bioihbjkbjnl/mcl2 huggingface dataset:
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study
Condition: Venous Thromboembolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Placebo
Intervention description: Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.; Patients allocated to placebo will receive a matching placebo tablet once daily.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled, event-driven,
      superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein
      thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with
      rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension
      study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months
             with VKA or rivaroxaban

        Exclusion Criteria:

          -  Legal lower age limitations (country specific)

          -  Indication for VKA other than DVT and/or PE

          -  Patients in whom anticoagulant treatment for their index PE or DVT should be continued

          -  Childbearing potential without proper contraceptive measures, pregnancy or breast
             feeding. Proper contraceptive measures are defined as a method of contraception with a
             failure rate < 1 % during the course of the study (including the observational
             period). These methods of contraception according to the note for guidance on
             non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP
             [Committee for Proprietary Medicinal Products]/ICH [International Conference on
             Harmonization]/286/95, modification) include consistent and correct use of hormone
             containing implants and injectables, combined oral contraceptives, hormone containing
             intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: adalimumab
Intervention description: 160 mg loading dose, 80 mg at week 2, 40 mg every other week
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To make adalimumab available to subjects suffering from moderately to severely active Crohn's
      Disease (CD) and to expand the safety information on adalimumab. The study also assessed
      changes in Patient Reported Outcome Measures from baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 18 years of age and older

          -  Females: Not of childbearing potential OR Practicing approved birth control throughout
             the study and for 150 days after study completion

          -  Diagnosis of moderate to severe CD for greater than 16 weeks prior to screening;
             Crohn's Disease Activity Index score > 220 OR Harvey Bradshaw Index equal to or higher
             than 7, and who are refractory to optimal conventional therapies such as,
             5-aminosalicylic acid (5-ASA), glucocorticoids, and immunosuppressive therapies
             (azathioprine, 6-MP and MTX)

          -  Subjects who failed prior infliximab therapy (as determined by the primary
             investigator), including those who never clinically responded ("primary
             non-responders")

        Exclusion Criteria:

          -  History of cancer other than some skin and cervical cancers

          -  History of opportunistic infections, central nervous system (CNS) demyelinating
             disease, chronic viral hepatitis, or untreated tuberculosis

          -  Subjects with other, poorly controlled medical conditions

          -  Subjects with any prior exposure to Tysabri® (natalizumab)

          -  Subjects who have received any investigational agent in the past 30 days or 5
             half-lives prior to screening (whichever is longer)

          -  Female subjects who are pregnant or breast-feeding or considering becoming pregnant
             during the study
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Risankizumab
Intervention description: Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic

Summary:

      This study will evaluate whether adult participants with moderate to severe plaque psoriasis
      who have been treated with secukinumab or ixekizumab for at least 6 months and are
      experiencing a suboptimal response may benefit from switching to risankizumab with regard to
      skin symptoms, quality of life symptoms and psoriasis symptoms.

      Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection
      at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being
      administered at Week 40). An additional visit will occur at Week 8 for a physical exam and
      questionnaire collection. A final follow-up phone call will occur at Week 60.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months
             before Baseline (Week 0).

          -  Participant must have been on labeled secukinumab or ixekizumab treatment for at least
             6 months and are experiencing suboptimal response at time of Screening and Baseline
             visits.

          -  Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global
             Assessment (sPGA) 2/3

          -  Participant must be eligible for continued biologic therapy as assessed by the
             investigator.

        Exclusion Criteria:

          -  History of erythrodermic psoriasis, generalized or localized pustular psoriasis,
             medication-induced or medication-exacerbated psoriasis, or new onset guttate
             psoriasis, psoriatic arthritis.

          -  Participant with active skin disease other than plaque psoriasis that could interfere
             with the assessment of plaque psoriasis.

          -  History of any documented active or suspected malignancy or history of any malignancy
             within the last 5 years except for successfully treated non-melanoma skin cancer
             (NMSC) or localized carcinoma in situ of the cervix.

