bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: Efinaconazole Topical
Intervention description: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
Intervention MeSH terms: Efinaconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic
      subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of
      subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the
      efficacy and safety of both topical and oral antifungal treatment options for onychomycosis
      in diabetic subjects. However, no study to date has specifically addressed the efficacy and
      safety of efinaconazole among diabetic subjects.

      The objective of this noncomparative, uncontrolled study is to determine the efficacy of
      topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus.
      Specific indicators to measure efficacy of treatment will be the mycological cure rate,
      complete cure rate, and treatment success. Furthermore, an additional goal of the study is to
      gain knowledge of safety in the setting of a cohort of diabetic subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive
             mycologic culture findings.

          -  Involvement of at minimum 20% of the target great toenail.

        Exclusion Criteria:

          -  Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual
             onychomycosis, diagnosis of superficial white onychomycosis

          -  Diagnosis of peripheral arterial disease or anatomic abnormalities of the target
             toenail

          -  Inability to follow through with all requisite office visits

          -  Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator,
             or history of systemic antifungals within the prior five years.

          -  Active interdigital tinea pedis refractory to topical antifungal treatments

          -  Known hypersensitivity to efinaconazole

          -  Use, within the month preceding screening, of: topical antifungal agents, topical
             anti-inflammatory agents to the toes

          -  Any history of oral systemic antifungal with known activity against dermatophytes
Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: C1 esterase inhibitor [human] liquid; Placebo
Intervention description: C1 Esterase Inhibitor [Human] Liquid administered Subcutaneously as specified on specified days; Placebo
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of subcutaneous administration
      of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in
      adolescent and adult subjects with hereditary angioedema.
    

Eligibility criteria:

        The maximum duration of participation is approximately 9 months. Patients will complete a
        screening period of up to 21 days. Following screening, eligible patients will be randomly
        assigned to 1 of 3 treatment sequences. Each patient will undergo 2 14-week treatment
        periods for a total of 28 weeks (Treatment Period 1 and Treatment Period 2). After
        completing the 2 treatment periods, patients will enter a 1-month follow-up period.
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Intervention: WC3011 Estradiol Vaginal Cream
Intervention description: WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 309.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Postmenopausal Women; Vaginal Dryness; Postmenopausal Vulvovaginal Atrophy

Summary:

      This is an open-label extension study evaluating the long-term safety and efficacy of WC3011
      in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Study PR-04409.3 (NCT01400776)

        Exclusion Criteria:

        Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy
        other than WC3011:

          -  Hypersensitivity to estrogen and/or progestin therapy

          -  Known or suspected premalignant or malignant disease (except successfully treated skin
             cancers)

          -  Manifestation of or treatment for significant cardiovascular disease, stroke or
             ischemic attack

          -  Insulin-dependent diabetes mellitus

          -  Smoking ≥ 15 cigarettes daily

          -  Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95
             mmHg
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2
Condition: Infertility
MeSH terms: Infertility
Intervention: Follitropin Delta (FE 999049); Follitropin Alfa (GONAL-F)
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 513.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This trial investigates the immunogenicity of FE 999049 in repeated cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent Documents signed prior to screening evaluations related to this
             protocol

          -  Participation in the pivotal efficacy trial (trial 000004/ESTHER-1)

          -  Anti-FSH antibody results from baseline and at least one post-dosing assessment in the
             previous cycle(s) available.

          -  Having undergone the oocyte retrieval procedure, or having had cycle cancellation
             prior to oocyte retrieval due to poor ovarian response or excessive ovarian response,
             in the previous cycle(s).

          -  Failure to achieve ongoing pregnancy in the previous cycle(s).

        Exclusion Criteria:

          -  Non-compliance to protocol compliance in the previous cycle(s).

          -  Having undergone any stimulation with gonadotropins since the end-of-trial /
             end-of-cycle visit in the previous cycle

          -  One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to start of
             dosing on stimulation day 1

          -  Severe OHSS in a previous cycle.

          -  Any clinically relevant change to any of the eligibility criteria in the previous
             cycle(s).

          -  Clinically relevant medical history since the previous cycle which precludes
             gonadotropin stimulation or is associated with a reduced chance of pregnancy.
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Condition: Cutaneous T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous
Intervention: SGX301 (synthetic hypericin); Placebo
Intervention description: 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.; USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.
Intervention MeSH terms: Hypericin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTCL; Mycosis fungoides; Hypericin; SGX301; MF

Summary:

      To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with
      patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage
             IB, or Stage IIA.

          -  Subjects must have a minimum of three (3) evaluable, discrete lesions.

          -  Subjects must be willing to refrain from sunbathing for the duration of the study.

        Exclusion Criteria:

          -  History of sun hypersensitivity and photosensitive dermatoses including porphyria,
             systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous
             light eruptions or radiation therapy within 30 days of enrolling.

          -  Pregnancy or mothers who are breast feeding.

          -  Males and females not willing to use effective contraception.

          -  Unhealed sunburn.

          -  Subjects receiving topical steroids or other topical treatments for CTCL within 2
             weeks.

          -  Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy
             (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic
             therapies for CTCL within 3 weeks of enrollment.

          -  Subjects with significant history of systemic immunosuppression due to drugs or
             infection with HIV or HTLV 1.

