bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older
Condition: Tick-Borne Encephalitis
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Intervention: TBE vaccine 0.5 mL; TBE vaccine 0.25 mL
Intervention description: TBE vaccine 0.5 mL (intramuscular injection).; TBE vaccine 0.25 mL (intramuscular injection).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to provide safety and immunogenicity data in Japanese
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or female participants ≥1 years old at Visit 1.

          -  Participants and/or a legally acceptable representative/parent/legal guardian are
             willing and able to comply with all scheduled visits, vaccination plan, and other
             study procedures including completion of the e-diary for 7 days for participants after
             each of 3 vaccinations.

          -  Participants and/or a legally acceptable representative/parent/legal guardian must be
             able to be contacted by telephone during study participation.

          -  Participants and/or a legally acceptable representative/parent/legal guardian are
             capable of giving signed informed consent.

        Exclusion Criteria:

          -  Major known congenital malformation or serious chronic disorder.

          -  Known history of TBEV infection.

          -  Known history of other flavivirus infection (eg, dengue fever, yellow fever, JEV, West
             Nile virus).

          -  Known history of infection with HIV, HCV, or HBV.

          -  Immunocompromised participants with known or suspected immunodeficiency.

          -  History of autoimmune disease or an active autoimmune disease requiring therapeutic
             intervention.

          -  Previous vaccination with any licensed or investigational TBE vaccine, or planned
             receipt of other flavivirus vaccines apart from JEV vaccine (eg, yellow fever, dengue
             fever) during the study. Administration of JEV vaccine is prohibited during
             participation.
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: NKTR-214; Nivolumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 783.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: NKTR-214; Nivolumab; Immunotherapy; bempegaldesleukin (BEMPEG: NKTR-214)

Summary:

      The purpose of the study is to test the effectiveness (how well the drug works), safety, and
      tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus
      nivolumab given alone in participants with previously untreated melanoma skin cancer that is
      either unable to be surgically removed or has spread
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or
             older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)

          -  Histologically confirmed stage III (unresectable) or stage IV melanoma

          -  Treatment-naive participants (ie, no prior systemic anticancer therapy for
             unresectable or metastatic melanoma) with the exception of prior adjuvant and/or
             neoadjuvant treatment for melanoma with approved agents

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases

          -  Uveal melanoma

          -  Participants with an active, known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria apply
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Intervention: beta blockers; amiodarone; ascorbic acid
Intervention description: metoprolol 25mg by mouth every 6 hours; amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively; ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
Intervention MeSH terms: Ascorbic Acid; Amiodarone; Metoprolol; Adrenergic beta-Antagonists
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; cardiac surgery; open heart surgery

Summary:

      Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring
      in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart
      valve repair/replacement patients. Efforts to decrease the high rates of AF have not made
      great inroads to the problem. The current standard of care is the use of preoperative and
      postoperative beta blockers. We propose to compare the use of prophylactic oral ascorbic acid
      with and without prophylactic oral amiodarone, in combination with oral beta blockers, for
      the prevention of atrial fibrillation after open heart surgery. The hypothesis is that either
      drug, or a combination of the two drugs, will be superior and safe when compared to beta
      blockers alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults (18 years of age or older)

          -  all comers for elective or urgent open heart surgery ( CABG, Valve repair or
             replacement, Combined CABG/Valves, CABG/other, Other)

        Exclusion Criteria:

          -  patients who refuse to participate

          -  patients with a history of atrial fibrillation or atrial flutter

          -  pediatric patients (under 18 years of age)

          -  Emergency surgery

          -  patients with contraindications to study medications

          -  patients with untreated thyroid disease, hepatic failure, pregnancy
FUTURE 3 Study Extension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Bosentan
Intervention description: Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
Intervention MeSH terms: Bosentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 3 Months
Maximum age: 12 Years
Healthy volunteers: No
Keywords: pediatric; pulmonary arterial hypertension; bosentan; Tracleer

Summary:

      The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety,
      tolerability and efficacy of the pediatric formulation of bosentan two versus three times a
      day in children with Pulmonary Arterial Hypertension (PAH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely
             discontinued due to PAH-progression, if bosentan was not permanently discontinued

          2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is
             considered beneficial at the end of the FUTURE 3 core study (AC-052-373)

          3. Signed informed consent by the parents or the legal representatives prior to any
             study-mandated procedure.

        Exclusion Criteria:

          1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the
             dispersible bosentan tablet

          2. Any clinically significant laboratory abnormality that precludes continuation of
             bosentan therapy

          3. Pregnancy

          4. AST and/or ALT values > 3 times the upper limit of normal range (ULN)

          5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C

          6. Premature and permanent study drug discontinuation during the FUTURE 3 core study
             (AC-052-373)

          7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: TAS-102; Placebo
Intervention description: 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.; Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 800.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Refractory, metastatic colorectal cancer

Summary:

      The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in
      patients with refractory metastatic colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has provided written informed consent

          2. Has adenocarcinoma of the colon or rectum

          3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic
             colorectal cancer

          4. ECOG performance status of 0 or 1

          5. Is able to take medications orally

          6. Has adequate organ function (bone marrow, kidney and liver)

          7. Women of childbearing potential must have a negative pregnancy test and must agree to
             adequate birth control if conception is possible. Males must agree to adequate birth
             control.

        Exclusion Criteria:

          1. Certain serious illnesses or medical condition(s)

          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,
             extended field radiation, received investigational agent, within the specified time
             frames prior to study drug administration

          3. Has received TAS-102

          4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any
             prior therapies

          5. Is a pregnant or lactating female
Strategies to Reduce Injuries and Develop Confidence in Elders
Condition: Accidental Falls; Wounds and Injuries
MeSH terms: Wounds and Injuries
Intervention: Evidence-based tailored fall prevention; Usual care
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 5451.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an
      evidence-based, patient-centered multifactorial fall injury prevention strategy in community
      dwelling older adults at risk of falls recruited from 86 primary care practices around the
      U.S.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is at least 70 years of age.

