bioihbjkbjnl/mcl2 huggingface dataset:
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Intervention: JZP-110
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter
      study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult
      subjects with OSA.
    

Eligibility criteria:

        Major Inclusion Criteria:

          1. Male or female between 18 and 75 years of age, inclusive

          2. Diagnosis of OSA according to ICSD-3 criteria

          3. Body mass index from 18 to <45 kg/m2

          4. Consent to use a medically acceptable method of contraception

          5. Willing and able to provide written informed consent

        Major Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating.

          2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             OSA that is associated with excessive sleepiness

          3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          4. History or presence of any acutely unstable medical condition, behavioral or
             psychiatric disorder (including active suicidal ideation), or surgical history that
             could affect the safety of the subject or interfere with study efficacy or safety
             assessments or the ability of the subject to complete the trial per the judgment of
             the principal investigator

          5. History of bariatric surgery within the past year or a history of any gastric bypass
             procedure

          6. Presence or history of significant cardiovascular disease

          7. Use of any over the counter (OTC) or prescription medications that could affect the
             evaluation of excessive sleepiness

          8. Received an investigational drug in the past 30 days or five half-lives (whichever is
             longer)

          9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05,
             R228060, or YKP10A)

         10. History of phenylketonuria (PKU) or history of hypersensitivity to
             phenylalanine-derived products
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Condition: Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Lampalizumab; Sham
Intervention description: Participants will receive 10 mg dose of lampalizumab administered intravitreally.; A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 906.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled
      study evaluating the efficacy and safety of lampalizumab administered by intravitreal
      injections in participants with geographic atrophy (GA) secondary to age-related macular
      degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular
             Degeneration (AMD) with no evidence of prior or active choroidal neovascularization
             (CNV) in both eyes

        Exclusion Criteria:

        Ocular Exclusion Criteria: Study Eye

          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for
             AMD

          -  Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
             occlusion, and proliferative diabetic retinopathy

          -  Previous intravitreal drug delivery (intravitreal corticosteroid injection,
             anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular
             Exclusion Criteria: Both Eyes

          -  GA in either eye due to causes other than AMD

          -  Previous treatment with eculizumab, lampalizumab and/or fenretinide
Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Tofacitinib; Placebo; Tofacitinib
Intervention description: tablets, 5 mg BID x 6 months; tablets, to match tofacitinib 5 mg BID x 3 months; tablets, 5 mg BID x 3 months
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriatic arthritis; tofacitinib; China

Summary:

      This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating
      signs and symptoms and improving physical function in Chinese patients with active psoriatic
      arthritis and had inadequate response to a conventional synthetic disease modifying
      anti-rheumatic drug. This is a China alone study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese patients

          -  Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3
             swollen joints

          -  Active plaque psoriasis at screening

          -  Inadequate response to at least one conventional synthetic DMARD

        Exclusion Criteria:

          -  Non-plaque forms of psoriasis (with exception of nail psoriasis)

          -  History of autoimmune rheumatic disease other than PsA; also prior history of or
             current, rheumatic inflammatory disease other than PsA
Dry Eye Assessment and Management Study
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Omega-3 supplements; Placebo
Intervention description: 2000 mg EPA and 1000 mg DHA per day; Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 535.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the DREAM study is to evaluate the effectiveness and safety of
      supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry
      eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than or equal to 2 of the following 4 signs in the same eye at screening and
             baseline visits (Same signs must be present at Screening and Baseline visits):
             Conjunctival staining present greater than or equal to 1 (out of possible score of 6
             per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a
             possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7
             seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5
             minutes.

          -  Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.

          -  Symptoms of DED for greater than or equal to 6 months.

          -  Use of or desire to use artificial tears at least 2 times per day in preceding 2
             weeks.

          -  Ability to swallow large, soft gelcaps

        Exclusion Criteria:

          -  Allergic to ingredients in supplements or placebo

          -  Contact lens wear

          -  Pregnant, nursing, or lactating

          -  Current ocular infection, inflammation, or acute allergic conjunctivitis

          -  History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery,
             use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation,
             hemophilia or bleeding tendencies

          -  Currently on anticoagulation therapy

          -  Eyelid abnormalities or extensive ocular scarring

          -  Use of EPA/DHA supplements in excess of 1200 mg per dayi

          -  Current use, insufficient washout period, or intent to change specific treatments for
             dry eye disease
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-122 Lotion; IDP-122 Vehicle Lotion
Intervention description: Topical lotion; Topical lotion. No active ingredient.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety and efficacy of a topical lotion when applied once daily
      to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's
      Global Assessment [IGA] score of 3 or 4).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a body
             surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms,
             soles, axillae, and intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or
             4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded
             from this calculation, if psoriasis is present).

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the Investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             Investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the Investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently
             participating in another clinical study with an investigational drug or device.
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: OPC-41061
Intervention description: Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Healthy volunteers: No
Keywords: ADPKD; Tolvaptan; OPC-41061

Summary:

      ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral
      administration of OPC-41061 at doses of 15 mg twice daily (morning and evening).
      Administration will be continued until the time of manufacturing and distribution approval of
      OPC-41061 for ADPKD in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed 3-year repeated administrations and the follow-up observation
             or those who were withdrawn from the study due to reasons other than occurrence of
             adverse events (based on the judgment of either the subject or the
             investigator/subinvestigator) in the preceding study (156-05-002)

          -  Patients in whom adverse events occurring in study 156-05-002 were resolved or became
             stable and do not require further follow-up.

