bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Alogliptin
Intervention description: Alogliptin tablets.
Intervention MeSH terms: Alogliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3323.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus,; Lipoatrophic; Dyslipidemia; Drug Therapy

Summary:

      The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD),
      following participation in 1 of 7 controlled studies in patients with type 2 diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

          -  Type 2 diabetes mellitus and was enrolled in one of the following 7 controlled Phase
             III studies. The study will be open to all patients who completed one of these studies
             through the end-of-treatment visit:

               -  SYR-322-PLC-010 - NCT00286455

               -  SYR-322-SULF-007 - NCT00286468

               -  SYR-322-MET-008 - NCT00286442

               -  SYR-322-TZD-009 - NCT00286494

               -  SYR-322-INS-011 - NCT00286429

               -  01-05-TL-322OPI-001 - NCT00328627

               -  01-06-TL-322OPI-002 - NCT00395512

          -  Alanine aminotransferase less than or equal to 3 times the upper limit of normal and
             serum creatinine less than or equal to 2.0 mg per dL.

          -  Able and willing to monitor own blood glucose concentrations with a home glucose
             monitor.

          -  No major illness or debility that in the investigator's opinion prohibits the patient
             from completing the study.

        Exclusion Criteria

          -  The occurrence of any adverse event or condition during the controlled Phase III
             studies, which, in the opinion of the investigator, should exclude the patient from
             participating in the open-label extension.

          -  Is required to take or intends to continue taking any disallowed medication, any
             prescription medication, herbal treatment or over-the counter medication that may
             interfere with evaluation of the study medication, including:

               -  Weight-loss drugs

               -  Investigational antidiabetics, additional dipeptidyl peptidase-4 (DPP-4) and
                  glucagon-like peptide-1 (GLP 1) inhibitors

               -  Incretin Mimetics,

               -  Oral or systemically injected glucocorticoids.
Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Intervention: Taliglucerase alfa
Intervention description: Intravenous infusion every 2 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Gaucher disease; imiglucerase; glucocerebrosidase; enzyme replacement therapy; lysosomal storage disorder

Summary:

      This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase
      alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase
      (Cerezyme®) enzyme replacement therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 2 years or older

          -  Confirmed diagnosis of Gaucher disease by the enzymatic activity assay

          -  Stable Gaucher disease

          -  Treatment with imiglucerase (Cerezyme®) for at least 2 years and on a stable
             maintenance regimen (dose and regimen unchanged, except for situation of drug
             shortage) for at least the last six months

          -  Able to provide written informed consent

        Exclusion Criteria:

          -  Currently taking another experimental drug for any condition

          -  History of allergy to carrots

          -  History of allergy to beta lactam antibiotics

          -  Previous infusion reaction suspected to be allergic in nature to Cerezyme® or
             Ceredase® or receiving premedication to prevent infusion reactions

          -  Presence of HIV and/or HBsAg and/or hepatitis C infection

          -  Presence of unresolved anemia due to iron, folic acid or vitamin B12 deficiency

          -  Presence of any significant comorbidity that could confound the interpretation of the
             clinical response to taliglucerase alfa

          -  Presence of any medical, emotional, behavioral or psychological condition that in the
             judgment of the Investigator would interfere with the patient's compliance with the
             requirements of the study
A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Months
Healthy volunteers: No

Summary:

      This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435)
      will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to
      severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible
      participants will be those who are expected to benefit from the study medicine based on the
      investigator's discretion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who completed their last WA19926 (NCT01649804) core study visit (Week
             104) and who may benefit from study drug treatment according to the Investigator's
             assessment

          -  No current or recent adverse event or laboratory finding preventing the use of
             tocilizumab 8 mg/kg at baseline visit

          -  Women of childbearing potential must agree to use highly reliable contraception during
             the treatment period

        Exclusion Criteria:

          -  Pregnant or breastfeeding females

          -  Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study
             for any reason

          -  Treatment with any investigational agent or cell-depleting therapies since the last
             administration of study drug in WA19926 (NCT01649804)

