bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
Condition: Food Preferences
MeSH terms: Noncommunicable Diseases
Intervention: Exposure to beverage health information; Exposure to beverage calorie information
Intervention description: Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information; Calories for sugar-sweetened and non-sugar-sweetened beverages
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three private schools will be enrolled in the study (two larger, one smaller) that have students between the ages of 12 and 18. There will be no posters displayed at any of the schools during the baseline period. The two larger schools will be randomized to either an SSB warning/non-SSB promoting poster or a calorie/control poster that will be implemented in the school cafeterias during a four-week intervention period. To increase the sample size for the intervention condition, the intervention will also be implemented at a smaller school. For the primary analysis, data only from schools that were randomized to condition will be used. Data was collected from both a sample of participants & from the cash registers directly.
Masking: None (Open Label)
Masking description: Participants will be told the researchers are interested in cafeteria purchase preferences, but participants will not know which condition has been assigned to individual participants.
Enrollment: 628.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Food Labeling; Adolescents

Summary:

      Sugar-sweetened beverages are a significant contributor to adult and childhood obesity in
      Guatemala. Policies to place health warning labels on sugar-sweetened beverages are being
      pursued, but there is little empirical data on how such labels influence people. The primary
      aim of this study is to test the association between sugar-sweetened beverage (SSB) warning
      posters compared to control posters and change in SSBs purchased compared to baseline by
      adolescents shopping at school cafeterias in Guatemala City, Guatemala. The hypothesis is
      that posters with information warning people of the health harms associated with
      overconsuming SSBs and promoting low sugar beverages will be associated with greater
      reductions in SSB purchases compared to a control poster.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 12 and 18 years old

          -  Made a food or beverage purchase

          -  Has permission from parent or caregiver to participate

          -  Has not yet completed the purchase assessment

        Exclusion Criteria:

          -  Under 12 or over 18 years old

          -  Did not make a food or beverage purchase

          -  Parent or caregiver refused to give child permission to participate

          -  Already participated in the purchase assessment
Caverject User Study
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: delivery system
Intervention description: syringe
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Erectile Dysfunction

Summary:

      The purpose of this study is to demonstrate the usability of the system.
    

Eligibility criteria:

        Inclusion Criteria:

        Age 40 to 70

        Exclusion Criteria:

        Prior syringe skills
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Volanesorsen; Placebo
Intervention description: 300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.; Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26
      weeks in participants with Hypertriglyceridemia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Body mass index (BMI) ≤ 45 kg/m2

          2. Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.

          3. If on statin or fibrate, participants must be on stable, labeled dose for at least 3
             months prior to screening. Participants not receiving these drugs within 4 weeks prior
             to screening are also eligible.

        Exclusion Criteria:

          1. Type 1 diabetes mellitus

          2. Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥
             9.0% at Screening

          3. Acute pancreatitis within 3 months of screening

          4. Acute Coronary Syndrome within 6 months of screening

          5. Major surgery within 3 months of screening

          6. Prior exposure to ISIS 304801

          7. Have any other conditions in the opinion of the investigator which could interfere
             with the participant participating in or completing the study
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Romosozumab 90 mg/mL; Placebo 90 mg/mL; Romosozumab 70 mg/mL; Placebo 70 mg/mL
Intervention description: Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).; Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.; Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.; Placebo administered as 3 SC injections with the 1.0 mL glass PFS.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 294.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Postmenopausal Osteoporosis

Summary:

      The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone
      mineral density (BMD) in postmenopausal women with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Postmenopausal women with osteoporosis at high risk for fracture defined as

          -  BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND

          -  a history of fragility fracture or at least 2 other risk factors

        Exclusion Criteria:

          -  BMD T score < -3.50 at the total hip or femoral neck.

          -  History of hip fracture.

          -  History of metabolic or bone disease (except osteoporosis).

          -  Use of agents affecting bone metabolism.

          -  Vitamin D insufficiency.

          -  History of solid organ or bone marrow transplants.

          -  Hyper- or hypocalcemia.

          -  Hyper- or hypothyroidism.

          -  Hyper- or hypoparathyroidism.
This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Pregabalin
Intervention description: 150 to 600mg/day
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this protocol is to evaluate the long-term safety of pregabalin in
      patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive
      open-label pregabalin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol
             A0081100, and must have received pregabalin/placebo under double-blind conditions.

        Exclusion Criteria:

          -  Patients may not participate in the study if they experienced a serious adverse event
             during the previous fibromyalgia Study A0081100 which was determined to be related to
             the study medication by the investigator or the sponsor.
A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Golimumab 50 mg; Golimumab 100 mg
Intervention description: SC injections; SC injections; SC injections
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
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: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Anti-TNFa agents; subcutaneous injection

Summary:

      The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in
      subjects who have active rheumatoid arthritis and have been treated previously with at least
      1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987
             criteria of the ACR) for at least 3 months prior to screening

          -  Have active RA as defined by persistent disease activity with at least 4 swollen and 4
             tender joints, at the time of screening and baseline

          -  Must have been previously treated with at least one dose of etanercept, adalimumab, or
             infliximab

          -  If currently using methotrexate, sulfasalazine and/or hydroxychloroquine must have
             tolerated these agents for at least 12 weeks and be on a stable dose for at least 4
             weeks prior to the first administration of study agent

          -  If using NSAIDs or other analgesics must be on a stable dose for at least 2 weeks
             prior to the first administration of study agent

          -  If using oral corticosteroids must be on a stable dose equivalent to <= 10 mg of
             prednisone/day for at least 2 weeks prior to first administration of study agent

          -  Are considered eligible according to specified tuberculosis (TB) screening criteria.

