bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: AZD1222; Placebo
Intervention description: AZD1222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.; Commercially available 0.9% (n/V) saline for injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double Blind: two or more parties are unaware of the intervention assignment.
Enrollment: 32450.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19 Vaccine

Summary:

      The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the
      prevention of COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Increased risk of SARS-CoV-2 infection

          -  Medically stable

        Exclusion Criteria:

          -  confirmed or suspected immunosuppressive or immunodeficient state

          -  significant disease, disorder, or finding

          -  Prior or concomitant vaccine therapy for COVID-19
Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: interferon γ-1b
Intervention description: ACTIMMUNE® will be administered three times per week by subcutaneous injection. The initial dose will be individualized for each participant and will be determined by the investigator, provided that the initial dose does not exceed the maximum tolerated dose in HZNP-ACT-302 (NCT02593773). The investigator may subsequently adjust the dose for any participant if deemed clinically appropriate, provided that the dose does not exceed 100 μg/m².
Intervention MeSH terms: Interferons; Interferon-gamma
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 11 Years
Maximum age: 27 Years
Healthy volunteers: No
Keywords: ACTIMMUNE; interferon y-1b

Summary:

      The purpose of this long term extension study is to evaluate the long-term safety of
      ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and child assent, if applicable.

          -  Completed 26 weeks of treatment and the Week 28 Follow-Up visit in Study HZNP-ACT-302
             (NCT02593773).

          -  If female, the subject is not pregnant or lactating or intending to become pregnant
             during the study, or within 30 days after the last dose of study drug. Female subjects
             of child-bearing potential must have a negative urine pregnancy test result at Week 26
             of Study HZNP-ACT-302 (NCT02593773) and agree to use a reliable method of
             contraception throughout the study and for 30 days after the last dose of study drug.

        Exclusion Criteria:

          -  If in the opinion of the Investigator, patients have a concomitant disease or
             condition that could interfere with the conduct of the study or potentially put the
             subject at unacceptable risk, the subject will be excluded from the study.
A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
Condition: Pain
MeSH terms: Toothache
Intervention: Ibuprofen/Caffeine; Ibuprofen; Placebo
Intervention description: Ibuprofen/Caffeine fixed-dose combination; Ibuprofen capsule; Placebo treatment
Intervention MeSH terms: Ibuprofen; Caffeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 374.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: third molar extraction; ibuprofen; ibuprofen/caffeine; post-surgical dental pain

Summary:

      An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental
      pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 16 years to 40 years of age (inclusive).

          -  Subjects who have undergone outpatient surgical extraction of 3 or more third molars,
             of which at least 2 must be a partial or complete bony mandibular impaction within 30
             days of Screening and have met baseline pain criteria as described in this protocol

          -  Examined by the attending dentist or physician and medically cleared to participate in
             the study.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
             metabolic or allergic disease (including drug allergies, but excluding untreated,
             asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator
             to place the subject at increased risk including the presence or history within 2
             years of screening of the following medical conditions/disorders:

               -  Bleeding disorder;

               -  Gastrointestinal ulcer or gastrointestinal bleeding;

               -  Paralytic ileus or other gastrointestinal obstructive disorders.

          -  Pregnant female subjects; breastfeeding female subjects; fertile male subjects and
             female subjects of childbearing potential who are unwilling or unable to use a highly
             effective method of contraception

          -  Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or
             other component of the product.
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Bardoxolone methyl
Intervention description: Capsules of Bardoxolone methyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; Pulmonary Hypertension; PH; PAH; Bardoxolone methyl; 6-minute walk distance; CDDO-ME; RTA 402; LARIAT; CATALYST; RANGER

Summary:

      This extended access study will assess the long-term safety and tolerability of bardoxolone
      methyl in qualified patients with pulmonary hypertension (PH) who previously participated in
      controlled clinical studies with bardoxolone methyl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment-compliant patients who are participating in qualifying ongoing studies and
             have completed required End-of-Treatment and/or Follow-up visits in a prior clinical
             study with bardoxolone methyl

