bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine; Aripiprazole; Placebo
Intervention description: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention MeSH terms: Aripiprazole; Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 617.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Acute Schizophrenia; Psychotropic Drugs; Aripiprazole; Antipsychotic Agents; Mental Disorders; Dopamine Agents; Central Nervous System Agents

Summary:

      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided informed consent prior to any study specific procedures

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,
             disorganized type, catatonic type or undifferentiated type), as confirmed by the
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (SCID)

          -  Patients with normal physical examination, laboratory, vital signs,and/ or
             electrocardiogram (ECG)

          -  Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1

          -  Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS)
             total score ≥ 80 and ≤ 120

          -  CGI-S score ≥ 4

        Exclusion Criteria:

          -  Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

          -  Bipolar I and II disorder

          -  Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and
             other cognitive disorders

          -  DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in
             this study

          -  Women who are pregnant or breast feeding
Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Brolucizumab 6 mg; Aflibercept 2 mg
Intervention description: Administered as opthalmic solution for an intravitreal injection to the study eye; Administered as an opthalmic solution for intravitreal injection to the study eye
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: double-masked, extension study; neovascular age-related macular degeneration; intravitreal injection; brolucizumab; aflibercept

Summary:

      The purpose of this extension study was to assess the safety and efficacy of the new
      formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who
      received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The
      medical condition treated in the core and extension trials was neo-vascular age-related
      macular degeneration (nAMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign written informed consent

          -  Completed the core study, CRTH258A2301, also known as CRTH258-C002 as defined by
             assessments at Visit 26/Week 96 within ≤12 weeks of the baseline.

        Exclusion Criteria:

          -  Patient discontinued the treatment or the core study prematurely at any time

          -  Patient received standard of care treatment for nAMD after completion of the core
             study

          -  Pregnant or nursing women and women of child-bearing potential

          -  Stroke or MI (myocardial infarction) within 3 months of the baseline extension visit
Surgical Pain After Inguinal Hernia Repair (SPAIHR)
Condition: Pain, Postoperative; Hernia, Inguinal
MeSH terms: Hernia; Pain, Postoperative; Hernia, Inguinal
Intervention: Pregabalin; placebo; Pregabalin; Pregabalin
Intervention description: 150 mg BID; Placebo; 75 mg BID; 25 mg BID
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 425.0
Sex: Male
Minimum age: 17 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: postoperative pain chronic pain

Summary:

      The purpose of this study is to test whether pregabalin added to the standard of care with
      dosing starting preoperatively and continuing for 1 week post surgery will decrease the
      intensity of acute post-operative pain following inguinal hernia repair.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject will have elective ( the subject chooses, but does not have to undergo
             surgery for an emergency) open unilateral inguinal herniorraphy (hernia repair), using
             mesh Lichtenstein surgery procedure and under general anesthesia and fentanyl or
             sufentanil/propofol initiation and sevoflurane or isoflurane maintenance plus local
             anesthetic infiltration at the conclusion of surgery. Study surgery should be
             anticipated to be in the morning.

          -  Expected to be able to use and tolerate non-steroidal anti-inflammatory drugs (such as
             naproxen), tramadol, oxycodone, and acetaminophen/paracetamol for pain control after
             surgery.

          -  The subject will be available for a visit within 72 hours of the day of surgery if not
             admitted the night before for baseline assessments before taking any study medication,
             and then to receive study medication prior to the day before surgery.

          -  The subject is expected and agrees to remain at the hospital (or intermediate care
             facility) for a minimum of 3 hours following surgery.

        Exclusion Criteria:

          -  Subjects with non elective or emergency surgery (must have the surgery no matter
             what), or hernia with incarceration (the trapping of abdominal contents within the
             hernia itself).

          -  Subjects with hernia repair that is not a primary repair. The planned use of nerve
             block or spinal/epidural/paravertebral anesthesia or surgery is not planned with
             general anesthesia.

