bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Study of Intramuscular TAK-816 in Healthy Infants
Condition: Healthy Volunteers; Haemophilus Influenzae Type b, Prevention
Intervention: TAK-816
Intervention description: TAK-816 intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy; Safety and immunogenicity of Hib vaccine

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of intramuscular
      TAK-816 in healthy Japanese infants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy Japanese infants.

          2. Male or female infants aged 2-6 months (≥2 and <7 months) at the time of the first
             dose of investigational product (excluding hospitalized infants).

          3. Infants whose parents or legal guardians have agreed to cooperate with the
             investigator during the study period.

          4. The legal guardian signed and dated a written, informed consent form prior to the
             initiation of any study procedures.

        Exclusion Criteria:

          1. Any serious acute illness.

          2. Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or
             developmental disorder.

          3. History of possible Haemophilus influenzae type b (Hib) infection.

          4. Previously diagnosed immunodeficiency.

          5. Documented history of anaphylaxis to any ingredients of the investigational product
             (e.g., diphtheria toxoid).

          6. A history of convulsions.

          7. Previous administration of another Hib vaccine.

          8. Treatment with any live vaccine during the 27 days before the first dose of TAK-816 or
             with any inactivated vaccine during the 6 days before dosing.

          9. Prior participation in any clinical study or post-marketing clinical study.

         10. Previously receipt of blood transfusions, gamma globulin preparations (except
             monoclonal antibody products not containing any components of Hib as antigens),
             systemic immunosuppressive therapy, or systemic corticosteroids, or a plan to receive
             any of these products during the study period.

         11. Presence of thrombocytopenia or coagulopathy.

         12. Children considered ineligible for the study for other reasons by the investigator or
             subinvestigator.
Comparison of Two Urostomy Bags (2-piece).
Condition: Urostomy Patent
Intervention: Convatec Uro 2-piece; SenSura Uro 2-piece
Intervention description: Specific name of the device: 'Combihesive Natura® with a Durahesive Convex-It® base plate, 45 mm coupling, moldable (13-22 and 22-33 mm) hole size with boarder tape'.
The subjects are asked to test each of the two products for 21 days plus/minus 3 days in a randomised order and in accordance with their normal frequency of change and normal use pattern. The duration of the clinical investigation should be enough time to identify any difference in user-preference. If the subject is in the middle of testing an urostomy base plate when the test period is turning into the next period, the urostomy base plate can be worn until it needs to be changed. It is not possible to blind the investigation as the appearance of the test- and refer-ence products are very different in the look.; SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urostomy,; 2-piece,; preference,

Summary:

      Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years old,

          -  Be able to complete a written consent form

          -  Be able to fill in the Case Report Form

          -  Have a urostomy with a diameter of 33 mm. or less.

          -  Have had the urostomy for 3 months or more.

          -  Use a 2-piece convex (or convex light) normally.

          -  Be able to use SenSura URO 2-piece product

          -  Be able to use ConvaTec, 2-piece product

          -  Be able to handle the product themselves (application, removal and emptying),

        Exclusion Criteria:

          -  In order to be enrolled in the clinical investigation, the subjects must not:

               -  Need to use an ostomy belt

               -  Be currently suffering from any dermatological problems, needing special
                  treatment, on the peristomal skin

               -  Being treated with chemo- or radiation therapy,

               -  Be hospitalized during study enrollment, or have a hospitalization or significant
                  surgery planned during the 4-week study period, or

               -  Be pregnant or breast-feeding.
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ombitasvir/paritaprevir/ritonavir and dasabuvir; ribavirin
Intervention description: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Hepatitis C Treatment Naive; Hepatitis C Genotype 1; Hepatitis C Treatment Experienced; Hepatitis C Virus

Summary:

      The purpose of this study is to evaluate the proportion of subjects achieving sustained
      virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic
      HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs;
      ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be post-menopausal for more than 2 years or surgically sterile or
             practicing acceptable forms of birth control

          -  Males must be surgically sterile or agree to practice acceptable forms of birth
             control

          -  Chronic hepatitis C virus (HCV) infection at screening

          -  Fibrosis stage F3 or greater, documented by acceptable tests

          -  Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by
             acceptable methods

