bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of NAC in Patients With TA-TMA
Condition: Thrombotic Microangiopathies; Hematologic Diseases
MeSH terms: Vascular Diseases; Hematologic Diseases; Thrombotic Microangiopathies
Intervention: N-Acetylcysteine; Placebo Oral Tablet
Intervention description: 50mg/Kg.d, oral; 50mg/Kg.d, oral
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 170.0
Sex: All
Healthy volunteers: No
Keywords: N-acetylcysteine; Complement; Thrombotic Microangiopathies

Summary:

      HSCT associated thrombotic microangiopathy(TA-TMA) is a heterogeneous, fatal disorder seen
      within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal
      failure, mental status changes and involvement of other organs. N-Acetylcysteine (NAC) is a
      small, simple molecule that began as a generic drug almost 40 years ago. It has since been
      approved by the FDA for many indications. The investigators conducted an prospective clinical
      trial to evaluate the safety and efficiency of NAC in patients with TA-TMA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients be scheduled to undergo HSCT;

          2. Not received decitabine 6 month ago;

          3. Without severe organ damage;

          4. ECOG 0-2;

          5. Informed consent were obtained.

        Exclusion Criteria:

          1. Be sensitive to NAC;

          2. Bronchial asthma；

          3. Peptic ulcer；

          4. Severe organ damage；

          5. Pregnancy and breastfeeding women；
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Intervention: APTIMA HPV Assay; FDA-Approved HPV DNA Test
Intervention description: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).; A FDA-Approved HPV DNA Test is used as the comparator assay.
Phase: Phase 3
Study type: Interventional
Primary purpose: Screening
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12896.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cervix Cancer; Cervical Intraepithelial Neoplasia (CIN); Human Papillomavirus Virus (HPV); APTIMA HPV Assay; FDA-Approved HPV DNA Test; TIGRIS DTS (direct tube sampling) System; Clinical Sensitivity (%); Clinical Specificity (%); Positive Predictive Value [PPV] (%); Negative Predictive Value [NPV] (%); Atypical Squamous Cells Undetermined Significance (ASC-US); Relative Risk

Summary:

      The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using
      the TIGRIS System in detecting HPV types that may cause cervical cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female 21 years or older (ASC-US study only)

          -  Female 30 years or older (Adjunct and ASC-US studies)

          -  Subject attending a participating clinic and undergoing a Pap screening exam during
             the clinic visit

          -  Ability to comprehend and sign an IRB-approved Informed Consent Form

        Exclusion Criteria:

          -  Diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months

          -  Abnormal Pap test result in the past 12 months

          -  Subject under 18 years of age and consenting to the study without the presence of
             their parent or legal guardian

          -  Known to be pregnant

          -  Having an illness or medical condition that could interfere with or affect the
             conduct, results, and/or completion of the clinical trial

          -  Having an illness or medical condition that the investigator or physician feels would
             create an unacceptable risk to the subject if she enrolled into the clinical trial

          -  Prior vaccination for HPV
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
Condition: Renal Disease
MeSH terms: Kidney Diseases
Intervention: Dotarem; Time of Flight
Intervention description: Each subject will receive one injection of Dotarem 0.2ml/kg; Each subject will undergo a TOF MRA
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal disease; Contrast agent; MRA

Summary:

      The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA
      in patients suffering from renal arterial disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged more than 18 years

          -  Strongly suspected of having renal arterial disease

          -  Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography
             examination

        Exclusion Criteria:

          -  Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)

          -  Contraindication to MRI

          -  Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA
             examination
A Study in Adults With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY2963016; Lantus; Insulin Lispro
Intervention description: Administered subcutaneously; Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 536.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Type 1 Diabetes; Diabetes Mellitus

Summary:

      The purpose of this study is to compare the effectiveness and safety of LY2963016 versus
      Lantus when taken once daily in combination with insulin lispro before meals three times a
      day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 1 diabetes mellitus based on the disease diagnostic criteria [World Health
             Organization (WHO) Classification]

          -  Have duration of diabetes greater than or equal to one year

          -  Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%

          -  On basal-bolus insulin therapy for at least 1 year [basal insulin must be once daily
             (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and
             combined with mealtime injections of human regular insulin, or insulin analog lispro,
             aspart or glulisine]

          -  Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter
             (kg/m²)

        Exclusion Criteria:

          -  Have had more than one episode of severe low blood sugar (defined as needing someone
             else to help because you had very low blood sugar) within the 6 months before entering
             the study

          -  Have had more than one episode of diabetic ketoacidosis or emergency room visits for
             uncontrolled diabetes leading to hospitalization within the 6 months before entering
             the study

          -  Have known hypersensitivity or allergy to any of the study insulins (insulin glargine
             or insulin lispro) or to excipients of the study insulins

          -  Have significant renal, cardiac, gastrointestinal or liver disease

          -  Have active cancer or cancer within the past 5 years
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
Condition: Transcatheter Aortic Valve Replacement
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Acetylsalicylic Acid (ASA); Clopidogrel; Rivaroxaban (Xarelto, BAY59-7939); Vitamin K antagonist (VKA)
Intervention description: 10mg OD (once-daily); 75-100mg OD; 75mg OD; In case of NOAF, 20/15 mg OD (once-daily); In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines
Intervention MeSH terms: Aspirin; Vitamin K; Rivaroxaban; Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1653.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TAVR; TAVI; Transfemoral aortic valve implantation

Summary:

      To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR,
      compared to an antiplatelet-based strategy, is superior in reducing death or first
      thromboembolic events (DTE).

