bioihbjkbjnl/mcl2 huggingface dataset:
Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
Condition: Leukaemia, Lymphocytic, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: OFC Infusion; FC infusion
Intervention description: Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles; Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed; Oncology; Safety; Chronic Lymphocytic Leukemia; Ofatumumab; Efficacy

Summary:

      The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to
      fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  confirmed and active CLL requiring treatment

          -  at least one previous treatment for CLL and having achieved a complete or partial
             remission/response but after a period of 6 or more months, shows evidence of disease
             progression

          -  fully active at a minimum or fully capable of selfcare and up and about more than 50%
             of waking hours

          -  age 18yrs or older

          -  signed written informed consent

        Key Exclusion Criteria:

          -  diagnosis of refractory CLL (failure to achieve a complete or partial
             remission/response or disease progression within 6 months of last anti-CLL treatment

          -  abnormal/inadequate blood values, liver and kidney function

          -  certain heart problems, serious significant diseases, AIHA, other current cancers or
             within the last 5 years

          -  active or chronic infections

          -  use of drugs to suppress allergic or inflammatory responses (glucocorticoids)

          -  CLL transformation

          -  CLL central nervous system involvement

          -  current participation in other clinical study

          -  inability to comply with the protocol activities

          -  lactating or pregnant women or female patients of child-bearing potential (or male
             patients with such partners) not willing to use adequate contraception
Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237; Tiotropium; Placebo to tiotropium; Placebo to NVA237; salbutamol/albuterol
Intervention description: NVA237 50 μg inhalation capsules once a day, delivered via SDDPI; Tiotropium 18 μg once a day delivered via HandiHaler® device; Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device.; Placebo to NVA237 50 μg once a day delivered via SDDPI; salbutamol/albuterol given as a rescue medication via inhaler when needed
Intervention MeSH terms: Glycopyrrolate; Albuterol; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 657.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This study compared the efficacy and safety of NVA237 with tiotropium in patients with
      moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate to severe stable COPD (Stage II or Stage III) according to the
             current GOLD Guidelines (GOLD 2010).

          -  Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥ 30%
             and < 80% of the predicted normal, and a post-bronchodilator FEV1/ Forced Vital
             Capacity (FVC) < 0.70 at screening

          -  Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10
             pack years = 1 pack/day x 10 yrs, or ½ pack/day x 20 yrs).

          -  Symptomatic patients, according to daily electronic diary data between Visit 2 (Day
             -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7
             days prior to Visit 3.

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Patients who, in the judgment of the investigator, or the responsible Novartis
             personnel, have a clinically relevant laboratory abnormality or a clinically
             significant condition before Visit 1.

          -  Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or
             bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
             (BPH patients who are stable on treatment can be considered).

          -  Patients receiving medications in the classes listed in the protocol as prohibited.

        Other protocol-defined inclusion/exclusion criteria apply and can be found in the study
        protocol
A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: MK-0954A; MK-954H; Placebo to MK-0954A; Placebo to MK-954H
Intervention description: Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily; Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily; Placebo tablet to match MK-0954A, once daily; Placebo tablet to match MK-954H, once daily
Intervention MeSH terms: Losartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 278.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Essential hypertension; Uncontrolled hypertension; Antihypertensive agents; Blood pressure

Summary:

      This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential
      hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).
    

Eligibility criteria:

        Inclusion criteria:

          -  Participant has a diagnosis of essential hypertension.

          -  Participant is being treated with a single, or dual combination treatment for
             hypertension and will be able to discontinue the prior antihypertensive medication.

          -  Participant has a mean trough SiDBP of >=90mmHg and < 110mmHg.

          -  Participant has a mean trough SiSBP of >=140mmHg and < 200mmHg.

          -  Participant has no clinically significant abnormality at screening visit.

        Exclusion criteria:

          -  Participant is currently taking > 2 antihypertensive medications.

          -  Participant has a history of significant multiple and/or severe allergies to
             ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e.,
             sulfonamide-containing "chlortalidone" medicines).

          -  Participant is, at the time of signing informed consent, a user of recreational or
             illicit drugs or has had a recent history within the last year of drug or alcohol
             abuse or dependence.

          -  Participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy
             test is positive at screening visit.