        Exclusion Criteria:

          -  Participation in other investigational clinical studies involving interventional
             products being tested or used in a way different from the approved form or when used
             for an unapproved indication;

          -  Patients who have an ongoing SAE from a clinical study that is assessed by the
             investigator as related to bardoxolone methyl;

          -  Unwilling to practice acceptable methods of birth control (both males who have
             partners of childbearing potential and females of childbearing potential) while taking
             study drug;

          -  Women who are pregnant or breastfeeding;

          -  Patient is, in the opinion of the investigator, unable to comply with the requirements
             of the study protocol or is unsuitable for the study for any reason;

          -  Known hypersensitivity to any component of the study drug
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Condition: Dry Eye Syndromes; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Intervention: KPI-121 0.25% Ophthalmic Suspension; Vehicle of KPI-121 0.25% Ophthalmic Suspension
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: 918.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular Discomfort; Pain; Corticosteroid; Hyperemia; Dry Eye

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%
      ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented
      clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2
      drops instilled in each eye four times daily (QID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a documented clinical diagnosis of dry eye disease in both eyes

        Exclusion Criteria:

          -  Known hypersensitivity or contraindication to the investigational 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; or have
             been exposed to an investigational drug within 30 days prior to screening.

          -  In the opinion of the Investigator or study coordinator, be unwilling or unable to
             comply with study protocol or unable to successfully instill eye drops.
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab SAR231893 (REGN668)
Intervention description: Pharmaceutical form: prefilled syringes
Route of administration: subcutaneous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 393.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To describe the long-term safety of dupilumab in treatment of participants with moderate to
      severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with asthma who completed the treatment period in the previous dupilumab
             asthma clinical study LTS12551.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Participants who experienced any systemic hypersensitivity reactions to the
             investigational medicinal product in the previous dupilumab asthma study LTS12551,
             which, in the opinion of the Investigator, could indicate that continued treatment
             with dupilumab might present an unreasonable risk for the participant.

          -  Clinically significant comorbidity/lung disease other than asthma.

          -  Participants with active autoimmune disease or participants who, as per Investigator's
             medical judgment, were suspected of having high risk for developing autoimmune
             disease.

          -  History of malignancy within 5 years before enrollment except completely treated in
             situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous
             or basal cell carcinoma of the skin.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Condition: Multiple Sclerosis; Walking Impairment
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: ADS-5102, 274 mg
Intervention description: Oral capsules
Intervention MeSH terms: Amantadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and
      walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102
      in subjects with MS (ADS-AMT-301).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed a current IRB-approved informed consent form

          -  Successful completion of a prior double blind study of ADS-5102 in patients with MS
             walking impairment.

        Exclusion Criteria:

          -  Based on the judgment of the investigator or Medical Monitor, participation in the
             study would jeopardize the safety of the subject.

          -  If female, is pregnant or lactating

          -  If a sexually active female, is not surgically sterile or at least 2 years
             post-menopausal, or does not agree to utilize a highly effective hormonal method of
             contraception (an IUD, or vasectomized male partner is also acceptable), in
             combination with a barrier method, from baseline through at least 4 weeks after the
             completion of study treatment. If a sexually active male, does not agree to utilize
             condoms from screening through at least 4 weeks after the completion of study
             treatment.

          -  Anticipated treatment with any amantadine formulation other than ADS-5102

          -  Planned participation in another interventional clinical trial
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
Condition: Cystic Fibrosis
MeSH terms: Infections; Cystic Fibrosis; Fibrosis
Intervention: Liposomal amikacin for inhalation
Intervention description: Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.
590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.
Administration time is approximately 13 minutes.
Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment.
Intervention MeSH terms: Amikacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Respiratory Infections; Pulmonary Cystic Fibrosis; cystic fibrosis transmembrane conductance regulator (CFTR); Anti-bacterial Agent; Arikayce; ALIS; LAI

Summary:

      The purpose of this study is to evaluate the long term safety and tolerability of Liposomal
      Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic
      infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension
      study enrolled subjects who had successfully completed study TR02-108, were compliant with
      the study protocol, and did not meet any of the listed study discontinuation criteria. The
      safety and tolerability of LAI were evaluated for up to approximately 2 years.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Written informed consent or assent

          -  Subject has completed study TR02-108, and has been compliant with the study protocol

          -  Women of childbearing potential must agree to use reliable methods of contraception
             for the duration of the study

        Key Exclusion Criteria:

          -  Subject met any of the listed criteria for study drug discontinuation in protocol
             TR02-108.

