bioihbjkbjnl/mcl2 huggingface dataset:
Methadone Maintenance for Prisoners
Condition: Heroin Addiction
MeSH terms: Heroin Dependence
Intervention: Counseling Only; Counseling + Transfer; Counseling + Methadone
Intervention description: Counseling only in prison, with passive referral to drug abuse treatment upon release; Counseling only in prison, with opportunity to enter methadone maintenance upon release; Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
Intervention MeSH terms: Methadone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This five-year study examines the benefits of methadone maintenance treatment initiated in
      prison and continued in the community to male offenders who were previously, but not
      currently, heroin-dependent. It is anticipated that such prisoners will have more favorable
      outcomes in the year following release with regard to drug abuse, crime, and HIV risk
      behavior than either prisoners who receive counseling only or begin initiation of methadone
      maintenance in the community
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heroin dependence in the year prior to current incarceration

          -  3-6 months left to serve in prison-male pre-release inmate suitability for methadone
             maintenance as determined by medical evaluation

          -  Willingness to enroll in methadone maintenance

          -  Having a Baltimore address

        Exclusion Criteria:

          -  Pending parole hearing

          -  Pending charges

          -  Kidney failure

          -  Liver failure
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: CINRYZE 500; CINRYZE 1000
Intervention description: 500 Units of CINRYZE administered by IV injection; 1000 Units of CINRYZE administered by IV injection
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Pediatric; C1 inhibitor; HAE; Cinryze; C1 INH; Prevention

Summary:

      Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units
      and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent
      angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).

      Secondary Objectives - To assess the safety and tolerability, characterize the
      pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose
      levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type I or Type II HAE.

          -  History of angioedema attacks.

        Exclusion Criteria:

          -  History of bleeding or clotting abnormality.

          -  Diagnosis of acquired angioedema or known to have C1 INH antibodies.

          -  History of allergic reaction to C1 esterase inhibitor or other blood products.

          -  Receipt of any experimental agents other than those required for prevention or
             treatment of angioedema attacks within 30 days prior to screening.
Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: fampridine; Placebo
Intervention description: Matched placebo
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 646.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Fampridine

Summary:

      The primary objective is to determine whether prolonged-release fampridine (10 mg twice
      daily) has a clinically meaningful effect on participant-reported walking ability over a
      24-week study period.

      The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken
      twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical
      impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period;
      to evaluate criteria for early assessment of response to fampridine that can predict
      clinically meaningful benefits in walking ability and balance; to assess the safety and
      tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment
      period.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have a diagnosis of primary-progressive, secondary-progressive,
             progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee
             criteria [McDonald 2001; Polman 2005] as defined by Lublin and Reingold [Lublin and
             Reingold 1996] of at least 3 months duration

          -  Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive

          -  Must have walking impairment, as deemed by the Investigator

        Key Exclusion Criteria:

          -  History of human immunodeficiency virus (HIV)

          -  Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis
             infection that has been serologically confirmed as resolved are not excluded from
             study participation

          -  Known allergy to fampridine, pyridine-containing substances, or any of the inactive
             ingredients in the prolonged-release fampridine tablet

          -  Creatinine clearance (CrCl) of <80 mL/min

          -  History of malignant disease

          -  Presence of pulmonary disease

          -  A body mass index (BMI) ≥40 (BMI formula: BMI = mass [kg]/[height(m)]2)

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Condition: Idiopathic Short Stature
MeSH terms: Dwarfism
Intervention: Aromatase Inhibitor; Growth Hormone; Aromatase Inhibitor and Growth Hormone
Intervention MeSH terms: Letrozole; Anastrozole; Hormones; Aromatase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Male
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Aromatase; Growth; Letrozole; Anastrozole; GH; Children; Puberty

Summary:

      When treating very short children in puberty we are time-limited, as sex hormones cause the
      growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty,
      increase height potential, but leave children sexually infantile at a critical time in
      development. Human and animal data show that estrogen, in females and males, is a principal
      regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs),
      which block testosterone to estrogen conversion, in boys with different growth disorders, we
      have shown that AIs may have beneficial effects enhancing height potential in growth-retarded
      males, without affecting their puberty. However, no direct comparison of the effect of AIs
      alone vs. conventional GH treatment has been done to date. This study will assess the effect
      of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent
      boys with idiopathic short stature.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males: Ages: 12 - less than 18 years.

