bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS
Condition: Anxiety Disorders; HIV Infections
MeSH terms: Anxiety Disorders
Intervention: Escitalopram
Intervention description: 10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.
Intervention MeSH terms: Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Escitalopram; Anxiety Disorder; HIV and AIDS; treatment experienced

Summary:

      The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and
      effective in the treatment of HIV-infected patients with generalized anxiety disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 to 65 years,

          -  DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for
             Generalized Anxiety Disorder

          -  confirmed stable HIV disease and attending a HIV treatment program

          -  stable dose of highly active anti-retroviral therapy for a minimum of 4 weeks

          -  ability to give informed consent

        Exclusion Criteria:

          -  bipolar disorders, any psychotic disorder

          -  current major depression

          -  substance dependence (except nicotine dependence) in the previous 3 months

          -  currently suicidal or high suicide risk, serious or unstable medical disorders (e.g.
             uncontrolled hypertension or diabetes)

          -  any hospitalization for HIV-related illness in the previous 3 months

          -  any active CNS (central nervous system) CNS opportunistic infection or CNS
             malignancies related to HIV

          -  current active treatment for opportunistic infections related to HIV

          -  any psychotropic drug treatment in the previous 2 weeks before screening

          -  history of hypersensitivity to escitalopram and/or citalopram

          -  admission BDI 23

          -  seizure disorder, traumatic brain injury

          -  pregnant, nursing mother or planning to get pregnant.

          -  Concomitant mediations: At least 2-week washout of antidepressant (4 weeks for
             fluoxetine) or antipsychotic or anti-anxiety medications.

          -  In the opinion of the investigator the clinical condition precludes participation in
             the trial.
An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Ubrogepant; Placebo-matching Ubrogepant; Usual Care
Intervention description: Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.; Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1254.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of intermittent treatment with
      ubrogepant for the acute treatment of migraine over 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

        -Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

        Exclusion Criteria:

          -  Patients with clinically significant electrocardiogram (ECG), vital sign, physical
             exam, or laboratory abnormalities

          -  Requirement for a medication during the study that is on the list of prohibited
             medications.
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461; Placebo
Intervention description: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 447.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Alkermes; ALKS 5461; Samidorphan

Summary:

      This study will evaluate the efficacy and safety of ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive

          -  Agree to use an acceptable method of contraception for the duration of the study

          -  Have a Major Depressive Disorder (MDD) primary diagnosis

          -  Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the
             current Major Depressive Episode (MDE)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Have a current primary Axis-I disorder other than MDD

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 2 years or received
             more than one course of electroconvulsive treatment during lifetime

          -  Have attempted suicide within the past 2 years

          -  Have a positive test for drugs of abuse

          -  Are pregnant, planning to become pregnant, or breastfeeding

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation within 60 days

          -  Additional criteria may apply
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: rIX-FP
Intervention description: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control
      and prevention of bleeding episodes in children who have previously received factor
      replacement therapy for hemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects, younger than 12 years old.

          -  Severe hemophilia B (Factor IX [FIX] activity of ≤ 2%).

          -  Body weight ≥ 10 kg.

          -  Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >
             150 exposure days (EDs) (6 to < 12 years), and > 50 EDs (< 6 years).

          -  No history of FIX inhibitor formation, no detectable inhibitors at Screening and no
             family history of inhibitors against FIX.

          -  Written informed consent for study participation.

        Exclusion Criteria:

          -  Known hypersensitivity to any FIX product or hamster protein.

          -  Known congenital or acquired coagulation disorder other than congenital FIX
             deficiency.

          -  Kidney or liver disease.

          -  Recent life-threatening bleeding episode.
Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Ranibizumab
Intervention description: Intravitreal injections of 0.5 mg Ranibizumab
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 671.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate and compare two individualized ranibizumab treatment regimens in
      patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual
      function benefit, while aiming to avoid unnecessary intravitreal injections.

      The results will be used to generate further recommendations on functional and anatomical
      monitoring of the disease and timing of treatment administration for patients with
      neovascular AMD. In this context, the study will investigate the utility of optical coherence
      tomography (OCT) to aid retreatment decisions with ranibizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Visual impairment predominantly due to neovascular age-related macular degeneration
             AMD

          -  Active, newly diagnosed, untreated CNV due to AMD

          -  CNV involving the center of the retina

          -  A qualifying vision score at study entry

        Exclusion Criteria:

          -  Stroke or myocardial infarction less than 3 Months prior to study entry

          -  Active injection or inflammation of either eye at the time of study entry
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab; Doxorubicin; Paclitaxel; CMF
Intervention description: 8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17; 60 mg/m2 IV on Day 1 of Cycles 1 through 3; 150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7; CMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) on Day 1 of Cycles 8 through 10
Intervention MeSH terms: Paclitaxel; Doxorubicin; Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing
      regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women
      with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel
      observational study patients with HER2-negative disease will receive the same chemotherapy
      without Herceptin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >=18 years of age, with locally advanced breast cancer.

