bioihbjkbjnl/mcl2 huggingface dataset:
Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
Condition: Pneumonia
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia
Intervention: Tedizolid phosphate; Linezolid
Intervention description: Tedizolid phosphate IV 200 mg once daily; Linezolid IV 600 mg twice daily
Intervention MeSH terms: Linezolid; Tedizolid; Tedizolid phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 726.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3
      study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus
      linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of
      ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia
      (HABP) or ventilator-associated bacterial pneumonia (VABP), collectively referred to as
      ventilated nosocomial pneumonia (VNP). Participants with concurrent gram-positive bacteremia
      are to receive 14 days of active therapy in either treatment arm.

      The primary objective is to determine the noninferiority (NI) in all-cause mortality (ACM)
      within 28 days after randomization of IV tedizolid phosphate compared with IV linezolid in
      the Intent to Treat (ITT) Analysis Set (NI is declared when the lower bound of the 95% CI >
      -10).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requires IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia

          -  Gram-positive bacteria on respiratory Gram stain

        Exclusion Criteria:

          -  Pneumonia of community, viral, fungal or parasitic etiology

          -  Structural lung abnormalities

          -  Immunosuppression

          -  Previous antibiotics for > 24 hours

          -  Expected survival of < 72 hours
A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: hydrochlorothiazide (+) losartan potassium; losartan potassium; Placebo for Losartan; Placebo for Losartan/HCTZ
Intervention description: losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.; Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period; losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the safety and effectiveness of Losartan as compared to
      Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male/female and 6 to 17 years of age at the time of study with hypertension
             (high blood pressure)

          -  Patient is able to swallow tablets

          -  Females of child bearing potential must use acceptable contraception throughout the
             trial

        Exclusion Criteria:

          -  Patient has a history of heart, metabolic or kidney disease

          -  Patient has a history of known heart, lung, liver and other body system disorders

          -  Patient is pregnant or nursing

          -  Patient has participated in another clinical trial within the last 28 days
Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo / Teneli (Teneligliptin) + pio (pioglitazone); Teneli / Teneli + pio
Intervention description: Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.; Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Intervention MeSH terms: Pioglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

      The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in
      combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12
      weeks administration and to evaluate the safety and efficacy of MP-513 in combination with
      thiazolidinedione with an extension treatment for up to 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are 20 - 75 years old

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 12 weeks before administration of investigational drug

          -  Patients whose HbA1c is between 6.5% and 10.0%

          -  Patients who took Thiazolidinedione for diabetes over 16 weeks before administration
             of investigational drug

          -  Patients who were not administered diabetes therapeutic drugs prohibited for
             concomitant use within 12 weeks before administration of investigational drug.

        Exclusion Criteria:

          -  Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or
             secondary diabetes (Cushing disease, acromegaly, etc)

          -  Patients who are accepting treatments of arrhythmias

          -  Patients with serious diabetic complications

          -  Patients who are the excessive alcohol addicts

          -  Patients with severe hepatic disorder or severe renal disorder.

          -  Patients who are pregnant, lactating, and probably pregnant patients, and patients who
             can not agree to contraception
A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Sunitinib + Capecitabine; Capecitabine
Intervention description: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.
Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day [1000 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.; Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day [1250 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.
Intervention MeSH terms: Capecitabine; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 442.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The treatment received with sunitinib plus capecitabine could delay tumor growth longer than
      with treatment with capecitabine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic disease that can be measured. Patients with bone-only
             disease are also allowed to enter the study.

          -  Previous treatment with an anthracycline and a taxane in any setting

          -  Progression on first or second line regimen or adjuvant regimen if disease free
             interval less than 12 months

        Exclusion Criteria:

          -  History of inflammatory carcinoma if there is no other measurable disease

          -  More than 2 chemotherapy agents in the advanced disease setting

          -  Brain metastases
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Intervention: turoctocog alfa pegol
Intervention description: Administered i.v.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to evaluate the safety and
      efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC
      0129-0000-1003 (N8-GP) in subjects with Haemophilia A.
    

Eligibility criteria:

        Inclusion Criteria: - Male patients with severe congenital haemophilia A (FVIII activity
        below 1%, according to medical records) - Documented history of at least 150 EDs (exposure
        days) to other FVIII products - At least 12 years and body weight at least 35 kg (except
        for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be
        18 years) Exclusion Criteria: - Previous participation in this trial defined as withdrawal
        after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or
        equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by
        medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral
        load of more than 400000 copies/mL. If the data is not available in medical records within
        last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired
        coagulation disorders other than haemophilia A - Previous significant thromboembolic events
        (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined
        by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value
        at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of
        normal reference ranges at central laboratory - Creatinine level equal to or greater than
        1.5 times above upper normal limit (according to central laboratory reference ranges) -
        Ongoing immune modulating or chemotherapeutic medication
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: diclofenac potassium (XP21L); Placebo
Intervention description: 25 mg capsule, every 6 hours; Oral placebo capsule, every 6 hours
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bunionectomy; Bunion surgery; Post-operative pain

Summary:

      A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain
      following bunionectomy surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years of age

          -  Have undergone bunionectomy surgery

          -  Have achieved adequate post-surgical pain

        Exclusion Criteria:

          -  Confounding medical conditions which preclude study participation

          -  Participated in a study of another investigational drug or device within 30 days prior
             to randomization
A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp
Condition: Actinic Keratosis; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Keratosis, Actinic; Keratosis
Intervention: ingenol disoxate gel 0.018%; ingenol disoxate gel 0.037%; Vehicle gel
Intervention description: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.; Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.; Vehicle to ingenol disoxate gel with no active ingredient
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 563.0
Sex: All
Healthy volunteers: No

Summary:

      One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of
      progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000
      AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and
      the disease is chronic the cumulative risk for a patient can be substantial.