          -  Subjects that are not allowed to receive the anesthesia agents indicated per protocol
             and general anesthesia.
A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Intervention: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Intervention description: V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1518.0
Sex: All
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years
      of age and in young women 16 to 26 years of age. From this study, the goal was to establish
      that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and
      girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that
      is not inferior to that observed in young women 16 to 26 years of age who received the
      standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503
      efficacy).
    

Eligibility criteria:

        Inclusion Criteria:

        All Participants:

        -Judged to be in good physical health on the basis of medical history, physical examination
        and laboratory results

        Boys and Girls 9 to 14 Years:

        -Must not have had coitarche and does not plan on becoming sexually active during the
        vaccination period

        Women 16 to 26 Years:

          -  Has never had a Papanicolaou (Pap) test or only had normal Pap test results

          -  A lifetime history of 0 to 4 male and/or female sexual partners

        Exclusion Criteria:

        All Participants:

          -  Known allergy to any vaccine component

          -  History of severe allergic reaction that required medical intervention

          -  Thrombocytopenia or any coagulation disorder

          -  Females only: participant is pregnant or expecting to donate eggs during day 1 through
             month 7

          -  Currently immunocompromised, or been diagnosed with immunodeficiency

          -  Had a splenectomy

          -  Receiving or has received immunosuppressive therapies within the last year

          -  Received any immunoglobulin product or blood-derived product within 3 months

          -  Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: zoster vaccine live (ZOSTAVAX™); Comparator: Placebo
Intervention description: 1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live; 1 dose 0.65 mL/dose subcutaneous injection of placebo.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether the investigational zoster vaccine, is
      generally well tolerated when administered to participants with a history of herpes zoster.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment

        Exclusion Criteria:

          -  History of allergy to any vaccine component

          -  Prior receipt of a varicella or zoster vaccine

          -  Ability to defend against infection is suppressed by a medical condition or medication
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Intervention: JZP-110; Placebo oral tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 476.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm
      parallel group study of safety and efficacy of JZP-110 in the treatment of excessive
      sleepiness in adult subjects with OSA.
    

Eligibility criteria:

        Major Inclusion Criteria:

          1. Male or female between 18 and 75 years of age, inclusive

          2. Diagnosis of OSA according to ICSD-3 criteria

          3. Body mass index from 18 to <45 kg/m2

          4. Consent to use a medically acceptable method of contraception

          5. Willing and able to provide written informed consent

        Major Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             OSA that is associated with excessive sleepiness

          3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          4. History or presence of any acutely unstable medical condition, behavioral or
             psychiatric disorder (including active suicidal ideation), or surgical history that
             could affect the safety of the subject or interfere with study efficacy, safety, PK
             assessments, or the ability of the subject to complete the trial per the judgment of
             the Investigator.

          5. History of bariatric surgery within the past year or a history of any gastric bypass
             procedure

          6. Presence or history of significant cardiovascular disease

          7. Use of any over-the-counter (OTC) or prescription medications that could affect the
             evaluation of excessive sleepiness

          8. Received an investigational drug in the past 30 days or five half-lives

          9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05,
             R228060, or YKP10A)

         10. History of phenylketonuria (PKU) or history of hypersensitivity to
             phenylalanine-derived products
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
Condition: Vasomotor Rhinitis; Rhinitis, Vasomotor
MeSH terms: Rhinitis; Rhinitis, Vasomotor
Intervention: GW685698X
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 350.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: nonallergic rhinitis; GW685698X; VMR; vasomotor rhinitis

Summary:

      The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg
      once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent
      subjects (12 years of age and older) with vasomotor rhinitis (VMR).
    

Eligibility criteria:

        Inclusion criteria:

          -  Must be outpatients.

          -  Diagnosis of VMR (vasomotor rhinitis).

          -  Literate in English or native language.

        Exclusion criteria:

          -  Significant concomitant medical condition.

          -  Use corticosteroids or other allergy medications during the study.

          -  Used tobacco products within the past year.
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Rabeprazole sodium; Esomeprazole
Intervention description: Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.; Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
Intervention MeSH terms: Esomeprazole; Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1397.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GERD; erosive GERD; erosive esophagitis

Summary:

      The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB)
      Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive
      gastroesophageal reflux disease (eGERD).
    

