bioihbjkbjnl/mcl2 huggingface dataset:
To Access the Effects of Mucositis in Adults With Dental Implants
Condition: Mucositis
MeSH terms: Mucositis
Intervention: Triclosan and Fluoride; Fluoride
Intervention description: Brush twice daily; Brush twice daily
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Clinical research for the treatment of mucositis subjects who have dental implants for a
      minimum of one-year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, ages 30-70.

          -  Availability for the six-month duration of the clinical research study.

          -  Good general health.

          -  Subjects who have lost teeth for periodontal disease reasons and who have been
             restored with implants.

          -  Minimum of 5 remaining teeth and a minimum of 2 implants.

          -  Initial evaluation of the gingival and peri-implant mucosal tissues by determining
             full mouth bleeding on probing.

          -  Initial plaque evaluation by determining full mouth presence/absence of plaque.

          -  Signed Informed Consent Form.

        Exclusion Criteria:

          -  Tumor(s) of the soft or hard tissues of the oral cavity.

          -  Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss
             or periodontal attachment or alveolar bone).

          -  Carious lesions requiring immediate restorative treatment.

          -  Uncontrolled Diabetes

          -  Use of antibiotics any time during the one month prior to entry into the study.

          -  Untreated peri-implantitis.

          -  Participation in any other clinical research study or test panel within the three
             months prior to entry into the study.

          -  Pregnant women or women who are breast feeding.

          -  History of allergies to personal care/consumer products or their ingredients.

          -  Medical condition which prohibits not eating/drinking for up to 2 hours.

          -  Current alcohol or drug abuse.

          -  Systemic or local disease conditions that would compromise post-operative healing.

          -  Regular use of anti-inflammatory drugs.
A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC.; Administered SC.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache; treatment-resistant; treatment resistant

Summary:

      The purpose of this study is to assess the safety and efficacy of galcanezumab in people with
      treatment-resistant episodic or chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of migraine or chronic migraine.

          -  History of migraine headaches at least 1 year prior to screening, with onset prior to
             age 50.

          -  History of at least 4 migraine headache days and at, with at least 1 headache-free day
             per month on average within the past 3 months.

          -  Have documentation of 2 to 4 migraine preventive medication category failures due to
             inadequate efficacy or tolerability, in the past 10 years.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to galcanezumab or another calcitonin gene-related
             peptide (CGRP) antibody.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine).

          -  Pregnant or nursing.
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: paricalcitol
Intervention description: Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 216.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Secondary hyperparathyroidism

Summary:

      Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in
      Chronic Kidney Disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is a Chinese male or female greater than or equal to 20 years old.

          2. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance
             hemodialysis three times a week for at least 2 months prior to the Screening Visit and
             expected to remain on hemodialysis for the duration of the study.

          3. For entry into the Treatment Phase, the subject must have:

               -  Intact parathyroid hormone greater than or equal to 300 pg/mL

               -  Serum calcium less than 10.2 mg/dL (2.55 mmol/L)

               -  Calcium-phosphorus product less than 65 mg^2/dL^2

        Exclusion Criteria:

          1. Subject has a history of an allergic reaction or significant sensitivity to vitamin D
             or vitamin D related compounds.

          2. Subject received a partial parathyroidectomy within one year prior to the Screening
             Phase.

          3. Subject with New York Heart Association (NYHA) Class III or IV.

          4. Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in
             the last 3 months prior to the Screening Phase, or requires such medications for
             greater than 3 weeks in the study.

          5. Subject has a current malignancy (with the exception of basal or squamous cell
             carcinoma of the skin), or clinically significant liver disease, in the opinion of the
             Investigator.

          6. Subject has a history of drug or alcohol abuse within 6 months prior to the Screening
             Phase.

          7. Subject is known to be human immunodeficiency virus (HIV) positive.

          8. Subject has evidence of poor compliance with diet, medication or hemodialysis that may
             interfere, in the Investigator's opinion, with adherence to the protocol.
Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
Condition: Rheumatoid Arthritis; Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic
Intervention: Etanercept / Autoinjector A
Intervention description: Autoinjector A, a hand-held, reusable electromechanical device, and a single-use, disposable cassette preassembled with an etanercept 50-mg liquid prefilled syringe (PFS).
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA)
      or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept
      (Enbrel®).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has diagnosis of RA or PsA and indicated for treatment with etanercept per the
             current label, based on history.