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody
             positive (HIV Ab)

          -  Use of contraindicated medications within 2 weeks of dosing

          -  Clinically significant abnormalities or co-morbidities

          -  History of solid organ transplant

          -  Abnormal laboratory tests

          -  Current or past clinical evidence of Child-Pugh B or C classification or clinical
             history of liver decompensation
Efficacy and Safety of SPD503 in Combination With Psychostimulants
Condition: ADHD
Intervention: SPD503-AM; SPD503-PM; Placebo
Intervention description: SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg; SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg; Placebo matched to Guanfacine Hydrochloride Extended Release
Intervention MeSH terms: Guanfacine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 461.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with
      ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years
      with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at
             least 4 weeks

          -  Aged 6-17 years with a sub-optimal

          -  Partial response to stimulants

          -  Subjects must be < 95th percentile for BMI with weight >= 55lbs and <= 176lbs
SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
Condition: ADHD
Intervention: SPD503 (Guanfacine hydrochloride); Placebo
Intervention description: Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).; Placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and
      oppositional symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects with ADHD and oppositional symptoms

          -  ADHD-RS>=24

          -  CGI >=4

          -  T-score of Opp subscale CPRS-R:L >=65

          -  Normal ECG and BP

          -  >= 55 lbs
Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs
Condition: Cardiac Catheterisation
Intervention: Nitroglycerin; Placebo
Intervention description: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion; Placebo (saline solution 10 ml) in radial artery after sheath insertion
Intervention MeSH terms: Nitroglycerin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Radial Spasm

Summary:

      Single-center study, randomized, double-blind, placebo controlled, with patients undergoing
      diagnostic or therapeutic catheterization via the transradial approach. Patients will be
      randomized into two groups: one group will receive the vasodilator nitroglycerin during the
      procedure (intervention group), and a second group will receive saline 0.9% in the same
      volume and time during the procedure (control group).

      Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure
      without the need to change the access site, pain presented by the patient, time and total
      radiation of the procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Indication for cardiac catheterization

          -  Suitable candidates for transradial approach

        Exclusion Criteria:

          -  AMI

          -  Intubated patients

          -  Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock,
             stroke)

          -  Prior inclusion in this trial
Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: carboxymethylcellulose sodium based New Eye Drop Formulation 1; carboxymethylcellulose sodium based New Eye Drop Formulation 2; carboxymethylcellulose sodium based Eye Drops
Intervention description: 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.; 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.; 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety, efficacy and acceptability of two new eye drop
      formulations compared with Refresh Tears® in patients with dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current use of an artificial tear product at least twice daily for at least 3 months,
             on average

          -  Ability/agreement to continue wearing existing spectacle correction (glasses) during
             study

        Exclusion Criteria:

          -  Anticipated contact lens wear during study or contact lens use within 6 months

          -  Active ocular infection or allergy

          -  Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma
             drops) within 2 weeks

          -  Use of any topical cyclosporine products within 3 months
Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: adalimumab; placebo
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection; Placebo pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: placebo controlled; double blind; adalimumab; TNF; psoriasis; HS; PIONEER II; hidradenitis suppurativa; acne inversa; boil; acne

Summary:

      A study to evaluate the safety and efficacy of treatment with adalimumab in adults with
      moderate to severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults must have a diagnosis of HS for at least 1 year prior to Baseline.

          -  HS lesions must be present in at least two distinct anatomical areas, one of which
             must be at least Hurley Stage II or Hurley Stage III.

          -  Subject must have stable HS for at least 60 days prior to Screening visit and at
             Baseline visit.

          -  Subject must have experienced an inadequate response to at least a 90-day treatment of
             oral antibiotics for treatment of HS.

          -  Subject must have a total AN count of greater than or equal to 3 at baseline.

        Exclusion Criteria:

          -  Subject was previously treated with adalimumab or another anti-tumor necrosis factor
             (anti-TNF) therapy (e.g., infliximab or etanercept).

          -  Subjects on permitted oral antibiotic treatment for HS who have not been on a stable
             dose for at least 28 days prior to the Baseline visit.

