bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
Condition: Arthralgia; Bunion; Hallux Valgus; Pain
MeSH terms: Hallux Valgus; Arthralgia; Acute Pain
Intervention: Tapentadol (CG5503); Tapentadol (CG5503); oxycodone; placebo
Intervention description: 50mg capsule q4-6 hrs for 3 days; 75mg capsule q4-6 hrs for 3 days; 10mg capsule q4-6 hrs for 3 days; 1 capsule q4-6 hrs for 3 days
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 901.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acute pain; bunionectomy; tapentadol

Summary:

      The purpose of this study is to evaluate the effectiveness (level of pain control) and safety
      of the administration of 2 different dose levels of tapentadol (CG5503) compared with
      oxycodone and with placebo in subjects who have had a bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must undergo primary unilateral first metatarsal bunionectomy

          -  Pain intensity must be moderate to severe following removal of a continuous popliteal
             sciatic block

          -  Female patients must be postmenopausal, surgically sterile, or practicing an effective
             method of birth control if they are sexually active.

        Exclusion Criteria:

          -  Patients will be excluded from the study if they have a history of seizure disorder or
             epilepsy

          -  History of malignancy within the past 2 years before starting the study

          -  History of alcohol or drug abuse

          -  Evidence of active infections that may spread to other areas of the body

          -  Clinical laboratory values reflecting severe renal insufficiency

          -  Moderately or severely impaired hepatic function

          -  Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs),
             tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake
             inhibitor (SNRI).
Tanezumab in Osteoarthritis of the Hip or Knee (2)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Intervention: tanezumab 10 mg; tanezumab 5 mg; naproxen; placebo
Intervention description: tanezumab 10 mg one dose at weeks 0 and 8; tanezumab 5 mg one dose at weeks 0 and 8; naproxen 1000 mg daily for 16 weeks; placebo to match tanezumab and naproxen dosing
Intervention MeSH terms: Naproxen; Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 849.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis

Summary:

      Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in
      patients with osteoarthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2

        Exclusion Criteria:

          -  pregnancy or intent to become pregnant

          -  BMI greater than 39

          -  other severe pain, significant cardiac, neurological or psychiatric disease
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Intervention description: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Antidepressive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1570.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is an optional continuation of previous short-term adult major depressive disorder
      (MDD) augmentation studies. Patients may only take part in this long-term, open-label
      research study if they completed a previous double-blind MDD augmentation study using SPD489.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and
             did not experience any clinically significant AEs in the antecedent study that would
             preclude exposure to SPD489.

        Exclusion Criteria:

          -  Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a
             lifetime history of psychosis) which was not present or recognized at entry into the
             antecedent study or has a concurrent chronic or acute illness or unstable medical
             condition that may deteriorate that could confound the results of safety assessments,
             increase risk to the subject or lead to difficulty complying with the protocol
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: FKB238 (bevacizumab); Avastin (bevacizumab); Paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 731.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Bevacizumab; Carboplatin; Paclitaxel

Summary:

      The purpose of this research study is to compare the effectiveness and safety of FKB238
      against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18 years or older

          -  Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had
             not received any systemic anti-cancer therapy for metastatic disease

          -  Histologically or cytologically confirmed diagnosis of predominantly non-squamous
             NSCLC

          -  Existence of at least 1 measurable lesion by RECIST v1.1

          -  Adequate hematological, renal and liver function

          -  Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1

          -  Life expectancy longer than 6 months

        Exclusion Criteria:

          -  Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and
             mixed adenosquamous carcinomas of predominantly squamous nature

          -  Any unresolved toxicities from prior systemic therapy

          -  Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm
             microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK)
             translocation positive mutations

          -  Previous dosing with vascular endothelial growth factor (VEGF) inhibitor

          -  Known hypersensitivity to any excipients of the Investigational Products (IPs) and
             combination chemotherapy

          -  Use of prohibited concomitant medication

          -  Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection

          -  Fertile men or women of childbearing potential not using adequate contraception.

        Other inclusion/exclusion criteria may apply.
Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: 33A; placebo; azacitidine; decitabine
Intervention description: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push; Volume equivalent to 10 mcg/kg, every 4 weeks via IV push; 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks; 20 mg/m2 given IV x 5 days, every 4 weeks
Intervention MeSH terms: Azacitidine; Decitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies, monoclonal; Antibody drug conjugate; Antigens, cluster of differentiation 33 (CD33); Drug therapy; Immunotherapy

Summary:

      The purpose of this study in AML patients is to test whether vadastuximab talirine
      (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and
      extends overall survival as compared to placebo combined with either azacitidine or
      decitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo
             or secondary AML according to World Health Organization (WHO) classification (except
             for acute promyelocytic leukemia (APL))

          -  Intermediate or adverse cytogenetic risk

          -  Eligible for therapy with either decitabine or azacitidine

          -  Acceptable hematologic and organ function

        Exclusion Criteria:

          -  AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or
             t(15;17)

          -  Patients who are candidates for allogeneic stem cell transplant at the time of
             enrollment

          -  Patients with a history of one of the following myeloproliferative neoplasms:
             essential thrombocythemia, polycythemia vera, and primary myelofibrosis

          -  Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic
             syndrome (MDS)
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Condition: Opioid-Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: NKTR-118; Usual care
Intervention description: 25 mg oral tablet once daily; As prescribed by the investigator
Intervention MeSH terms: Naloxegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 844.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Non-Cancer-Related Pain; Opioid-Induced Constipation

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118
      treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study-specific procedures.

