bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Condition: Jawline Definition
Intervention: VOLUX XC; No-treatment control
Intervention description: Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.; No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel
      for restoring jawline definition
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using
             the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the
             same on both sides, but must be Grade 2 or 3

          -  Treating Investigator (TI) considers the subject's jaw amenable to an improvement of
             at least 1 grade on the scale for the jawline definition

          -  Written Informed Consent (IC) has been obtained

        Exclusion Criteria:

          -  Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone,
             polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted
             with any of these products during the study

          -  Has ever undergone fat injections in the malar, chin or jawline area or is planning to
             undergo this procedure during the study

          -  Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite,
             poly-L-lactic acid) below the subnasale within 36 months before enrollment or is
             planning to undergo such treatment during the study

          -  Has received deoxycholic acid treatment in the submental region in the last 6 months

          -  Has active autoimmune disease

          -  Females who are pregnant, nursing, or planning a pregnancy during the course of the
             study
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: bromfenac ophthalmic solution; placebo
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Bromfenac; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cataract extraction with intraocular lens implantation

Summary:

      Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for cataract surgery

        Exclusion Criteria:

          -  Known hypersensitivity to bromfenac and salicylates
Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: rizatriptan benzoate; rizatriptan benzoate; Comparator: sumatriptan; Comparator: Placebo
Intervention description: single dose administration of 5mg rizatriptan (by Mouth) p.o.; single dose administration of 10 mg rizatriptan p.o.; single dose administration of sumatriptan 100 p.o.; placebo to rizatriptan
Intervention MeSH terms: Sumatriptan; Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1268.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine
      attacks and duration of relief provided. This study will also provide additional efficacy
      data on rizatriptan 5 mg and 10 mg for the treatment of migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had at least a 6-month history of migraine, with or without aura

          -  Patient was male, or if female must have been postmenopausal, surgically sterilized,
             or taking adequate contraceptive precautions.

          -  Patient was judged to be in good health, apart from migraine

        Exclusion Criteria:

          -  Patient was pregnant or a nursing mother

          -  Patient had abused drugs or alcohol within 12 months prior to entering the study

          -  Patient had a history of cardiovascular disease

          -  Patient had clinically significant Electrocardiography (ECG) abnormality

          -  Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic
             of less than 95 mm Hg at screening

          -  Patient received treatment with an investigational device or compound within 30 days
             of the study start

          -  Patient typically suffered from less then 1 or more than 8 attacks of migraine per
             month

          -  Patient had difficulty in distinguishing his/her migraine attacks from tension or
             interval headaches

          -  Patient had hypersensitivity to sumatriptan

          -  Patient had participated in any previous study involving rizatriptan
18F-AV-1451 Autopsy Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; PET Scan
Intervention description: 370 megabecquerel (MBq) IV single-dose; positron emission tomography (PET) scan
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is designed to test the relationship between ante-mortem flortaucipir Positron
      Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with
      Alzheimer's disease (AD), as measured at autopsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a projected life expectancy of ≤ 6 months

          -  Can tolerate a 20 minute PET scan

          -  Give informed consent or have a legally authorized representative to consent for study
             procedures and brain donation consistent with the legal requirements of the State in
             which they die

        Exclusion Criteria:

          -  Aggressively being treated with life sustaining measures

          -  Known to have a structural brain lesion that would interfere either with PET imaging
             or pathological assessment

          -  Clinically significant infectious disease

          -  Currently receiving any investigational medications except with permission from the
             study sponsor

          -  Participated in an experimental study with an amyloid or tau targeting agent

          -  Suspected encephalopathy due to alcoholism or end-stage liver disease

          -  Females of childbearing potential

          -  History of risk factors for Torsades de Pointes or are currently taking medication
             known to cause QT prolongation
A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Saxagliptin; Saxagliptin; Glyburide; Placebo; Glyburide; Metformin
Intervention description: Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT]); Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).; Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT); Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT); Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT); Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Intervention MeSH terms: Metformin; Saxagliptin; Glyburide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 768.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe
      and works better than increasing the amount of sulfonylurea a patient takes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes.

          -  Treated with a sulfonylurea for at least 2 months.

          -  Inadequate blood sugar control.

          -  Are not on any other medications to lower blood sugar.

          -  No major heart, liver or kidney problems.

          -  Women not pregnant or breast feeding.
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: 5 FU; Leucovorin; Oxaliplatin; Oxaliplatin; capecitabine [Xeloda]
Intervention description: As prescribed, in 2 week cycles; As prescribed, in 2 week cycles; As prescribed, in 3 week cycles; As prescribed, in 2 week cycles; 1000mg/m2 po bid on days 1-15 of each 3 week cycle
Intervention MeSH terms: Leucovorin; Capecitabine; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 627.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv
      fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients
      previously treated for metastatic colorectal cancer. Patients will be randomized to receive
      either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)
      FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study
      treatment is until disease progression, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  metastatic colorectal cancer;

          -  >=1 target lesion;

          -  failed first-line chemotherapy with 5-fluorouracil and irinotecan.

