bioihbjkbjnl/mcl2 huggingface dataset:
A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo; Metformin (blinded); Metformin (open-label)
Intervention description: Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT); Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST); Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12); Tablets, Oral, 500-1500 mg, as needed (starting in LT)
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn whether Saxagliptin can improve the
      body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Drug naive

          -  Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%

          -  Fasting C-peptide ≥1.0 ng/mL

          -  Body mass index ≤40 kg/m²

        Exclusion Criteria:

          -  Recent cardiac or cerebrovascular event

          -  Elevated serum creatinine
Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
Condition: Post-operative Pain; Post-partum Pain; Cesarean Section Complications
MeSH terms: Pain, Postoperative
Intervention: Ketorolac
Intervention description: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
Intervention MeSH terms: Ketorolac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The subjects, care providers, and investigators will be blinded to the assignments of groups.
Enrollment: 148.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ketorolac; opiate; cesarean section

Summary:

      To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean
      section.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women presenting for care at Tufts Medical Center as an outpatient in obstetrics
             clinic or on Labor and Delivery.

          -  The subject must have had a cesarean section for any indication at Tufts Medical
             Center to be randomized to the study

          -  The subject is willing to have a phone call follow up conversation 2 weeks after their
             surgery.

        Exclusion Criteria:

          -  Patients with allergy to ketorolac, NSAIDS or aspirin

          -  Patients with peptic ulcer disease, preexisting kidney or liver disease.

          -  Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean
             section.

          -  Patient is hemodynamically unstable due to hemorrhage.

          -  Patient requires therapeutic anticoagulation in the post-operative period

          -  Patients with peripartum cardiomyopathy

          -  Provider decision to exclude patient.

          -  Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia,
             HELLP syndrome, or eclampsia

          -  A study subject may participate in another research study while participating in this
             research study.
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
Condition: Genital Warts; Anal Cancer; Anal Intraepithelial Neoplasia
MeSH terms: Condylomata Acuminata; Anus Neoplasms
Intervention: 9vHPV Vaccine
Intervention description: 9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2520.0
Sex: All
Minimum age: 16 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV
      vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV
      efficacy findings in young women to young men based on the demonstration of similar
      immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody
      responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody
      responses in young women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Good physical health

          -  Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap
             test results

          -  Other inclusion criteria will be discussed with the investigator

        Exclusion Criteria:

          -  History of severe allergic reaction that required medical intervention

          -  Currently enrolled in a clinical trial

          -  If participant is female, pregnant

          -  Currently immunocompromised or having received immunosuppressive therapy in the last
             year

          -  Positive test for HPV

          -  History of HPV-related external genital lesions or HPV-related anal lesions or anal
             cancer

          -  If participant is female, history of abnormal cervical biopsy results

          -  Other exclusion criteria will be discussed with the investigator
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)
Condition: Visual Impairment; Macular Edema; Branch Retinal Vein Occlusion
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Ranibizumab; Dexamethasone Implant; Sham injection
Intervention description: Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split; Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.; Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration
Intervention MeSH terms: Dexamethasone; Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Visual impairment; macular edema; branch retinal vein occlusion; Dexamethasone implant; Ranibizumab

Summary:

      This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone
      implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a
      pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with
      sham injections PRN afterwards.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with visual impairment due to macular edema following BRVO

          -  Diagnosis of BRVO at maximum 6 months prior to Screening

          -  BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

        Exclusion Criteria:

          -  Media clarity, pupillary dilation and patient cooperation not sufficient for adequate
             fundus photographs

          -  Central retinal thickness (CRT) < 250 µm in the study eye

          -  Prior episode of RVO in the study eye

          -  Active formation of new vessels in the study eye

          -  Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline

          -  IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if
             they have undergone glaucoma treatment

          -  Improvement of > 10 letters on BCVA between Screening and Baseline

        Other protocol-defined inclusion/exclusion criteria may apply
Treatment of Patients With Nocturia
Condition: Nocturia
MeSH terms: Nocturia
Intervention: SER120; Placebo
Intervention description: SER120; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that
      SER120 will decrease the number of nocturic episodes compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female 50 years or older

