bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Intervention: turoctocog alfa pegol
Intervention description: Administered i.v.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to evaluate the safety and
      efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC
      0129-0000-1003 (N8-GP) in subjects with Haemophilia A.
    

Eligibility criteria:

        Inclusion Criteria: - Male patients with severe congenital haemophilia A (FVIII activity
        below 1%, according to medical records) - Documented history of at least 150 EDs (exposure
        days) to other FVIII products - At least 12 years and body weight at least 35 kg (except
        for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be
        18 years) Exclusion Criteria: - Previous participation in this trial defined as withdrawal
        after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or
        equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by
        medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral
        load of more than 400000 copies/mL. If the data is not available in medical records within
        last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired
        coagulation disorders other than haemophilia A - Previous significant thromboembolic events
        (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined
        by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value
        at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of
        normal reference ranges at central laboratory - Creatinine level equal to or greater than
        1.5 times above upper normal limit (according to central laboratory reference ranges) -
        Ongoing immune modulating or chemotherapeutic medication
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
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Intervention description: Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment; Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 433.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; Etrasimod; APD334

Summary:

      The purpose of this study is to determine whether oral etrasimod is a safe and effective
      treatment for moderately to severely active ulcerative colitis.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening

          2. Active UC confirmed by endoscopy

        Exclusion criteria:

          1. Severe extensive colitis

          2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history
             of a fistula consistent with CD

          3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
Condition: Pneumonia, Pneumococcal
MeSH terms: Pneumonia, Pneumococcal
Intervention: Pneumosil; Synflorix
Intervention description: 10-Valent Pneumococcal Conjugate Vaccine; Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2250.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 8 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at
      the immune response in infants. In addition, the study will compare the immunogenicity of the
      Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.
    

Eligibility criteria:

        Inclusion Criteria:

          -  They are healthy infants based on medical history and clinical assessment.

          -  They are between 6 and 8 weeks (ie 42 to 56 days) old, inclusive.

          -  Subject's parent must provide voluntary written/thumb-printed informed consent and be
             willing to comply with study requirements and procedures.

        Exclusion Criteria:

          -  Use of any investigational medicinal product prior to randomization.

          -  Previous vaccination against or infection with S. pneumoniae.

          -  History of anaphylactic shock or an allergic reaction to any prior vaccination.

          -  Any fever, illness (including malaria).

          -  Receipt of another vaccine within 30 days of study start.

          -  Chronic administration of an immunosuppressant or administration of immunoglobulins

          -  History of blood disorder, primary immunodeficiency, or a sibling who has such a
             diagnosis or who died of suddenly without apparent cause.

          -  History of meningitis, seizures or any neurological disorder.
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Condition: Bipolar I Disorder
Intervention: Inhaled Placebo; Inhaled loxapine 5 mg; Inhaled loxapine 10 mg
Intervention description: Inhaled loxapine Placebo, may repeat after 2 hours x 2; Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2; Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
Intervention MeSH terms: Loxapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar 1 disorder,; agitation,; acute,; treatment

Summary:

      Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in
      bipolar 1 disorder patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult patients with bipolar 1 disorder and acute agitation

        Exclusion Criteria:

          -  Agitation caused primarily by acute intoxication

          -  History of drug or alcohol dependence

          -  Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug
             administration
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Condition: Progressive Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Placebo
Intervention description: Oral; Oral
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 395.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Enzalutamide; Androgen receptor; Prostate cancer; Xtandi

Summary:

      Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific
      Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with
      progressive metastatic prostate cancer who have failed androgen deprivation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate without neuroendocrine
             differentiation or small cell features

          -  Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy

          -  Progressive disease despite androgen deprivation therapy as defined by rising PSA
             levels or progressive soft tissue or bone disease

          -  No prior treatment with cytotoxic chemotherapy

          -  Asymptomatic or mildly symptomatic from prostate cancer

        Exclusion Criteria:

          -  Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
             Investigator, would make the patient inappropriate for enrollment

          -  Known or suspected brain metastasis or active leptomeningeal disease

          -  History of another malignancy within the previous 5 years other than curatively
             treated non-melanomatous skin cancer

          -  History of seizure including febrile seizure or any condition that may predispose to
             seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss
             of consciousness requiring hospitalization).
A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Cardiovascular Diseases
Intervention: Degarelix; Leuprolide
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 545.0
Sex: Male
Healthy volunteers: No

Summary:

      The purpose of this trial is to test if a marketed drug for advanced prostate cancer
      (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another
      marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer
      and cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced prostate cancer

          -  Indication to initiate androgen deprivation therapy (ADT)

          -  Predefined cardiovascular disease

        Exclusion Criteria:

          -  Previous or current hormonal management of prostate cancer (unless terminated at least
             12 months prior to trial)

          -  Acute cardiovascular disease in the previous 30 days
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Filgotinib; Placebo to match filgotinib; csDMARDs
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effects of filgotinib versus placebo
      for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the
      percentage of participants achieving an American College of Rheumatology 20% improvement
      response (ACR20) at Week 12.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League
             Against Rheumatism [EULAR] criteria for RA), and are ACR functional class I-III.