          -  The patient must answer 'yes' to one or more of the following questions:

          -  Have you fallen and hurt yourself in the past year?

          -  Have you fallen 2 or more times in the past year?

          -  Are you afraid that you might fall because of balance or walking problems?

        Exclusion Criteria:

          -  The patient is enrolled in hospice.

          -  The patient resides in a nursing home.

          -  The patient is not capable of providing informed consent (or assent), and a proxy is
             not available.

          -  The patient does not speak English or Spanish
Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)
Condition: FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Intervention: Inotersen
Intervention description: Inotersen SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis

Summary:

      This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in
      patients with Familial Amyloid Polyneuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Satisfactory completion of dosing & efficacy assessments in ISIS 420915-CS2

        Exclusion Criteria:

          -  Any new condition or worsening of existing condition that could make the patient
             unsuitable for participation, or interfere with the patient participating in and/or
             completing the study
Improving Pregnancy Outcomes With Progesterone
Condition: Pre-term Birth; HIV-1-infection
MeSH terms: Premature Birth
Intervention: 17P; Placebo
Intervention description: Synthetic progestin; Non-active placebo comparator
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase III, double-masked, placebo-controlled, randomized controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 800.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PreTerm Birth; HIV-1-infection; Antiretroviral Treatment

Summary:

      This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking
      place in Zambia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  less than 24 0/7 weeks of gestation

          -  viable intrauterine singleton pregnancy confirmed by ultrasound

          -  antibody-confirmed HIV-1 infection

          -  currently receiving antiretroviral l therapy (ART) or intending to commence ART in
             pregnancy

          -  ability and willingness to provide written informed consent

          -  intent to remain in current geographical area of residence for the duration of study

          -  willing to adhere to weekly study visit schedule

        Exclusion Criteria:

          -  confirmed prior spontaneous preterm birth

          -  multiple gestation

          -  known uterine anomaly

          -  planned or in situ cervical cerclage

          -  major fetal anomaly detected on screening ultrasound

          -  indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean)

          -  threatened abortion, preterm labor, or ruptured membranes at time of enrollment

          -  known allergy or medical comorbidity listed as a contraindication to 17P in the
             prescribing information

          -  prior participation in the trial

          -  any other condition (social or medical) which, in the opinion of the study staff,
             would make trial participation unsafe or complicate data interpretation.
Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Intervention: Omega 3 fatty acids; Corn oil
Intervention description: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids; Corn oil will be the placebo comparator for omega 3 fatty acids supplement
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly selected to receive 3.7 g of a supplement containing docosahexanoic and eicosapentanoic acids or a supplement containing corn oil. The supplements will be provided for 12 weeks
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Albuminuria; Carotid Intima-Media Thickness; Pulse Wave Velocity; Inflammation

Summary:

      To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and
      vascular function and inflammatory parameters in patients with chronic renal disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary albumin excretion over 30 mg/g creatinin

          -  Chronic renal failure stage 2 to 4

          -  Absence of serious conditions such as cáncer, decompensated heart failure, chronic
             infections and severe arterial lesions

        Exclusion Criteria:

          -  Blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8%

          -  Presence of cognitive impairment that does not allow to sigin a written informed
             consent

          -  Alcohol or illicit drug abuse
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: OnabotulinumtoxinA
Intervention description: OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 95.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum
      toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor
      overactivity in participants who successfully completed Study 191622-120 (NCT01852045).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed participation in Study 191622-120

          -  Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120

          -  Regularly using clean intermittent catheterization to empty the bladder

        Exclusion Criteria:

          -  Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

          -  Current or planned use of a baclofen pump

          -  Current or planned use of an electrostimulation/neuromodulation device for urinary
             incontinence

          -  Use of an indwelling catheter for urinary incontinence instead of using clean
             intermittent catheterization to empty the bladder

          -  Previous or current use of botulinum toxin therapy of any serotype for any urological
             condition, or treatment with botulinum toxin of any serotype for any other condition
             since entering study 191622-120
Study Assessing Double-masked Uveitis Treatment
Condition: Uveitis; Posterior, Disorder
MeSH terms: Uveitis
Intervention: DE-109 44 ug; DE-109 440 ug; DE-109 880 ug
Intervention description: Low dose; Medium dose; High dose
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 592.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of intravitreal injections
      of DE-109 ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of active uveitis

          -  18 years of age or older

          -  Sign informed consent

          -  Meet best corrected ETDRS visual acuity

        Exclusion Criteria:

          -  Uveitis of infectious etiology

          -  Suspected/confirmed central nervous system or ocular lymphoma

          -  Primary diagnosis of anterior uveitis

          -  Uncontrolled glaucoma

          -  Use of topical oculary medication

          -  Implanted device

          -  Significant ocular disease

          -  Lens/media opacities or obscured ocular media

          -  Intraocular surgery or treatments

          -  Capsulotomy

          -  Ocular or periocular infection

          -  Pupillary dilation

          -  History of herpetic infection

          -  Toxoplasmosis or toxoplasmosis scar

          -  Ocular malignancy

          -  Allergy or hypersensitivity to study drug

          -  Participation in other uveitis trial within 30 days

          -  Monoclonal antibody treatment or biologic therapy

          -  Any systemic condition/infection

          -  Immunosuppressive therapy or immunocompromised

          -  Malignancy remission

          -  Females who are pregnant or lactating and females not using adequate contraceptives