          -  Bone age less than 14 ½ years at study initiation.

          -  Presence of puberty.

          -  Idiopathic short stature will be defined as a short child equal or less than -2SD for
             height, with normal GH responses to stimuli (> or = 5ng/ml to at least 2
             secretagogues) or a normal IGF-I and BP-3, normal body proportions and no other
             identifiable growth pathology.

          -  Accurate growth data for at least 6 months at baseline is available.

        Exclusion Criteria:

          -  Chronic illnesses.

          -  Chronic use of glucocorticosteroids.

          -  Previous use of hormonal treatment with AIs, sex steroids or GH in the preceding 6
             months.

          -  Birth weight small for gestational age (SGA).
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy); Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Intervention description: One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.; One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of Triple Combination Therapy compared with
      Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary
      open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or primary open-angle glaucoma in each eye

          -  Requires treatment with IOP-lowering medication in both eyes

        Exclusion Criteria:

          -  Required chronic use of ocular medications during the study other than study
             medication

          -  Use of any corticosteroids within 30 days

          -  History of any traumatic eye surgeries

          -  Cataract surgery in the past 6 months

          -  Anticipated wearing of contact lenses during the study
Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
Condition: Growth Hormone Deficiency
Intervention: Somatropin
Intervention description: Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Healthy volunteers: No

Summary:

      To estimate the evolution of height and growth rate over 5 years of growth hormone (GH)
      treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the
      good clinical and biological safety of GH treatment in such children
    

Eligibility criteria:

        Inclusion Criteria:

          -  Glucocorticosteroid treatment for 12 months at least

          -  Bone age < 15 years for a boy and < 13 years for a girl

          -  Child measured height < - 2 SD, Child currently treated by GH

        Exclusion Criteria:

          -  Known diabetes (type 1 or type 2)

          -  A previous history of intolerance or hypersensitivity to the study drug or to drugs
             with similar chemical structures
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Dapagliflozin; Metformin; Dapagliflozin Placebo; Pioglitazone
Intervention description: Tablets, Oral, 5 mg, Once daily, 24 weeks; Tablets, Oral, 10 mg, Once daily, 24 weeks; Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks; Tablets, Oral, 0 mg, Once daily, 24 weeks; Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Intervention MeSH terms: Metformin; Pioglitazone; Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1484.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can
      help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well
      controlled on metformin alone. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate
             glycemic control

          -  Drug naive or treated with anti-diabetic medication for < 24 weeks

          -  C-peptide ≥ 1.0 ng/mL

          -  Body Mass Index ≤ 45.0 kg/m²

        Exclusion Criteria:

          -  AST and/or ALT > 3 times ULN

          -  Serum total bilirubin > 2 mg/dL

          -  Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women

          -  Creatine kinase ≥ 3 times ULN

          -  Symptoms of severely uncontrolled diabetes

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematological,
             oncological, endocrine, psychiatric, or rheumatic diseases
Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer
Condition: Non-squamous Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab + Pemetrexed; Bevacizumab + Pemetrexed + Carboplatin
Intervention description: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks; Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Intervention MeSH terms: Bevacizumab; Carboplatin; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 271.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: lung cancer; NSCLC; elderly; non-squamous; Elderly patients at least 65 years old; first line therapy; non-squamous non-small cell lung cancer stage IIIb or IV

Summary:

      Multi-center, open, randomized (parallel) and comparative phase III.

      Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed
      by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.