          -  Participant is currently participating or has participated in a study with an
             investigational compound or device within 30 days of signing informed consent.
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Condition: Acute Blunt Soft Tissue Injuries/Contusions
MeSH terms: Wounds and Injuries; Soft Tissue Injuries; Contusions
Intervention: placebo; Placebos
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 215.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction
      of the pain associated with acute blunt trauma injuries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 16 years and over Fresh impact injury of the upper or
             lower limbs, not requiring admittance to hospital & meeting baseline pain intensity
             level Anticipated time between injury and treatment must be ≤ 6 hours

        Exclusion Criteria:

          -  Pain medication prior to randomization Topical analgesic or anti-inflammatory
             treatment over the previous month in the area to be treated Any physical impairment
             that would influence efficacy assessments, such as peripheral or central neurological
             disease, significant back pain, painful conditions of the upper or lower extremities
             Other protocol-defined inclusion/exclusion criteria may apply
Compare the Clinical Efficacy of Prototype Toothpastes.
Condition: Gingival Diseases
MeSH terms: Gingival Diseases
Intervention: Fluoride; Triclosan and fluoride; Herbal Ingredient and fluoride
Intervention description: Brush twice daily; Brush twice daily; Brush twice daily
Intervention MeSH terms: Listerine; Triclosan; Fluorides; Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival
      inflammation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers 18-65 years of age

          -  Good general health

          -  Must sign informed consent form

          -  Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.

          -  No history of allergy to personal care consumer products, or their ingredients,

          -  relevant to any ingredient in the test products as determined by the dental/medical

          -  Professional monitoring the study.

          -  Dental Selection Criteria: Average full mouth GI score should be in the range of

          -  - 2.0. heavy plaque formers should be avoided. Target a full mouth PI

          -  (Quigley-Hein) to be in the range of 1.5-3.0

          -  If of child bearing potential and on birth control (diaphragm, birth control pills,

          -  Birth control implants, IUD (Intrauterine device), condoms)

        Exclusion Criteria:

          -  Subjects unable or unwilling to sign the informed consent form.

          -  Medical condition which requires pre-medication prior to dental visits/procedures

          -  Moderate or advanced periodontal disease

          -  2 or more decayed untreated dental sites at screening.

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that are currently affect salivary flow.

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

          -  Pregnant or nursing women.

          -  Participation in any other clinical study within 1 week prior to enrollment into this

          -  study.

          -  Use of tobacco products

          -  Subjects who must receive dental treatment during the study dates.

          -  Current use of Antibiotics for any purpose.

          -  History of allergy to common dentifrice ingredients

          -  Presence of an orthodontic appliance which interferes with plaque scoring.

          -  History of allergy to natural remedies, such as herbal ingredients

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

          -  Smoker
Proton/Photon Rt - Benign Meningiomas(P92-13)
Condition: Benign Meningioma
MeSH terms: Meningioma
Intervention: Standard Treatment; Higher Dose
Intervention description: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.; 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sphenoid region; parasellar area; photon radiation therapy; proton radiation therapy

Summary:

      The purpose of this study is to determine the best radiation dose for participants with
      meningioma that has grown back after previous surgery, or which the surgeon has been unable
      to remove completely. This research study is designed to determine whether a higher dose of
      radiation will decrease the likelihood that the tumor will grow back, compared to the
      probability of re-growth that occurs after standard radiation doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or over

          -  Histological documentation of benign meningioma

          -  Documentation by imaging studies (CT and/ or MRI) or residual or recurrent
             intracranial tumor

          -  Karnofsky performance status of ≥ 70

          -  Study specific informed consent

        Exclusion Criteria:

          -  Malignant meningiomas

          -  Prior cranial irradiation, except treatment of localized skin cancer of the face or
             scalp

          -  Patients having a concurrent primary cancer (except skin)

          -  Patients having another cancer controlled < 3 years

          -  Pregnant patients
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; CP-690,550; Placebo; Placebo
Intervention description: 5mg CP-690,550 BID PO for 6 months; 10 mg CP-690,550 BID PO for 6 months; Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit; Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 611.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antirheumatic Agents Clinical Trial

Summary:

      This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550
      when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to
      severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in
      improving signs and symptoms and physical function that were observed in the Phase 2
      Rheumatoid Arthritis studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a diagnosis of RA based upon the American College of Rheumatology
             (ACR) 1987 Revised Criteria.

