bioihbjkbjnl/mcl2 huggingface dataset:
Atomoxetine for Freezing of Gait in Parkinson's Disease
Condition: Parkinson's Disease; Freezing of Gait
MeSH terms: Parkinson Disease
Intervention: ATM FOG in PD
Intervention description: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Subjects are being asked to participate in this study to determine the safety and
      effectiveness of a drug called atomoxetine in the treatment of freezing of gait for
      Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market
      for the treatment of attention deficit. It works to increase the amount of norepinephrine (a
      chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been
      approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has
      been found to be well tolerated in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn
             and Yahr stage 2-4

          2. A positive response to item 14 of the UPDRS, part 2.

          3. Age range 18-80

          4. Ability to walk a minimum of 20 feet without assistive device and with one observed
             freezing episode which may be triggered by visual cue

          5. Letter of medical clearance by primary care physician dated within preceding 2 months
             of subject's initial active study visit.

          6. Stable on PD medications for ≥ 3 months

             -

        Exclusion Criteria:

          1. Intolerance to drug class

          2. Mini-Mental Status Examination <26/30

          3. No observable episodes of freezing of gait despite common visual cues

          4. Not on stable PD medications for 3 months

          5. Subjects who whose gait disturbance is due to other conditions not related to PD or
             FOG.

          6. Current use of monoamine oxidase inhibitor (MAO-I)

          7. Hypersensitivity to drug class

          8. Narrow angle glaucoma

          9. Pheochromocytoma

         10. Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would
             be expected to deteriorate if their heart rate or blood pressure were to increase in a
             clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats
             per minute in heart rate).

         11. Patients with uncontrolled hypertension.

         12. Patients with a history of symptomatic tachyarrhythmias.

         13. Presence of uncontrolled depression and suicidal ideation.

             -
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: NBI-98854
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered
      once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately
      150 medically stable male and female subjects with clinical diagnoses of schizophrenia or
      schizoaffective disorder with neuroleptic-induced TD or mood disorder with
      neuroleptic-induced TD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently during the screening,
             treatment and follow-up periods of the study.

          2. Female subjects must not be pregnant.

          3. Have one of the following clinical diagnoses for at least 3 months prior to screening:
             Schizophrenia or Schizoaffective Disorder, or Mood Disorder

          4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to
             screening.

          5. Have moderate or severe TD

          6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or
             mood disorder, be on stable doses.

          7. Be in general good health.

          8. Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

          9. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine,
             phencyclidine, cocaine, opiates, or cannabinoids.

        Exclusion Criteria

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening.

          2. Have a known history of substance dependence, substance (drug) or alcohol abuse.

          3. Have a significant risk of suicidal or violent behavior.

          4. Have a known history of neuroleptic malignant syndrome.

          5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.

          6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

          7. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study.

          8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

          9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

         10. Are currently pregnant or breastfeeding.
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Bromfenac Ophthalmic Solution A; Bromfenac Ophthalmic Solution B; Placebo Comparator
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Bromfenac; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 840.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sign and symptoms of dry eye disease

Summary:

      A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry
      eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be of either gender and any race 18 years or older

        Exclusion Criteria:

          -  Have a local or systemic disease that could interfere with the assessment of safety or
             efficacy or that is likely to result in early discontinuation from the study
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
Condition: Ocular Inflammation and Pain
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: APP13007, 0.05%; Matching Vehicle Placebo for APP13007, 0.05%
Intervention description: APP13007 eye drop, 0.05%; Matching vehicle placebo eye drop
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 378.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a
      randomized, parallel-group, double-masked fashion. The subjects will have undergone routine
      cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day
      1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age or older expected to undergo unilateral uncomplicated
             cataract extraction via phacoemulsification and posterior chamber intraocular lens
             implantation in one eye.

          -  Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of
             the minimum angle of resolution (logMAR) in the study eye to be operated and
             contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study
             (ETDRS) chart at Visit 1.

          -  Willing and able to comply with study requirements and visit schedule.

          -  Provide signed and dated informed consent.

        Exclusion Criteria:

          -  Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any
             of the study medication's components including benzalkonium chloride and soybean
             lecithin or any routine medication required during cataract surgery or for the conduct
             of study procedures

          -  Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in
             either eye at the Screening visit

          -  Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit

        Note: Other inclusion/exclusion criteria apply.
Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
Condition: Dry Eye Disease (DED)
MeSH terms: Dry Eye Syndromes; Eye Diseases
Intervention: NOV03
Intervention description: 100% Perfluorohexyloctane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this trial are to evaluate the safety and tolerability of
      perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry
      Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction).

      Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during
      long-term use in subjects with DED associated with MGD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed ICF (Informed Consent Form)

          -  Subject-reported history of Drye Eye Disease (DED) in both eyes

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Women who are pregnant, nursing or planning pregnancy

          -  Unwillingness to submit a blood pregnancy test at screening and the last visit (or
             early termination visit) if of childbearing potential, or unwillingness to use
             acceptable means of birth control

          -  Clinically significant slit-lamp findings or abnormal lid anatomy at screening

          -  Ocular/peri-ocular malignancy

          -  History of herpetic keratitis

          -  Active ocular allergies or ocular allergies that are expected to be active during the
             study

          -  Ongoing ocular or systemic infection

          -  Wear contact lenses within 1 month prior to screening or anticipated use of contact
             lenses during the study

          -  Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have
             planned ocular and/or lid surgeries over the study period

          -  Presence of uncontrolled systemic diseases

          -  Presence of known allergy and/or sensitivity to the study drug or saline components

          -  Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears
             or topical anti-glaucoma medication within 2 months prior to screening
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Intervention: Mepolizumab
Intervention description: 100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 347.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extension study; Severe refractory asthma; safety; SB-240563; mepolizumab; eosinophils

Summary:

      This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab
      administered subcutaneously (SC) in addition to standard of care in subjects who participated
      in the MEA112997 study. At each clinic visit, adverse events will be assessed and
      exacerbations will also be reviewed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent.