        Exclusion Criteria:

          -  Patients with eGFR of less than 15 mL/min/1.73 m2

          -  Patients with any of the following complications:

               -  Uncontrolled hypertension

               -  Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg.
                  cirrhosis)

          -  Patients with any of the following complications or history thereof:

               -  Clinically significant drug allergies (anaphylaxis) or hypersensitivity
                  (especially, hypersensitivity to benzazepine derivatives or suspected
                  hypersensitivity

               -  Inability to personally give consent due to a mental illness
Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Condition: Recurrent or Metastatic Head and Neck Carcinoma
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck
Intervention: Vinflunine; Methotrexate
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vinflunin; Vinflunin + Methotrexate; Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary:

      For patients relapsing after platinum-based therapy, few data are available. The current use
      of cetuximab associated with radiotherapy in localized disease and associated with
      platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic
      options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine
      demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent
      preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based
      on a clinical review, show encouraging antitumour activity and an acceptable safety profile.
      Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen
      after platinum failure.

      The present study has been designed as a multicenter, randomised phase III study which will
      compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN
      patients having failed platinum-based therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed recurrent and/or metastatic squamous cell
             carcinoma

          -  Documented progressive disease after chemotherapy for locoregionally advanced or
             recurrent/metastatic SCCHN which included a platinum derivative

          -  Measurable or non measurable disease

          -  adequate haematological, hepatic and renal functions

          -  WHO performance status < 1

        Exclusion Criteria:

          -  Nasopharyngeal carcinoma

          -  History of brain or leptomeningeal involvement

          -  Albumin level < 35 g/L

          -  Patients with weight loss ≥ 5% within the last 3 months

          -  Grade > 2 peripheral neuropathy at study entry

          -  "Third space" fluids (pleural effusion, ascites, massive edema)

          -  Prior treatment with vinca-alkaloids and methotrexate
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: Rilpivirine
Intervention description: 25 mg once daily
Intervention MeSH terms: Rilpivirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1 Infection; HIV-1; HIV; TMC278-TiDP6-C222; TMC278-C222; TMC278; Rilpivirine

Summary:

      The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients
      who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are HIV-1 infected and were previously randomized to receive TMC278 in a
             TMC278 clinical trial and completed the protocol-defined treatment period.

          -  Patients continue to benefit from treatment with TMC278 in the opinion of the
             investigator.

          -  Patient can comply with the current protocol requirements.

          -  The patient's general medical condition, in the investigator's opinion, does not
             interfere with participation in the trial.

        Exclusion Criteria:

          -  Use of disallowed concomitant therapy.

          -  Females of childbearing potential who are pregnant, or without the use of effective
             birth control methods, or not willing to continue practicing these birth control
             methods during the trial and for at least 1 month after the end of the trial (or last
             intake of TMC278).

          -  Non-vasectomized heterosexually active male patients without the use of effective
             birth control methods or not willing to continue practicing these birth control
             methods during the trial and for at least 1 month after the end of the trial (or after
             last intake of TMC278).
Sublingual Fentanyl and Procedural Burn Pain
Condition: Burn Pain
MeSH terms: Burns
Intervention: Sublingual Fentanyl Spray
Intervention description: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Burn pain; Procedural pain; Sublingual fentanyl; Morphine

Summary:

      The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray
      (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn
      injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject capable of giving consent

          -  Age 18-65

          -  Total burn surface area greater than or equal to 5%

          -  Opioid tolerant

          -  BMI less than or equal to 35

        Exclusion Criteria:

          -  Subjects with cognitive or psychiatric impairment that would preclude study
             participation or compliance with protocol

          -  Allergy to fentanyl, morphine, naloxone

          -  Pregnancy, intent to become pregnant or lactating

          -  Evidence of burn injury to oral mucosa

          -  Active illicit drug use or illicit drug abuse history
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
Condition: Major Depressive Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: Administered as capsules.; Administered as capsules.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study is a randomized, double-blind, placebo-controlled study of the safety,
      tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with
      comorbid major depressive disorder (MDD) and insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant had a diagnosis of MDD as diagnosed by structured clinical interview for
             diagnostic and statistical manual of mental disorders, fifth edition, clinical trials
             version (SCID-5-CT), with symptoms that have been present for at least a 4-week
             period.

          2. Participant had a diagnosis of Insomnia that is confirmed at screening based on the
             diagnostic and statistical manual of mental disorders, fifth edition (DSM-5)
             diagnostic criteria using the SCID-5-CT.

          3. Participant had an Insomnia Severity Index (ISI) score greater than or equal to (>=)
             15 (moderate to severe insomnia).

          4. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥28 prior
             to dosing and a Hamilton Rating Scale for Depression (HAM-D) total score of ≥20.

        Exclusion Criteria:

          1. Participant had attempted suicide associated within the current episode of MDD.

          2. Participant had onset of the current depressive episode during pregnancy or 4 weeks
             postpartum, or the participant had presented for screening during the 6-month
             postpartum period.

          3. Participant had a medical history of bipolar disorder, schizophrenia, and/or
             schizoaffective disorder.

          4. Participant had a medical history of seizures.

          5. Participant had active psychosis per Investigator assessment.