          -  Subject is willing to self-inject per investigator judgement at screening.

          -  Subject has no known history of tuberculosis.

        Exclusion Criteria:

          -  Latex allergy.

          -  Subject has any active infection (including chronic or localized infections) for which
             anti-infectives were indicated within 4 weeks prior to first study dose of etanercept.

          -  Subject had prosthetic joint infection within 5 years of screening or native joint
             infection within 1 year of screening.

          -  Other criteria may apply.
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: SAR153191 (REGN88)
Intervention description: Pharmaceutical form: solution
Route of administration: subcutaneous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2023.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Main Study:

      Primary Objective:

      Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA).

      Secondary Objective:

      Assess the long term efficacy of sarilumab in participants with RA.

      Sub-Study:

      This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by
      participants with moderate or severe RA, or their professional or non-professional healthcare
      providers in an unsupervised real-world situation. To mimic the real-world practice, the
      sub-study was incorporated into the LTS11210 study without additional visits compared to the
      scheduled visits in the main study. The duration of this sub-study was 12 weeks.
    

Eligibility criteria:

        Inclusion criteria :

        Main study:

        Participants with RA who were previously randomized in the sarilumab RA clinical program:
        e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study.

        Sub-study:

        Participants enrolled in the LTS11210 study who were receiving either sarilumab 200mg q2w
        PFS or sarilumab 150mg q2w PFS and who were able and willing to participate in this
        sub-study.

        Participants who had been enrolled in the main study for at least 24 weeks. Participants
        must sign a sub-study written informed consent prior to any sub-study related procedure.

        Exclusion criteria:

        Main study:

        Participants with any adverse event (AE) led to permanent study drug discontinuation from a
        prior study.

        Participants with an abnormality(ies) or AEs that per investigator judgment would adversely
        affect participation of the participant in the study.

        Sub-study: There are no additional exclusion criteria to those defined in main study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: saxagliptin; sitagliptin
Intervention description: tablet, per oral, once daily; capsule, per oral, once daily
Intervention MeSH terms: Sitagliptin Phosphate; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 822.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; metformin

Summary:

      Saxagliptin is a new investigational medication being developed for treatment of type 2
      diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in
      addition to metformin and compare to sitagliptin in addition with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes

          -  Treatment with metformin alone on stable doses of 1500 mg or higher per day for at
             least 8 weeks

        Exclusion Criteria:

          -  Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma

          -  Insulin therapy within one year

          -  Previous treatment with DPP-4 inhibitor
Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large-Cell, Anaplastic
Intervention: doxorubicin hydrochloride; mercaptopurine; methotrexate; prednisone; vinblastine sulfate; vincristine sulfate
Intervention description: Given IV; Given by mouth; Given IV and intrathecally; Given by mouth; Given IV; Given IV
Intervention MeSH terms: Prednisone; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Mercaptopurine; Vinblastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Maximum age: 20 Years
Healthy volunteers: No
Keywords: anaplastic large cell lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining more than one drug may kill more cancer cells. It is
      not yet known if combination chemotherapy with vinblastine is more effective than combination
      chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination
      chemotherapy regimens with either vinblastine or vincristine in treating patients who have
      newly diagnosed advanced anaplastic large cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed advanced anaplastic large cell lymphoma

               -  Cluster of differentiation antigen 30 (CD30+)

               -  Murphy stage III or IV

          -  No B-cell large cell lymphoma

          -  No disease limited to the skin (regardless of how wide-spread)

        PATIENT CHARACTERISTICS:

        Age

          -  Under 21

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) or alanine transaminase (ALT) less than 2.5 times ULN
             (unless due to lymphoma)

        Renal

          -  Not specified

        Cardiovascular

          -  Shortening fraction (SF) at least 27% by echocardiogram OR

          -  Ejection fraction (EF) at least 50% by radionuclide angiogram

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Prior steroids for management of a mediastinal mass allowed