        Exclusion Criteria:

          -  previous therapy for any invasive malignancy.
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: N1539; Placebo
Intervention description: Once Daily; Once Daily
Intervention MeSH terms: Meloxicam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Total Knee Arthroplasty; Pain; Analgesia; N1539; Phase 3b; Knee Replacement

Summary:

      The primary objective of this study is to assess the effect of preoperative administration of
      N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty
      compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily provide written informed consent.

          -  Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral
             total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an
             inpatient setting for ≥24 hours, and receive at least two doses of study drug.

          -  ASA physical status category 1, 2, or 3.

          -  Female subjects not pregnant or planning/attempting to become pregnant, not lactating;
             or commits to the use of an acceptable form of birth control for the duration of the
             study.

          -  Have a body mass index <40 kg/m^2

        Exclusion Criteria:

          -  Have a known allergy or hypersensitivity to any study treatment.

          -  Have a history of previous TKA.

          -  Has plans for a concurrent surgical procedure (eg, bilateral TKA).

          -  Has TKA planned to be performed under general anesthesia.

          -  Have a history of myocardial infarction within the preceding 12 months.

          -  Have, as determined by the investigator or the sponsor's medical monitor, a history or
             clinical manifestations of significant condition that would preclude participation.

          -  Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.

          -  Have a known bleeding disorder which may be worsened with the administration of an
             NSAID.

          -  Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within
             48 hours prior to surgery.

          -  Have previously received N1539/IV meloxicam or received any investigational product
             within 30 days before dosing with study medication.

          -  Have undergone or be expected to undergo radiation therapy, chemotherapy, or other
             biological therapy for cancer treatment, within 60 days prior to screening through
             last follow-up.
A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
Condition: Epilepsy; Generalized Tonic-Clonic Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam; Placebo
Intervention description: Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks; Matching oral placebo tablets twice daily for 28 weeks
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 361.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Levetiracetam; epilepsy; generalized tonic-clonic

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of
      levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients
      aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with
      1 or 2 anti-epileptic drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An epilepsy patient with generalized tonic-clonic seizures that are classifiable
             according to the ILAE classification of epileptic seizures (Epilepsia, 1981)

          -  A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks
             (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the
             combined baseline period

        Exclusion Criteria:

          -  Presence of any sign (clinical or imaging procedures) suggesting a progressive brain
             lesion/disease, in particular, progressive disorder with epileptic seizures

          -  Diagnosis of Lennox-Gastaut Syndrome

          -  Confirmed focal epilepsy based on clinical signs (seizure types), with consistent
             electroencephalogram and magnetic resonance imagining features

          -  A history of convulsive or non-convulsive status epilepticus while taking concomitant
             anti-epileptic drugs for the last 3 months prior to Visit 1
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Intervention: Lyophilized formulation of HRV vaccine; Liquid formulation of HRV vaccine
Intervention description: Lyophilized formulation of HRV vaccine; Liquid formulation of HRV vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1274.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis against gastroenteritis caused by Rotavirus

Summary:

      This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the
      liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of
      GSK Biologicals' HRV vaccine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female infant between, and including, 6 and 12 weeks of age born after
             a gestation period of 36 to 42 weeks.

          -  Written informed consent obtained from the parent or guardian of the subject.

        Exclusion Criteria:

          -  se of any investigational or non-registered product (drug or vaccine) other than the
             HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use
             during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Planned administration/ administration of a vaccines not foreseen by the study
             protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of
             HRV vaccine and ending 14 days after.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Household contact with an immunosuppressed individual or pregnant women.

          -  Previous confirmed occurrence of RV GE.
Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Blonanserin; Risperidone
Intervention description: Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.; Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.
Intervention MeSH terms: Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 267.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Blonanserin

Summary:

      A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical
      trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text
             Revision(TR) criteria for a primary diagnosis of schizophrenia

          -  Patients are 18≤age<65 years of age on the day when informed consent is obtained.

          -  Subject had a PANSS total score ≥70 and 120≥ at Screening

          -  Subject had a score ≥4 on the PANSS at Screening and Baseline.

          -  Subjects are willing and able to comply with study protocol including treatment in
             hospital.

          -  Subjects or their legal guardians have signed the written informed consent form.

        Exclusion Criteria:

          -  The subject was treatment with other Investigate product within 30 days.

          -  Subject had a history of treatment with long-acting drug for anti schizophrenia within
             56 days.

          -  Subject had a history of treatment with clozapine within 28 days.

          -  Subject With parkinson disease,etc