      To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an
      antiplatelet-based strategy, following TAVR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis
             (either native or valve-in-valve)

               -  By iliofemoral or subclavian access

               -  With any approved/marketed device

        Exclusion Criteria:

          -  Atrial fibrillation (AF), current or previous, with an ongoing indication for oral
             anticoagulant treatment

          -  Any other indication for continued treatment with any oral anticoagulant (OAC)

          -  Known bleeding diathesis (such as but not limited to active internal bleeding,
             clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin
             level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history
             of intracranial hemorrhage or subdural hematoma)

          -  Any ongoing absolute indication for dual antiplatelet therapy (DAPT) at time of
             screening that is unrelated to the TAVR procedure

          -  Clinically overt stroke within the last 3 months

          -  Planned coronary or vascular intervention or major surgery

          -  Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR
             unresolved acute kidney injury with renal dysfunction stage 2 or higher

          -  Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic
             disease associated with coagulopathy
Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo; insulin
Intervention description: Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.; Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.; All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 257.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and
      safety of liraglutide in combination with insulin therapy compared to insulin alone in
      Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial
      insulin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in
             addition to diet and exercise therapy for at least 12 weeks prior to trial start.
             Their therapy is stable and fluctuation of total daily insulin dose is within
             plus/minus 20% for at least 12 weeks prior to trial start and current total daily
             insulin dose equal to or greater than 10 (I)U/day

          -  Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)

          -  Body Mass Index (BMI) below 45.0 kg/m^2

        Exclusion Criteria:

          -  Anticipated change in concomitant medication known to interfere significantly with
             glucose metabolism, such as, but not limited to systemic corticosteroids,
             beta-antagonists or monoamine oxidase (MAO) inhibitors

          -  Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last
             12 months) or hypoglycaemic unawareness as judged by the investigator or
             hospitalisation for diabetic ketoacidosis during the previous 6 months

          -  Known proliferative retinopathy or maculopathy requiring treatment according to the
             investigator

          -  Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior
             to screening

          -  Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening
A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy
Condition: Anemia
Intervention: r-HuEPO
Intervention description: All participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular
      (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and
      histologically or cytologically confirmed cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological confirmed cancer

          -  Participants who are treated with at least first line chemotherapy

          -  Hemoglobin less than (<) 11 grams per deciliter (g/dL)

          -  Participants able to receive iron supplement, if necessary

        Exclusion Criteria:

          -  History of hypersensitivity to active or inactive excipients of r-HuEPO

          -  Insufficient controllable hypertension

          -  Thalassemic syndromes

          -  Anemia caused by hematic loss

          -  Women who are pregnant or lactating
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vedolizumab
Intervention description: Vedolizumab intravenous infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this multicenter, open-label study is to collect data on the occurrence of
      important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study
             C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the
             investigator, was well tolerated OR b. Moderate to severe Crohn's disease or
             ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)

          2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or
             ulcerative colitis as defined by the protocol

        Exclusion Criteria:

        1. Development of any new, unstable, or uncontrolled disease
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: VIVITROL 380 mg; Placebo for VIVITROL 380 mg
Intervention description: Administered via IM injection once every 4 weeks.; Administered via IM injection once every 4 weeks.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Addiction; Alcoholism; Inpatient detoxification

Summary:

      VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to
      abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.
      This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus
      placebo. Injections were administered to patients in whom abstinence was enforced by a period
      of inpatient hospitalization of 7 to 21 days.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria

          -  Expected to complete inpatient treatment for alcohol dependence within 24 hours of
             randomization

          -  Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to
             first dose

          -  Negative urine toxicological screen for opioids on the day of randomization

          -  Women of childbearing potential must agree to use an approved method of contraception
             for the study duration

        Primary Exclusion Criteria:

          -  Pregnancy or lactation

          -  Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of
             normal and/or esophageal variceal disease

          -  Current dependence (within the past year) to benzodiazepines, opioids or cocaine by
             DSM-IV criteria

          -  Use of any opioids and/or methadone within 14 days prior to the screening visit, or
             subjects likely to require opioid therapy during the study period

          -  Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening

          -  Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or
             PLG

          -  Parole, probation, or pending legal proceedings having the potential for incarceration
             during the study period
A Study in Japanese Participants With Moderate-to-Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: 80 mg ixekizumab
Intervention description: Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of ixekizumab in participants with moderate to
      severe psoriasis in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men must agree to use a reliable method of birth control during the study

          -  Women must agree to use birth control or remain abstinent during the study and for at
             least 12 weeks after stopping treatment

          -  Candidates for phototherapy and/or systemic therapy

          -  Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6
             months prior to enrollment

          -  At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for
             participants with plaque psoriasis

          -  Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and
             Severity Index (PASI) score of at least 12 at screening and at enrollment for
             participants with plaque psoriasis

        Exclusion Criteria:

          -  History of drug-induced psoriasis

          -  Concurrent or recent use of any biologic agent

          -  Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light
             therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis
             treatment within the previous 2 weeks prior to enrollment for participants with plaque
             psoriasis

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to enrollment and during the study

          -  Have participated in any study with interleukin-17(IL-17) antagonists, including
             ixekizumab

          -  Serious disorder or illness other than psoriasis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women

          -  Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for
             participants with plaque psoriasis