bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix; Fluzone
Intervention description: One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.; One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 3317.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline
      Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine)
      in children, 6 to 35 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female child aged 6 to 35 months at the time of the first vaccination;
             children who may or may not have had previous administration of influenza vaccine in a
             previous season are acceptable.

          -  Subjects having a parent/guardian who the investigator believes can and will comply
             with the requirements of the protocol.

          -  Written informed consent obtained from the subject's parent/guardian.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the administration of the study vaccine, or planned use during the study
             period. Routine, registered childhood vaccinations are not an exclusion criterion.

          -  History of hypersensitivity to any vaccine.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine.

          -  Acute disease at the time of enrolment.

          -  History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated
             influenza virus vaccine.

          -  Receipt of an influenza vaccine outside of this study, during current (2008-09) flu
             season.

          -  Administration of immunoglobulins and/or blood products within the 3 months preceding
             the first dose of study vaccine or planned administration during the study period.
The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia
Condition: Child Development
Intervention: Home visiting professional support model; Control
Intervention description: Home visits and telephone calls keyed to well child visits.; The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 4 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: child, preschool; intelligence; environment; home visiting

Summary:

      The purpose of the MOM Program Continuation is to promote child development by helping
      families become more competent in accessing and using available health, developmental and
      educational resources. The program focuses are childhood immunizations, Early Intervention
      services, lead screening, Early Head Start and Head Start enrollment. The Intervention
      consists of frequent phone calls and home visits to encourage mothers to have their babies
      immunized on schedule and to participate in needed developmental and educational services.
      The program seeks to fill the gap between children's need for services and mothers' ability
      to assure their children's participation in those services.
    

Eligibility criteria:

        Inclusion Criteria: Previous enrollment in The MOM Program; child age of 5 years (plus or
        minus 3 months); willingness to come to office for follow-up assessment visit; parental
        consent and child assent.

        Exclusion Criteria: None.
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Condition: Pain; Inflammation
MeSH terms: Inflammation
Intervention: Bromfenac Ophthalmic Solution; Placebo Comparator
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: 299.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain and Inflammation as a function of cataract surgery

Summary:

      Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age who are scheduled for unilateral cataract
             surgery

        Exclusion Criteria:

          -  Have known hypersensitivity to bromfenac or to any component of the investigational
             product
A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab
Intervention description: Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the longer term safety of the study drug known
      as galcanezumab in participants with episodic or chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of episodic or chronic migraine as defined by International Headache
             Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta
             guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at
             least 1 year prior to screening, and migraine onset prior to age 50.

          -  Prior to baseline, a history of 4 or more migraine headache days per month on average
             for the past 3 months.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to galcanezumab or another CGRP antibody.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to galcanezumab.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
Condition: Obesity; Overweight
MeSH terms: Overweight; Body Weight
Intervention: NB; CLI; Usual Care
Intervention description: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage); The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.; Usual Care is a self-directed lifestyle intervention program
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: obesity, overweight

Summary:

      The purpose of this Phase 3b study is to assess the effects of combination therapy with
      naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle
      intervention (CLI) and in a manner consistent with its intended use after marketing approval,
      on body weight and cardiovascular risk factors compared to the effects of Usual Care in
      subjects who are overweight with dyslipidemia and/or controlled hypertension or obese.
      Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment
      at Week 16. Subjects are to be discontinued from full participation if they do not lose at
      least 5% of their body weight relative to baseline and/or are experiencing sustained
      increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26,
      subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects
      assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment
      period).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male, 18 to 60 years old

          -  Body mass index (BMI) ≥30 kg/m2 and ≤45 kg/m2 for subjects with uncomplicated obesity,
             or BMI ≥27 kg/m2 and ≤45 kg/m2 for subjects with dyslipidemia and/or controlled
             hypertension

        Exclusion Criteria:

          -  History of type 1 or type 2 diabetes mellitus diagnosis

          -  Myocardial infarction within 6 months prior to screening

          -  Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading
             scheme

          -  Clinical history of large vessel cortical strokes, including ischemic and hemorrhagic
             strokes (i.e., transient ischemic attack is not exclusionary)

          -  History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia
             nervosa, or other conditions that predispose subjects to seizures

          -  Past or planned surgical or device intervention (e.g., gastric banding) for obesity

          -  Chronic use or positive screen for opioids

          -  Regular use of tobacco products
Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab Auto-Injector; Ixekizumab Prefilled Syringe
Intervention description: Administered SC by auto-injector; Administered SC by prefilled syringe
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the serum concentration of ixekizumab after
      administration using either prefilled syringe or auto-injector in participants with moderate
      to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety
      extension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic
             psoriasis vulgaris for at least 6 months prior to randomization

          -  At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization

          -  Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and
             Severity Index (PASI) score of at least 12 at screening and at randomization

          -  Candidate for phototherapy and/or systemic therapy

          -  Men must agree to use a reliable method of birth control during the study

          -  Women must agree to use birth control or remain abstinent during the study and for at
             least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  Pustular, erythrodermic, and/or guttate forms of psoriasis

          -  History of drug-induced psoriasis

          -  Clinically significant flare of psoriasis during the 12 weeks prior to randomization

          -  Concurrent or recent use of any biologic agent

          -  Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light
             therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis
             treatment within the previous 2 weeks prior to randomization