          -  Nocturia of 6 or more months duration averaging 2 episodes or more per night

        Exclusion Criteria:

          -  CHF

          -  Diabetes

          -  Diabetes Insipidus

          -  Renal Insufficiency

          -  Hepatic Insufficiency

          -  Incontinence

          -  Illness requiring steroids

          -  Current or past urologic malignancy

          -  Nephrotic Syndrome

          -  Unexplained pelvic masses

          -  Urinary bladder neurological dysfunction

          -  Urinary bladder surgery or radiotherapy

          -  Sleep Apnea

          -  Pregnant or breast feeding
A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: 0.15% azelastine hydrochloride; Mometasone furoate
Intervention description: 1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM; 200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
Intervention MeSH terms: Mometasone Furoate; Azelastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 703.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if one allergy treatment (0.15% azelastine
      hydrochloride) is as safe as mometasone furoate (nasonex) alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 12 years and older with a compatible history greater than or
             equal to 1 year of rhinitis due to perennial allergies.

          -  Must be willing and able to provide informed consent and to participate in all study
             procedures

          -  Must be in generally good health

          -  Positive skin test to a prevalent perennial allergen

        Exclusion Criteria:

          -  On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal
             septal perforation

          -  Use of any investigational drug within 30 days of the first visit

          -  Any nasal surgery or sinus surgery within the previous year

          -  Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate
             and to either sorbital or sucralose

          -  Women who are pregnant or nursing

          -  Women who are not using an acceptable method of birth control

          -  Nasal Diseases likely to affect deposition of intranasal medication, such as
             sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal
             structural abnormalities.

          -  Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered
             after consultation with investigator.

          -  Patients with Arrythmia

          -  Patients with know history of alcohol and drug abuse

          -  Existence of any surgical or medical condition, which in the opinion of the
             investigator or sponsor, might significantly alter the evaluation of the study.

          -  Use of medications that could affect the study results
An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Metformin XR
Intervention description: Tablets, Oral, Once daily, 24 weeks; Tablets, Oral, Once daily, 24 weeks
Intervention MeSH terms: Metformin; Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 994.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if initiating treatment with
      BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in
      patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes,
      when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety
      of this treatment will also be studied
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males & females, 18-77 years old inclusive, with type 2 diabetes and with inadequate
             glycemic control

          -  Drug naive or treated with anti-diabetic medication for < 24 weeks since original
             diagnosis

          -  C-peptide ≥ 1.0 ng/mL

          -  Body Mass Index ≤ 45.0 kg/m

          -  Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

        Exclusion Criteria:

          -  AST and/or ALT >3.0 times the upper limit of normal (ULN)

          -  Serum total bilirubin > 2.0 mg/dL

          -  Creatine kinase > 3X the upper limit of normal (ULN)

          -  Symptoms of severely uncontrolled diabetes

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematological,
             oncological, endocrine, psychiatric or rheumatic diseases
Study to Learn How the Drug Aflibercept Works in in Japanese Patients With Increased Eye Pressure That is Caused by New Blood Vessels Growing in the Eye (Neovascular Glaucoma or NVG). Safety of the Drug and Patients' Tolerability of the Drug Injection is Also Studied
Condition: Glaucoma, Neovascular
MeSH terms: Glaucoma; Glaucoma, Neovascular
Intervention: Aflibercept (EYLEA, BAY86-5321); Topical IOP-lowering drugs
Intervention description: 2 mg (0.05 mL), Intravitreal injection (IVT), single dose.; A combination of at least 3 topical IOP-lowering drugs will be administered during a run-in phase before treatment and should be kept unchanged until IOP evaluation at Week 1, after which they may be reduced according to the investigator's opinion
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The researchers in this trial want to learn how the drug aflibercept works in in Japanese
      patients with increased eye pressure that is caused by new blood vessels growing in the eye
      (neovascular glaucoma or NVG). They also want to find out how patient tolerate the
      application of the drug that is injected in the vitreous humor of the eye and if this will
      cause any medical problems during the trial (vitreous humor, also called vitreous body is the
      clear gel that fills the space between the lens and the retina of the eyeball).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese men and women aged 20 years or older

