bioihbjkbjnl/mcl2 huggingface dataset:
Drug Treatment for Pathologic Gambling Disorder
Condition: Gambling
MeSH terms: Gambling
Intervention: Naltrexone; Placebo
Intervention description: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.; For subjects who were randomly assigned to placebo.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Impulse Control Disorders

Summary:

      This study will establish the best dose of the drug naltrexone to treat patients with
      Pathological Gambling Disorder (PGD) and severe urge symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual IV criteria for Pathological Gambling Disorder

          -  Moderate or severe gambling urge assessed by the Gambling Symptom Assessment Scale

          -  No psychiatric drug use for 2 weeks or more

          -  Score >= 5 on The South Oaks Gambling Screen

          -  Hamilton Depression Rating Scale and Anxiety Rating score < 26. An increase (up to 10
             points) of the scores is allowed unless the subject shows the risks of suicide.

          -  Completion of complete blood count, urinalysis, liver and thyroid function tests, and
             pregnancy tests, with no evidence of significant lab abnormalities

          -  Reliable birth control in women of child-bearing potential
Levocarnitine in Treating Fatigue in Cancer Patients
Condition: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Fatigue
Intervention: levocarnitine; placebo
Intervention description: Given orally; Given orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fatigue; unspecified adult solid tumor, protocol specific; levocarnitine; depression; pain; carnitine deficiency

Summary:

      RATIONALE: Levocarnitine may help improve energy levels in cancer patients.

      PURPOSE: This randomized phase III trial is studying how well levocarnitine works compared to
      a placebo in treating fatigue in cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of an invasive malignant disorder

          -  Moderate to severe fatigue within the past 4 weeks, defined as a score of ≥ 2 (on a
             scale of 0-4) on the Functional Assessment of Chronic Illness Therapy-Fatigue
             (FACIT-F) question "I feel fatigued"

          -  Age 18 and over

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of 0-3

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

        Exclusion Criteria:

          -  Brain metastases

          -  Hemoglobin < 9 g/dL, taken <=4 weeks prior to registration

          -  Severe, uncontrolled liver disease

          -  Evidence of severely compromised renal function including any 1 of the following:

               -  Renal failure

               -  End stage renal disease

               -  Ongoing renal dialysis

          -  Severe, uncontrolled cardiovascular disease

          -  Severe, uncontrolled pulmonary disease

          -  Pregnant or nursing

          -  History of seizures

          -  Known sensitivity to carnitine

          -  Delirium

          -  Nausea > grade 1

          -  Taking any form of levocarnitine (L-carnitine) supplementation or nutritional
             supplements containing carnitine within 2 months prior to registration
Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Desvenlafaxine Succinate Sustained-Release 10mg; Desvenlafaxine Succinate Sustained-Release 50 mg; placebo
Intervention description: 10 mg tablet, once daily dosing for 8 weeks; 50 mg tablet, once daily dosing for 8 weeks; Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 682.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder

Summary:

      The primary purpose of this study is to compare the antidepressant efficacy and safety of two
      doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major
      Depressive Disorder. The study will also assess changes in sexual function and general and
      functional quality of life outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive
             symptoms for at least 30 days prior to screening).

          -  Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20.

          -  Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

        Exclusion Criteria:

          -  Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from
             screening to baseline).

          -  Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia
             Suicide-Severity Rating Scale scores Other eligibility criteria also apply.
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Mirikizumab; Placebo; Secukinumab
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1484.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interleukin-23 (IL-23)

Summary:

      The reason for this study is to see how effective and safe mirikizumab is compared to
      secukinumab and placebo for moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have chronic plaque psoriasis for at least 6 months.

        Exclusion Criteria:

          -  Participant must not be breastfeeding or nursing woman.

          -  Participant must not have had serious, opportunistic, or chronic/recurring infection
             within 3 months.

          -  Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within
             12 months or received live vaccine(s) (including attenuated live vaccines) within 12
             weeks of baseline or intend to receive either during the study.

          -  Participant must not have any other skin conditions (excluding psoriasis).

          -  Participant must not have previous exposure to Cosentyx and any other biologic therapy
             targeting IL-17 (including Taltz).

          -  Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8
             weeks.