        Exclusion Criteria:

          -  Patients cannot have other inflammatory diseases other than RA that might interfere
             with the evaluation of the benefit of golimumab therapy

          -  No history of treatment with natalizumab, rituximab or cytotoxic agents

          -  No history of demyelinating diseases such as multiple sclerosis or optic neuritis or
             of concurrent congestive heart failure (CHF), lymphoproliferative disease, known
             malignancy or history of malignancy within the previous 5 years (with the exception of
             a nonmelanoma skin cancer that has been treated with no evidence of recurrence)

          -  No history of, or ongoing, chronic or recurrent infectious disease

          -  No serious infection within 2 months prior to first administration of study agent.
3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
Condition: Post-menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Placebo; Zoledronic acid
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Osteoporosis; zoledronic acid; post-menopausal

Summary:

      This second extension will evaluate the efficacy and long term safety of zoledronic acid in
      women with post-menopausal osteoporosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who have received the 4th and 6th dose of zoledronic acid in study
             CZOL446H2301E1

        Exclusion Criteria:

          -  Poor kidney, eye, liver health

          -  Use of certain therapies for osteoporosis in study CZOL446H2301E1

          -  Abnormal calcium levels

        Other protocol-defined inclusion/exclusion criteria may apply
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Intervention: Taliglucerase alfa
Intervention description: Taliglucerase infusion every two weeks for 21 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: enzyme replacement therapy

Summary:

      This is a multi-center trial to further extend the assessment of the safety and efficacy of
      taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled
      in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of
      taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months
      or until taliglucerase alfa is commercially available to the subject at the discretion of the
      Sponsor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003

          -  The subject signs an informed consent

        Exclusion Criteria:

          -  Currently taking another investigational drug for any condition.

          -  Presence of any medical, emotional, behavioral or psychological condition that in the
             judgment of the Investigator would interfere with the subject's compliance with the
             requirements of the study.
A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Prasugrel; Clopidogrel
Intervention description: Oral, daily, 90 days; Oral, daily, 90 days
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 720.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will compare the safety and efficacy of prasugrel, administered at different doses
      with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS)
      undergoing percutaneous coronary intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a
             percutaneous coronary intervention (PCI)

          -  A person who is of East or Southeast Asian descent

          -  A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally
             competent to provide a signed written informed consent before entering the study

          -  If a woman is of childbearing potential, she must test negative for pregnancy and
             agree to use a reliable method of birth control

        Exclusion Criteria:

          -  A person who has a severe cardiovascular condition such as cardiogenic shock at the
             time of randomization, ventricular arrhythmias or congestive heart failure

          -  A person who is at an increased risk of bleeding (e.g. active internal bleeding,
             history of bleeding disorder, recent fibrinolytic therapy before randomization into
             the study)

          -  A person who has prior history of any one of the following: ischemic or hemorrhagic
             stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history
             of transient ischemic attack (TIA)

          -  A person who needs to take other antiplatelet therapy other than Aspirin for the
             duration of the study

          -  A person who receives daily treatment with nonsteroidal anti-inflammatory drugs
             (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued

          -  A person who has a severe liver disease, such as cirrhosis

          -  A person who has a condition such as alcoholism, mental illness, or drug dependence
Fesoterodine Flexible Dose Study
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine; Placebo
Intervention description: 4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.; Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
Intervention MeSH terms: Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 896.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Overactive Bladder

Summary:

      This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more
      effective than placebo in reducing micturition frequency and other overactive bladder (OAB)
      symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder
      and if the fesoterodine regimen is safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overactive bladder symptoms for greater than or equal to 3 months.

          -  Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in
             bladder diary.

          -  Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder
             diary.

        Exclusion Criteria:

          -  Contraindication to fesoterodine (antimuscarinics).

          -  Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).

          -  Previous history of acute urinary retention requiring catheterization or severe
             voiding difficulties in the judgment of the investigator, prior to baseline.

          -  Unable to follow the study procedures, including completion of self-administered
             bladder diary and patient reported outcome questionnaires.
Study of Rivoglitazone in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Pioglitazone; Placebo; Rivoglitazone; Rivoglitazone
Intervention description: 45 mg over-encapsulated tablet administered orally, once daily; Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule; 1.0 mg tablet administered orally, once daily; 1.5 mg tablet administered orally, once daily
Intervention MeSH terms: Pioglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1912.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus

Summary:

      This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled
      by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total
      duration of a subject's participation will be approximately 30 weeks, including a 2-week
      placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment
      follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes

          -  Male or female at least 18 years of age

          -  Hemoglobin A1C > 7% and less or equal to 8.5%

          -  Non-fasting C-peptide > 0.5 ng/mL

          -  Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD)
             antihyperglycemic medication for greater or equal to 3 months prior to screening or

          -  Untreated with any antihyperglycemic agent during 2 months prior to screening

        Exclusion Criteria:

          -  History of type 1 diabetes or ketoacidosis

          -  History of long-term therapy with insulin

          -  Body Mass Index (BMI) > 45 kg/m^2

          -  Known history of Congestive Heart Failure (CHF)

          -  Impaired hepatic function

          -  History of prior treatment failure with, or intolerance of, a TZD

          -  Contraindication to treatment with pioglitazone

          -  Treatment with fibrates

          -  If untreated with oral antihyperglycemic, considered to have failed diet and exercise
             modification as the sole treatment for type 2 diabetes