bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection
Condition: Prolonged Air Leak; Lung Resection
Intervention: Hemopatch; standard preventive measures
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Prevention PAL Prolonged Air Leak (PAL); Lung Resection; Thoracic Surgery; Post-operative Thoracic Air Leak

Summary:

      The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection
      procedures remains unproved. The investigators hypothesize that one of the main reasons for
      that is the heterogeneity of previously studied populations. Since currently the risk of
      postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to
      investigate the effect of routine application of a novel tissue sealant in patients selected
      on the basis of a high risk of PAL estimated before surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled anatomical lung resection indicated for any non-infectious disease
             (excluding Pneumonectomy)

          -  Patients classified in class D according estimated risk of PAL

          -  Age between 18 and 80 years

        Exclusion Criteria:

          -  Those patients that according to Investigator assessment are not going to tolerate the
             procedure

          -  Clinical and anesthetic criteria that contraindicate surgery

          -  Severe uncontrolled illness

          -  Pregnancy

          -  Patients that are under Investigational New Drug treatment or have participated in
             study with a investigational drug (authorized or not) in 30 days before randomization.

          -  Lack of Informed Consent or patient refusal

          -  Postsurgery mechanical ventilation or repeated surgery in follow-up month.
Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Condition: Thyroid Neoplasms
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo
Intervention description: Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).; Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RAI-Refractory; Differentiated; Follicular; Papillary; Hurthle

Summary:

      Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic
      differentiated thyroid cancer refractory to radioiodine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular
             and Hurthle cell)

          -  Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are
             eligible provided that the histology has no medullary differentiation nor anaplastic
             features

          -  Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors]
             should be used as a basis for the assessment of disease progression)

          -  RAI (radioactive iodine) refractory

        Exclusion Criteria:

          -  Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic
             and medullary carcinoma, lymphoma or sarcoma)

          -  Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies
             (licensed or investigational) that target VEGF (vascular endothelial growth factor) or
             VEGF Receptors or other targeted agents

          -  Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose
             chemotherapy for radiosensitization is allowed) or Thalidomide or any of its
             derivatives
Varenicline for Adolescent Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; placebo
Intervention description: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.; participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: All
Minimum age: 14 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21.
      After assessment and inclusion into the study, participants will be randomized to receive a
      12-week double blind course of varenicline or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 14-21

          -  Daily smoker for ≥6 months

          -  Desire to quit smoking, with at least one prior failed quit attempt and willingness to
             participate in a treatment study

          -  If under age 18, parent(s) or guardian(s) able to participate in informed consent and
             initial assessment (unless the participant provides evidence of emancipated status)

          -  If female, agreement to use birth control (any form of hormonal contraception such as
             Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine
             device; sterilization; or double barrier contraception, which is a combination of any
             two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy

        Exclusion Criteria:

          -  Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive
             disorder, bipolar disorder, schizophrenia)

          -  Lifetime history of suicidality, homicidality, or clinically significant
             hostility/aggression

          -  Current substance dependence, other than nicotine

          -  Current unstable major medical disorder

          -  Current pregnancy or breastfeeding

          -  Current use of medications with smoking cessation efficacy

          -  Known hypersensitivity to varenicline
Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
Condition: Bacterial Pneumonia; Community-Acquired Infections
MeSH terms: Pneumonia; Pneumonia, Bacterial; Community-Acquired Infections
Intervention: Omadacycline; Moxifloxacin
Intervention description: Injection for IV; Oral tablets; IV solution; Oral tablets
Intervention MeSH terms: Moxifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 774.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared
      to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, ages 18 years or older who have signed the informed consent

          -  Has qualifying bacterial pneumonia

          -  Female patients must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

        Exclusion Criteria:

          -  Known or suspected hospital-acquired pneumonia

          -  Evidence of significant immunological disease

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to any
             fluoroquinolone antibiotic

          -  Has received an investigational drug within past 30 days

          -  Women who are pregnant or nursing
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
Condition: Complicated Urinary Tract Infection; Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: plazomicin; meropenem; levofloxacin (oral)
Intervention MeSH terms: Levofloxacin; Meropenem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 609.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cUTI; AP; ACHN-490; anti-infective; anti-bacterial; antibiotic; anti-microbial; UTI; bacterial infection; Gram-negative

Summary:

      This was a randomized, multicenter, multinational, double-blind study comparing the efficacy
      and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in
      the treatment of cUTI, including AP, in adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Pyuria

          -  Have a pretreatment baseline urine culture obtained within 36 hours before the start
             of administration of the first dose of study drug

          -  Clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract
             infection

          -  Normal renal function or moderate renal impairment

        Key Exclusion Criteria:

          -  Confirmed fungal urinary tract infection at the time of randomization

          -  Known urinary tract infection or colonization with Gram-positive pathogens

          -  Current cUTI or AP is known to be caused by a pathogen resistant to meropenem

          -  Female participants of childbearing potential if they are known to be pregnant or have
             a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a
             highly effective method of birth control during the study and for at least 30 days
             following the last dose of study medication

          -  Any rapidly progressing disease or immediately life-threatening illness

          -  Documented presence of immunodeficiency or an immunocompromised condition

          -  Documented or known history of otologic surgery or disease including use of hearing
             aid, head injury leading to otologic damage, Ménière's disease, tumor of the head,
             neck, or auditory system, perilymphatic fistula, or autoimmune disease of the inner
             ear, or family history of hearing loss (excluding age-related hearing loss [onset
             after age of 65 years])
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Condition: Meniere Disease
MeSH terms: Meniere Disease
Intervention: OTO-104; Placebo
Intervention description: Single intratympanic injection of 12 mg dexamethasone; Single intratympanic injection of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Placebo-controlled, Multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Meniere's Disease; Vertigo; Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Summary:

      The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of
      Meniere's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of
             Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo
             for the 2 months prior to the study lead-in period.

