bioihbjkbjnl/mcl2 huggingface dataset:
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant); Comparator: Modified Process Hepatitis B Vaccine (Experimental); Comparator: ENGERIX-B™ (currently licensed product)
Intervention description: RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.; Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.; ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 540.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to determine if there is an improvement in the immune response
      of older adults over 50 years of age using a modified process hepatitis B vaccine and a
      currently licensed hepatitis B vaccine (RECOMBIVAX HB™).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female older adults greater than or equal to 50 years of age

        Exclusion Criteria:

          -  Any adult with a history of previous hepatitis B infection

          -  A history of vaccination with any hepatitis B vaccine

          -  Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)

          -  Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™
             (e.g., aluminum, yeast)

          -  Recent administration (within 3 months prior to first injection with the study
             vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other
             blood-derived product

          -  Receipt of licensed inactivated vaccines within 14 days prior to first injection with
             the study vaccine

          -  Receipt of licensed live virus vaccines within the 30 days prior to injection with the
             study vaccine

          -  Receipt of investigational drugs or other investigational vaccines within 3 months
             prior to first injection with the study vaccine

          -  Known or suspected impairment of immunologic function or recent use of
             immunomodulatory medications (e.g., systemic corticosteroids). Does not include
             topical and inhaled steroids

          -  Pregnant women, nursing mothers, and women planning to become pregnant within the
             study period

          -  Any condition that, in the opinion of the investigator, might interfere with the
             evaluation of the study objectives
A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)
Condition: Acute Pain Following a Total Abdominal Hysterectomy
MeSH terms: Acute Pain
Intervention: etoricoxib (MK0663) 120 mg; Comparator: Placebo; etoricoxib (MK0663) 90 mg
Intervention description: 120 mg of etoricoxib (MK0663) for a total of 5 days; Placebo tablets once daily on Days 1-5. Total treatment is 5 days.; 90 mg of etoricoxib (MK0663) for a total of 5 days
Intervention MeSH terms: Etoricoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 430.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to
      placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years or older in generally good health who are scheduled to have a total
             hysterectomy and who are willing to limit alcohol consumption

        Exclusion Criteria:

          -  Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2)
             inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or
             oxycodone or has hypersensitivity to aspirin or other NSAIDS

          -  Patient has uncontrolled high blood pressure

          -  Patient has a history of drug and/or alcohol abuse within the last 5 years

          -  Patient has taken part in another investigational study within 4 weeks of the start of
             study

          -  Patient is breast-feeding

          -  Patient has an active ulcer or inflammatory bowel disease
Topical Ibuprofen for Delayed Onset Mulscle Soreness
Condition: Pain
Intervention: IBU BID; Placebo BID; IBU TID; Placebo TID
Intervention description: 10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days; 10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days; 10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days; 10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days
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: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Delayed onset muscle soreness; ibuprofen; topical

Summary:

      The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel
      versus placebo administered two or three times daily for the treatment of pain associated
      with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor
      muscles.
    

Eligibility criteria:

        Inclusion Criteria:

        Males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness
        activities for a minimum of 3 months prior to entry in the study; subjects must be willing
        to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice,
        massage) and other forms of soreness relief during the study

        Exclusion Criteria:

        Use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs
Study of Glycopyrronium in Axillary Hyperhydrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: glycopyrronium Topical Wipes; Vehicle
Intervention description: Topical wipes containing glycopyrronium; Vehicle (placebo) topical wipes
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The study is a randomized, double-blind, vehicle controlled, parallel group study, designed
      to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to
      vehicle in subjects with axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 9 years of age.

          -  Primary, axillary hyperhidrosis of at least 6 months duration

          -  Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline

          -  Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline

          -  Sweat production of at least 50 mg over 5 minutes in each axilla assessed
             gravimetrically

        Exclusion Criteria:

          -  Prior surgical procedure for hyperhidrosis.

          -  Prior axillary treatment with an anti-hyperhidrosis medical device (approved or
             investigational).

          -  Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within
             1 year of Baseline/Day 1.

          -  Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.

          -  Axillary use of nonprescription antiperspirants within 1 week or prescription
             antiperspirants within 2 weeks of Baseline.

          -  Subjects on new or regimens of psychotherapeutic medications that have changed within
             2 months of baseline.

          -  Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless
             dosing has been stable for at least 4 months.

          -  Other treatment with glycopyrrolate within 4 weeks prior to Baseline.

          -  Secondary axillary hyperhidrosis or presence of a condition that may cause secondary
             hyperhidrosis.

          -  History of Sjögren's syndrome or Sicca syndrome.

          -  History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.

          -  Men with a history of urinary retention requiring catheterization due to prostatic
             hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

          -  History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.

          -  Other systemic diseases or active uncontrolled infections, or any other condition
             which, in the judgment of the Investigator, would put the subject at unacceptable risk
             for participation in the study.
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; Comparator: Placebo
Intervention description: one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks; one chewable placebo tablet, once daily at bedtime for 12 weeks
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 689.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and
      placebo administered once daily at bed time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has history of physician diagnosed asthma

          -  Patient is in otherwise good stable health

          -  Patient is able to chew a tablet

        Exclusion Criteria:

          -  Patient is hospitalized

          -  Patient and/or parent of guardian intends to move or vacation away from home during
             the course of the study

          -  Patient had any major surgical procedure within 4 weeks before the study

          -  Patient had active sinus disease within 3 weeks before the study

          -  Patient had required intubation for asthma in the past

          -  Patient required a visit to the emergency room due to an asthma exacerbation, or has
             been hospitalized for asthma with in 1 month prior to the study