          -  History of major surgery within 12 weeks prior to Baseline or planned to be performed
             during the conduct of the trial as assessed by the investigator.

          -  Participant with exposure to risankizumab or any IL-23 inhibitors.
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; Cariprazine
Intervention description: Placebo was supplied in capsules.; Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: There was no masking in the Open-Label Phase. There was masking in the Double-Blind Phase
Enrollment: 765.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizophrenic disorder

Summary:

      The objective of this study is to evaluate the efficacy and safety of cariprazine relative to
      placebo in the prevention of relapse of symptoms in participants with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have provided informed consent prior to any study specific
             procedures.

          -  Participants currently meeting the Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.

          -  Participants with normal physical examination, laboratory, vital signs, and/or
             electrocardiogram (ECG).

          -  Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).

          -  Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1
             (Screening) and Visit 2 (beginning of Run-in Phase).

          -  Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to
             female participants of childbearing potential only).

          -  Body mass index between 18 and 40 kg/m^2, inclusive.

        Exclusion Criteria:

          -  Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder,
             schizophreniform disorder, bipolar I and II and known or suspected borderline or
             antisocial personality disorder. or other DSM-IV-TR axis II disorders.

          -  Participants in their first episode of psychosis.

          -  Treatment-resistant schizophrenia over the last 2 years.

          -  Positive result from the blood alcohol test or from the urine drug screen for any
             prohibited medication.

          -  At imminent risk of injuring self or others or causing significant damage to property.

          -  Suicide risk.
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
Condition: Primary Immune Deficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: IgPro20
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 2 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CVID; XLA

Summary:

      The purpose of this study is to determine whether a long-term use of a new human
      immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary
      immunodeficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with primary humoral immunodeficiency who have participated in the study
             ZLB04_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency
             (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID
             (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as
             defined by PAGID and ESID

          -  Women of childbearing potential must be using and agree to continue using medically
             approved contraception and must have a negative pregnancy test at screening

          -  Written informed consent

        Exclusion Criteria:

          -  Ongoing serious bacterial infection at the time of screening

          -  Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma,
             and immunodeficiency with thymoma

          -  Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total
             urine protein concentration > 0.2 g/L)

          -  Other significant medical conditions that could increase the risk to the patient

          -  Females who are pregnant, breast-feeding or planning a pregnancy during the course of
             the study

          -  A positive result at screening on any of the following viral markers: Human
             immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)

          -  Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration >
             2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04_009CR
             (NCT00419341)

          -  Creatinine concentration > 1.5 times UNL at Completion Visit of study ZLB04_009CR
             (NCT00419341)

          -  Participation in a study with an investigational product other than IgPro20 within 3
             months prior to enrollment

          -  Evidence of uncooperative attitude

          -  Any condition that is likely to interfere with evaluation of the study drug or
             satisfactory conduct of the trial

          -  Subjects who are employees at the investigational site, relatives or spouse of the
             investigator
Study of T-PRED(TM) Compared to Pred Forte(R) II
Condition: Cataract
MeSH terms: Cataract
Intervention: T-Pred; Pred Forte
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Prednisone; Prednisolone acetate; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of T-PRED(TM) Compared to Pred Forte(R)
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

        Exclusion Criteria:

          -  No active or adverse disease
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
Condition: Subjects With Hyperlipidemia, Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Inflammation
Intervention: Evolocumab; Placebo
Intervention description: Administered subcutaneously once a month using an autoinjector/pen.; Administered subcutaneously once a month using an autoinjector/pen.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hyperlipidemia; Dyslipidemia; Proprotein convertase subtilisin/kexin type 9 (PCSK9) Inhibition; Arterial Wall Inflamation; Elevated lipoprotein a

Summary:

      A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9)
      inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting lipoprotein(a) (Lp(a)) 50 mg/dL or more at screening 1

          -  Fasting Low-density lipoprotein-cholesterol (LDL-C) 100 mg/dL or more at screening 1

          -  Lipid lowering therapy including statin dose unchanged for at least 8 weeks prior to
             screening

          -  Target-to-background ratio (TBR) maximum higher than 1.6 (either right, left carotid
             or thoracic aorta) on fluorodeoxyglucose-positron emission tomography/computed
             tomography (FDG-PET/CT).

