bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Multiple Attacks of Acute Migraine (0462-025)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: rizatriptan benzoate; Comparator: Placebo
Intervention description: Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache; Placebo to Rizatriptan, Oral Tablet
Intervention MeSH terms: Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 473.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine
      compared to placebo.
    

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 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 prior exposure to rizatriptan
Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: GEn (XP13512); GEn (XP13512); Placebo
Intervention description: 1200 mg GEn (XP13512) orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks; 1200 mg GEn (XP13512), orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks; Placebo, orally, once daily for 12 weeks following single blind 24-week phase
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to assess the maintenance of efficacy of gabapentin
      enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering
      from Restless Legs Syndrome (RLS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with primary RLS, based on the International RLS Study Group Diagnostic
             Criteria.

        Exclusion Criteria:

          -  A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of
             RLS;

          -  Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's
             disease, Multiple Sclerosis, dyskinesias, and dystonias);

          -  Abnormal laboratory results, electrocardiogram (ECG) or physical findings;

          -  Pregnant or lactating women;

          -  Women of childbearing potential who are not practicing an acceptable method of birth
             control.
Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis
Condition: Scalp Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Intervention: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week); clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week); clobetasol propionate shampoo (2/week); ketoconazole shampoo (2/week)
Intervention description: Association: clobetasol propionate shampoo & ketoconazole shampoo; Association: clobetasol propionate shampoo & ketoconazole shampoo; Monotherapy with clobetasol propionate shampoo; Monotherpay ketoconazole shampoo (2/week)
Intervention MeSH terms: Ketoconazole; Clobetasol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective is to assess different treatment regimens with Clobetasol propionate shampoo
      0.05% in the treatment of scalp Seborrheic Dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with moderate to severe scalp Seborrheic Dermatitis

        Exclusion Criteria:

          -  Subjects suffering from psoriasis,

          -  Subjects with a known allergy to one of the components of the test products,

          -  Female subjects who are pregnant, nursing or planning a pregnancy during the study
Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Intervention: Omega 3 fatty acids; Corn oil
Intervention description: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids; Corn oil will be the placebo comparator for omega 3 fatty acids supplement
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly selected to receive 3.7 g of a supplement containing docosahexanoic and eicosapentanoic acids or a supplement containing corn oil. The supplements will be provided for 12 weeks
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Albuminuria; Carotid Intima-Media Thickness; Pulse Wave Velocity; Inflammation

Summary:

      To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and
      vascular function and inflammatory parameters in patients with chronic renal disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary albumin excretion over 30 mg/g creatinin

          -  Chronic renal failure stage 2 to 4

          -  Absence of serious conditions such as cáncer, decompensated heart failure, chronic
             infections and severe arterial lesions

        Exclusion Criteria:

          -  Blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8%

          -  Presence of cognitive impairment that does not allow to sigin a written informed
             consent

          -  Alcohol or illicit drug abuse
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: FMX-101, 4% minocycline foam; Vehicle Foam
Intervention description: FMX-101, 4% minocycline foam applied topically once daily for 12 weeks; Vehicle foam applied topically once daily for 12 weeks
Intervention MeSH terms: Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 466.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: acne

Summary:

      This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical
      administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne
      vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has facial acne vulgaris with:

               -  20 to 50 inflammatory lesions (papules, pustules, and nodules);

               -  25 to 100 noninflammatory lesions (open and closed comedones);

               -  no more than 2 nodules on the face; and

               -  IGA score of moderate (3) to severe (4)

          -  Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin
             Cleanser) and to refrain from use of any other acne medication, medicated cleanser,
             excessive sun exposure, and tanning booths for the duration of the study

        Exclusion Criteria:

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
             that could interfere with the clinical evaluations

          -  Sunburn on the face

          -  Severe systemic disease, which might interfere with the conduct of the study or the
             interpretation of the results.