          -  Subjects taking other investigational drugs or drugs of abuse within 30 days of entry
             into this study.
A Trial of AXS-05 in Patients With Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: AXS-05; Placebo
Intervention description: Oral AXS-05 tablets, taken daily for 6 weeks.; Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depressive Disorder; Depressive Disorder, Major; Bupropion; Dextromethorphan; MDD; Dopamine Reuptake Inhibitor; AXS-05; NMDA Receptor Antagonist; Central Nervous System; CNS; Sigma-1 Receptor Agonist; Nicotinic Acetylcholine Receptor Antagonist; Norepinephrine Reuptake Inhibitor; Glutamate Modulator; Axsome Therapeutics; GEMINI; Serotonin Reuptake Inhibitor

Summary:

      A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in
      patients with major depressive disorder (MDD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 18 - 65

          -  Currently meets DSM-5 criteria for MDD

          -  Body Mass Index between 18 and 40 kg/m^2, inclusive

        Key Exclusion Criteria:

          -  Suicide risk

          -  History of treatment resistance in current depressive episode

          -  History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic
             stimulation or any experimental central nervous system treatment during the current
             episode or in the past 6 months

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: MAL 16.8% cream; MAL Vehicle Cream
Intervention description: Day light photodynamic therapy with MAL 16.8% cream; Day light photodynamic therapy with MAL vehicle cream
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 557.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and
      Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle
      cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented
      actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants aged ≥ 18 years at the Screening visit.

          -  Participants had at least 4, but no more than 12, clinically-confirmed thin or
             moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g.,
             forehead, cheek, chin), and balding scalp.

          -  Female Participants of non-childbearing potential.

          -  Participants fully understood and signed an ICF before any investigational
             procedure(s) are performed.

        Exclusion Criteria:

          -  Participants with pigmented AK in the treatment areas.

          -  Female participants who were pregnant, nursing, or planning a pregnancy during the
             study.

          -  Participants with a clinical diagnosis of a skin disease other than AK.

          -  Immunocompromised participants.

          -  Participants with any condition that may be associated with a risk of poor protocol
             compliance.
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination (FDC) tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor
      (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in
      subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating
      or residual function mutation (F/G and F/RF genotypes).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completed study drug treatment in parent study (VX18-445-104); or had study drug
             interruption(s) in parent study but completed study visits up to the last scheduled
             visit of the Treatment Period in the parent study

        Key Exclusion Criteria:

          -  History of study drug intolerance in parent study

        Other protocol defined Inclusion/Exclusion criteria may apply.
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Daridorexant 25 mg; Daridorexant 50 mg; Placebo
Intervention description: Daridorexant will be administered as tablets, orally, once daily in the evening.; Daridorexant will be administered as tablets, orally, once daily in the evening.; Matching placebo will be administered as tablets, orally, once daily in the evening.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 930.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant)
      in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective
      and subjective sleep parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure;

          -  Male or female aged ≥ 18 years;

          -  Insomnia disorder according to DSM-5 criteria;

          -  Insomnia Severity Index score ≥ 15;

          -  Insufficient sleep quantity as collected subjectively in the sleep diary;

          -  Women of childbearing potential must have a negative and urine pregnancy test and use
             the contraception scheme up to at least 30 days after last study treatment intake.

        Exclusion Criteria:

          -  Body mass index below 18.5 or above 40.0 kg/m2;

          -  Any lifetime history of of related breathing disorder, periodic limb movement
             disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM)
             behavior disorder, narcolepsy, or apnea/ hypopnea;

          -  Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1
             month prior to Visit 3 and the subject agrees to continue this CBT throughout the
             study;

          -  Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;

          -  Acute or unstable psychiatric conditions diagnosed by the Mini International
             Neuropsychiatric Interview;

          -  Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;

          -  For female subjects: pregnant, lactating or planning to become pregnant during
             projected duration of the study;

          -  History or clinical evidence of any disease or medical condition or treatment, which
             may put the subject at risk of participation in the study or may interfere with the
             study assessments.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             the subject's full participation in the study or compliance with the protocol.
BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab
Intervention description: 10 mg/kg administered intravenously over 1 hour every 4 weeks
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SELENA; belimumab; Lupus; systemic lupus erythematosus; PGA; BLys; SLE Flare Index; continuation; phase III; BILAG; extension; efficacy; SRI; B cell; SLEDAI; safety; Asia; B lymphocyte

Summary:

      This study provides subjects who complete the BEL113750 study and subjects who complete the
      open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of
      continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those
      randomized to belimumab, or the option to begin treatment with belimumab for those randomized
      to placebo, as an add-on to their standard of care SLE therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the BEL113750 Protocol in Northeast Asia through Week 48 OR have
             completed the open-label extension of C1115 in Japan.

          -  Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2
             weeks, maximum of 8 weeks) after the last dose in BEL113750 OR be able to receive the
             first dose of IV belimumab 1 week (plus a 1 week visit window) after the last dose of
             open-label SC belimumab in C1115..

        Exclusion Criteria:

          -  Have developed clinical evidence of significant, unstable or uncontrolled, acute or
             chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic,
             gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or
             experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of
             the principal investigator, put the subject at undue risk.

          -  Have developed any other medical diseases (e.g., cardiopulmonary), laboratory
             abnormalities, or conditions (e.g., poor venous access) that in the opinion of the
             principal investigator, makes the subject unstable for the study.