          -  Subject received oral concomitant analgesics (including opioids) for HS-related pain
             within 14 days prior to Baseline visit.

          -  If entering the study on concomitant oral analgesics for non-HS related pain:

               -  Subject on opioid analgesics within 14 days prior to Baseline visit;

               -  Subject not on a stable dose of non-opioid oral analgesics for at least 14 days
                  prior to the Baseline visit ("as needed" is not considered a stable dose).
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Condition: Atrophy
MeSH terms: Atrophy
Intervention: estrace cream (Perrigo); estrace cream (Reference); Placebo cream
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 695.0
Sex: Female
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug
      product in the treatment of vulvar and vaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal female and otherwise healthy, 30 - 75 years of age.

          -  ≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.

          -  vaginal pH > 5.0 at Visit 1/Screening

          -  Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal
             Atrophy identified by the subject as being the most bothersome

          -  For women with an intact uterus, vaginal ultrasonography confirmation at Visit
             1/Screening of an inactive endometrial lining with an endometrial thickness less than
             4 mm.

          -  Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no
             greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

        Exclusion Criteria:

          -  Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial
             cancer.

          -  Known, suspected, or history of cancer of the breast or mammogram indicating any
             abnormalities or subject has a history of cervical cancer.

          -  Vaginal ultrasonography for all women with an intact uterus confirming endometrial
             thickness of 4mm or more

          -  History of hypersensitivity or allergy to estradiol or any of the other study
             medication ingredients.

          -  Known or suspected estrogen-dependent neoplasia.

          -  Has deep vein thrombosis, pulmonary embolism or history of these conditions.

             • Subject has active arterial thromboembolic disease (e. g. stroke, myocardial
             infarction) or history of these conditions.

          -  Known acute or chronic hepatic disease or dysfunction
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Tolterodine ER; Placebo; Fesoterodine
Intervention description: The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.; Placebo treatment will be once daily(QD) for 12 weeks.; The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.
Intervention MeSH terms: Tolterodine Tartrate; Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2417.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of overactive bladder

Summary:

      To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo
      for overactive bladder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects with overactive bladder symptoms (subject-reported) for greater than or
             equal to 3 months prior to Screening/Enrollment visit.

          -  Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary
             prior to the Randomization/Baseline visit

          -  Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as
             verified by the 3-day bladder diary prior to randomization/Baseline visit.

        Exclusion Criteria:

          -  Subjects with any condition that would contraindicate their usage of fesoterodine
             including: hypersensitivity to the active substance (fesoterodine fumarate) or to
             peanut or soya or any of the excipients, urinary retention, gastric retention,
             uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment
             (Child Pugh C), severe ulcerative colitis, and toxic megacolon.

          -  Subjects with clinically significant hepatic or renal disease or other significant
             unstable diseases.

          -  OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
             etc.

          -  Subjects with previous history of acute urinary retention requiring catheterization,
             or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Asthma Action at Erie Trial
Condition: Asthma; Children
MeSH terms: Asthma
Intervention: Community Health Worker; Certified asthma educator
Intervention description: A community health worker is para-professional who performs education, case management, and social support.; A certified asthma educator has is certified and performs asthma education.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 223.0
Sex: All
Minimum age: 5 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The Asthma Action at Erie Trial compares the current best practice in asthma self-management
      education (certified asthma educator services) to an integrated community health worker (CHW)
      home intervention in which the real-life challenges of patients and the health care system
      are taken fully into account. This trial will provide clarity as to the expected effect size,
      cost savings, and resources needed to integrate asthma CHWs into clinical practice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child is a patient at Erie Family Health Center

          -  Child is age 5-16 at the start of the study

          -  Child lives with the index caregiver at least 5 days out of the week

          -  Child has uncontrolled asthma. This is defined as a score of 1.25 or greater on the
             Asthma Control Questionnaire, or report of oral corticosteroid use in the past year

          -  Family has a working telephone

        Exclusion Criteria:

          -  Exclusion criteria include family not fluent in English or Spanish, family lives in
             temporary housing such as a shelter, caregiver does not have permanent custody of
             child, or child has significant developmental delays or co-morbidities that would
             limit their ability to participate in the program.