bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Condition: Bacterial Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial; Healthcare-Associated Pneumonia
Intervention: Telavancin; Vancomycin
Intervention description: Telavancin 10 mg/kg/day IV for up to 21 days.; Vancomycin 1 Gm IV q 12 hrs for up to 21 days
Intervention MeSH terms: Vancomycin; Telavancin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 761.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nosocomial pneumonia; MRSA

Summary:

      Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug,
      telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours
             of continuous stay in an inpatient acute or chronic care facility or acquired within 7
             days after being discharged from a hospitalization of greater than or equal to 3 days
             duration.

        Exclusion Criteria:

          -  Received more than 24 hours of potentially effective systemic (IV, IM or PO)
             antibiotic therapy for Gram-positive pneumonia immediately prior to randomization
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Condition: Lung Cancer - Non Small Cell Squamous
MeSH terms: Lung Neoplasms
Intervention: Ipilimumab; Placebo; Paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Carboplatin; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1289.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin
      will extend the lives of patients with squamous only non small cell lung cancer more than
      placebo plus Paclitaxel and Carboplatin.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Non small cell lung cancer (NSCLC) - squamous cell

          -  Stage IV or recurrent NSCLC

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Brain Metastases

          -  Autoimmune diseases
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Placebo
Intervention description: Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.; Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 362.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive
      disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-80 years old

          -  Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

          -  The patient's current depressive episode must be at least 4 weeks in duration

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control

          -  Patients with a history of meeting DSM-IV-TR criteria for:

               -  any manic or hypomanic episode

               -  schizophrenia or any other psychotic disorder

               -  obsessive-compulsive disorder

          -  Patients who are considered a suicide risk
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Condition: Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary; Bone Neoplasms; Bone Marrow Diseases
Intervention: Denosumab
Intervention description: Administered by subcutaneous injection every 4 weeks (Q4W)
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; bone metastases; breast cancer; prostate cancer

Summary:

      This trial will facilitate access to denosumab for adults with advanced cancer who have
      participated in a denosumab phase 3 study until denosumab is approved and available for sale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was previously enrolled in a denosumab phase 3 study and participated in the
             Open-label Extension portion of that study.

          -  Subject or subject's legally acceptable representative has provided informed consent.

        Exclusion Criteria:

          -  Subject is of child bearing potential and planning to become pregnant within 7 months
             after the end of treatment.

          -  Subject is of child bearing potential and is not willing to use, in combination with
             her partner, two highly effective methods of contraception during treatment and for 7
             months after the end of treatment.

          -  Subject has known sensitivity to any of the products to be administered during dosing.

          -  Subject will not be available for protocol required study visits or procedures, to the
             best of the subject and investigator's knowledge.

          -  Subject has any kind of disorder that, in the opinion of the investigator, may
             compromise the ability of the subject to give written informed consent and/or to
             comply with all required study procedures.
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: GP2013; rituximab
Intervention description: Type: Biological/Vaccine; Type: Biological/Vaccine
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A subset of patients is switched from GP2013 to MabThera or continued with MabThera during the maintenance phase, for these patients the treatment is finished as an open labeled parallel arm study. The original treatment assignment is kept blinded.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 629.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Follicular Lymphoma; Biosimilar; GP13-301; rituximab; Antibodies; CD20

Summary:

      The purpose of this study is to demonstrate comparability of the ORR in patients with
      previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive
      MabThera-treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with previously untreated advanced stage, CD20-positive FL

          -  Patient with ECOG performance status 0, 1 or 2.

        Exclusion Criteria:

          -  Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a

          -  Patient who has previously received any prior therapy for lymphoma

          -  Patient with evidence of any uncontrolled, active infection (viral, bacterial or
             fungal).

          -  Patient with any malignancy within 5 years prior to date of randomization, with the
             exception of adequately treated in situ carcinoma of the cervix uteri, basal or
             squamous cell carcinoma or non-melanomatous skin cancer.

        Other protocol-defined inclusion/exclusion criteria may apply
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab; ABP 501
Intervention description: Participants will receive subcutaneous (SC) injection of adalimumab; Participants will receive SC injection of ABP 501
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Study is double-blind.
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Adalimumab; Biosimilars; Tumor necrosis factor; Psoriasis Area and Severity Index

Summary:

      Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches
      between Humira® and ABP 501 (new high concentration formulation) compared with continued use
      of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study
      is composed of two periods: A lead-in period of treatment with Humira® followed by a
      randomized two parallel arm period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants has moderate to severe plaque psoriasis (with or without psoriatic
             arthritis) for at least 6 months and has stable disease for at least 2 months

          -  Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA)
             and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline

          -  Participant has no known history of latent or active tuberculosis

        Exclusion Criteria:

          -  Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication induced psoriasis, or other skin conditions at the time of screening (eg,
             eczema) that would interfere with evaluations of the effect of investigational product
             of psoriasis

          -  Participant has an active infection or history of infections

          -  Participant has received biologic treatment for psoriasis within the previous month or
             5 drug half-lives (whichever is longer) prior to enrollment

          -  Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior
             to enrollment

          -  Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or
             excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks
             prior to enrollment

          -  Participant has received topical psoriasis treatment within 2 weeks prior to
             enrollment
Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
Condition: Aging
Intervention: Botulinum Toxin Type A (Azzalure); Restylane ranges
Intervention description: Powder for solution for injection; Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The aim of this study is to assess subjects' satisfaction linked to the pan facial management
      of rejuvenation with injections of Azzalure® and Restylane® fillers.

