bioihbjkbjnl/mcl2 huggingface dataset:
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab-Pfizer; Bevacizumab-EU; Paclitaxel; Carboplatin
Intervention description: Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.; bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy.; Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.; carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 719.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial
      evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin
      versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients
      with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients age at least 18 years of age, or age of consent in the
             region.

          -  Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised
             International System for Staging Lung Cancer criteria of 2010) or recurrent non-small
             cell lung cancer (NSCLC).

          -  Histologically or cytologically confirmed diagnosis of predominately non-squamous
             NSCLC.

          -  Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin
             based on local standard of care, for the treatment of advanced or metastatic
             non-squamous NSCLC.

        Exclusion Criteria:

          -  Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and
             mixed adenosquamous carcinomas of predominantly squamous nature.

          -  Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation
             that is likely to bleed.

          -  Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK
             translocation positive mutations.

          -  Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if
             surgical resection for primary disease was performed.
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Intervention: EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Intervention description: Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 470.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to
      tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and
             eligible for bilateral myringotomy and tympanostomy tube insertion.

          -  Suspected bacterial infection at time of surgery in at least 1 ear.

          -  Willing to refrain from water immersion of the ears following surgery without the use
             of adequate ear protection during swimming, bathing, showering and other water-related
             activities.

          -  Legally Authorized Representative (LAR) must read and sign the informed consent.

          -  Parent or caregiver must agree to comply with the requirements of the study and
             administer study medication as directed, complete required study visits, and comply
             with the protocol.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Previous otologic or otologic-related surgery within the past 30 days or ongoing
             complications.

          -  Middle ear pathology in either ear other than otitis media.

          -  Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions
             which could interfere with evaluation of the study drug.

          -  Any systemic disease or disorder, complicating factor or structural abnormality that
             would negatively affect the conduct or outcome of the study based upon assessment by
             the Investigator.

          -  Known or suspected allergy or hypersensitivity to quinolones or other active or
             inactive ingredients present in the medications to be used in the study.

          -  Other protocol-specified exclusion criteria may apply.
CORAL XT - Open-label Extension Trial of the CORAL Trial
Condition: Pain; Neoplasms; Chronic Pain
MeSH terms: Chronic Pain
Intervention: Cebranopadol
Intervention description: Film-coated tablet; strengths: 200, 400, or 600 µg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer-related pain; cebranopadol

Summary:

      The purpose of this trial was to find out how well cebranopadol is tolerated and how often,
      and which, adverse reactions occur when it is taken every day for a longer period of time. In
      addition, information was collected how cebranopadol affects pain and well-being in patients
      suffering from cancer-related pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent signed indicating that the participant understands the purpose of and
             procedures required for the trial and is willing to participate in the trial.

          -  Participants must be at least 18 years of age at the Enrollment Visit.

          -  Women of childbearing potential must have a negative pregnancy test at enrollment and
             must not be lactating at the Enrollment Visit.

          -  Participants must be willing to use medically acceptable and highly effective methods
             of birth control.

          -  Participants who have completed treatment in KF6005/07 and are still in need of
             around-the-clock pain analgesia with strong opioids.

        Exclusion Criteria:

          -  The participant has a clinically significant disease or condition other than cancer
             which in the investigator's opinion may affect efficacy or safety assessments.

          -  Known to or suspected of not being able to comply with the protocol and the use of
             cebranopadol.

          -  Participants taking forbidden concomitant medications or not being able to follow the
             rules of use of concomitant treatment.

          -  History of torsade de pointes and/or presence of risk factors for torsade de pointes
             (e.g., heart failure, hypokalemia, bradycardia).

          -  Concurrent participation in another trial (except participation in KF6005/07) or
             planning to be enrolled in another clinical trial (i.e., administration of
             experimental treatment in another clinical trial) during the course of this trial, or
             previous participation in this trial.

          -  Employees of the sponsor, investigator, or trial site or family members of the
             employees, sponsor, or investigator.
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
Condition: Opioid-Induced Bowel Dysfunction
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Opioid-Induced Constipation
Intervention: Lubiprostone 24
Intervention description: 24 mcg capsules for oral administration
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone
      administration in participants with opioid-induced bowel dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428

          -  Will continue to be treated consistently for chronic, non-cancer-related pain with any
             full agonist opiate and will continue opiate therapy for the duration of the study

          -  Willing to continue to abstain from use of disallowed medications as defined per
             protocol

        Exclusion Criteria:

          -  Has newly diagnosed impaired renal function identified at the Screening Visit [i.e.,
             serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]

          -  Has experienced an unexplained and/or clinically significant weight loss defined as >
             5% within 90 days prior to Screening Visit.

          -  Has plans to participate in another trial with an investigational drug or device
             during the course of the extension study
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Tolvaptan
Intervention description: Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1803.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADPKD

Summary:

      The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in
      participants with autosomal dominant polycystic kidney disease (ADPKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants ≥ 18 years with confirmed diagnosis of ADPKD (during
             participation in prior tolvaptan trials) who have completed and transferred from the
             double-blind Trial 156-13-210 (12-month period including post treatment follow-up,
             regardless of whether this was on-treatment or off-treatment), or completed Trial
             156-08-271 or a prior tolvaptan trial, or interrupted or discontinued treatment in a
             prior tolvaptan ADPKD trial other than Trial 156-13-210. Participants may be enrolled
             with the medical monitor approval, and additional close monitoring may be required at
             the beginning of the trial.