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to randomization and during the study

          -  Have participated in any study with interleukin-17 (IL-17) antagonists, including
             Ixekizumab

          -  Serious disorder or illness other than plaque psoriasis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women
Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED)
Condition: Sun Protection
Intervention: Sunscreen Test Code: V53-028; Sunscreen Test Code: V53-030; Standard SPF 4 Sunscreen
Intervention description: Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole; Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone; 8% Homosalate Standard SPF 4 Sunscreen
Intervention MeSH terms: Sunscreening Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sunscreens

Summary:

      Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor
      (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with
      and without ensulizole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 70 years of age

          -  Have Fitzpatrick skin types I, II, or III

          -  In good general health based on a medical history review

          -  Be free of any acute or chronic illness/disease that might interfere with or increase
             risk of study participation

          -  Be able to cooperate with the investigator and research staff

          -  Be willing to have the test materials applied according to the protocol

          -  Be capable of understanding and provide written informed consent

        Exclusion Criteria:

          -  Subjects with a history of adverse effects upon sun exposure

          -  Subjects currently taking any medication that may alter the sunlight response or is a
             known photosensitizer

          -  Subjects with a history of any form of cancer, lupus, psoriasis, rosacea, porphyria
             cutanea tarda, connective tissue disease, diabetes or any disease that would increase
             the risks associated with study participation

          -  Subjects with an abnormal sensitivity to any sunscreen agent

          -  Females who indicate that they are pregnant or nursing an infant during the period of
             the study

          -  Subjects with excessive hair, blemishes, nevi, warts, moles, scars, sunburn, suntan or
             uneven pigmentation in the test areas

          -  Subjects who have been administered an investigations drug or have participated in
             another SPF or PFA study within 30 days prior to this study

          -  Subjects who are allergic to latex or latex products

          -  Subjects who have any conditions that would make study participation inappropriate as
             determined by the investigator
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
Condition: Hypoglycemia; Diabetes Mellitus; Drug-Specific Antibodies
MeSH terms: Diabetes Mellitus; Hypoglycemia
Intervention: Nasal Glucagon
Intervention description: 3 mg nasal glucagon powder
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Hypoglycemia; Glucagon; Anti-glucagon Antibody; Immunogenicity

Summary:

      Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years
      will be selected for inclusion in the study. The target is to obtain treatment response and
      user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of
      hypoglycemia. The population will be enriched to include participants who suffer from
      impaired hypoglycemia awareness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female Person with diabetes (PWD) lives with or is in frequent contact with
             one or more caregivers who are available to administer the glucagon in case of an
             episode of severe or moderate hypoglycemia

          -  With a history of type 1 diabetes >1 year

          -  At least 18 years of age but not older than 75 years

          -  Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.

          -  PWD will be otherwise healthy according to medical history, general physical
             examination (including vital signs), nasal examination, and laboratory tests
             (biochemistry, hematology, and urinalysis).

          -  For female subjects, a urine pregnancy test must be negative.

        Exclusion Criteria:

          -  Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.

          -  Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic
             drugs.
Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Docetaxel
Intervention MeSH terms: Docetaxel; Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 639.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab improves life expectancy compared
      to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have
      failed prior platinum-based doublet chemotherapy.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Disease progression experienced during or after one prior platinum containing doublet
             chemotherapy

          -  Stage IIIb/IV or recurrent disease

          -  Male and Female ≥ 18 years of age

          -  Measurable disease per RECIST 1.1

          -  Performance Status ≤ 1

        Exclusion Criteria:

          -  History of Carcinomatous meningitis

          -  Active Central nervous system (CNS) metastases

          -  History of auto immune diseases

          -  Prior treatment with Docetaxel

          -  Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or
             checkpoint pathways
Prostin and Propess in Induction of Labor
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Propess; Prostin E2
Intervention description: The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation.; 3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.
Intervention MeSH terms: Dinoprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of the study was to compare the safety and efficacy of two agents used in
      induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2
      (Dinoprostone vaginal Tablet).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age 37 weeks or more

          -  Singleton pregnancy

          -  Cephalic presentation.

        Exclusion Criteria:

          -  Previous cesarean section

          -  Any contraindication for vaginal delivery

          -  Suspected Cephalo-Pelvic Disproportion

          -  Unexplained antepartum Hemorrhage
A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Double-blind Abatacept; Double-blind Placebo; Open-label Abatacept
Intervention description: Concentrate and diluted in a solution, IV, 500 mg (body weight < 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight > 100 Kg), Once daily, Day 1, 15, and 29.; Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.; Concentrate and diluted in a solution, IV, 500 mg (body weight < 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight > 100 Kg), Once daily, Every 28 days.
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1795.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if abatacept is safe when
      co-administered with other approved rheumatoid arthritis medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid
             arthritis and the American College of Rheumatology functional classes I, II III or IV

          -  Participants must be taking 1 or more DMARDs and/or biologic approved for rheumatoid
             arthritis (RA) for at least 3 months and be on a stable dose for 28 days prior to Day
             1.

        Exclusion:

          -  Other auto-immune disease as a main diagnosis (e.g. Systemic Lupus Erythematosus
             [SLE], Scleroderma)

          -  Active tuberculosis (TB) requiring treatment within last 3 years