bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Intervention: Bevacizumab; Temozolomide; Radiation therapy; Placebo
Intervention description: 10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.; 75 mg/m^2 once daily for 6 weeks, followed by 150-200 mg/m^2 once daily on days 1-5 of six 4 week cycles.; 30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.; Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.
Intervention MeSH terms: Bevacizumab; Temozolomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 921.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the
      current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide
      followed by adjuvant temozolomide) as compared to the current standard of care alone.
      Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram
      (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with
      radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus
      temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6
      weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10
      mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4
      week cycle) for 6 cycles of maintenance treatment or until disease progression or
      unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab
      (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study
      treatment was until disease progression.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  newly diagnosed glioblastoma

          -  World Health Organization (WHO) performance status less than or equal to (<=2)

          -  stable or decreasing corticosteroid dose within 5 days prior to randomization

        Key Exclusion Criteria:

          -  evidence of recent hemorrhage on postoperative magnetic resonance imaging (MRI) of
             brain

          -  any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas

          -  any prior radiotherapy to brain

          -  clinically significant cardiovascular disease

          -  history of greater than or equal to (>=) grade 2 hemoptysis within 1 month prior to
             randomization

          -  previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status
             for enrollment into a clinical trial
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: Oteseconazole (VT-1161) 150mg capsule; Fluconazole 150mg capsule; Placebo
Intervention description: 600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.; 150mg administered every 72 hours in 3 sequential doses starting on Day 1.; Administered once weekly starting on Day 14.
Intervention MeSH terms: Fluconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 219.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is
      defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months.
      Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective
      treatment of RVVC than other oral antifungal medications.

      This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the
      treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part
      of the study is a 2-week induction phase for the treatment of the patient's current VVC
      episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to
      a random assignment. The second part consists of an 11-week maintenance phase, when the
      patient will take either oteseconazole (VT-1161) or a placebo according to the random
      assignment from the first part of the study, and then a 37-week follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  3 or more episodes of acute VVC in the past 12 months

          -  Positive KOH test

          -  Total vulvovaginal signs and symptoms score of ≥3 at screening visit

          -  Total vulvovaginal signs and symptoms score of <3 at Day 14

          -  Must be able to swallow pills

        Exclusion Criteria:

          -  Presence or a history of another vaginal or vulvar condition(s)

          -  Evidence of major organ system disease

          -  History of cervical cancer

          -  Poorly controlled diabetes mellitus

          -  Pregnant

          -  Recent use of topical or systemic antifungal or antibacterial drugs

          -  Recent use of immunosuppressive or systemic corticosteroid therapies
Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
Condition: Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Hyperlipidemia
MeSH terms: Renal Insufficiency; Diabetic Nephropathies; Kidney Failure, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Extended release niacin; Placebo
Intervention description: Extended release niacin 1500-2000mg once daily; Placebo tablets
Intervention MeSH terms: Niacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Hyperlipidemia; Randomized Controlled Trials

Summary:

      The primary purpose of this study is to test the effectiveness and tolerability of Niaspan®
      to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in
      people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan®
      slows down further development of kidney damage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes

          -  Diagnosis of chronic kidney disease stage 2 or 3 with an estimated GFR of 30-89 ml/min
             using the four variable MDRD (Modification of Diet in Renal Disease Study Group)
             formula

          -  Presence of microalbuminuria or proteinuria less than 3.5 g/d

          -  Diagnosis of hyperlipidemia currently treated with a "statin" drug

        Exclusion Criteria:

          -  Not meeting inclusion criteria

          -  HDL-C > 40 mg/dL for men, > 50 mg/dL for women

          -  TG (triglycerides) < 150 mg/dL and > 800 mg/dL

          -  Documented intolerance to Niaspan or Aspirin

          -  Treatment with other lipid-lowering agents (fibrates, BAS [bile acid sequestrants], or
             ezetimibe)

          -  Elevated transaminases (AST or ALT >1.3 x ULN)

          -  Unstable type 2 diabetes (FBG >200 mg/dL or HbA1c >9.5%)

          -  Known seropositivity for Hepatitis B, C, or HIV

          -  Documented history of malignancy

          -  Age < 18 years

          -  Pregnant women or nursing mothers

          -  Inability to give informed consent

          -  Start or change in "statin" dose < 2 months ago
Clinical Research Study Efficacy of a Prototype Oral Rinse
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Iodine; water
Intervention description: Rinse 2 times per day for 6 weeks; Use 2 times per day for 6 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female volunteers 18-65 years of age

          2. Good general health

          3. Must sign informed consent form

          4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.

          5. No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

          6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth
             with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified
             according to gingivitis severity. Average full mouth GI score should be in the range
             of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI
             (Quigley-Hein) to be in the range of 1.5-3.0

        Exclusion Criteria:

          1. Subjects unable or unwilling to sign the informed consent form.

          2. Medical condition which requires pre-medication prior to dental visits/procedures

          3. Moderate or advanced periodontal disease

          4. History of allergy to iodine

          5. History of thyroid disease

          6. History of diabetes

          7. 2 or more decayed untreated dental sites at screening.

          8. Other disease of the hard or soft oral tissues.

          9. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

         10. Use of medications that are currently affect salivary flow.

         11. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

         12. Pregnant or nursing women.

         13. Participation in any other clinical study within 1 week prior to enrollment into this
             study.

         14. Use of tobacco products

         15. Subjects who must receive dental treatment during the study dates.

         16. Current use of Antibiotics for any purpose.

         17. Presence of an orthodontic appliance.

         18. History of allergy to common dentifrice ingredients

         19. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

         20. Women of childbearing potential and not on birth control (Diaphragm, birth control
             pills or implants, IUD (Intrauterine device), condoms).