          -  Participant must not have previous exposure to any biologic therapy targeting IL-23
             (including Stelara).
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; Ortho-Novum® 1/35
Intervention description: Tocilizumab 8 mg/kg was administered in a single 1-hour infusion on Day 1 of Cycle 2.; Each Ortho-Novum® 1/35 tablet contained 1 mg of norethindrone and 0.035 mg of ethinyl estradiol.
Intervention MeSH terms: Norinyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: Female
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on
      the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female
      patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child
      bearing age. The RA patients received OC in combination with TCZ, whereas the healthy
      volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8
      mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The
      healthy volunteers received OC for only one 21-day cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with child bearing potential, 18-44 years of age.

          -  Rheumatoid arthritis (RA) for over 6 months duration.

          -  On oral contraceptive without interruption for at least 3 months with normal cycle
             control.

          -  Treatment with disease-modifying anth-rheumatic drugs (DMARD) for at least 12 weeks
             prior to study start.

          -  Body weight < 150 kg.

        Exclusion Criteria:

          -  Functional class IV rheumatoid arthritis (American College of Rheumatology [ACR]
             classification).

          -  History of amenorrhea (unrelated to pregnancy).

          -  History or current inflammatory joint disease other than RA.

          -  Rheumatic autoimmune disease other than RA.
Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin 5 mg; Placebo 5 mg for Saxagliptin; Placebo 500 mg for metformin (with titration); Metformin 500 mg with titration
Intervention description: Tablet, Oral, 5 mg, Once daily in the morning; Tablet, Oral, 5 mg, Once daily in the morning; Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.; Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1136.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus, Dipeptidyl-Peptidase 4 Inhibitors, Saxagliptin, Metformin, Endocrine System Diseases

Summary:

      A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the
      Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy
      Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2
      Diabetes who have Inadequate Glycaemic Control
    

Eligibility criteria:

        Inclusion Criteria:

        1. Subjects with type 2 diabetes mellitus; 2. HbA1c ≥8% but ≤12%; 3.Fasting C-peptide ≥1.0
        ng/ml; 4. Subject will be drug naïve; 5. Body mass index ≤40 kg/m2.

        Exclusion Criteria:

        1. Symptoms of poorly controlled diabetes; 2. Chronic or repeated intermittent
        corticosteroid treatment ; 3. Calculated creatinine clearance <60 ml/min or serum
        creatinine >132.6 μmol/L (>1.5 mg/dL) for men, >123.8 μmol/L (>1.4 mg/dL) for women; 4.
        Creatine Kinase ≥3x ULN; 5.Abnormal TSH value at screening will be further evaluated by
        free T4, subjects with an abnormal free T4 will be excluded; 6. History of administration
        of any antihyperglycaemic therapy for a total of 28 days or for more than three consecutive
        days or a total of seven non-consecutive days during the eight weeks prior to screening; 7.
        Current treatment with a strong CYP3A4/5 inhibitor; 8. Prior treatment with saxagliptin or
        any DPP-4 inhibitor; 9. Significant or history of cardiovascular disease, renal disease,
        psychiatric disorders, Immunocompromised individuals, hemoglobinopathies, liver disease,
        Pancreatitis.
Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: T2380; Mydriatics; Tetracaine
Intervention description: 200 microlitres of T2380 will be administrated intracamerally; 3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery. The second and the third instillation of both phenylephrine and tropicamide will be realised respectively within 20 and 10 minutes before surgery.; Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Intervention MeSH terms: Tetracaine; Tropicamide; Mydriatics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 609.0
Sex: All
Minimum age: 40 Years
Maximum age: 88 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety assessment of T2380 for
      mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group
      (topical mydriatics and anaesthetic) 2X246 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Male or female aged from 40 to 88 years old

          -  Scheduled to undergo unilateral cataract surgery

        Exclusion criteria:

          -  Combined surgery

          -  Previous intraocular surgery
A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI); Tiotropium
Intervention description: fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI); • Tiotropium (18 mcg) administered QD via a HandiHaler
Intervention MeSH terms: Fluticasone; Xhance; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 260.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate the effect of fluticasone furoate (FF,
      GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness
      compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic
      pulse wave velocity (aPWV) > 12.0 m/s at Visit 1. Arterial stiffness will be measured as
      aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group,
      multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the
      randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment
      period. There will be an approximate 7-day Follow-up period after the treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type of subject: Outpatient

          -  Informed consent: Subjects must give their signed and dated written informed consent
             to participate.

