bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)
Condition: Human Papillomavirus
Intervention: V503; GARDASIL
Intervention description: 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine; Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 600.0
Sex: Female
Minimum age: 9 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary objective:

      • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers
      (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.

      Secondary objectives:

        -  To evaluate the tolerability of V503 in 9-15 year-old girls.

        -  To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or
           GARDASIL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female from 9 to 15 years old.

          -  Good physical health.

        Exclusion Criteria:

          -  Known allergy to any vaccine component.

          -  History of severe allergic reaction.

          -  Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular
             injections.

          -  Pregnant subject.

          -  Immunocompromised or immunodeficient subject.

          -  Splenectomy.

          -  Receipt of medication / vaccine that may interfere with study assessment.

          -  Fever

          -  History of a positive test for HPV, prior receipt of HPV vaccine or prior
             participation to HPV trial.

          -  Any condition that might interfere with study assessment.
Child and Adolescent Anxiety Disorders (CAMS)
Condition: Anxiety Disorders; Social Phobia; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: Sertraline (SRT); Cognitive Behavioral Therapy (CBT); Placebo
Intervention description: Participants were treated with sertraline.; Participants received CBT.; Participants were treated with a placebo pill.
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 488.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phobic Disorders; Anxiety, Separation

Summary:

      This randomized, controlled trial compared the efficacy of the medication sertraline
      (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for
      youth with anxiety disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation
             anxiety disorder, social phobia, or generalized anxiety disorder

        Exclusion Criteria:

          -  Major neurological disorder or medical illness that would interfere with participation
             in the study
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: idarucizumab
Intervention description: idarucizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 503.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g
      idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or
      require emergency surgery or procedures.
    

Eligibility criteria:

        Inclusion criteria:

          -  Group A (Bleeding patients)

               -  Overt bleeding judged by the physician to require a reversal agent

               -  Currently taking dabigatran etexilate

               -  At least 18 years of age

               -  Written informed consent

          -  Group B (Patients who are taking dabigatran who may not be bleeding, but do require an
             emergency surgery or procedure for a condition other than bleeding

               -  Condition requiring emergency surgery or invasive procedure where adequate
                  hemostasis is required. Emergency is defined as within the following 8 hours.

               -  Current treatment with dabigatran

               -  At least 18 years of age

               -  Written Informed consent.

        Exclusion criteria:

          -  Group A (Bleeding Patients)

               -  Patients with minor bleeds (epistaxis, hematuria) who can be managed with
                  standard supportive care.

               -  Patients with no clinical signs of bleeding

               -  Contraindications to study medication including known hypersensitivity to the
                  drug or its excipients.

          -  Group B (Patients who require emergency surgery or procedure)

               -  A surgery or procedure which is elective or where the risk of uncontrolled or
                  unmanageable bleeding is low.

               -  Contraindications to study medication including known hypersensitivity to the
                  drug or its excipients (subjects with hereditary fructose intolerance may react
                  to sorbitol).
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
Condition: GENITAL HERPES
MeSH terms: Herpes Simplex; Herpes Genitalis
Intervention: Famciclovir; Aciclovir
Intervention description: Famciclovir 125 mg every 12 hours for 5 days; Aciclovir 200 mg every 4 hours fo 5 days
Intervention MeSH terms: Acyclovir; Famciclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Herpes Simplex Virus

Summary:

      Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by
      herpes simplex virus (HSV). There are effective oral prescription antiviral medicines
      available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.

      This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy
      and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with
      active recurrent genital herpes.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients must be able to understand the study procedures agree to participate and give
             written consent.