          -  Patients diagnosed as having NVG (neovascular glaucoma) with neovascularization in the
             anterior segment (both iris and anterior chamber angle)

          -  Patients with IOP (intraocular pressure) higher than 25 mmHg in the study eye due to
             anterior segment (both iris and anterior chamber angle) neovascularization

        Exclusion Criteria:

          -  Patients with angle-closure due to conditions other than NVG or complete angle-closure
             due to NVG

          -  Patients with a known or suspected ocular or peri-ocular infection

          -  Patients with severe intraocular inflammation in the study eye

          -  Women who are pregnant, suspected of being pregnant or lactating

          -  Patients with known allergy to aflibercept
Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Lanreotide, non steroidal anti androgens and LHRH-a; Non steroidal anti androgens and LHRH-a
Intervention description: Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months.
Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression.; Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression
Intervention MeSH terms: Ascorbic Acid; Methyltestosterone; Lanreotide; Androgens; Estrogens, Conjugated (USP); Prolactin Release-Inhibiting Factors; Androgen Antagonists; Nonsteroidal Anti-Androgens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of the study is to compare in an exploratory fashion the efficacy on progression-free
      survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non
      metastatic castrate resistant prostate cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven diagnosis of prostate cancer

          -  Evidence of PSA progression despite castrate levels of testosterone (<50 ng/dL)
             following orchiectomy or during therapy with luteinizing hormone releasing hormone
             agonists (LHRH-a)

          -  Patients with non-metastatic or stable metastatic disease

          -  Chromogranin A elevation above normal range (confirmed by a second evaluation at least
             1 week later) [cut off levels will be > 20 U/L for enzyme linked immunosorbent (ELISA)
             assay and > 100 ng/ml for immunoradiometric (IRMA) assay]

        Exclusion Criteria:

          -  Patients who according to the investigator opinion are candidates to be treated
             immediately with chemotherapy (e.g. docetaxel)

          -  First line treatment with antiandrogen in monotherapy

          -  Visceral metastasis

          -  Previous or concomitant treatment with a somatostatin analogue
Patisiran in Patients With Hereditary Transthyretin-mediated Amyloidosis (hATTR Amyloidosis) Disease Progression Post-Liver Transplant
Condition: Amyloidosis, Familial; Transthyretin Amyloidosis
MeSH terms: Amyloidosis, Familial; Amyloidosis; Disease Progression
Intervention: Patisiran
Intervention description: Patisiran was administered via IV infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of
      patisiran in participants with hereditary transthyretin-mediated amyloidosis (hATTR
      amyloidosis) with disease progression after liver transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received liver transplant for treatment of hATTR amyloidosis ≥12 months before study
             start

          -  Has increase in polyneuropathy disability (PND) score after liver transplant

          -  Has received stable immunosuppressive regimen with ≤10 mg/day of prednisone for at
             least 3 months before study start

          -  Has Karnofsky Performance Status (KPS) of ≥70%

          -  Has vitamin A level greater than or equal to lower limit of normal

        Exclusion Criteria:

          -  Has previously received inotersen or patisiran

          -  Has clinically significant liver function test abnormalities

          -  Has known portal hypertension with ascites

          -  Has estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m^2

          -  Has known leptomeningeal amyloidosis

          -  Has infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)

          -  Has New York Heart Association heart failure classification of >2

          -  Is wheelchair bound or bedridden

          -  Has received organ transplants other than liver transplant

          -  Will be using another tetramer stabilizer during the study
Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Carbidopa/levodopa/entacapone; Immediate release carbidopa/levodopa
Intervention description: Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.; Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Entacapone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 747.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Parkinson's disease, levodopa therapy, dyskinesia

Summary:

      The CELC200A2401 study has been designed in order to evaluate the hypothesis that
      administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy
      is initiated results in a decrease in the risk of the development of motor complications for
      patients with Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of idiopathic Parkinson's disease

          -  Diagnosis of Parkinson's disease for no more than 5 years

        Exclusion Criteria:

          -  History, signs, or symptoms of atypical or secondary parkinsonism

          -  Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor
             complications

          -  Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1

        Other inclusion/exclusion criteria applied to this study.