bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial of Lurasidone in Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone tablets; Risperidone tablets
Intervention description: Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo); Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)
Intervention MeSH terms: Risperidone; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 388.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; Lurasidone; LATUDA

Summary:

      This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose,
      non-inferiority and multicentre study designed to evaluate the efficacy and safety of
      lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent and aged between 18 and 65 years of age.

          -  Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total
             score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at
             Screening and Baseline.

          -  Not pregnant, if of reproductive potential agrees to use adequate and reliable
             contraception for duration of study.

          -  Able and agrees to remain off prior antipsychotic medication for the duration of
             study.

          -  Willing and able to comply with the protocol, including the inpatient requirements and
             outpatient visits.

        Exclusion Criteria:

          -  Considered by the investigator to be at imminent risk of suicide or injury to self,
             others or property.

          -  Any chronic organic disease of the CNS(other than schizophrenia)

          -  Subjects are participating or participated in other clinical studies including
             marketed drugs or medical devices within 30 days before signing the informed consent
             form.

          -  Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence
             within the last 6 months.
A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: ciclesonide HFA 160 μg
Intervention description: ciclesonide HFA 160 μg once daily
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 824.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Perennial allergic rhinitis; allergic rhinitis; ciclesonide

Summary:

      6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147).
      Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered
      once-daily in patients with Perennial Allergic Rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has successfully completed all visits of Study 060-633.

          -  Subject has given written informed consent and assent, including privacy authorization
             as well as adherence to concomitant medication withholding periods, prior to
             participation.

          -  Subject is male or female 12 years and older.

          -  Subject must be in general good health (defined as the absence of any clinically
             relevant abnormalities as determined by the Investigator) based on screening physical
             examination, clinical laboratory tests, and medical history.

          -  Subject, if female 65 years of age or younger, must have a negative urine pregnancy
             test (performed at Visit 1). Females of childbearing potential must be instructed to
             and agree to avoid pregnancy during the study and must use an acceptable method of
             birth control:

               1. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive,
                  transdermal or injectable contraceptive for at least 1 month prior to entering
                  the study with continued use throughout the study and for thirty days following
                  study participation.

               2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide
                  while participating in the study.

               3. Abstinence.

        Exclusion Criteria:

          -  Female subject who is pregnant or lactating.

          -  History of physical findings of nasal pathology, including nasal polyps.

          -  Subject has any condition that, in the judgment of the investigator, would preclude
             the subject from completing the study.
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; sitagliptin; metformin; liraglutide
Intervention description: 1.2 mg once daily, subcutaneous (under the skin) injection; Tablets, 100 mg daily; Tablets, minimum 1500 mg daily; 1.8 mg once daily, subcutaneous (under the skin) injection
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and North America. The aim of this trial is to compare the
      effect on blood sugar control of liraglutide or sitagliptin, both in combination with
      metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

      The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

        1. Week 27-52 after randomisation

           - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and
           dosing regimen.

        2. Week 53-78 after randomisation

             -  Subjects receiving sitagliptin at the end of week 52 after randomisation will
                discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or
                liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and
                increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.

             -  Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after
                randomisation will continue the treatment at unchanged dose and dosing regimen.
                Trial completion is planned for June 2010.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Treatment with metformin alone for at least three months

          -  HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)

          -  Body Mass Index (BMI) less than or equal to 45.0

        Exclusion Criteria:

          -  Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or
             dipeptidyl peptidase-4 (DPP-4) inhibitors

          -  Treatment with anti-diabetic drugs other than metformin within the last three months

          -  Any serious medical condition

          -  Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Condition: Prevention; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: edoxaban; enoxaparin sodium
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 610.0
Sex: All
Minimum age: 20 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Anticoagulants; Venous thromboembolism; Thromboembolism; Thrombosis; enoxaparin sodium; Embolism; Deep vein thrombosis; DU-176b; edoxaban; factor Xa; total hip arthroplasty

Summary:

      The objective of this study is to assess the efficacy and safety of DU-176b compared with
      enoxaparin sodium for the prevention of venous thromboembolism in patients after elective
      total hip arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing unilateral total hip arthroplasty

        Exclusion Criteria:

          -  Subjects with risks of hemorrhage

          -  Subjects with thromboembolic risks

          -  Subjects who weigh less than 40 kg

          -  Subjects who are pregnant or suspect pregnancy, or subjects who want to become
             pregnant
Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
Condition: HIV Infections; Cytomegalovirus Retinitis
MeSH terms: Cytomegalovirus Retinitis; Retinitis
Intervention: Foscarnet; Ganciclovir
Intervention description: 60 mg/kg every 8 hours, 90 mg/kg/day; 5 mg/kg every 12 hours, 5 mg/kg every 24 hours
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate; Foscarnet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial
      treatment of patients with cytomegalovirus (CMV) retinitis.
    

Eligibility criteria:

        Inclusion criteria:

          -  CMV retinitis in one or both eyes

          -  At least 1/4 disk are of one CMV lesion photographable

          -  Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV
             infection

          -  Age 13 and greater

          -  Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis

          -  Absolute neutrophil count ≥ 1,000 cells/µl

          -  Platelet ≥ 25,000 cells/µl

          -  Serum creatinine ≥ 2.0 mg/dl

          -  Karnofsky score ≥ 60

          -  Informed consent

        Exclusion criteria:

          -  Previous treatment of CMV retinitis

          -  Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the
             past 28 days

          -  Known or suspected allergy to study drugs

          -  Pregnant or Lactating
Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
Condition: Prevention
MeSH terms: Duodenal Ulcer
Intervention: Esomeprazole; Placebo
Intervention description: 20mg, capsule, 72 weeks; Placebo, capsule, 72 weeks
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 427.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Gastric ulcer; Duodenal ulcer; Low-dose aspirin

Summary:

      To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous
      treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily
      Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric
      and/or duodenal ulcers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent before starting the study-related procedures and
             examinations

          -  Patients who have the history of gastric and/or duodenal ulcer.

          -  A diagnosis of a chronic condition (angina pectoris, myocardial infarction and
             ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or
             embolism) which requires taking the prescribed LDA during the study treatment period.

        Exclusion Criteria:

          -  Having gastric or duodenal ulcer (except for ulcer scar).

          -  History of esophageal, gastric or duodenal surgery, except for simple closure of
             perforation.
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
Condition: Pre-Exposure Prophylaxis of HIV-1 Infection
MeSH terms: Infections; Communicable Diseases; HIV Infections
Intervention: F/TAF; F/TDF; F/TAF Placebo; F/TDF Placebo
Intervention description: 200/25 mg tablet administered orally once daily; 200/300 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5399.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM)
      and transgender women (TGW) who have sex with men and who are administered daily
      emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate
      (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks
      of follow-up after randomization.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must be at high risk of sexual acquisition of HIV

          -  HIV-1 negative status

          -  MSM and TGW (male at birth) who have at least one of the following:

               -  condomless anal intercourse with at least two unique male partners in the past 12
                  weeks (partners must be either HIV-infected or of unknown HIV status)

               -  documented history of syphilis in the past 24 weeks

               -  documented history of rectal gonorrhea or chlamydia in the past 24 weeks

          -  Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to
             the Cockcroft-Gault formula

          -  Adequate liver and hematologic function:

               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper
                  limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

               -  Absolute neutrophil count ≥ 1000/mm^3; platelets ≥ 75,000/mm^3; hemoglobin ≥ 10
                  g/dL

        Key Exclusion Criteria

          -  Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically
             manageable.