          -  Gender: Male or female subjects.

          -  Age: greater then or equal to 40 years of age at Screening (Visit 1)

          -  COPD diagnosis: Subjects with a clinical history of COPD in accordance with the
             following definition by the American Thoracic Society (ATS) /European Respiratory
             Society(ERS).

          -  Subjects with a current or prior history ofgreater then or equal to 10 pack-years of
             cigarette smoking at Screening (Visit 1).

          -  Subjects with a measured post-albuterol/salbutamol FEV1 less then 70% of predicted at
             Screening (Visit 1).

          -  Subjects with a measured post-albuterol/salbutamol FEV1/FVC ratio of less then or
             equal to 0.70 at Screening (Visit 1).

          -  Exacerbation History: Subjects who have been hospitalised or have been treated with
             oral corticosteroids or antibiotics for their COPD within the last 3 years prior to
             Screening (V1).

          -  Baseline aPWV: subjects with a measured aPWV greater then 12.0 m/s at Screening (Visit
             1).

        Exclusion Criteria:

          -  Body Mass Index of less then or equal to 35
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
Condition: Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: secukinumab 150mg; secukinumab 10mg/kg i.v. regimen
Intervention description: secukinumab 150mg (2 injections per dose); secukinumab 10mg/kg i.v. regimen
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
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
Healthy volunteers: No
Keywords: Psoriasis; plaque; inflammatory skin disease; scaly patches; AIN457; secukinumab; Moderate to severe

Summary:

      The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous
      (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial
      responders to secukinumab.
    

Eligibility criteria:

        Inclusion criteria:

          -  Written Informed Consent must be obtained before any assessment is performed,

          -  Subject must be able to understand and communicate with the investigator and comply
             with the requirements of the study.

          -  Subjects must have participated in the study CAIN457A2304 and have achieved a partial
             response after twelve weeks of treatment with no major protocol deviations.

        A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

        Exclusion criteria

          -  Pregnant women or lactating women

          -  Forms of psoriasis other than chronic plaque -type

          -  Ongoing use of prohibited psoriasis treatments

          -  Ongoing use of other non-psoriasis prohibited treatments

          -  Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor,
             except secukinumab in study CAIN457A2304

          -  Active ongoing inflammation diseases other than psoriasis that might confound the
             evaluation of the benefits of secukinumab therapy

          -  UV therapy or excessive exposure to sunlight
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Intervention: Famciclovir
Intervention description: Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
Intervention MeSH terms: Famciclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: No
Keywords: herpes simplex; cold sores; fever blisters; children; Famvir; famciclovir

Summary:

      This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir
      in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir
      (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive
      multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess
      safety and tolerability. Part B will start only after PK data from Part A had been analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History or laboratory evidence of herpes simplex infection

          -  Clinical evidence or suspicion of herpes simplex infection

        Exclusion Criteria:

          -  Patients unable to swallow

          -  Concomitant use of probenecid

          -  Positive pregnancy test

        Additional protocol-defined inclusion/exclusion criteria may apply. For detailed
        information on eligibility, please contact the study center nearest to you or call the
        following numbers: 1-862-778-3544 or 1-434-951-3228
A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
Condition: Forehead Rhytides; Glabellar Rhytides
Intervention: OnabotulinumtoxinA; Normal Saline
Intervention description: OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.; Placebo (normal saline) injected into the protocol-specified areas on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and
      glabellar facial rhytides (frown lines).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe forehead and glabellar lines

          -  Willing to have facial photos taken

        Exclusion Criteria:

          -  Prior exposure to botulinum toxin of any serotype for any indication

          -  Anticipated need for treatment with botulinum toxin of any serotype for any indication
             during the study, other than study treatment

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral
             sclerosis

          -  Any facial resurfacing laser or light treatment, microdermabrasion, or superficial
             peels in the past 3 months

          -  Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or
             permanent facial make-up in the past 6 months

          -  Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past
             year

          -  Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or
             eyebrow surgery)

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg,
             Gore-Tex®), and/or fat transplantation