      This will be an open, multi-centre study.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Male or female subjects, aged 18 to 64 years, seeking treatment for correction of
             dynamic wrinkles of the upper third of the face and correction of facial volume loss,
             and meeting other specific eligibility criteria

        Main Exclusion Criteria:

          -  Female subject who is pregnant, nursing or planning a pregnancy during the study

          -  Subject with any contraindications to the injection of hyaluronic acid (see package
             inserts)

          -  Subject with any contraindications to the injection of botulinum toxin (see package
             insert)

          -  Subject with a personal history of allergic/anaphylactic reactions including
             hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin

          -  Concurrent treatment that, in the investigator's opinion, would interfere with the
             evaluation of the safety or efficacy of at least one of the study treatments

          -  Subject with a history of dissatisfaction with facial aesthetic procedures involving
             dermal implant injections or subject with unattainable expectations

          -  Subject currently enrolled in another investigational study or who participated in
             such a study in the past 30 days prior to baseline visit
A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Carboxymethylcellulose Sodium Based Eye Drops; Systane® Gel Drops; Genteal® Lubricant Gel Drops
Intervention description: 1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.; 1 to 2 drops of Systane® Gel Drops in each eye.; 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the tolerability and acceptability of an investigational eye drop
      formulation in patients with Dry Eye Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current use of an artificial tear product

          -  Visual Acuity of at least 20/40 (while wearing glasses, if necessary).

        Exclusion Criteria:

          -  Use of contact lenses in the last 3 months, or anticipated use of contact lenses
             during the study

          -  Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive
             keratectomy within 6 months

          -  Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3
             months

          -  Diagnosis of glaucoma.
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
Condition: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Intervention: Comparator: GARDASIL; Experimental: V503
Intervention description: GARDASIL (quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen; V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen (and a fourth injection for Cohort 1 only).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14840.0
Sex: Female
Minimum age: 16 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in
      comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered
      to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503
      reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease
      compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type
      6/11/16/18 antibodies compared with GARDASIL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female between 16- to 26-years-old

          -  Has never had Pap testing or has only had normal Pap (Papanicolaou) test results

          -  For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in
             the base study and was in the per-protocol immunogenicity population for ≥1 HPV type

          -  For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized
             to GARDASIL in the base study and received ≥1 dose of GARDASIL

        Exclusion Criteria:

          -  History of an abnormal cervical biopsy result

          -  History of a positive test for HPV

          -  History of external genital/vaginal warts

          -  Currently a user of any illegal drugs or an alcohol abuser

          -  History of severe allergic reaction that required medical attention

          -  Are pregnant

          -  Received marketed HPV vaccine or participated in an HPV trial

          -  Currently enrolled in a clinical trial

          -  Currently has or has a history of certain medical conditions or is currently taking or
             has taken certain medications (details will be discussed at the time of consent.)
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Condition: Papillomavirus Type 16/18 Infection; Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Intervention: Cervarix™
Intervention description: Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 770.0
Sex: Female
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Non-inferiority; Immunogenicity; HPV Vaccine Consistency

Summary:

      The study will be extended for subjects who received all three doses of vaccine in Finland,
      Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18
      vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin
      and genitals in men and women. Several types of HPV infection are transmitted by sexual
      activity and, in women, can infect the cervix (part of the uterus or womb). This infection
      often goes away by itself, but if it does not go away (this is called persistent infection),
      it can lead in women over a long period of time to cancer of the cervix. If a woman is not
      infected by HPV, it is very unlikely that she will get cervical cancer. This study will
      evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified
      manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine
      safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and
             Finland, received three doses of vaccine and completed Visit 4 (Month 7).

          -  Written informed consent obtained from the subject prior to enrolment (for subjects
             below the legal age of consent, written informed consent must be obtained from a
             parent or legally acceptable representative (LAR) and, in addition, the subject must
             sign and personally date a written informed assent).

        Exclusion criteria

          -  Use of any investigational or non-registered product (drug or vaccine) or planned use
             during the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device).

          -  Chronic administration of immunosuppressants or other immune-modifying drugs occurring
             less than three months prior to blood sampling.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding blood sampling.
Iressa Follow-up Trial
Condition: Lung Cancer; Breast Cancer
MeSH terms: Breast Neoplasms; Lung Neoplasms
Intervention: Gefitinib
Intervention description: ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
Intervention MeSH terms: Gefitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: lung cancer; breast cancer

Summary:

      The purpose of this study is to assess the long-term safety profile and the secondary
      objective to estimate clinical benefit of ZD1839 (gefitinib).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent to participate in the trial.

          -  Female or male aged 18 years and over.

          -  Patients with previously diagnosed cancer who have been treated with ZD1839 in a
             parent ZD1839 clinical trial and may benefit from continuation

        Exclusion Criteria:

          -  Known severe hypersensitivity to ZD1839

          -  Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's
             Wort.

          -  Withdrawal from a parent ZD1839 trial because of tumor progress