bioihbjkbjnl/mcl2 huggingface dataset:
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
Condition: ATTR-PN
MeSH terms: Amyloidosis
Intervention: Tafamidis
Intervention description: 20 mg oral Fx-1006A daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, open-label study designed to obtain additional long-term safety and
      efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD).
      In addition, this study continued to provide tafamidis to Val30Met subjects who had completed
      Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a
      randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and
      efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase
      2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for
      up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon
      regulatory approval for the treatment of ATTR-PN in their respective country and access to
      prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were
      considered study completers.
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Subject had successfully completed either Protocol Fx-006 or Fx-1A-201.

          -  Male or female subjects with ATTR-PN who had not undergone liver or heart
             transplantation at time of enrollment.

          -  If female, subject was post-menopausal, surgically sterilized, or willing to use an
             acceptable method of birth control

        Key Exclusion criteria:

          -  Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs)

          -  Pregnant or breast feeding female subjects.

          -  Clinically significant medical condition that, in the opinion of the investigator,
             would place the subject at an increased risk to participate in the study.

          -  An alanine aminotransferase (ALT) and aspartate aminotransferase (AST) value >3 ×
             upper limit of normal (ULN) that, in the medical judgment of the investigator, was due
             to reduced liver function or active liver disease.

          -  Sexually active males with partners of childbearing potential not using highly
             effective contraception or not agreeing to continue highly effective contraception for
             at least 3 months after last dose of study drug.
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
Condition: Surgical Skin Preparation
Intervention: ZuraPrep Clear Solution; ChloraPrep; ZuraPrep Vehicle
Intervention description: Apply topically.; Apply topically.; Apply topically.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex
      Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of
      human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good general health

          -  Minimum bacterial baseline requirements on abdomen and groin

          -  Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder
             near or on the applicable test area.

        Exclusion Criteria:

          -  Topical or systemic antimicrobial exposure within 14 days prior to screening and
             treatment days, including antibiotics.

          -  Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to
             screening and treatment days, excluding contraception or post-menopausal treatment.

          -  Subjects with allergies to study materials including isopropyl alcohol or
             chlorhexidine gluconate.

          -  Subjects with a history of skin sensitivity, skin allergies, or skin cancer.

          -  Subjects who are pregnant, attempting pregnancy or nursing.
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Riociguat (Adempas, BAY63-2521)
Intervention description: BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
Intervention MeSH terms: Riociguat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic thromboembolic Hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC

Summary:

      Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348)
      will be asked to participate in this long term extension study with BAY63-2521. The aim of
      the long term study is to collect additional information to evaluate the safety and
      tolerability of BAY63-2521. Patients will be treated with open label medication on their
      individual optimal dose between 0,5 mg - 2,5 mg tid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

        Exclusion Criteria:

          -  Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as
             related to BAY63-2521 are not allowed to participate in the extension trial
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab; Placebo
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      This study will evaluate higher versus standard adalimumab dosing regimens for induction and
      maintenance therapy in subjects with moderately to severely active Crohn's Disease and
      evidence of mucosal ulceration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during
             the Screening Period.

          -  Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral
             corticosteroids and/or immunosuppressants.

          -  Mucosal ulceration on endoscopy.

        Exclusion Criteria:

          -  Subject with ulcerative colitis or indeterminate colitis.

          -  Subject who has had surgical bowel resections in the past 6 months or is planning
             resection.

          -  Subjects with an ostomy or ileoanal pouch.

          -  Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

          -  Subject who has short bowel syndrome.

          -  Chronic recurring infections or active Tuberculosis (TB).
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: Botulinum Toxins, Type A; Placebos
Intervention description: Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: glabellar lines, frown lines

Summary:

      This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to
      severe frown lines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent including authorization to release health information

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the
             Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient
             Frown Wrinkle Severity (PFWS) scale

          -  Willing and able to follow all trial procedures, attend all scheduled visits, and
             successfully complete the trial

        Exclusion Criteria:

          -  Any neurological condition that may place the subject at increased risk with exposure
             to botulinum toxin type A, including peripheral motor neuropathic diseases such as
             amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional
             disorders such as Lambert-Eaton syndrome and myasthenia gravis

          -  Active skin disease, infections or inflammation at the injection sites

          -  Plan to receive botulinum toxin type A anywhere in the face through the duration of
             the study

          -  History of allergy or sensitivity to any botulinum toxin preparations or to any
             component of the test article

          -  Current enrollment in an investigational drug or device trial or participation in such
             a trial within the last 30 days prior to screening through end of trial
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Condition: Uncontrolled Asthma
MeSH terms: Asthma
Intervention: Experimental: Tralokinumab; Placebo
Intervention description: Tralokinumab subcutaneous injection; Placebo subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 856.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3
      Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with
      Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12 -75

          2. Documented physician-diagnosed asthma.

          3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg
             fluticasone propionate dry powder formulation equivalents) and a LABA

          4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of
             age) of their PNV.

          5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1

          6. ACQ-6 score ≥1.5

        Exclusion Criteria:

          1. Pulmonary disease other than asthma

          2. History of anaphylaxis following any biologic therapy

          3. Hepatitis B, C or HIV

          4. Pregnant or breastfeeding

          5. History of cancer

          6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years

          7. Previous receipt of tralokinumab
Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Wilate
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to obtain additional data on the safety and efficacy of Wilate
      in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII
      concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs,
      thus supplementing the existing database to obtain approval of Wilate for the indication
      hemophilia A in the USA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Severe hemophilia A (<1% FVIII:C) according to medical history

          2. Male patients aged ≥12 years

          3. Previous treatment with a FVIII concentrate for at least 150 exposure days (EDs)

          4. Immunocompetence (CD4+ count >200/µL)

          5. Good documentation of the historical bleeding rate (at least for the 6 months
             preceding study start)

          6. Voluntarily given, fully informed written and signed consent obtained by the patient
             (or parent/legal guardian in case of adolescents) before any study-related procedures
             are conducted

        Whenever possible, the interval between the Screening Visit and the PK or Non-PK Visit
        should not exceed 30 days. If the 30-day interval is exceeded, determination of the CD4+
        count is to be repeated and must be >200/µL for patients to be enrolled (i.e., exclusion
        criterion no. 4).