          -  The patient has active disease at both Screening and Baseline, as defined by both: ≥6
             joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the
             following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local
             laboratory. 2. CRP >7 mg/L in the central laboratory

          -  Patient had an inadequate response to at least one DMARD (traditional or biologic) due
             to lack of efficacy or toxicity.

          -  No evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis.

          -  Patient has washed out of all DMARDs other that antimalarials

        Exclusion Criteria:

          -  Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2.
             White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4.
             Platelet count <100 x 109/L

          -  History of any other autoimmune rheumatic disease other than Sjogren's syndrome

          -  No malignancy or history of malignancy.

          -  History of infection requiring hospitalization, parenteral antimicrobial therapy, or
             as otherwise judged clinically significant by the investigator, within the 6 months
             prior to the first dose of study drug
Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
Condition: Healthy
MeSH terms: Amyloidosis
Intervention: [18F] Flutemetamol
Intervention description: Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Intervention MeSH terms: Flutemetamol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amyloid; Magnetic resonance imaging; Positron Emission Tomography; Standard uptake value ratios; Healthy Subjects

Summary:

      Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD).
      The study drug helps produce pictures of amyloid in the brain. The purpose of this study is
      to determine how well the study drug performs in young healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject age is 18 to 40 years.

          -  The subject has no evidence of thinking or memory problems by medical history.

          -  The subject has a normal MRI scan.

          -  The subject's general health is adequate to comply with study procedures.

          -  The subject is willing and able to participate in all study procedures.

        Exclusion Criteria:

          -  The subject has received any medical ionizing radiation exposure in the last 12 months
             (except planar x-ray or head CT).

          -  The subject has a contraindication for (cannot undergo) MRI.

          -  The subject has a history of head injury with loss of consciousness.

          -  The subject has any significant medical, psychiatric or neurological condition that
             might be associated with brain pathology.

          -  The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree
             relative.
Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ipragliflozin; Sitagliptin
Intervention description: one 50 mg tablet QD; one 50 mg tablet QD
Intervention MeSH terms: Sitagliptin Phosphate; Ipragliflozin
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: 20 Years
Healthy volunteers: No

Summary:

      This is a study to assess the safety and efficacy of the addition of ipragliflozin to
      sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate
      glycemic control on sitagliptin, diet, and exercise therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has Type 2 diabetes mellitus

          -  Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy

          -  Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis

          -  History of any of the following medications: Thiazolidinediones (TZD) and/or insulin
             within 12 weeks prior to study participation, sodium glucose cotransporter 2 (SGLT2)
             inhibitors anytime

          -  Currently has a urinary tract infection or genital infection with subjective symptom
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY2963016; Lantus®; Insulin Lispro
Intervention description: Administered SC; Administered SC; Administered SC
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: 272.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin Glargine

Summary:

      The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus®
      in combination with mealtime insulin lispro in adult Chinese participants with Type 1
      Diabetes Mellitus (T1DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO]
             Classification).

          -  Have duration of T1DM ≥1 year.

          -  Have HbA1c ≤11 %.

          -  Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90
             days prior to screening.

          -  Have a body mass index (BMI) ≤35 kilograms per meter squared.

        Exclusion Criteria:

          -  Exposure to an insulin glargine other than Lantus® within previous 30 days.

          -  Have had more than one episode of severe hypoglycemia within 6 months prior to entry
             into the study.

          -  Have had more than one episode of diabetic ketoacidosis or emergency room visits for
             uncontrolled diabetes leading to hospitalization within 6 months prior to entry into
             the study.

          -  Have known hypersensitivity or allergy to any of the study insulins (Lantus® or
             insulin lispro) or to excipients of the study insulins.

          -  Are pregnant, intend to become pregnant during the course of the study.

          -  Women who are breastfeeding.

          -  Are currently taking traditional medicine (herbal medicine or patent medicine) with
             known/specified content of anti-hyperglycemic effects within 3 months before
             screening.

          -  Have congestive heart failure Class III and IV.

          -  Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease.

          -  Have any active cancer.

          -  Have a history or diagnosis of human immunodeficiency virus (HIV) infection.

          -  Have presence of clinically significant gastrointestinal disease.

          -  Have a history of renal transplantation, or are currently receiving renal dialysis.

          -  Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.