         21. Smoker
Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets
Condition: Hypophosphatemia, Familial; Hyperparathyroidism
MeSH terms: Rickets; Rickets, Hypophosphatemic; Familial Hypophosphatemic Rickets; Hypophosphatemia, Familial; Hypophosphatemia; Hyperparathyroidism
Intervention: Paricalcitol; Placebo
Intervention description: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits.; Placebo sugar pill
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: Rickets, Hypophosphatemia; Rickets, Vitamin D-Resistant; Rickets, X-linked hypophosphatemic

Summary:

      The purpose of this study is to determine the effectiveness of paricalcitol, a form of
      synthetic vitamin D, in lowering parathyroid hormone (PTH) levels and reducing disease
      symptoms in children and adults with X-linked hypophosphatemic (XLH) rickets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of XLH rickets

          -  Fasting serum calcium of 10.7 mg/dl or less

          -  Fasting PTH greater than 40 nleq/ml and less than 120 nleq/ml in the mid-molecule PTH
             assay at screening (upper limit of normal is 25 nleq/ml)

          -  Willing and able to participate in the trial

          -  Taking stable dose of standard therapy for XLH rickets for at least 2 months prior to
             study entry

          -  Concomitant therapy for XLH rickets will not be an exclusion criteria

          -  Parent or guardian willing to provide informed consent, if applicable

        Exclusion Criteria:

          -  Concomitant kidney failure (estimated creatinine clearance less than 60 cc/min or
             serum creatinine greater than 1.5 mg/dl)

          -  Serum 25-hydroxy vitamin D less than 20 ng/ml. Participants meeting this criterion
             will receive vitamin D3 supplementation for 3 months and then be rescreened.

          -  Unable to comply with protocol and appropriate follow-up visits

          -  Treatment with agents that may affect skeletal metabolism, such as glucocorticoids and
             anticonvulsants
A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide/formoterol (SYMBICORT) pMDI; Budesonide HFA pMDI
Intervention description: Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID); Budesonide HFA pMDI 160 ug x 2 actuations BID
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 742.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Moderate Asthma; Severe Asthma

Summary:

      The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a
      medication approved by the Food and Drug Administration, FDA) in the African American
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female, African American (self-reported), ≥12 years of age

          -  Moderate to severe asthma requiring treatment with an inhaled corticosteroid

          -  Diagnosis of asthma for at least 6 months

        Exclusion Criteria:

          -  Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral,
             ocular)

          -  Any significant disease or disorder that may jeopardize a subject's safety
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Enbrel (etanercept); Etanercept
Intervention description: Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly; Arm 2 = Enbrel 50 mg Autoinjector twice weekly
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary objective of this study is to compare patient satisfaction with the prefilled syringe
      (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12
      weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary
      evaluation focus on the identification of patient and device attributes associated with
      patient satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment of adults with moderate to severe plaque psoriasis who failed to respond to,
             or who have a contraindication to, or are intolerant to other systemic therapy
             including cyclosporine, methotrexate or PUVA

          -  Eligible for treatment with etanercept according to Summary of Product Characteristics
             (SmPC), and applicable local guidelines.

          -  Aged 18 years or more

          -  Willing and able to self-inject etanercept.

          -  Able to store test drug at 2-8oC.

          -  Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week
             0) for all women of childbearing potential. Sexually active women of childbearing
             potential must use a medically acceptable form of contraception. Medically acceptable
             forms of contraception include oral contraceptives, injectable or implantable methods,
             intrauterine devices, or properly used barrier contraception. Sexually active men must
             agree to use a reliable form of contraception during the study.

          -  Capable of understanding and willing to provide signed and dated written voluntary
             informed consent before any protocol-specific procedures are performed.

        Exclusion Criteria:

          -  Prior experience of biologics and anti-TNF treatment for their Psoriasis including
             etanercept.

          -  Sepsis or risk of sepsis.

          -  Current or recent infections, including chronic or localized.

          -  Latex sensitivity.

          -  Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination
             during the course of the study.
P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: SB204 4%; Vehicle Gel
Intervention description: Applied topically once daily; Applied topically one daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1330.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel
      group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe acne

          -  Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones)
             on the face

          -  Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

        Exclusion Criteria:

          -  Women of child-bearing potential who are pregnant, nursing, considering becoming
             pregnant

          -  Any dermatologic condition that could interfere with clinical evaluations including
             severe, recalcitrant cystic acne
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Condition: Intraocular Lens Replacement
Intervention: OMS302; Placebo
Intervention description: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available balanced saline salt (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.; Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cataract; lens replacement

Summary:

      The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302
      (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain
      in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Competent and willing to voluntarily provide informed consent

          -  18 years of age or older

          -  In good general health needing to undergo cataract extraction or lens extraction with
             lens replacement surgery in one eye, under topical anesthesia

        Exclusion Criteria:

          -  No allergies to the medications and/or the active ingredients of any of the study
             medications

          -  No medications with the same activities of the active ingredients in OMS302 for
             defined time intervals prior to and after surgery

          -  No other significant eye injuries, eye conditions or general medical conditions likely
             to interfere with the evaluation of the study medication