      In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the
      incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients
      over a period of 2 years, so that the total follow-up time for each patient will be 3 years
      and 2 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent has been obtained.

          -  The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196
             and has been evaluated at the end of follow-up visit (month 14) of that trial.

        Exclusion Criteria:

          -  The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the
             selected treatment area .

          -  The subject is enrolled in any other interventional clinical trial.

        For subjects where there is a gap between end of follow-up visit (month 14) in one of the
        trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial:

          -  The subject has been treated with ingenol mebutate or ingenol disoxate in the selected
             treatment area after end of follow-up visit (month 14) in one of the trials
             LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.

          -  The subject has been enrolled in any other interventional clinical trial after end of
             follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196
             and until participation in the current trial.
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Ziprasidone oral capsules
Intervention description: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 169.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Summary:

      The purpose of this study is to assess the safety and tolerability of ziprasidone during
      long-term open-label administration in children and adolescents (ages 10-17) with bipolar I
      disorder (manic or mixed)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in double-blind treatment study A1281132, meeting specific criteria of
             duration and safety

        Exclusion Criteria:

          -  Imminent risk of suicide or homicide, as judged by the site investigator;serious
             adverse event related to study medication in study A1281132; significant prolongation
             of QT interval in study A1281132.
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Condition: Ocular Inflammation Associated With Blepharaconjunctivitis
MeSH terms: Inflammation
Intervention: Tobramycin 0.3%/Dexamethasone 0.05%; TOBRADEX
Intervention description: Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days; TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days
Intervention MeSH terms: Tobramycin; Tobramycin, Dexamethasone Drug Combination; Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Ocular inflammation; blepharaconjunctivitis

Summary:

      The purpose of this study is to describe the differences in efficacy between TOBRADEX
      Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the
      treatment of ocular inflammation and infection associated with blepharaconjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular inflammation associated with blepharaconjunctivitis

        Exclusion Criteria:

          -  ocular allergy

          -  ocular disorders that would preclude safe administration of test article
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
Condition: Emergency Contraception
MeSH terms: Emergencies
Intervention: Use Phase (Ulipristal Acetate, 30 mg)
Intervention description: All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take 30 mg of ulipristal acetate.
Subjects are to use the investigational product based on their understanding of the directions on the outer packaging including Drug Facts Label and inside the product packaging (in the Consumer Information Leaflet).
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1270.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Emergency contraception

Summary:

      This study is designed to assess whether consumers select and use ella® (ulipristal acetate
      30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in
      an OTC-like setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are self-pay or who are willing to be self-pay for the purposes of the study
             and who present for emergency contraception only for their own use

        Exclusion Criteria:

          -  Cannot read, speak and understand English

          -  Cannot see well enough to read information on the label
Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Metformin; Oral Contraceptive Pills (Yasmin); Lifestyle Modification; placebo
Intervention description: Metformin 425mg. capsules, 2 capsules BID x 24 weeks; Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks; weekly classes x 24 weeks for training in diet, exercise and behavior modification skills; placebo to the active metformin arm. 2 capsules BID x 24 weeks.
Intervention MeSH terms: Metformin; Contraceptive Agents; Contraceptives, Oral; Drospirenone and ethinyl estradiol combination; Contraceptives, Oral, Combined
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 43.0
Sex: Female
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Polycystic Ovary Syndrome; Overweight Adolescent Girls; Irregular Menstrual Cycles

Summary:

      A 24 week study to compare the use of Metformin, birth control pills and a carefully planned
      intensive lifestyle program that includes weight loss and exercise. These approaches will be
      compared to placebo (a pill that contains no active substances. Metformin, birth control
      pills and the lifestyle management program will be used on this research study to compare
      their ability to:

        1. reduce fasting glucose levels

        2. reduce androgen hormone levels

        3. improve sex steroid binding, and

        4. improve lipids (fatty substances in the blood)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Menstrual irregularity defined as cycle length > 45 days

          -  Overweight as BMI > 25

          -  Clinical evidence of hirsuitism or acne

          -  Testosterone > 50ng/dL

        Exclusion Criteria:

          -  History of diabetes mellitus

          -  History of Cushing's disease

          -  History of hyperprolactinemia

          -  Untreated hypo or hyperthyroidism

          -  History of adrenal hyperplasia

          -  Significant renal impairment

          -  Received oral contraceptives, estrogen or progestin or other drugs known to effect
             lipoprotein metabolism within 2 months of starting the study

          -  Exercise > 10 hours per week