      Arm A: Bevacizumab + pemetrexed

      Arm B: Bevacizumab + pemetrexed + carboplatin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIb and IV NSCLC, excluded squamous cell NSCLC

          -  Age ≥ 65 years

          -  ECOG 0-2

        Exclusion Criteria:

          -  Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a
             predominant squamous component

          -  History of haemoptysis

          -  Evidence of tumour invading major blood vessels on imaging

          -  Radiotherapy within 28 days prior to enrolment

          -  Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory
             agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day
             period for long-acting agents, such as piroxicam)

          -  Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral
             or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.
             Prophylactic use of anticoagulants is allowed

          -  Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months
             before enrolment), myocardial infarction (≤6 months before enrolment), unstable
             angina, CHF NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the
             study and might interfere with regularity of the study treatment, or not controlled by
             medication

          -  Non-healing wound, active peptic ulcer or bone fracture

          -  History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
             within 6 months of enrolment
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
Condition: Acute Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: ISV-403; Vehicle
Intervention description: Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.; Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.
Intervention MeSH terms: Besifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 957.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the
      treatment of bacterial conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent
             conjunctival discharge and redness in at least one eye.

          -  Females of childbearing potential must utilized reliable contraceptive methods and
             have a negative pregnancy test.

        Exclusion Criteria:

          -  Pregnant or nursing females.

          -  Known hypersensitivity to fluoroquinolones or to any of the study ingredients.

          -  Use of any antibiotic within 72 hours of treatment.

          -  Any disease or condition that could interfere with the safety and efficacy evaluations
             of the study medications.

          -  Participation in an ophthalmic drug or device research study within 30 days prior to
             entry into the study.
Safety and Maintenance Study of Entocort for Children With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Entocort
Intervention description: Entocort capsules, taken orally, 6 mg daily.
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All male and female subjects must be aged 5 to 17, inclusive, and must not have
             reached their 18th birthday by the estimated final office visit.

          -  All subjects must weight >= 15 kg at the time of enrollment.

          -  Subjects must have been diagnosed and treated for active Crohn's disease of the ileum
             and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or
             evidence of mucosal erosions and/or histology and have a PCDAI <= 10

        Exclusion Criteria:

          -  Subjects who have had any previous intestinal resection proximal to and including the
             ascending colon.

          -  Subjects with evidence of active Crohn's disease (PCDAI > 10) and/or stricturing,
             prestenotic dilatation, clinical evidence of obstruction, perirectal abscess,
             perirectal disease with active draining fistulas, perforation, or any septic
             complications.

          -  Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal
             range for age and gender (NOTE: Subjects from the induction protocol with abnormal
             morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility
             criteria, may be enrolled if the investigator decides that Entocort 6 mg is an
             appropriate therapy option.
Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin
Condition: Hypotrichosis
MeSH terms: Hypotrichosis
Intervention: Bimatoprost 0.03% solution; Vehicle solution
Intervention description: Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).; Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 368.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: eyelashes

Summary:

      This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution
      application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis
      of the eyelashes (inadequate or not enough eyelashes). There will be two different types of
      subjects participating in the study 1)those with inadequate eyelashes due to natural causes
      or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment.
      There will be two treatment periods of six months each. Subjects will receive either the
      study medication or vehicle in either of the two treatment periods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have inadequate eyelashes due to natural causes and are not satisfied
             with their eyelash appearance.

          -  For the post-chemotherapy population: subjects who have inadequate eyelashes following
             a complete course of chemotherapy treatment and are not satisfied with their eyelash
             appearance, are considered free of cancer and are well enough to complete the study.

        Exclusion Criteria:

          -  Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye
             surgery, permanent eyeliner, eyelash implants, eyelash extension application.

          -  Any use of over the counter or prescription use eyelash growth products.

          -  Subjects requiring eye drop medications for glaucoma.

          -  Females who are pregnant, nursing or planning a pregnancy during the study or who are
             of childbearing potential and not using a reliable method of contraception.