        Radiotherapy

          -  Prior limited-dose radiotherapy for a mediastinal mass allowed

        Surgery

          -  Not specified
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 9072; Placebo
Intervention description: Intramuscular (IM) injection, 441 mg or 882 mg given monthly; Placebo for IM injection, given monthly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 623.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alkermes; schizophrenia; ALKS 9072; ALKS 9070; aripiprazole lauroxil

Summary:

      The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or
      ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia according to DSM-IV-TR criteria

          -  Has been able to achieve outpatient status for more than 3 months in the past year

          -  Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)

          -  Resides in a stable living situation

          -  Willing and able to be confined to an inpatient study unit for 2 weeks or longer

        Exclusion Criteria:

          -  History of poor or inadequate clinical response to treatment with aripiprazole

          -  History of treatment resistance

          -  Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its
             ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or
             glycerol)

          -  Diagnosis of current substance dependence (including alcohol)

          -  Pregnant, lactating, or breastfeeding

          -  Receipt of any antipsychotic medication by IM injection within 60 days before
             Screening

          -  Current involuntary hospitalization or incarceration

          -  Hospitalized for more than 30 days during the 90 days before Screening

        Additional inclusion/exclusion criteria may apply.
Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial
Condition: Haemophilia A
MeSH terms: Hemophilia A
Intervention: Turoctocog alfa
Intervention description: Intravenous (i.v., under the skin) administration.A maximum dose of 200 IU/kg daily.
The maximum treatment period for this trial is 24 months and the patient(s) will be called for visit to the clinic every 3rd month.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
      the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog
      alfa (a recombinant factor VIII) in patients who have developed neutralising antibodies
      against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation
      in NN7170-4213 (NCT02994407)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in the NN7170-4213 trial (male, age at least 18 years (part A)
             and age at least 12 years (part B))

          -  Development of a confirmed high titre neutralising antibody towards factor VIII
             (greater than 5 Bethesda Unit) after exposure to subcutaneous turoctocog alfa pegol in
             the NN7170-4213 trial or development of a confirmed clinically relevant low titre
             inhibitor (at least 0.6 to below or equal to 5 Bethesda Unit), defined as factor VIII
             activity measures (recovery) and/or bleedpattern indicating a lack of clinical
             response to factor VIII treatment

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to trial product(s) or related products, defined
             as allergic reactions

          -  Participation in another clinical trial within 1 month before screening (except
             participation in NN7170-4213)

          -  Any disorder, except for conditions associated with Haemophilia A which in the
             investigator's opinion might jeopardise patients' safety or compliance with the
             protocol

          -  Currently receiving immune tolerance induction treatment with a factor VIII containing
             product other than turoctocog alfa
A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: placebo; ustekinumab 45 mg; ustekinumab 90 mg
Intervention description: SC injections; SC injections; SC injections
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ustekinumab; CNTO 1275; Stelara; Psoriatic Arthritis; Psoriasis; TNF alpha

Summary:

      The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and
      safety of ustekinumab in patients with psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a documented diagnosis of psoriatic arthritis (PsA) at least 6 months

          -  Have a diagnosis of active PsA at the time of entry into the study with at least 5
             tender and 5 swollen joints at baseline

          -  May have previously received at least 8 weeks of etanercept, adalimumab, golimumab or
             certolizumab pegol or at least 14 weeks of infliximab or proven inability to tolerate
             anti-TNF therapy for 8-14 weeks

          -  If the patient is using methotrexate, they should have started treatment at a dose not
             to exceed 25 mg/week at least 3 months prior to the beginning of the study and should
             have no serious toxic side effects attributable to methotrexate

        Exclusion Criteria:

          -  Have other inflammatory diseases, including but not limited to rheumatoid arthritis,
             ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease

          -  Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but not
             limited to ustekinumab and ABT-874

          -  Have used infliximab, golimumab or certolizumab pegol within 12 weeks of first study
             drug injection, or etanercept or adalimumab within 8 weeks of first study drug
             injection

          -  Have a medical history of latent or active granulomatous infection, including TB,
             histoplasmosis, or coccidioidomycosis, prior to screening

          -  Have any known malignancy or have a history of malignancy (with the exception of basal
             cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in
             situ that has been treated with no evidence of recurrence, or squamous cell carcinoma
             of the skin that has been treated with no evidence of recurrence within 5 years of the
             beginning of the study