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
Condition: Paget's Disease of Bone
MeSH terms: Bone Diseases; Osteitis Deformans
Intervention: zoledronic acid; placebo to zoledronic acid; Risedronate; Placebo to risedronate; Calcium and vitamin D supplements
Intervention description: 5 mg zoledronic acid in 5 mL of sterile water for infusion; 5 mL of sterile water for infusion; 30mg oral tablets overencapsulated to match the placebo capsules; oral capsules; Calcium and vitamin D supplements were supplied
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Risedronic Acid; Etidronic Acid; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Zoledronic acid, risedronate, Paget's disease of bone

Summary:

      The primary objective of this core study was to show non-inferiority of zoledronic acid to
      risedronate, with respect to the proportion of patients who achieved therapeutic response.
      The extended observation period included participants of the core study who responded to
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  30 years or older

          -  SAP 2 times ULN

          -  Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance
             imaging, computerized tomography, radioisotope imaging, etc.).

          -  90 days washout calcitonin

          -  180 day washout bisphosphonate

        Exclusion Criteria:

          -  Allergic reaction to bisphosphonates

          -  History of upper GI disorders

          -  History of iritis, uveitis

          -  Calculated creatinine clearance < 30 ml/min at baseline

          -  Evidence of vitamin D deficiency

        Other protocol-defined inclusion/exclusion criteria may apply.
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab pegol (CDP870)
Intervention description: 400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's Disease; Certolizumab pegol; CDP870; Cimzia

Summary:

      The study will continue to assess the safety of certolizumab pegol (CDP870) as well as
      examine the evolution of long term efficacy in Crohn's disease patients who completed study
      C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct
      cost parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients having completed study C87042 [NCT00308581] (previously treated with
             infliximab)

        Exclusion Criteria:

          -  Subject withdraw from C87042 [NCT00308581] study

          -  Subject who received treatment other than certolizumab pegol and other than
             medications permitted in C87042 [NCT00308581] study

          -  Subjects from countries where certolizumab pegol is authorized in Crohn's disease
             treatment

          -  Female patients of childbearing age who are NOT practicing (in the Investigator's
             opinion) effective birth control. All female patients must test negative on a serum
             pregnancy test before study entry and negative on urine testing immediately before
             every certolizumab pegol administration
Long-Term Safety and Efficacy Study of Peginterferon Beta-1a
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: peginterferon beta-1a
Intervention description: Administered as specified in the treatment arm
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1077.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Subcutaneous; Extension; Interferon; MS; PEGylated; Injectable; SC; PEG; peginterferon beta-1a; Relapsing

Summary:

      The primary objective of this study is to evaluate the long-term safety and tolerability of
      peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301
      (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this
      study is to describe long-term multiple sclerosis (MS) outcomes in participants originally
      treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have completed the study treatment and visit schedule through Week 96 in Study
             105MS301 (NCT00906399).

        Key Exclusion Criteria:

          -  Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study
             105MS301 (NCT00906399).

          -  Subjects with any clinically significant laboratory abnormalities, malignancies,
             cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic,
             pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease

          -  Pregnant or nursing women.

        NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: ChimeriVax™-JE; JE-VAX®
Intervention description: 0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline); 0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 820.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine non-inferiority in seroconversion and to compare
      the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous
      virus strain after completion of vaccination course.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 or above

          -  Subjects in good general health.

          -  Females must have negative pregnancy test and be using adequate form of contraception

        Exclusion Criteria:

          -  History of vaccination/infection with JE or Yellow fever or other flaviviruses

          -  History of residence/travel to flavivirus endemic regions

          -  History of anaphylaxis/serious adverse reactions

          -  Administration of vaccine within 30 days of study or during treatment period

          -  Clinically significant physical exam/medical history/lab abnormalities

          -  Pregnancy

          -  Excessive alcohol/drug abuse

          -  Hypersensitivity to constituents of JE-VAX®

          -  Blood transfusion/treatment with blood product within 6months of study and during
             study treatment period

          -  Known/suspected immunodeficiency

          -  Compromised blood brain barrier

          -  Employees of Clinical Research Organization (CRO)/study site staff

          -  Any other condition which would exclude subject.