          -  Subject has experienced active vertigo during the lead-in period.

          -  Subject has documented asymmetric sensorineural hearing loss.

          -  Subject agrees to maintain their current treatments for Meniere's disease while
             on-study.

        Exclusion Criteria:

          -  Subject is pregnant or lactating.

          -  Subject has a history of immunodeficiency disease.

          -  Subject has a history of significant middle ear or inner ear surgery, or endolymphatic
             sac surgery in the affected ear.

          -  Subject has a history of tympanostomy tubes with evidence of perforation or lack of
             closure.

          -  Subject has a history of vestibular migraine.

          -  Subject has used an investigational drug or device in the 3 months prior to screening.

          -  Subject has previously been randomized to a clinical study of OTO-104.
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
Condition: Kidney Neoplasms
MeSH terms: Kidney Neoplasms
Intervention: Sunitinib malate; Placebo
Intervention description: sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.; Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent
Intervention MeSH terms: Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 674.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the disease free survival time and safety of sunitinib with placebo in adjuvant
      treatment patients at high risk of recurrent kidney cancer after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High risk renal cancer per modified UISS criteria

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

          -  predominant clear cell histology

          -  No prior anti-cancer treatment

          -  Kidney tumor has been removed

          -  No evidence of macroscopic disease following surgery

        Exclusion Criteria:

          -  Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma,
             sarcoma or subjects with metastatic renal sites.

          -  Diagnosis of any second malignancy within the last 5 years, except basal cell
             carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that
             has been adequately treated with no evidence of recurrent disease for 12 months

          -  known HIV or Hepatitis

          -  any severe acute or chronic medical or psychiatric condition or laboratory abnormality
             that may increase the risk associated with study participation or study drug
             administration
A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
Condition: Asthma
MeSH terms: Asthma
Intervention: Zero-dose; 90 mcg of PROAIR® HFA; 180 mcg of 90 mcg of PROAIR® HFA; 90 mcg of albuterol sulfate inhalation aerosol
Intervention description: Treatment A; Treatment B; Treatment C; Treatment D
Intervention MeSH terms: Albuterol; Procaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90
      mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate)
      Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild
      Asthma
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or non-pregnant women 18 to 65 years of age.

          2. Signed informed consent form that meets all criteria of current Food and Drug
             Administration (FDA) regulations.

          3. Females of childbearing potential must not be pregnant or lactating (as confirmed by a
             negative urine pregnancy test

          4. Ability to use inhalation aerosol correctly.

        Exclusion Criteria:

          1. Any clinically significant finding on physical exam in the opinion of the
             Investigator, would compromise subject's safety or data integrity.

          2. Employees of the Investigator or research center or their immediate family members.

          3. Previous participation in this study.

          4. Inability to understand the requirements of the study and the relative information and
             are unable or not willing to comply with the study protocol.
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Faster-acting insulin aspart; insulin aspart; insulin degludec
Intervention description: Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.; Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.; Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy
      in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in
      combination with insulin degludec in adults with Type 1 Diabetes Mellitus.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and
        Taiwan: age greater than or equal to 20 years) at the time of signing informed consent -
        Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory
        analysis as per local guidelines) 12 months or more prior to screening - Currently treated
        with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) -
        Currently treated with a basal insulin analogue for at least 4 months prior to screening
        (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central
        laboratory - Body Mass Index less than or equal to 35.0 kg/m^2 Exclusion Criteria: - Within
        the past 180 days any of the following: myocardial infarction, stroke or hospitalization
        for unstable angina and/or transient ischemic attack - Subjects presently classified as
        being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or
        peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation
        within the last 180 days prior to screening (Visit 1) - Treatment with any medication for
        the indication of diabetes or obesity other than stated in the inclusion criteria in a
        period of three months before screening (Visit 1)
Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: ARQ-151 0.3% cream; ARQ-151 vehicle cream
Intervention description: ARQ-151 0.3% cream; ARQ-151 vehicle cream
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 442.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day
      for 56 days by subjects with chronic plaque psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants legally competent to sign and give informed consented and if appropriate
             assent as required by local laws

          -  Males and females ages 2 years and older (inclusive)

          -  Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for
             children) as determined by the Investigator

          -  Females of childbearing potential (FOCBP) must have a negative pregnancy test at
             Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must
             agree to use at least one form of highly effective contraception throughout the trial.

          -  In good health as judged by the Investigator, based on medical history, physical
             examination, serum chemistry labs, hematology values, and urinalysis.

          -  Subjects considered reliable and capable of adhering to the Protocol and visit
             schedule, according to the judgment of the Investigator.

        Exclusion Criteria:

          -  Planned excessive exposure of treated area(s) to either natural or artificial
             sunlight, tanning bed or other LED.

               -  Females who are pregnant, wishing to become pregnant during the study, or are
                  breast-feeding.

               -  Previous treatment with ARQ-151 or its active ingredient

               -  Subjects with any serious medical condition or laboratory abnormality that would
                  prevent study participation or place the subject at significant risk, as
                  determined by the Investigator.

               -  Subjects with a history of chronic alcohol or drug abuse within 6 months of
                  initiation of investigational product

               -  Subjects who are unable to communicate, read or understand the local language, or
                  who display another condition, which in the Investigator's opinion, makes them
                  unsuitable for clinical study participation