          -  Abnormal baseline laboratory values that are considered clinically significant

          -  Allergy to tetracycline-class antibiotics or to any ingredient in the study drug

          -  Pseudomembranous colitis or antibiotic-associated colitis
Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Dexamethasone; Bortezomib; Cyclophosphamide
Intervention description: Type=exact number, number=20, unit=mg, form=tablet, route=oral. The patients will receive 20 mg of dexamethasone on days 1+2,4+5,8+9,11+12 for 21 days for 8 cycles.; Type=exact number, number=1.3, unit=mg, form=injection, route=intravenous. The patients will receive 1.3mg/m2 on days 1,4,8,11 for 21 days for 8 cycles.; Type=exact number, number=50, unit=mg, form=tablet, route=oral. The patients will receive 50 mg of cyclophosphamide once daily continuously from cycle 1 to 8.
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Bortezomib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma; Bortezomib; Dexamethasone; Cyclophosphamide; Oncology

Summary:

      The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to
      bortezomib and dexamethasone alone for primary refractory or relapsed multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously diagnosed with multiple myeloma

          -  Primary refractory multiple myeloma or relapsed following 1 to 3 previous lines of
             therapy

          -  Karnofsky performance status must be equal to 60 percentage (ie, better or equal
             performance than requiring some help and taking care of most personal requirements)

          -  Has life expectancy estimated at screening must be of at least 6 months

          -  Agrees to protocol-defined use of effective contraception

        Exclusion Criteria:

          -  Not received more than three previous lines of therapy for multiple myeloma

          -  Not received nitrosoureas or any other chemotherapy or immunotherapy or antibody
             therapy for multiple myeloma within 6 to 8 weeks before enrolment. Plasmapheresis must
             not be applied within 2 weeks before enrolment

          -  Patients with peripheral neuropathy or neuropathic pain of Grade 2 or greater
             intensity

          -  Patients with poorly controlled cardio vascular, vascular, pulmonary,
             gastro-intestinal, endocrine, neurological, psychiatric, hepatic, renal or metabolic
             diseases or hematological disorders

          -  Not have oligosecretory or non-secretory multiple myeloma
Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Buprenorphine transdermal system; Placebo
Intervention description: Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days; transdermal system (placebo) worn for 7 days
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 539.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic pain; opioid; transdermal; Moderate to severe chronic low back pain

Summary:

      The objective of this study is to determine the analgesic efficacy and safety of
      Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve
      subjects with moderate to severe chronic low back pain. The double-blind treatment
      intervention duration is 12 weeks, during which time supplemental analgesic medication
      (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or
      ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in
      addition to study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with moderate to severe chronic low back pain (lasting several hours daily)
             as their predominant pain condition for at least 3 months prior to screening,

          -  Subjects treated within the 14 days prior to screening with nonopioid therapy only, or
             with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day,

          -  Subjects whose low back pain is not adequately controlled with non-opioid analgesic
             medication and who the Investigator feels are appropriate candidates for
             around-the-clock opioid therapy

        Exclusion Criteria:

          -  Subjects who had a surgical procedure directed towards the source of back pain within
             6 months of screening or planned during the study conduct period,

          -  Subjects who are allergic to buprenorphine or who had a history of allergies to other
             opioids,

          -  Subjects who have allergies or other contraindications to transdermal delivery systems
             or patch adhesives.

        Other protocol-specific inclusion/exclusion criteria may apply.
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Intervention: Ivabradine; Placebo
Intervention description: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.; Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 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: 6505.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to demonstrate the superiority of ivabradine over
      placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart
      failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left
      ventricular ejection fraction and currently receiving recommended therapy for this disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic Chronic heart failure (NYHA II, III or IV)

          -  Left ventricular systolic dysfunction (LVEF ≤ 35%)

          -  Sinus rhythm and resting heart rate ≥ 70 bpm

          -  Optimal and unchanged CHF medications or dosages

        Exclusion Criteria:

          -  Unstable condition within previous 4 weeks

          -  Myocardial infarction or coronary revascularisation within previous 2 months

          -  Stroke or transient cerebral ischaemia within previous 4 weeks

          -  Congenital heart disease

          -  Severe valvular disease

          -  Active myocarditis

          -  Permanent atrial fibrillation or flutter
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Condition: Infant, Newborn, Diseases; Other Preterm Infants; Infant, Small for Gestational Age; Premature Birth; Bronchopulmonary Dysplasia; Retinopathy of Prematurity
MeSH terms: Bronchopulmonary Dysplasia; Retinopathy of Prematurity; Premature Birth; Infant, Newborn, Diseases; Birth Weight
Intervention: Surfactant; Continuous Positive Airway Pressure (CPAP); Supplemental oxygen with target saturation of 85 to 89%; Supplemental oxygen with target saturation of 91 to 95%
Intervention description: Intubation and administration of surfactant by 1 hour of age.; Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU; Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen; Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 1316.0
Sex: All
Minimum age: 24 Weeks
Maximum age: 27 Weeks
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Very Low Birth Weight (VLBW); Prematurity; Mechanical ventilation; Surfactant; Intubation; Neurodevelopmental impairment; Pulse oximetry; Oxygen saturation; Positive-Pressure Respiration

Summary:

      This study compared the use of continuous positive airway pressure initiated at birth with
      the early administration of surfactant administered through a tube in the windpipe within 1
      hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these
      infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor
      their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped
      determine whether or not these two management strategies affect chronic lung disease and
      survival of premature infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants with a minimal gestational age of 24 weeks 0 days to 27 completed weeks (up to
             27 6/7ths) by best obstetrical estimate

          -  Infants who will receive full resuscitation as necessary, i.e., no parental request or
             physician decision to forego resuscitation

          -  Infants whose parents/legal guardians have provided consent for enrollment, or

          -  Infants without known major congenital malformations

        Exclusion Criteria:

          -  Any infant transported to the center after delivery

          -  Infants whose parents/legal guardians refuse consent

          -  Infants born during a time when the research apparatus/study personnel are not
             available

          -  Infants < 24 weeks 0 days or > 28 weeks 0 days, completed weeks of gestation
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: ranibizumab; bevacizumab
Intervention description: • 0.5 mg (0.05 mL)intravitreal injection; • 1.25 mg (0.05 mL)intravitreal injection
Intervention MeSH terms: Bevacizumab; Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1208.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: bevacizumab; ranibizumab; choroidal neovascularization

Summary:

      The purpose of the study is to evaluate the relative efficacy and safety of treatment of
      neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a
      variable schedule, and Avastin on a variable schedule.

      A five year follow-up visit is being conducted in 2014 to gather information on long term
      outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active, subfoveal choroidal neovascularization (CNV)

          -  Fibrosis < 50% of total lesion area

          -  Visual acuity (VA) 20/25-20/320

          -  Age ≥ 50 yrs

          -  At least 1 drusen (>63μ) in either eye or late AMD in fellow eye

        Exclusion Criteria:

          -  Previous treatment for CNV in study eye

          -  Other progressive retinal disease likely to compromise VA

          -  Contraindications to injections with Lucentis or Avastin
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: adalimumab; placebo
Intervention description: subcutaneous injections of adalimumab; subcutaneous injections of placebo
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: China; Tumor necrosis factor (TNF)-alpha; Biologic

Summary:

      This study will evaluate the efficacy and safety of adalimumab induction and maintenance
      treatment in subjects with moderately to severely active Crohn's disease in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of Chinese descent with full Chinese parentage.

          -  Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.

          -  Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
             equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.

          -  Subject has a negative Tuberculosis (TB) Screening Assessment.

          -  Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening
             Period.

        Exclusion Criteria:

          -  Subject with ulcerative colitis or indeterminate colitis.

          -  Subject who has had a surgical bowel resection within the past 6 months or who is
             planning any resection at any time point in the future.

          -  Subject with an ostomy or ileoanal pouch.

          -  Subject who has short bowel syndrome.

          -  Subject with symptomatic known obstructive strictures.

          -  Subject with an internal or external fistula (with the exception of an anal fistula
             without abscess).

          -  Active, or chronic or recurring infections, or active tuberculosis.