Eligibility criteria:

        KEY INCLUSION CRITERIA:

          1. Male or female, ages 18 to 75 years.

          2. History of gastroesophageal reflux disease (GERD) symptoms for at least 3 months
             immediately before screening.

          3. Heartburn for at least 2 days a week for at least 1 month before screening.

          4. Esophageal erosions of Los Angeles (LA) Grades A or B based on EGD taken within 14
             days prior to enrollment.

          5. Subjects who are H. pylori negative based on a screening test.

          6. Females should be either of non-childbearing potential or of childbearing potential.
             Females of childbearing potential must have negative pregnancy tests prior to
             randomization. Female subjects of childbearing potential must agree to use medically
             acceptable methods of contraception.

          7. Subjects must be able to read, write, and understand the language of the symptom
             diary.

        KEY EXCLUSION CRITERIA:

          1. Current or a history of esophageal motility disorders.

          2. Current or a history of Barrett's esophagus. Current esophageal strictures or
             esophagitis (known or suspected to be due to etiology other than GERD such as
             infection or medications).

          3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory
             conditions, or current gastric or duodenal ulcer.

          4. Current or a history of cancer, with the exception of fully excised skin basal cell
             carcinoma.

          5. Inflammatory bowel disease.

          6. Unstable diabetes mellitus.

          7. History of esophageal, gastric and duodenal surgery except simple suturing of an
             ulcer.

          8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral
             steroids (>=20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day).
Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo
Condition: Cancer of Bone
MeSH terms: Bone Neoplasms
Intervention: 99mTc MDP Injection:neutron-bombardment
Intervention description: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.
Intervention MeSH terms: Sodium Pertechnetate Tc 99m; Technetium Tc 99m Medronate
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 99mTc Pertechnetate; Sodium Pertechnetate; Technetium; Molybdenum; MDP; neutron activation

Summary:

      A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP,
      is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology
      using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Oncology out-patients in whom an acceptable quality standard-of-care Technetium
             (99mTc) Medronate bone scan has been ordered or obtained within the last 28 days.

          -  If female of child-bearing potential is outside of the window of 10 days since the
             last menstrual period, a negative serum pregnancy test is required.

          -  Age greater than or equal to 18 years.

        Exclusion Criteria:

          -  Oncology out-patients in whom an acceptable quality standard-of-care Technetium
             (99mTc) Medronate bone scan has been ordered or obtained within the last 28 days.

          -  If female of child-bearing potential is outside of the window of 10 days since the
             last menstrual period, a negative serum pregnancy test is required.

          -  Age greater than or equal to 18 years.

          -  Identified interval events which have occurred after the standard of care bone scan
             but prior to the administration of non-fission sourced Technetium (99mTc) Medronate
             which could influence or change bone scan uptake (e.g. skeletal trauma, orthopedic
             surgery, bone infection, or interval therapy (i.e. radiation therapy, non-maintenance
             chemotherapy). -
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Condition: Primary Immune Deficiency Disorder
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Immune globulin subcutaneous (Human)
Intervention description: IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Immune globulin subcutaneous; SCIG; Primary immunodeficiency; PID

Summary:

      The objective of this study is to assess the long-term safety, tolerability, and efficacy of
      IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study
      ZLB06_002CR (NCT01199705).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20
             well.

          -  Written informed consent by the subject/parent/legally acceptable representative.
             Written assent for an underage subject (≥7 years at the time of obtaining informed
             consent), as far as possible.

        Exclusion Criteria:

          -  Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia,
             osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time
             of the first infusion.

          -  Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine
             protein concentration >0.2 g/L or urine protein ++ by dipstick).

          -  Pregnancy or nursing mother.

          -  Participation in a study with an investigational medicinal product (IMP) within 3
             months prior to enrollment except for ZLB06_002CR.

          -  Subjects who are planning to donate blood during the study.

          -  Re-entry of subjects previously participating in the current follow-up study.

          -  Known or suspected antibodies to the IMP, or to excipients of the IMP.