bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Abicipar Pegol; Ranibizumab; Sham Procedure
Intervention description: Abicipar pegol intravitreal injection.; Ranibizumab intravitreal injection.; Sham injection.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 939.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of abicipar pegol in participants with neovascular
      age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of age-related macular degeneration in at least 1 eye

          -  Best corrected visual acuity of 20/40 to 20/320 in the study eye

          -  Best corrected visual acuity of 20/200 or better in the non-study eye

        Exclusion Criteria:

          -  History of vitrectomy, macular surgery, or glaucoma surgery in the study eye

          -  Cataract or refractive surgery in the study eye within the last 3 months
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
Condition: Vasomotor Symptoms; Hot Flashes
MeSH terms: Hot Flashes
Intervention: 0.5mg DRSP / 0.5mg E2 (BAY86-4891); 0.25mg DRSP / 0.5mg E2 (BAY86-4891); Estradiol (E2 0.3mg); Placebo
Intervention description: One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).; One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).; One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).; Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Intervention MeSH terms: Drospirenone; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 735.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Vasomotor symptom relief; Postmenopausal women; Severe to Moderate Vasomotor symptoms

Summary:

      The purpose of this study is to determine the lowest effective dose of the study drug for the
      relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        - Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe
        hot flushes per day or 50 to 60 moderate to severe hot flushes per week

        Exclusion Criteria:

          -  The usual exclusion criteria for hormone therapy apply

          -  Intake of medications other than hormones affecting hot flushes
Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene/Benzoyl Peroxide
Intervention description: Adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 452.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; Adapalene; Benzoyl Peroxide

Summary:

      This was a multi-center, open-label, non-comparative study that evaluated the long-term
      safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

      Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

      Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability
      Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing
      (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations.
      Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory,
      Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of acne vulgaris with facial involvement.

          -  A minimum of 20 but not more than 50 Inflammatory lesions.

          -  A minimum of 30 but not more than 100 Noninflammatory lesions.

        Exclusion Criteria:

          -  Subjects with presence of nodules or cysts.

          -  Acne conglobate, acne fulminans, secondary acne, or severe acne.

          -  Underlying diseases that required the use of interfering topical or systemic therapy.

          -  Use of prohibited medications prior to the study unless appropriate washout period was
             documented.
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
Condition: Pharyngitis
MeSH terms: Pharyngitis
Intervention: placebo; flurbiprofen; acetaminophen 650mg
Intervention description: Sugar-based lozenge flavoured to match the active treatment lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for sore throat pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.; Sugar-based, flavoured flurbiprofen 8.75 mg lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.; Rescue medication to be taken as needed. Rescue medication was not blinded.
Intervention MeSH terms: Acetaminophen; Flurbiprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pharyngitis; swollen throat; difficulty swallowing

Summary:

      The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg
      lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen
      lozenge throughout the course of treating sore throat due to acute pharyngitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient has a complaint of sore throat.

          2. If the patient is a female of childbearing potential, she has been using effective
             contraception since the last date of menses and is not breast-feeding or lactating.

          3. If the patient is a female of childbearing potential, the patient must have a negative
             urine pregnancy.

          4. The patient has provided written informed consent prior to any study-related
             procedures.

        Exclusion Criteria:

          1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days,
             is currently experiencing clinically significant upper gastrointestinal complaints, or
             is currently taking medication regularly (≥ three times in the previous week).

          2. The patient has a history of any hepatic disease or renal dysfunction.

          3. The patient has a history of chronic analgesic use (≥ three times per week over the
             prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study
             per investigator's clinical decision.)
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
Condition: Neoplasms
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Rivaroxaban; Placebo
Intervention description: Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.; Placebo tablet will be administered orally once daily for 180 days.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 841.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Rivaroxaban; Venous thromboembolism

Summary:

      The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for
      reducing the risk of the primary composite outcome as defined by objectively confirmed
      symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity
      proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT,
      symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism
      (VTE)-related death in ambulatory adult participants with various cancer types receiving
      systemic cancer therapy who are at high risk of developing a VTE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically confirmed solid malignancy including but not limited to: pancreas,
             lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic),
             with locally advanced or metastatic disease

          -  Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

          -  Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2

          -  Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)

          -  Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving
             the first dose of study drug with the intention of receiving systemic cancer therapy
             during the double-blind treatment period for an intended duration determined by the
             treating oncologist according to standard protocols of clinical care

        Exclusion Criteria:

          -  Diagnosis of primary brain tumors

          -  Known history of brain metastases

          -  Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a
             high risk for bleeding

          -  Hematologic malignancies with the exception of lymphoma

          -  Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than
             or equal to (<=) 6 months
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin; atorvastatin
Intervention description: Lovaza + atorvastatin; atorvastatin + placebo
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Lovaza; Hyperlipidemias; Triglycerides; Lipids; omega-3 fatty acids; Hypercholesterolemia; Hypertriglyceridemia; omega-3-acid ethyl esters; Omacor; Dyslipidemias

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid
      ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein
      cholesterol (non-HDL-C) in hypertriglyceridemic subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, ages 18-79 years, inclusive

          -  Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C) level above
             NCEP ATPIII goals

          -  Fasting, untreated triglyceride (TG) level in the high to very high range

          -  Provide written informed consent and authorization for protected health information
             disclosure

        Exclusion Criteria:

          -  Pregnancy

          -  Use of lipid-altering drugs which cannot be stopped

          -  History of certain cardiovascular conditions or cardiac surgery within prior 6 months

          -  Body mass index above 40 kg per square meter

          -  Allergy or sensitivity to omega-3 fatty acids or to statin drugs

          -  Poorly-controlled conditions including diabetes, hypertension, or thyroid disease

          -  Certain muscle, liver, kidney, lung, or gastrointestinal conditions

          -  Certain medications

          -  Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Safety of Vitamin D Supplementation in Older Persons
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: cholecalciferol (vitamin D); cholecalciferol (vitamin D)
Intervention description: 400 IU daily (low dose); 2000 IU daily (high dose)
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 65 Years
Maximum age: 95 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin D; deficiency; elderly

Summary:

      This study will evaluate the safety over 6 months of two different doses of vitamin D
      (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation
      with vitamin D improves physical performance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ambulatory

        Exclusion Criteria:

          -  hypercalcemia

          -  hypercalciuria > 4 mg/kg body weight/day

          -  primary, secondary, or tertiary hyperparathyroidism

          -  renal insufficiency (serum creatinine > 2 mg/dL )

          -  history of nephrolithiasis

          -  treatment with vitamin D (ergocalciferol, cholecalciferol, calcitriol)

          -  treatment with anticonvulsants

          -  Paget's disease

          -  severe cardiac, pulmonary, hepatic, renal, or neurological disease

          -  life expectancy < 1 year

          -  participation in another trial
Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic
Condition: HIV; Sexually Transmitted Diseases; HIV Infections
MeSH terms: Infections; Sexually Transmitted Diseases
Intervention: DVD 1; DVD 2
Intervention description: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health; The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1010.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: STD; STI; Sexual Behavior; Prevention; HIV seronegativity

Summary:

      This study will determine whether showing an educational DVD to people at sexually
      transmitted infection clinics can reduce incidence of new infections and risky sexual
      behaviors and improve overall health.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of sexual risk behavior, defined as either signs, symptoms, or diagnosis
             indicative of an STD during the past 3 months; or unprotected vaginal or anal
             intercourse with two or more sexual partners, a partner with two or more partners, an
             anonymous partner, an injection drug using partner, or a partner with an STD

        Exclusion Criteria:

          -  Impaired mental status that would prevent participant from providing informed consent
             or participating meaningfully

          -  Inability to understand English
Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; Comparator: Placebo (unspecified); montelukast sodium
Intervention description: Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.; Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.; Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1771.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This is a year-long study evaluating the efficacy of both daily and intermittent treatment of
      asthma in children who experience symptoms episodically (i.e., seasonally, usually in the
      context of upper respiratory tract infection).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 6 months to 5 years with episodic (periodic) asthma

        Exclusion Criteria:

          -  Patients who are not in otherwise good health

          -  Patients who have persistent asthma (continual asthma symptoms)
A Multi-Center Study Evaluating the Safety of AC-170 0.24%
Condition: Atopic Disease (Including Allergic Conjunctivitis)
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Drug: AC-170 0.24%; AC-170 0%
Intervention MeSH terms: Cetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 512.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in
      Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic
      disease (including allergic conjunctivitis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 2 years of age

          -  be able to self-administer eye drops or have a parent/legal guardian available for
             this purpose

          -  if less than 18 years old have a history or family history of atopic disease
             (including allergic conjunctivitis)

          -  have ocular health within normal limits

        Exclusion Criteria:

          -  known contraindications or sensitivities to the study medication or its components

          -  any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety trial parameters

          -  use of disallowed medication during the period indicated prior to the enrollment or
             during the study
A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Hepatoma; Liver Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: DEB-TACE; Sorafenib
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, multicenter study that will be conducted at up to 40 centers in the
      United States and Outside United States (OUS). Participants in the study will be randomly
      assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the
      study participants' outcomes (medical condition) after being treated with ONCO-DOX and
      compare it to those treated with sorafenib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed Consent

          2. ≥18 years of age

          3. Diagnosis of HCC

          4. Locally advanced HCC

          5. Preserved liver function

          6. Eastern Cooperative Oncology Group 0 or 1

        Exclusion Criteria:

          1. Presence of extra-hepatic spread of disease.

          2. Macrovascular invasion of lobar portal vein branches or main portal vein.

          3. Candidate for surgical resection, transplantation, or local ablation.

          4. Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC.

          5. Any contraindication for TACE.

          6. Platelet count <50,000/mm3 or international normalized ratio >1.5.

          7. Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib.

          8. Unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).

          9. Known ejection fraction < 50%.

         10. Current infections requiring antibiotic therapy.

         11. Suffering from a known bleeding disorder.

         12. Renal insufficiency (serum creatinine > 2 mg/dL).

         13. Aspartate aminotransferase and/or alanine transaminase >5 times upper limit of normal.

         14. Presence of advanced liver disease.

         15. Any contraindication for doxorubicin administration:

         16. Any co-morbid condition or social situation, which has a high likelihood of causing
             poor compliance with the study protocol or jeopardizes the patient's safety.

         17. Patient has another primary tumor, with the exception of conventional basal cell
             carcinoma, superficial bladder cancer, melanoma in situ, or treated prostate cancer
             currently without biochemical or radiographic evidence of active disease

         18. Participation in a clinical trial of an investigational device or drug within 4 weeks
             of study entry.

         19. Pregnant or breast-feeding patients.