          -  Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints [SJC66]) and ≥6
             tender joints (from a tender joint count based on 68 joints [TJC68]) at screening and
             Day 1

          -  Ongoing treatment with a stable prescription of 1 or 2 csDMARDs

          -  Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for
             the treatment of RA to which they have had an inadequate response or intolerance

        Key Exclusion Criteria:

          -  Previous treatment with any janus kinase (JAK) inhibitor

        NOTE: Other protocol Inclusion/ Exclusion criteria may apply.
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Palbociclib; Letrozole; Placebo; Letrozole
Intervention description: Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment; Letrozole, 2.5mg, orally once daily (continuously); Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment; Letrozole, 2.5mg, orally once daily (continuously)
Intervention MeSH terms: Letrozole; Palbociclib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 340.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: breast cancer; postmenopausal women; estrogen-receptor positive; HER2 negative; locoregionally recurrent; metastatic

Summary:

      The study is designed to compare the clinical benefit following treatment with letrozole in
      combination with Palbociclib versus letrozole in combination with placebo in Asian
      postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior
      systemic anti cancer therapies for their advanced/metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult Asian women with locoregionally recurrent or metastatic disease not amenable to
             curative therapy

          -  Confirmed diagnosis of ER positive breast cancer

          -  No prior systemic anti-cancer therapy for advanced ER+ disease

          -  Postmenopausal women

          -  Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or
             bone-only disease

          -  Eastern Cooperative Oncology Group [ECOG] 0-1

          -  Adequate organ and marrow function

          -  Patient must agree to provide tumor tissue

        Exclusion Criteria:

          -  Confirmed diagnosis of HER2 positive disease

          -  Patients with advanced, symptomatic, visceral spread that are at risk of life
             threatening complication in the short term

          -  Known uncontrolled or symptomatic CNS metastases

          -  Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie,
             anastrozole or letrozole) with disease recurrence while on or within 12 months of
             completing treatment

          -  Prior treatment with any CDK 4/6 inhibitor
Combined Behavioral and Analgesic Trial for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Tramadol; Placebo; Cognitive Behavior Therapy for FM; Health Education
Intervention description: 50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day.
Minimum accepted dose of 200mg per day; Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg; Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.; Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
Intervention MeSH terms: Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 134.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a randomized control study that involves a combination of a drug treatment,
      behavioral health, and placebo controls.

      Some participants will receive a medication approved by the Food and Drug Administration for
      treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive
      an inactive pill, called a placebo. There will also be 2 different types of behavioral health
      treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have
      been recommended for the treatment of patients with FM by the American Pain Society.

      There are 4 possible study treatment combinations:

        1. Tramadol + CBT,

        2. Tramadol + HE,

        3. Placebo + CBT,

        4. Placebo + HE.

      Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there
      have been no studies that have evaluated the combination of medication and a behavioral
      health treatment. The primary purpose of this study is to compare the benefits of the 4
      combinations listed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females 21-70

          -  Diagnosis of Fibromyalgia

          -  Current primary care physician

          -  Fluent in English

        Exclusion Criteria:

          -  Rheumatologic disorders

          -  Drug and alcohol abuse in the past year

          -  Psychiatric hospitalization in the past 6 months

          -  Current use of Tramadol

          -  Certain antidepressant and other pain medications
Adductor Canal Block Versus Femoral Nerve Block for Total Knee Arthroplasty
Condition: Arthropathy of Knee
MeSH terms: Joint Diseases
Intervention: Adductor Canal Nerve Block; Femoral Nerve Block
Intervention description: Adductor Canal never technique; Traditional technique
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The first two groups will have 50 participants each (100 total) the "Adductor Canal Nerve Catheter" group and the "Femoral Nerve Catheter," group. Participants will be randomized using block randomization. The blocks will be assigned randomly based on computer generated numbers.
Masking: Single (Participant)
Enrollment: 94.0
Sex: All
Minimum age: 19 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adductor Canal Block; Femoral Canal Block

Summary:

      Peripheral nerve blocks catheters of the femoral nerve have long been used for perioperative
      analgesia in total knee arthroplasty (TKA). These blocks provide effective analgesia and
      patient satisfaction for surgical pain relief. However, one of the main drawbacks to the
      femoral nerve block (FNB) is a denser motor block of the quadriceps muscle that can delay
      aggressive physical therapy and subsequent recovery from surgery. (1) Recently, there has
      been increasing interest in performing adductor canal blocks (ACB) with the aim of less motor
      blockade while providing commensurate analgesia compared to the FNB. (1,2) Current
      investigative reports have provided only preliminary data, and there is potential to change
      the standard of care for TKA as more data mounts in favor of ACBs. The goal of this study is
      to verify the analgesic equivalence of the two blocks, compare patient satisfaction, surgeon
      satisfaction, and physical therapy grading between the two blocks. Potentially, this would
      change the standard of care for TKA patients at this institution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient undergoing total knee arthroplasty with regional anesthesia planned for
             postoperative analgesia.

          -  Adult, 19 years of age or older

          -  Patient classified as American Society of Anesthesiology (ASA) class I, II, or III

        Exclusion Criteria:

          -  Any subject not classified as an ASA I, II, or III

          -  Allergy/intolerance to local anesthetic

          -  Pre-existing neurologic or anatomic deficit in lower extremity on the side of the
             surgical site

          -  Coexisting coagulopathy such as hemophilia or von Willebrand disease