          -  NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening (<3 SBMs/week and
             experiencing >1 reported symptom of hard/lumpy stools, straining, or sensation of
             incomplete evacuation/anorectal obstruction in at least 25% of the BMs over the
             previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the
             2-week OIC confirmation period.

          -  PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid
             regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or
             equianalgesic amount(s) of 1 or more opioid therapies.

          -  FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and
             other bowel regimens including prune juice and herbal products throughout the 52-week
             treatment period, and to use only bisacodyl as rescue medication if BM has not
             occurred within at least 72 hours of the last recorded BM.

        Exclusion Criteria:

          -  Patients receiving Opioid regimen for treatment of pain related to cancer.

          -  History of cancer within 5 years from first study visit with the exception of basal
             cell cancer and squamous cell skin cancer.

          -  Medical conditions and treatments associated with diarrhea, intermittent loose stools,
             or constipation.

          -  Other issues related to the gastrointestinal tract that could impose a risk to the
             patient.

          -  Pregnancy or lactation.
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
Condition: Postmenopausal Vulvovaginal Atrophy
MeSH terms: Atrophy
Intervention: WC3011 Estradiol Vaginal Cream; Vehicle
Intervention description: WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks; Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 722.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Postmenopausal Women, Vaginal Dryness

Summary:

      Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due
      to vulvovaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal females ≥35 years with either or both ovaries removed or naturally
             menopausal with moderate to severe vaginal dryness

        Exclusion Criteria:

          -  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, congestive heart
             failure, stroke or ischemic attacks

          -  Insulin-dependent diabetes mellitus

          -  Increased frequency or severity of headaches while on hormone or estrogen therapy

          -  Drug or alcohol addiction within last 2 years

          -  Participation in a clinical trial within 30 days

          -  Smoking ≥ 15 cigarettes daily

          -  Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥
             95 mmHg
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone furoate 50mcg; Placebo
Intervention description: Inhalation powder delivered by Novel Dry Powder Inhaler; Inhalation powder delivered by Novel Dry Powder Inhaler
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 248.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study
      to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of
      persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before
             first visit

          -  Both genders; females of child bearing potential must be willing to use appropriate
             contraception during the study

          -  Pre-bronchodilator FEV1 of at least 60% predicted

          -  FEV1 reversibility of at least 12% and 200mls

          -  Current asthma therapy that includes a non-corticosteroid controller and/or
             short-acting beta agonist

        Exclusion Criteria:

          -  History of life-threatening asthma exacerbation within the past 10 years

          -  Asthma exacerbation requiring treatment with oral corticosteroids within the last 3
             months or that required overnight hospital stay within 6 months

          -  Current or recent respiratory infection or current oral candida infection

          -  Presence of another significant respiratory disease or medical condition that is not
             controlled or that could affect subject safety or study outcome

          -  Known or suspected allergy to study drug or materials

          -  Taking another investigational medication or prohibited medication during the study

          -  Previous treatment with inhaled fluticasone furoate in a phase II or III study

          -  Current smokers or former smokers with significant tobacco exposure

          -  Children in Care
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Placebo; Vilazodone; Vilazodone
Intervention description: Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,; Vilazodone, 20mg, oral administration once per day.; Vilazodone, 40mg, oral administration once per day.
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 680.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; GAD

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone
      relative to placebo in the treatment of generalized anxiety disorder (GAD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female, 18 - 70 years of age

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)

          -  Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study and women of
             childbearing potential who are not practicing a reliable method of birth control

          -  History of meeting DSM-IV-TR criteria for any of the following:

               -  Any manic or hypomanic or mixed episode, including bipolar disorder and
                  substance-induced manic, hypomanic or mixed episode

               -  Any depressive episode with psychotic or catatonic features

               -  Panic disorder with or without agoraphobia

               -  Obsessive-compulsive disorder

               -  Schizophrenia, schizoaffective, or other psychotic disorder

               -  Bulimia or anorexia nervosa

               -  Presence of borderline personality disorder or antisocial personality disorder

               -  Mental retardation, dementia, amnesia, or other significant cognitive disorders

          -  Patients who are considered a suicide risk
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab 0.3 mg - 3 times monthly, then quarterly; Ranibizumab 0.5 mg - 3 times monthly, then quarterly; Ranibizumab 0.3 mg monthly
Intervention description: Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.; Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.; Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age-related macular degeneration, ranibizumab

Summary:

      The study will test if the efficacy and safety of an alternative dosing regimen is as
      effective as monthly injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with primary or recurrent subfoveal CNV secondary to AMD, including those
             with predominantly classic, minimally classic or occult lesions with no classic
             component

          -  Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study
             eye using ETDRS-like grading charts (approximately 20/40 to 20/320)

        Exclusion Criteria:

          -  Prior treatment in the study eye with verteporfin, external-beam radiation therapy,
             subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.

          -  History of submacular surgery or other surgical intervention for AMD in the study eye,
             glaucoma filtration surgery, corneal transplant surgery.

          -  Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month
             preceding Baseline.

        Other protocol-defined inclusion/exclusion criteria applied to the study.