          -  eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m^2) within 3 months prior
             to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m^2 may be
             enrolled with medical monitor approval.

        Exclusion Criteria:

          -  Need for chronic diuretic use

          -  Hepatic impairment based on liver function abnormalities other than that expected for
             ADPKD with cystic liver disease

          -  Women of childbearing potential who do not agree to practice 2 different methods of
             birth control or remain abstinent during the trial and for 30 days after the last dose
             of investigational medicinal product (IMP)

          -  Women who are breast-feeding and/or who have a positive pregnancy test result prior to
             receiving IMP.

          -  Participants with contraindications to required trial assessments (contraindications
             to optional assessments, for example, magnetic resonance imaging [MRI] are not a
             limitation).

          -  Participants who in the opinion of the investigator or the medical monitor, have a
             medical history or medical finding inconsistent with safety or trial compliance
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Intervention: LPCN 1021
Intervention description: Oral testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021
      in adult hypogonadal male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6
             and 10 AM, on two separate days at approximately the same time of day, following an
             appropriate washout of current androgen replacement therapy.

          2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary
             hypogonadal (congenital or acquired).

          3. Naïve to androgen replacement or has discontinued current treatment and completed
             adequate washout of prior androgen therapy. Washout must be completed prior to
             collection of baseline serum T samples to determine study eligibility.

        Exclusion Criteria:

          1. History of significant sensitivity or allergy to androgens, or product excipients.

          2. Clinically significant findings in the pre-study examinations including abnormal
             breast examination requiring follow-up.

          3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).

          4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.

          5. Clinically significant abnormal laboratory value, in the opinion of the investigator,
             in serum chemistry, hematology, or urinalysis

          6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human
             immunodeficiency virus antibodies (HIV Ab).

          7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical
             procedure that might interfere with gastrointestinal motility, pH or absorption.

          8. History of any clinically significant illness, infection, or surgical procedure within
             1 month prior to study drug administration.

          9. History of stroke or myocardial infarction within the past 5 years.

         10. History of or current or suspected prostate or breast cancer.

         11. History of untreated and severe obstructive sleep apnea.

         12. History of long QT syndrome (QTc > 450) or unexplained sudden death in a first degree
             relative (parent, sibling, or child).
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Condition: Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Glecaprevir/Pibrentasvir
Intervention description: Fixed-dose combination tablets taken orally once a day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glecaprevir; pibrentasvir; compensated cirrhosis; non-cirrhotic; interferon (IFN); pegylated interferon (pegIFN); ribavirin (RBV); sofosbuvir (SOF); Sustained Virologic Response 12 weeks post dosing (SVR12); Chronic; Genotype 5 or 6 Infection

Summary:

      A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of
      glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic
      hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis
      respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.

          -  Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid
             (RNA) greater than or equal to 1000 IU/mL at Screening Visit.

          -  Participant must be HCV treatment-naïve (i.e., has never received a single dose of any
             approved or investigational anti-HCV medication) or treatment-experienced (i.e., has
             failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without
             ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior
             HCV treatment with any other approved or investigational medications is not allowed.
             Previous HCV treatment must have been completed greater than or equal to 2 months
             prior to screening.

          -  Participant must be documented as having no cirrhosis or compensated cirrhosis.

        Exclusion Criteria:

          -  Female participant who is pregnant, breastfeeding, or is considering becoming pregnant
             during the study or for approximately 30 days after the last dose of study drug.

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          -  Positive test result at screening for hepatitis B surface antigen (HBsAg) or
             anti-human immunodeficiency virus antibody (HIV Ab).

          -  HCV genotype performed during screening indicating co-infection with more than one HCV
             genotype.

          -  History of severe, life-threatening or other significant sensitivity to any excipients
             of the study drug.
Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Placebo; Vilazadone
Intervention description: Viibryd
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 402.0
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

          -  Patients with a history of meeting DSM-IV-TR criteria for:

               -  any manic, 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 cognitive disorders

          -  Patients who are considered a suicide risk
Ketamine to Prevent PPD After Cesarean
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression
Intervention: Ketamine 50 MG/ML; Control
Intervention description: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).; Administration of 0.9% Sodium Chloride (N/S)
Intervention MeSH terms: Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised to one of three groups (two interventional and one control).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The ketamine and placebo study injectates (subcutaneous and intravenous) will be prepared, in way that does not allow differentiation, by pharmacy staff who are otherwise uninvolved in the study. Participants will be allocated to groups using a random sequence generator. The patients, investigators and outcome assessors will remain unaware of their group until data collection is complete for all participants.
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The investigators plan to randomise participants to receive ketamine or placebo control
      subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to
      assess the incidence of postpartum depression. This feasibility pilot study is designed to
      explore the adequacy of the study procedures and tolerability of the interventions.
    

Eligibility criteria:

        Inclusion criteria:

          -  Term pregnancy

          -  Age 18-45 years of age

          -  Scheduled cesarean delivery under neuraxial anesthesia

        Exclusion criteria:

          -  ASA classification IV or V

          -  History of psychotic episodes

          -  History of allergy to ketamine

          -  Inability to communicate in English or any other barrier to providing informed consent