bioihbjkbjnl/mcl2 huggingface dataset:
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Intervention: Flibanserin; Placebo
Intervention description: patients will be randomized to flibanserin or placebo in a double-blind manner; patients will be randomized to flibanserin or placebo in a double-blind manner
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1090.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The object of this trial is to assess the safety and efficacy of a 24 week course of
      flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.
    

Eligibility criteria:

        Inclusion criteria:

          1. Premenopausal women who are 18 years old and older

          2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type
             according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition,
             Text Revision, at least 24 weeks in duration.

          3. Stable, monogamous heterosexual relationship for at least one year.

          4. Willing to discuss sexual issues.

          5. Willing to engage in sexual activity at least once a month

          6. Normal pap smear

          7. Must use medically acceptable method of contraception

          8. Able to comply with daily use of a handheld entry device

        Exclusion criteria:

          1. Patients who have taken any medication in the protocol List of Prohibited Medications
             within 30 days before the screening visit.

          2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth
             Edition, Text Revision for: Sexual aversion disorder, substance induced sexual
             dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual
             dysfunction do to a general medical condition.

          3. Partner with inadequately treated organic or psychosexual dysfunction

          4. History of Major Depressive Disorder within six months prior to the screening visit or
             history of suicidal behavior.

          5. Sexual function impaired by psychiatric disorder

          6. Sexual function impaired by gynecological disorder

          7. Major life stress that could impair sexual function

          8. Substance abuse
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: IDP-124 Lotion; IDP-124 Vehicle Lotion
Intervention description: IDP-124 Lotion, twice-daily application; IDP-124 Vehicle Lotion, twice-daily application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 328.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic
      Dermatitis in Pediatric and Adult Subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 2 years of age and older

          -  Written and verbal informed consent must be obtained; subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit)

          -  Nonimmunocompromized male or female who failed to respond adequately to other topical
             prescription treatment for AD or for whom those treatments are not advisable

          -  Subjects must be willing to comply with study instructions and return to the clinic
             for required visits; subjects under the age of consent must be accompanied by the
             parent or legal guardian at the time of assent/consent signing

        Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or who wish to become pregnant during the
             study period

          -  Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg,
             clinically infected AD)

          -  Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline,
             which would interfere with evaluations

          -  History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or
             ichthyosis (other than ichthyosis vulgaris)

          -  History or presence of:

          -  basal cell carcinoma of skin effectively treated more than 2 years ago

          -  carcinoma of cervix effectively treated more than 5 years ago

          -  immunological deficiencies or diseases, HIV, or serious recurrent infection

          -  clinically significant severe renal insufficiency or severe hepatic disorders

          -  Current or recent serious infection
Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Zileuton; Placebo
Intervention description: Zyflo tablets, 600 mg, 4 times a day; Placebo 4 x daily
Intervention MeSH terms: Zileuton
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 119.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Exacerbation; Anti-leukotriene; Length of Stay; LOS

Summary:

      Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by
      cigarette smoking or by breathing in other lung irritants, including pollution, dust, or
      chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a
      medication that is used to control asthma symptoms, at reducing the length of a hospital stay
      for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to the hospital for a COPD exacerbation

          -  FEV1 less than 60% of predicted level

          -  At least 10 pack years of smoking

        Exclusion Criteria:

          -  Any uncontrolled systemic disease

          -  Known hypersensitivity to zileuton

          -  Asthma

          -  Lobar pneumonia or pulmonary edema

          -  Interstitial lung disease

          -  Medical condition that is likely to limit survival to less than 30 days at the time of
             study entry

          -  History of liver disease

          -  Current use of theophylline

          -  Participation in another clinical trial in the COPD Clinical Research Network

          -  Incarceration

          -  Institutionalization

          -  Pregnant

          -  History of a suicide attempt

          -  Prior inpatient admission for a psychiatric disorder

          -  Bipolar disorder

        '
The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
Condition: Deep Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome; Syndrome
Intervention: Knee-length, graduated elastic compression stocking; Knee-length, placebo stocking
Intervention description: Worn daily for 2 years, 30-40 mm Hg; Worn daily for two years
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 806.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postphlebitic Syndrome; Post-Thrombotic Syndrome; Elastic Stockings; Stockings, Compression; Randomized Controlled Trials; Quality of Life

Summary:

      The purpose of this study is to determine whether elastic compression stockings used for 2
      years are effective in preventing the post-thrombotic syndrome in patients with symptomatic
      proximal deep venous thrombosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT
             diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary
             embolism)

          -  Who have no contraindications to standard treatment with heparin and/or warfarin, and

          -  Who provide informed consent to participate

        Exclusion Criteria:

          -  Contraindication to compression stockings

          -  Limited lifespan (estimated < 6 months)

          -  Geographic inaccessibility preventing return for follow-up visits

          -  Inability to apply stockings daily and unavailability of a caregiver to apply
             stockings daily

          -  Treatment of acute DVT with thrombolytic agents
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study
Condition: HIV Infection; Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Atazanavir; current antiretroviral regimen
Intervention description: atazanavir 400 mg once daily; Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus > 2 NRTIs
Intervention MeSH terms: Atazanavir Sulfate; Anti-Retroviral Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atazanavir; Endothelial function; Treatment Experienced

Summary:

      The purpose of this study is to evaluate the change in brachial artery reactivity in
      HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing
      antiretroviral regimen
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infection