          2. Patients with clinical diagnosis of recurrent genital herpes;

          3. Score symptoms higher than 4;

          4. Negative pregnant urine test.

        Exclusion criteria:

          1. Pregnancy or risk of pregnancy.

          2. Lactation

          3. Any pathology or past medical condition that can interfere with this protocol.

          4. Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive
             drugs (in the last 30 days and during the study);

          5. Patients with immunodeficiency and/or immunosuppressive disease;

          6. Hypersensitivity to components of the formula;

          7. Other conditions deemed reasonable by the medical investigator as to the
             disqualification of the individual from study participation.
Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Condition: Postoperative Pain in Infants
MeSH terms: Pain, Postoperative
Intervention: Ketorolac Tromethamine 1 mg/kg; Ketorolac Tromethamine 0.5 mg/kg; Placebo
Intervention description: Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.; Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.; Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 2 Months
Maximum age: 18 Months
Healthy volunteers: No
Keywords: ketorolac pharmacokinetics; ketorolac stereo-isomers; infants; postoperative analgesia; safety

Summary:

      Infants handle ketorolac differently than adults. Study of handling of this pain medication
      given to infants following surgery. Detailed analysis of how the drug is eliminated from age
      2 months to 18 months. Compared morphine use in infants who received the drug to the group
      getting placebo. Safety testing for kidney and liver function, breathing measured by
      continuous oximetry, and any bleeding issues.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months,
             studied by age group 12-18 months, 6-12 months, < 6 months

        Exclusion Criteria:

          -  Bleeding history in infant or family

          -  Coagulopathy

          -  Gastrointestinal bleeding history

          -  Renal or hepatic disease assessed by history and by pre-drug blood tests

          -  Premature birth (<36 weeks gestation)
A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; placebo
Intervention description: For oral use once daily.; For oral use once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3183.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate the cardiovascular
      safety of oral semaglutide in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female diagnosed with type 2 diabetes

          -  Age at least 50 years at screening and presence of cardiovascular disease, or age at
             least 60 years at screening and presence of at least one cardiovascular risk factor

        Exclusion Criteria:

          -  Current or previous (within 90 days prior to screening) treatment with any GLP-1
             (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor
             or pramlintide

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary
             thyroid carcinoma (MTC)

          -  History of pancreatitis (acute or chronic)

          -  History of major surgical procedures involving the stomach potentially affecting
             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
             gastric bypass surgery)

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV
             heart failure

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  Any of the following: myocardial infarction, stroke or hospitalisation for unstable
             angina or transient ischaemic attack within the past 60 days prior to screening

          -  Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment
             (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73
             m^2)

          -  History or presence of malignant neoplasms within the last 5 years (except basal and
             squamous cell skin cancer and carcinoma in situ)
A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tofacitinib; Tofacitinib
Intervention description: tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks; tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 209.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Tofacitinib, CP-690,550, Janis kinase, JAK inhibitor, modified release, Xeljanz

Summary:

      This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib
      modified release tablet taken once a day in patients with rheumatoid arthritis who continue
      taking methotrexate. Results for the modified release tablets will be compared to the
      efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in
      patients with rheumatoid arthritis who continue taking methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of rheumatoid arthritis

          -  currently taking a stable dose of methotrexate

          -  no evidence of active or latent or inadequately treated tuberculosis

        Exclusion Criteria:

          -  evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or
             allergic disease

          -  clinically significant infections within the past 6 months
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Condition: Genital Warts
MeSH terms: Warts; Condylomata Acuminata
Intervention: Imiquimod; 3.75% imiquimod cream; placebo cream
Intervention description: daily topical application for up to 8 weeks; 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.; placebo cream applied daily to wart areas for up to 8 weeks
Intervention MeSH terms: Imiquimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 470.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: external genital warts; perianal warts; condylomata acuminata; venereal warts; HPV types 6 and 11

Summary:

      The purpose of this study is to determine whether imiquimod creams are effective in treating
      external genital warts (EGW). The secondary objective of this study is to provide information
      on recurrence of EGW. Additionally the study will also look at any adverse events associated
      with the use of the creams.