          -  Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1
             month before study
Efficacy of Topical Capsaicin Cream for Stable Angina
Condition: Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Intervention: Capsaicin; Placebo cream
Intervention description: 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise; cream, 4cm spread over 8cm x 15cm area of skin
Intervention MeSH terms: Capsaicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the hypothesis that application of topical capsaicin in
      patients with stable angina will result in improved exercise tolerance and reduced cardiac
      ischemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > or = 3 month history of chronic, stable, angina triggered by physical effort or
             mental/emotional stress

          -  documented stress-induced ST depression, reversible perfusion imaging, or wall motion
             abnormality or CAD >50%

          -  Canadian Cardiovascular (CV) Class I-III

          -  Receiving medical therapy for > or = 2 months

          -  Ability to perform Bruce Protocol treadmill test

          -  non-pregnant female

        Exclusion Criteria:

          -  unstable angina

          -  revasc within 2 months

          -  Myocardial infarction (MI) within 2 months

          -  congestive heart failure (CHF) hospitalization within 2 months

          -  New York Heart Association (NYHA) class III or IV

          -  left ventricular ejection fraction (LVEF) < 25%

          -  abnormal ECG; Acute changes on ECG

          -  Currently receiving treatment with investigational drugs/devices

          -  Uncontrolled hypertension

          -  contraindication to exercise stress testing

          -  allergy to red peppers or capsaicin

          -  skin deformity, scar, or rash at application site

          -  abdominal surgery within 3 months
Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
Condition: Manic or Mixed Episode Associated With Bipolar I Disorder
MeSH terms: Mania
Intervention: olanzapine; lithium; valproate; carbamazepine
Intervention description: oral, daily; Dose adjusted according to local package insert; Dose adjusted according to local package insert; Dose adjusted according to local package insert
Intervention MeSH terms: Carbamazepine; Valproic Acid; Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The efficacy and safety of the extended treatment to patients with most recent episode manic
      or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be
      examined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrolled in and completed Study BMAC (NCT00129220), or those who discontinued Study
             BMAC at Visit 4 or Visit 5 due to lack of efficacy and for whom the Young Mania Rating
             Scale (YMRS) total score at the time of discontinuation was not lower than that at
             baseline of Study BMAC

          -  Are diagnosed as "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x
             Bipolar I Disorder, Most Recent Episode Mixed," as determined by the
             Mini-International Neuropsychiatric Interview (MINI)

        Exclusion Criteria:

          -  Have a diagnosis of diabetes mellitus

          -  Significant protocol deviation in Study BMAC

          -  The actual date of the final visit of Study BMAC is 4 days or more later than the
             scheduled date of first visit in Study BMEX
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
Condition: Endocrine Tumors
MeSH terms: Endocrine Gland Neoplasms
Intervention: lanreotide (Autogel formulation); Placebo
Intervention description: 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.; Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Intervention MeSH terms: Lanreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non functioning entero-pancreatic tumours

Summary:

      The study will compare the difference between lanreotide Autogel and placebo on progression
      free survival in patients who have an endocrine tumour in the pancreas or intestines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic
             disease

          -  No hormone related symptoms

          -  Well or moderately differentiated tumour confirmed by histology

          -  Tumour lesions which are measurable by a CT or MRI scan

        Exclusion Criteria:

          -  Previously treated with a somatostatin analogue unless more than 6 months ago and
             given for no more than 15 days

          -  Treated within the last 6 months with interferon, chemoembolisation or chemotherapy or
             at any time with a radionuclide

          -  Had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the
             cervix/uterus and/or patients treated with curative intent and free from disease for 5
             years

          -  Pregnant or lactating

          -  Females must use adequate contraception during the study
A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)
Condition: Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Intervention: Moxifloxacin Placebo; Moxifloxacin; Azithromycin SR Placebo; Azithromycin SR
Intervention description: 1 capsule once daily for 5 days; 1 X 400mg capsule once daily for 5 days; single dose, oral.; single dose 2.0 g oral
Intervention MeSH terms: Moxifloxacin; Azithromycin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 398.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)

Summary:

      This trial is a research drug study to compare the effects of two antibiotics for the
      treatment of acute exacerbation of chronic bronchitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for
             three consecutive months for more than two consecutive years) and clinical evidence of
             AECB as demonstrated by both the following symptoms:

          -  Production of purulent sputum as defined by Gram stained sputum specimen

          -  Presence of all of the following:

          -  Increased sputum production

          -  Increased dyspnea

          -  Increased cough

          -  At least two exacerbations of AECB in the past 12 months

          -  Documented FEV1 less than 80% of predicted

        Exclusion Criteria:

          -  A chest radiograph consistent with pneumonia

          -  Treatment with any systemic antibiotic within the twenty-one days prior to study entry
             or those with a chance of receiving other systemic antibiotics during study
             participation
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Blood Sampling
Intervention description: A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 697.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningococcal vaccine GSK 134612

Summary:

      Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24
      months after vaccination and the subjects who were vaccinated in the primary study will be
      enrolled in this extension phase. No new subjects will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parent(s)/guardian(s)
             can and will comply with the requirements of the protocol should be enrolled in the
             study.

          -  A male or female having been vaccinated with a meningococcal vaccine in the primary
             study 109069.

          -  Written informed consent obtained from parent(s)/guardian(s) of the subject and
             written informed assent obtained from the subject if the subject is less than 18 years
             of age, or written informed consent obtained from the subject if the subject has
             achieved the 18th birthday.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the subject's first visit.

          -  History of meningococcal disease; such cases will be documented.

          -  Administration of a meningococcal polysaccharide or a meningococcal polysaccharide
             conjugate vaccine since previous vaccination in study 109069.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the subject's first visit.

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy

          -  Subjects who withdrew consent to be contacted for follow-up studies.