        Exclusion Criteria:

          -  previous treatment with oxaliplatin;

          -  progressive or recurrent disease during or within 6 months of completion of first-line
             chemotherapy;

          -  >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic
             disease.
Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy
Condition: Vomiting; Cisplatin Adverse Reaction
MeSH terms: Vomiting
Intervention: Placebo; Gabapentin
Intervention description: Placebo, given orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3); Gabapentin 300mg, orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vomiting; Antiemetics; Dexamethasone; Cisplatin; Antineoplastic combined chemotherapy protocols

Summary:

      Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic
      surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy
      induced emesis.

      The purpose of this study is to determine whether the addition of gabapentin to dexamethasone
      plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First course of chemotherapy ( cisplatin or doxorubicin at a dose of at least 50mg per
             square meter)

          -  Written informed consent must be obtained before initiating the protocol procedures

        Exclusion Criteria:

          -  ECOG 3

          -  Nausea and vomiting within the past 1 day

          -  Gastrointestinal obstruction

          -  Concurrent use of opioid

          -  Patients with brain metastases

          -  History of allergic or other adverse reaction to gabapentin
Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea); Teneli / Teneli + SU
Intervention description: Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea; Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea
Intervention MeSH terms: Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
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 safety and efficacy of MP-513 (Teneligliptin) in
      combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration
      and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea 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 7.0% and 10.0%

          -  Patients who took Sulfonylurea for diabetes over 12 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 with Class III/IV heart failure symptoms according to NYHA functional
             classification

          -  Patients who are gastrointestinal disorder (diarrhea, vomiting)

          -  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
Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants
Condition: Hyperemia
MeSH terms: Hyperemia
Intervention: Brimonidine Tartrate; Vehicle; Sodium Fluorescein; Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Intervention description: Ophthalmic solution to be applied as directed.; Ophthalmic solution to be applied as directed.; For use as needed during the study for evaluating corneal damage.; For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 507.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ocular redness

Summary:

      To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025%
      versus its vehicle in a population of pediatric, adult, and geriatric participants. At least
      51% of participants will be 40 years of age or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and
             any race or ethnicity;

          -  Have ocular health within normal limits, including a calculated best-corrected (if
             necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR)
             or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy
             Study (ETDRS) chart.

        Exclusion Criteria:

          -  Have any ocular/systemic health problems

          -  Use of any disallowed medications during the period indicated prior to Baseline (Visit
             1) and for the duration of the study.
A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness
Condition: Muscle Soreness
MeSH terms: Myalgia
Intervention: Diclofenac sodium gel 1%; Placebo
Intervention description: Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).; Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction
      of the pain associated with DOMS
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18-35 years

          -  Not engaged in regular lower extremity fitness activities in the past 6 months prior
             to screening

          -  Willing to refrain from use of ice, heat and massage during the study

          -  DOMS score ≥4 Pain at Rest (PAR) and a DOMS score ≥5 Pain on Walking (POW), with
             moderate or severe on categorical scale

        Exclusion Criteria:

          -  Pain medication & corticosteroids prior to randomization

          -  Topical analgesic or anti-inflammatory treatment over the previous month

          -  Body mass index of >32 kg/m2

        Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: DiaPep277; Placebo
Intervention description: 1.0 mg dose in 0.5 mL of solution; 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 475.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: beta-cells; autoimmune; Diabetes; immunomodulation

Summary:

      This study will look at the treatment effect of DiaPep277 on preservation of beta-cell
      function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that
      changes the way the immune system behaves, stopping its attack on the beta-cells.

      Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10
      injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of type 1 diabetes within last 6 months

          -  Age 20-45 years

          -  fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L

          -  BMI between 17 and 30 at screening

        Exclusion Criteria:

          -  Significant disease or condition other than type 1 diabetes

          -  Diabetes-related complications

          -  Ongoing treatment with immunosuppressive or immunomodulating agents including chronic
             corticosteroids
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Ibandronate [Bonviva/Boniva]; Ibandronate [Bonviva/Boniva]; Ibandronate [Bonviva/Boniva]; Ibandronate [Bonviva/Boniva]; Calcium; Vitamin D
Intervention description: 2.5mg po daily; 100mg po monthly on a single day; 100mg po monthly over 2 consecutive days; 150mg po monthly; 500 mg/day; 400 IU/day
Intervention MeSH terms: Vitamin D; Ibandronic Acid; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1609.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy and safety of different treatment regimens of oral
      Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily
      supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+
      years, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women 55-80 years of age;

          -  post-menopausal for >= 5 years;

          -  ambulatory.

        Exclusion Criteria:

          -  malignant disease diagnosed within the previous 10 years (except basal cell cancer
             that has been successfully removed);

          -  breast cancer within the previous 20 years;

          -  allergy to bisphosphonates;

          -  previous treatment with an intravenous bisphosphonate at any time;

          -  previous treatment with an oral bisphosphonate within the last 6 months, >1 month of
             treatment within the last year, or >3 months of treatment within the last 2 years.