          -  Abnormal laboratory assessments including LFT (≥ 3× upper limit of normal [ULN]),
             serum creatinine (> 2× ULN) and absolute neutrophil count [ANC] (< 1000).

          -  Psychotic, addictive or other disorder limiting the ability to provide informed
             consent or to comply with study requirements.

          -  History of alcohol, medication or illicit drug abuse within the 6 months prior to
             consent.

          -  Smoking tobacco or any substance within 6 months prior to consent or anticipated
             inability to refrain from smoking throughout the study
Pentoxifylline Treatment in Acute Pancreatitis (AP)
Condition: Acute Pancreatitis (AP); Gallstone Pancreatitis; Alcoholic Pancreatitis; Trauma Acute Pancreatitis; Hypertriglyceridemia Acute Pancreatitis; Idiopathic (Unknown) Acute Pancreatitis; Medication Induced Acute Pancreatitis; Cancer Acute Pancreatitis; Miscellaneous (i.e. Acute on Chronic Pancreatitis)
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Gallstones; Pancreatitis, Alcoholic; Hypertriglyceridemia
Intervention: Pentoxifylline; Placebo
Intervention description: Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits Tumor Necrosis Factor (TNF) and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors; A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug
Intervention MeSH terms: Pentoxifylline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) pancreatitis

Summary:

      The purpose of this study was to determine the effects (good and bad) of giving a drug called
      pentoxifylline to patients with acute pancreatitis.
    

Eligibility criteria:

        Inclusion criteria

          -  Enrollment within 72 hours of diagnosis of acute pancreatitis (AP)

          -  Ability to give informed consent or a Legal Adult Representative (LAR) able to give
             informed consent for subject when needed as defined buy LAR use guidelines.

          -  Adult subjects of age ≥18 years.

        Exclusion Criteria:

          -  Moderate or severe congestive heart failure

          -  History of seizure disorders or demyelinating disease

          -  Nursing mothers

          -  Pregnancy

          -  History of prior tuberculosis or risk factors for tuberculosis

          -  Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal
             failure, chemotherapy within 60 days, and HIV)

          -  Evidence of active hemorrhage

          -  Paralytic ileus with severe nausea and vomiting
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Condition: Agitation in Dementia, Including Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation
Intervention: ITI-007; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled study comparing the efficacy and
      safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation
      in patients with dementia, including Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of probable Alzheimer's disease

          -  Clinically significant symptoms of agitation secondary to probable Alzheimer's disease

          -  Able to attend outpatient clinic visits with primary caregiver

        Exclusion Criteria:

          -  Unable to comply with study procedures

          -  Considered medically inappropriate for study participation
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spondyloarthritis; Spondylarthropathy

Summary:

      The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab
      compared to placebo in participants with active psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6
             months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

          -  Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints

          -  Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)

          -  Men must agree to use a reliable method of birth control or remain abstinent during
             the study

          -  Women must agree to use reliable birth control or remain abstinent during the study
             and for at least 12 weeks after stopping treatment

          -  Have been treated with 1 or more conventional disease-modifying antirheumatic drugs
             (cDMARDs)

        Exclusion Criteria:

          -  Current or prior use of biologic agents for treatment of Ps or PsA

          -  Inadequate response to greater than or equal to 4 conventional disease-modifying
             antirheumatic drugs (DMARDS)

          -  Current use of more than one cDMARDs

          -  Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other
             than PsA

          -  Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal
             antibody (MAb) therapy

          -  Serious disorder or illness other than psoriatic arthritis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women