        Exclusion Criteria:

          1. Any coagulation disorders other than hemophilia A

          2. History of FVIII inhibitor activity (≥0.6 BU) or detectable FVIII inhibitory
             anti-bodies (≥0.6 BU using the Nijmegen modification of the Bethesda assay) at
             screening, as determined by the central laboratory

          3. Severe liver or kidney diseases (alanine aminotransferase [ALAT] and aspartate
             transaminase [ASAT] levels >5 times of upper limit of normal, creatinine>120 µmol/L)

          4. Patients receiving or scheduled to receive immunomodulating drugs (other than
             anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10
             mg/day), or similar drugs

          5. Treatment with any investigational medicinal product in another interventional
             clinical study currently or within 4 weeks before enrollment
Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's
Condition: Dupuytren's Disease
MeSH terms: Dupuytren Contracture
Intervention: collagenase injection; limited palmar fasciectomy
Intervention description: injection; surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both
      the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus
      limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms
      of improved quality of life and reducing recurrence of the disease without serious
      complications. Since collagenase injections are costly it is also important to know if this
      novel intervention is cost-effective from the patient, Ministry of Health and societal
      perspectives.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Canadian Citizen

          2. 18 years of age or older

          3. Dupuytren's contracture of the metacarpophalangeal (MCP) joint or of the proximal
             interphalangeal (PIP) joint with a fixed flexion contracture of 20º or greater in at
             least 1 finger (not the thumb)

          4. Demonstrated inability to simultaneously place the affected finger and palm flat on a
             table

          5. Able to understand and communicate in English

        Exclusion Criteria:

          1. Previous treatment of the primary joint within 90 days of study inclusion

          2. Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel
             release, stenosing tenosynovitis release)

          3. Persistent extension deficit from a previous surgery of the same digit

          4. Any chronic muscular or neuromuscular disorder affecting wrist or hand

          5. Patient generally unfit for surgery

          6. Patient with specific treatment preference

          7. Bleeding disorder or recent stroke

          8. Allergy to collagenase

          9. Collagenase treatment or treatment with any investigational drug within 30 days of
             study inclusion

         10. Use of a tetracycline derivative within 14 days of first dose of study drug (because
             tetracycline derivatives may inhibit the collagenolytic activity of mammalian
             collagenase homologs [i.e., matrix metalloproteinases])

         11. Pregnant or breast feeding patients

         12. Patients who do not have insurance coverage for collagenase injections

         13. Patients who are unable to provide informed consent or are unable to complete quality
             of life questionnaires due to mental capacity or neuro-psychological problems.
A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin
Condition: Various Advanced Cancer
Intervention: Nivolumab; Ipilimumab; Cisplatin; Fluorouracil
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Fluorouracil; Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 970.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare how long subjects with esophageal cancer live
      overall or live without disease progression after receiving nivolumab and ipilimumab or
      nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have histologically confirmed squamous cell carcinoma or adenosquamous cell
             carcinoma of esophagus

          -  Male or Female at least 18 years of age

          -  Must have esophageal cancer that cannot be operated on, or treated with definitive
             chemoradiation with curative intent, that is advanced, reoccurring or has spread out

          -  Must have full activity or, if limited, must be able to walk and carry out light
             activities such as light house work or office work

          -  Must agree to provide tumor tissue sample, either from a previous surgery or biopsy
             within 6 months or fresh, prior to the start of treatment in this study

        Exclusion Criteria

          -  Presence of tumor cells in the brain or spinal cord which are symptomatic or require
             treatment

          -  Active known or suspected autoimmune disease

          -  Any serious or uncontrolled medical disorder or active infection

          -  Known history of positive test for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome (AIDS)

          -  Any positive test result for hepatitis B or C indicating acute or chronic infection
             and/or detectable virus

        Other protocol defined inclusion/exclusion criteria apply
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: TEZ/IVA; IVA
Intervention description: Fixed-dose combination tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of tezacaftor in combination
      with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older,
      homozygous or heterozygous for the F508del mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the Week 24 Visit in Study 113 Part B or the Week 8 Visit in Study 115.

          -  Eligible CFTR Mutation.

        Exclusion Criteria:

          -  Pregnant and nursing females.

          -  History of poor compliance with study drug and/or procedures in a previous study as
             deemed by the investigator.

          -  Ongoing participation in another study with investigational drug.

        Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461
Intervention description: Sublingual tablet taken once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: depression; major depressive disorder; Alkermes; ALKS 5461; samidorphan; buprenorphine

Summary:

      This is a Phase 3 study designed to evaluate the safety and tolerability of two titration
      schedules for ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index of 18-40 kg/m2

          -  Have a diagnosis of MDD

          -  Have a current major depressive episode (MDE) lasting 8 weeks to 24 months

          -  Have been treated with an adequate dose of an approved antidepressant during the
             current MDE for at least 8 weeks

          -  Have an inadequate response to current antidepressant treatment

          -  Agree to use an approved method of birth control for the duration of the study

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Currently pregnant or breastfeeding

          -  History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human
             Immunodeficiency Virus (HIV)

          -  Have experienced hallucinations, delusions, or any psychotic symptoms in the current
             MDE

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 5 years

          -  Have attempted suicide within the past 2 years

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation with 60 days of screening

          -  Additional criteria may apply