          -  Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,
             or a T-cell costimulation modulator since the last administration of study drug in
             WA19926 (NCT01649804)

          -  Immunization with a live/attenuated vaccine since the last administration of study
             drug in WA19926 (NCT01649804)

          -  Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune
             disease other than RA

          -  Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint
             disease other than RA

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies, including tocilizumab and its excipients

          -  Evidence of severe uncontrolled concomitant disease or disorder

          -  Known active infections or history of recurrent infections

          -  Active tuberculosis requiring treatment in the previous 3 years

          -  History of alcohol, drug or chemical abuse since inclusion in the WA19926
             (NCT01649804) study
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation
Intervention: Brexpiprazole; Brexpiprazole
Intervention description: 2 or 3 mg tablet; 0.5 to 3 mg tablet
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 259.0
Sex: All
Minimum age: 55 Years
Maximum age: 91 Years
Healthy volunteers: No
Keywords: Agitation

Summary:

      Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and
      tolerability of oral brexpiprazole as treatment in adult participants with agitation
      associated with dementia of the Alzheimer's type (AAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have participated in the 331-14-213 study.

          -  Participants must have an identified caregiver who has contact, at a minimum of 2
             hours per day, 4 days per week to describe the participant's symptoms and can observe
             participant behavior.

        Exclusion Criteria:

          -  Participants with a substantial protocol violation during the course of their
             participation in the double-blind trial 331-14-213.
Metformin for the Prevention of Episodic Migraine (MPEM)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Metformin; Matching Placebo
Intervention description: Metformin 500mg twice daily; Matching Placebo twice daily
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The investigators will evaluate the safety and efficacy of metformin for preventive treatment
      of migraine in a randomized, double-blind, placebo-controlled, crossover trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age 18-65 years

          2. a diagnosis of migraine with or without aura for >1 year according to the
             International Classification of Headache Disorders-IIIb

        Exclusion Criteria:

          1. a diagnosis of diabetes mellitus or polycystic ovarian syndrome

          2. overuse of acute migraine treatments

          3. failure to respond to 3 or more classes of preventive drug treatments

          4. change in dose of migraine-preventive medication within 2 months of beginning the
             baseline diary phase

          5. significant somatic or psychiatric disease

          6. known alcohol or other substance abuse

          7. pregnant or breastfeeding.
n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: n-3 PUFAs; Placebo; RASS inhibitors and/or RAS blockers; Amiodarone
Intervention description: 1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day; 1.0 g of olive oil,one capsule twice a day; Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.; Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.
Intervention MeSH terms: Amiodarone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: PUFA atrial fibrillation

Summary:

      The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone
      and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm
      after electrical conversion in patients with persistent Atrial fibrillation (AF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  persistent Atrial Fibrillation (AF) lasting > one month

          -  history of at least one AF relapse after previous electrical or Pharmacological
             cardioversion

        Exclusion Criteria:

          -  left atrium size > 6 cm

          -  severe valvulopathy

          -  myocardial infarction during the previous 6 months

          -  unstable angina

          -  NYHA heart failure class IV or hemodynamic instability

          -  cardiac surgery during the previous 3 months

          -  significant pulmonary thyroid and hepatic disease

          -  contraindications to treatment with amiodarone or RASS inhibitors

          -  chronic renal dysfunction

          -  QT > 480 msec in the absence of bundle-branch block

          -  bradycardia < 50 b/min

          -  diagnosis of paroxysmal AF

          -  hyperkalemia

          -  pregnancy

          -  any disease or other medical treatment that, in the opinion of the investigators,
             could interfere with the study.
A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: TAU-284; TAU-284; Placebo
Intervention description: TAU-284 Low; TAU-284 High; Placebo
Intervention MeSH terms: Bepotastine besilate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 490.0
Sex: All
Minimum age: 7 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists

Summary:

      The objectives of this study are: to confirm the superiority of TAU-284 over placebo after
      two weeks of administration to pediatric patients with perennial allergic rhinitis, and to
      investigate the dose response, safety, and plasma concentrations of TAU-284.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged between 7 and 15 years

          -  Patients with a weight of at least 20 kg

          -  Patients who have received a diagnosis of perennial allergic rhinitis according to the
             diagnostic criteria

          -  Patients with a mean rhinorrhea score of at least 2 and a mean total score for the
             three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4
             on the basis of symptoms recorded in the nasal allergy diary during the observation
             period

        Exclusion Criteria:

          -  Patients with vasomotor rhinitis or eosinophilic rhinitis

          -  Patients who have concurrent nasal disease that may affect the efficacy of TAU-284

          -  Patients with a history of any of the nasal surgical procedures

          -  Patients who have a positive result for pollen antigens which are dispersed during the
             study period

          -  Patients who have a positive result for dog dander or cat dander antigen

          -  Patients with current or previous history of drug allergy

          -  Patients who concurrently have renal function abnormalities that may cause safety
             problems
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Bosentan
Intervention description: For patients who were administered Bosentan during BUILD 3 (NCT00391443):
continue on same dose
For patients who were administered placebo during BUILD 3 (NCT00391443):
Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.)
Intervention MeSH terms: Bosentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actelion; Idiopathic Pulmonary Fibrosis; bosentan; Tracleer; Interstitial Lung Disease; BUILD 3 (NCT00391443)

Summary:

      This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed
      protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability
      of bosentan in patients with idiopathic pulmonary fibrosis (IPF).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of
        study (EOS) visit.

          -  Signed informed consent prior to initiation of any study-related procedures.

          -  Women of childbearing potential must have a negative serum pregnancy test and use
             reliable methods of contraception during study treatment and for 3 months after study
             treatment termination.

        Exclusion Criteria:

          -  Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).

          -  Pregnancy or breast-feeding.

          -  AST and/or ALT > 3 times the upper limit of the normal range.

          -  Any known factor or disease that might interfere with treatment compliance, study
             conduct or interpretation of the results, such as drug or alcohol dependence or
             psychiatric disease.

          -  Known hypersensitivity to bosentan or any of the excipients.
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
Condition: Recurrent Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: Metronidazole (male partner); Placeob (male partner)
Intervention description: 500 mg PO BID for 7 days; matching placebo capsules PO BID for 7 days
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 214.0
Sex: All
Minimum age: 19 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: bacterial vaginosis; recurrence; male partner

Summary:

      Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with
      metronidazole or placebo to compare the rates of recurrent BV in the women
    

Eligibility criteria:

        Inclusion Criteria: Female

          1. At least 18 years of age (19 years of age in Alabama due to State law)

          2. Sexual partner to a female who meets study eligibility

          3. Willingness to provide informed consent

          4. Willingness to abstain from sexual intercourse or use condoms {during the study}

          5. Willingness to abstain from alcohol for the first week of the study

        Inclusion Criteria: Male

          1. At least 18 years of age (19 years of age in Alabama due to State law)

          2. Heterosexual with a regular partner

          3. History of 2 or more episodes of BV in the previous 12 months

          4. Symptoms of BV including vaginal discharge and/or odor

          5. Positive Amsel criteria for BV including vaginal pH >4.5, positive whiff test,
             presence of clue cells

          6. Willingness to provide informed consent

          7. Willingness to abstain from sexual intercourse or use condoms {during the study}

          8. Willingness to abstain from alcohol for the first week of the study

        Exclusion criteria (both genders)

          1. Allergy to metronidazole

          2. Failure of the male partner to keep his appointment to be seen within 48 hours

          3. Pregnant or breast feeding (females)

          4. HIV or other chronic disease which in the opinion of the investigator would interfere
             with the ability to participate in this study

          5. Subject requires concurrent lithium, coumadin, dilantin, or antabuse

          6. Presence of trichomonas on wet prep of vaginal fluid (females)

          7. Women with a history of recurrent BV for >3 years or women who have failed previous
             treatment studies for BV