frequency and factor use

          -  Willingness to make every 3 month visits, coagulation testing at wks 2, 28

        Exclusion Criteria:

          -  Acquired hemophilia

          -  Any bleeding disorder other than hemophilia A

          -  Presence of an inhibitor to factor VIII

          -  Historic platelet count < 100,000

          -  Use of experimental drugs

          -  Surgery anticipate in the next 52 weeks

          -  Symptomatic HCV(splenomegaly,varices,GI bleed,ascites,edema,encephalopathy)

          -  Symptomatic HIV(CD4<200/ul or HIV VL 48 or more copy/ml,cART noncompliant)

          -  Life expectancy less than 5 years

          -  Investigational drug or study within 4 weeks prior to study

          -  Inability to comply with study requirements