      External genital and perianal warts are caused by the infection of human papillomavirus or
      HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like
      small flesh-colored, pink, or red growths on or around the external skin of sex organs or
      perianal area. The warts may look similar to the small parts of a cauliflower or they may be
      very tiny and difficult to see. They often appear in clusters of three or four, and may grow
      and spread rapidly. They usually are not painful, although they may cause mild pain,
      bleeding, and itching.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good general health

          -  Diagnosis of external genital / perianal warts with at least 2 warts and no more than
             30 warts

          -  Negative pregnancy test (for women who are able to become pregnant)

        Exclusion Criteria:

          -  Women who are pregnant, lactating or planning to become pregnant during the study

          -  Evidence of clinically significant or unstable disease (such as stroke, heart attack)

          -  Have any of the following conditions: HIV infection; current or history of high risk
             HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart
             areas; internal warts requiring or undergoing treatment; dermatological disease (e.g.,
             psoriasis) or skin condition in the wart areas

          -  Have received specific treatments in the treatment area(s) within the designated time
             period prior to study treatment initiation.
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
Condition: Kidney Transplant
Intervention: Everolimus and tacrolimus; mycophenolate mofetil and tacrolimus
Intervention description: Everolimus:
Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets
Dose: 1.5 mg per day
Frequency: 0.75 mg twice daily
Tacrolimus:
Dose adjusted to maintain specific blood levels; Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels
Intervention MeSH terms: Mycophenolic Acid; Everolimus; Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 613.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Kidney transplant; renal transplant; immunosuppression; mycophenolate mofetil; tacrolimus; everolimus

Summary:

      The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with
      low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney
      transplant recipients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female renal recipients 18-70 years of age undergoing kidney transplantation,
             either primary or re-transplant;

          -  Recipient of a cadaveric, deceased donor (including expanded criteria donor organs and
             deceased donor organs after cardiac death), living unrelated or non-HLA identical
             living related donor kidney;

          -  Graft must be functional (producing greater than or equal to 100 ml of urine within 24
             hours after transplantation) at time of randomization.

        Exclusion criteria:

          -  Donor organ with a cold ischemic time > 30 hours;

          -  Males or females who produce less than 100 ml of urine in the first 24 hours
             post-transplantation;

          -  Males or females who are recipients of ABO incompatible transplants, or T cell, or B
             cell crossmatch positive transplant;

          -  Males or females with severe total hypercholesterolemia or total hypertriglyceridemia
             (Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);

          -  Males or females who have any surgical or any medical condition, such as severe
             diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in the
             opinion of the investigator, might alter the absorption, distribution, metabolism
             and/or excretion of study medication.

        Other protocol related inclusion/exclusion criteria may apply.
The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
Condition: Acetabular Fractures
MeSH terms: Hemorrhage
Intervention: Tranexamic Acid; Placebo
Intervention description: Tranexamic acid: anti-fibrinolytic agents; Placebo
Intervention MeSH terms: Fibrinolytic Agents; Tranexamic Acid; Antifibrinolytic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if patients undergoing acetabular ORIF (open
      reduction with internal fixation) who receive tranexamic acid have a reduced risk of
      allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for
      thromboembolic events compared to patients who receive placebo. Investigators want to
      determine the cost-effectiveness related to allogenic blood transfusion as a blood loss
      management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic
      surgery carries with it a significant risk for blood loss. Current management of
      perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood
      transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse
      reactions. There have been significant efforts to reduce the use of allogenic blood
      transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been
      used in management of blood during surgery. In order to determine the impact of tranexamic
      acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will
      conduct a prospective randomized study. Patients undergoing acetabular surgery will be
      screened for this study. Patients will be then randomized to placebo or tranexamic acid which
      will be administered during and after surgery. The following data will be collected: patient
      characteristics, surgery information, blood loss, blood transfusions, wound complication
      within 30 days of surgery, and cost.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients aged 18 or above undergoing acetabular ORIF.

        Exclusion Criteria:

          -  All patients aged below 18 years undergoing acetabulum surgery

          -  Patients with color-blindness (color vision changes used to assess toxicity)

          -  Patients with subarachnoid hemorrhage.

          -  Patients with active intravascular coagulation.

          -  Patients with a previous history of venous thromboembolism or with a history of
             hypercoaguable conditions (i.e. Factor V Leiden, antiphospholipid antibody).

          -  Prisoners

          -  Pregnant women