          -  MEA112997 Study Participation: Received at least 2 doses of double-blind
             investigational product during the MEA112997 trial.

          -  MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have
             had a positive risk: benefit ratio.

          -  Currently being treated with a controller medication and the subject has been on a
             controller medication for the past 12 weeks.

          -  Male or Eligible Female Subjects. To be eligible for entry into the study, females of
             childbearing potential must commit to consistent and correct use of an acceptable
             method of birth control for the duration of the trial and for 4 months after the last
             study drug administration.

        Exclusion Criteria:

          -  Hypersensitivity related to mepolizumab.

          -  Clinically significant change in health status since completing participation in the
             MEA112997 trial.

          -  A current malignancy or previous history of cancer in remission for less than 12
             months prior to screening.

          -  For those subjects who had a SAE in MEA112997 that was assessed as possibly related to
             mepolizumab by the investigator.

          -  Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they
             plan to become pregnant during the time of study participation.

          -  Screening ECG which has a clinically significant abnormality.

          -  Received Xolair (omalizumab) within the past 130 days.

          -  Participated in a clinical trial within the past 30 days or have received
             investigational medication within five terminal half-lives of Screen Visit, whichever
             is longer.

          -  Current smokers.
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: FMX103 1.5%
Intervention description: FMX103 1.5% minocycline foam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 504.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up
      to an additional 40 weeks, is safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.

          2. Have not had a worsening of disease, determined by the Investigator's Global
             Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline
             assessment in Study FX2016-11 or Study FX2016-12.

        Exclusion Criteria:

          1. Have a new systemic disease or condition, including an ongoing AE that might interfere
             with the conduct of the study or the interpretation of results.

          2. Have developed a condition that would have been exclusionary for Study FX2016-11 or
             Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis,
             hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.
A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Hepatoma; Liver Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: DEB-TACE; Sorafenib
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, multicenter study that will be conducted at up to 40 centers in the
      United States and Outside United States (OUS). Participants in the study will be randomly
      assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the
      study participants' outcomes (medical condition) after being treated with ONCO-DOX and
      compare it to those treated with sorafenib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed Consent

          2. ≥18 years of age

          3. Diagnosis of HCC

          4. Locally advanced HCC

          5. Preserved liver function

          6. Eastern Cooperative Oncology Group 0 or 1

        Exclusion Criteria:

          1. Presence of extra-hepatic spread of disease.

          2. Macrovascular invasion of lobar portal vein branches or main portal vein.

          3. Candidate for surgical resection, transplantation, or local ablation.

          4. Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC.

          5. Any contraindication for TACE.

          6. Platelet count <50,000/mm3 or international normalized ratio >1.5.

          7. Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib.

          8. Unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).

          9. Known ejection fraction < 50%.

         10. Current infections requiring antibiotic therapy.

         11. Suffering from a known bleeding disorder.

         12. Renal insufficiency (serum creatinine > 2 mg/dL).

         13. Aspartate aminotransferase and/or alanine transaminase >5 times upper limit of normal.

         14. Presence of advanced liver disease.

         15. Any contraindication for doxorubicin administration:

         16. Any co-morbid condition or social situation, which has a high likelihood of causing
             poor compliance with the study protocol or jeopardizes the patient's safety.

         17. Patient has another primary tumor, with the exception of conventional basal cell
             carcinoma, superficial bladder cancer, melanoma in situ, or treated prostate cancer
             currently without biochemical or radiographic evidence of active disease

         18. Participation in a clinical trial of an investigational device or drug within 4 weeks
             of study entry.

         19. Pregnant or breast-feeding patients.
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Condition: Bipolar I Disorder; Mania; Depression
MeSH terms: Recurrence; Depression
Intervention: Cariprazine; Placebo
Intervention description: Cariprazine capsules, oral administration, once daily; Matching placebo capsules, oral administration, once daily
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 901.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared
      with placebo in prevention of relapse in patients with bipolar I disorder whose current
      episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To
      evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with
      placebo in prevention of relapse in patients with bipolar I disorder whose current episode
      (i.e. index episode) is manic or depressive, with or without mixed features who were
      initially stabilized on a target dose of 3.0 mg/day
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth
             Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two
             criteria:

          -  Current episode manic, with or without mixed features, having a total Young Mania
             Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items
             (irritability, speech, content, or disruptive/aggressive behavior);

          -  OR current episode depressive, with or without mixed features, having a
             Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at
             least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or
             inability to feel).

        Exclusion Criteria:

          -  Four or more episodes of a mood disturbance within the 12 months before Visit 1;

          -  Diagnosis of another psychiatric disorder other than bipolar disorder with the
             exception of specific phobias.