        Exclusion Criteria:

          -  Currently receiving, or less than 4 weeks since receiving, treatment in another
             investigational device or drug study(ies), or participating in other investigational
             procedures

          -  Known diagnosis of diabetes mellitus or screening fasting serum glucose ≥ 126 mg/dL or
             hemoglobin A1C (HbA1C) ≥ 6.5%

          -  Subject with a history of homozygous familial hypercholesterolemia

          -  History of a Cardiovascular event

          -  Subject currently undergoing lipid apheresis

          -  Known contraindications or limitations to FDG-PET/ CT (scanner weight limit, devices
             that can cause image artifacts, or carotid/aortic stents/grafts

          -  Subject has had exposure to investigational drugs targeting Lp(a) within the last 12
             months, prior to Screening

          -  Other Exclusion Criteria May Apply.
A Study for Patient With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Duloxetine; Placebo
Intervention description: 60 mg orally once daily for 12 weeks; Placebo once daily orally for 12 weeks
Intervention MeSH terms: Duloxetine 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: 401.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if duloxetine reduces the severity of chronic low
      back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients with chronic low back pain

        Exclusion Criteria:

          -  Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical
             or psychiatric condition that, in the opinion of the investigator, would compromise
             participation or be likely to lead to hospitalization during the course of the study.

          -  Acute liver injury (such as hepatitis) or severe cirrhosis.

          -  Previous exposure to duloxetine.

          -  Body Mass Index (BMI) over 40.

          -  Major depressive disorder.

          -  Daily use of narcotics.
Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Fluoro-Calcium-Phospho-Silicate based dentifrices; 8% Arginine based dentifrices; 8% Strontium Acetate; Sodium Fluoride
Intervention description: Bio-Active glass based formulation; Tubular occluding formulation; Tubular occluding formulation; No claim of relieving Dentin Hypersensitivity
Intervention MeSH terms: Listerine; Calcium; Fluorides; Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Statistician will be masked.
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dentine hypersensitivity; Dentine Sensitivity; Oral dentifrices; Bio-active glasses

Summary:

      This will be multi-centered, triple blinded, randomized, four parallel treatments assigned
      study to compare clinical efficacy of commercially available dentifrices with placebo for
      immediate and sustained relief from Dentin Hypersensitivity after short term use.

      Condition or disease: Dentin hypersensitivity Intervention/Treatment: Product 1;
      Fluoro-Calcium-Phospho-silicate based BioMin F Product 2; Pro-Argin formula based Colgate
      Sensitive Pro-Relief Product 3; Strontium Acetate based Sensodyne Rapid Action Product 4;
      Sodium Fluoride based Colgate Total
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with at least two teeth sensitive to cold, touch and air blow stimulus

          -  Sensitive teeth anterior to molars either due to erosions or abrasions with or without
             associated gingival recession

          -  Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold
             Air Sensitivity Scale on screening.

        Exclusion Criteria:

          -  Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)

          -  Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks

          -  Localized or generalized gingivitis or pulpitis with heavy calculus

          -  Periodontal surgery in the preceding three months

          -  Patients using any desensitizing tooth paste or mouth wash up to six weeks before
             study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in
             routine.

          -  Pregnant or breastfeeding females.
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide
Intervention description: 0.05 mg/kg/day subcutaneously taken once per day for 12 months
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parenteral nutrition; TPN; HPN; PN; SBS; Short bowel syndrome

Summary:

      This study is a 1-year open label extension study to collect long term efficacy and safety
      data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At completion of Study CL0600-021, subjects will be invited to participate in this
             trial if they meet the following criteria:

               1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from
                  PN/I.V. support

               2. Signed and dated informed consent form (ICF) to participate before any
                  study-related procedures of Study TED-C11-001 are performed

        Exclusion Criteria:

          -  None