          -  HIV-1 RNA < 500 copies/ml

          -  Fasting LDL cholesterol >130 mg/dl OR fasting triglycerides >200 mg/dl

          -  CD4 count >100 cells/mm

          -  Stable antiretroviral regimen for at least 12 weeks prior to study entry that includes
             a protease inhibitor (PI) with or without ritonavir boosting

        Exclusion Criteria:

          -  History of heart disease, uncontrolled hypertension, peripheral vascular disease

          -  Current non-nucleoside reverse transcriptase inhibitor (NNRTI) in the PI-containing
             regimen within 4 weeks

          -  Prior or current use of atazanavir

          -  Initiation of treatment with lipid-lowering drugs within 4 weeks prior to study entry
Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
Condition: Complicated Urinary Tract Infection; Complicated Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Intraabdominal Infections
Intervention: Ceftazidime - Avibactam ( CAZ-AVI); Best Available Therapy; Metronidazole
Intervention description: Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes; Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation; Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion
Intervention MeSH terms: Metronidazole; Ceftazidime; Avibactam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Ceftazidime,; avibactam,; metronidazone,; Anti-Infectives

Summary:

      To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with
      complicated urinary tract infections and complicated intra-abdominal infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be ≥18 and ≤90 years of age

          -  Female patients can participate if they are surgically sterile or completed menopause
             or females capable of having children and agree not to attempt pregnancy while
             receiving IV study therapy and for a period of 7 days after

          -  Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an
             appropriate culture within 5 days prior to study entry (ie, within 5 days prior to
             Screening; the study-qualifying culture), which was determined to be the causative
             agent of the entry infection

        Exclusion Criteria:

          -  Patient has an APACHE II score >30 (cIAI patients only)

          -  Patient has an infection due to Gram negative pathogen that is unlikely to respond to
             CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)

          -  Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
             Patient is immunocompromised

          -  Patient has a rapidly progressive or terminal illness with a high risk of mortality
             due to any cause, including acute hepatic failure, respiratory failure or severe
             septic shock such that they are unlikely to survive the 4- to 5-week study period.
Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Condition: Generalized Pustular Psoriasis (GPP); Adalimumab; Japanese
MeSH terms: Psoriasis
Intervention: Adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
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: 15 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: efficacy; safety

Summary:

      The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of
      adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not
      have an adequate response to their currently approved treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of generalized pustular psoriasis

          -  Total skin score of at least 3 and erythema with pustules (skin score of at least 1)
             at baseline in the Japan Dermatology Association (JDA) severity index of Generalized
             Pustular Psoriasis (GPP) in GPP Medical Care Guideline 2014 in Japan

          -  Inadequate response to, or intolerance to, or contraindication to the currently
             approved GPP treatment (excluding infliximab)

          -  Infliximab secondary failure, or intolerant to infliximab

        Exclusion Criteria:

          -  Erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis at
             Screening

          -  Drug-induced GPP

          -  Cannot stop ongoing use of prohibited GPP treatments

          -  Total JDA severity index of GPP of 14 or more in GPP Medical Care Guideline 2014 in
             Japan
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Condition: Post Surgical Ocular Inflammation and Pain
MeSH terms: Inflammation
Intervention: KPI-121 1% Ophthalmic Suspension dosed BID; Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 520.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: postsurgical; postoperative; ocular; cataract; inflammation; pain; corticosteroid

Summary:

      The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0%
      ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        Candidates for routine, uncomplicated cataract surgery

        In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of
        at least 20/200 in study eye.

        Exclusion Criteria:

          -  Known hypersensitivity/contraindication to study product(s) or components.

          -  History of glaucoma, intraocular pressure (IOP) >21 mmHg at the screening or
             randomization visits, or being treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of
             Investigator could confound study assessments or limit compliance; or have been
             exposed to an investigational drug within the 30 days prior to screening or 18 days
             following surgery.

          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply
             with study protocol or unable to successfully instill eye drops.
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
Condition: Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorders, Intrinsic
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Sleep Disorders, Intrinsic; Mental Disorders
Intervention: esmirtazapine
Intervention MeSH terms: Mirtazapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This trial is a 26-week, open label extension trial to investigate safety and explore
      efficacy of esmertazapine in participants with insomnia who completed protocol
      21106/P05701/MK-8265-002 (NCT00631657).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign written informed consent

          -  Completed clinical trial 21106/P05701/MK-8265-002

        Exclusion Criteria:

          -  Any (serious) adverse event, medical condition or required concomitant medication
             deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the
             investigator

          -  Were significantly non compliant with protocol criteria and procedures of trial
             21106/P05701/MK-8265-002, as judged by the investigator

          -  Pregnancy
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study will evaluate the safety, tolerability and efficacy of
      RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid
      arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current
      non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous
      infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment
      is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Moderate to severe active rheumatoid arthritis (DAS28>/=3.2) of >/=6 months duration

          -  Body weight </=150 kg

          -  Patients are on one or more non-biologic DMARDs at a stable dose for a period >/=8
             weeks prior to study treatment

          -  Patients with inadequate clinical response to a stable dose of non-biologic DMARD

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following randomization

          -  Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus
             erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or
             significant systemic involvement secondary to rheumatoid arthritis

          -  History of or current inflammatory joint disease other than rheumatoid arthritis