bioihbjkbjnl/mcl2 huggingface dataset:
The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth
Condition: Primary Teeth; Microbial Colonization; Caries; Dental Caries in Children
MeSH terms: Communicable Diseases; Infections; Dental Caries
Intervention: Nanosilver Fluoride (NSF); Silver diamine fluoride
Intervention description: Optimized synthesis of Nanosilver Fluoride; Silver Diamine Fluoride
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nano silver fluoride; silver diamine fluoride; antibacterial; caries arrest; microbiology; primary teeth; pediatric; clinical trial; nanosilver; SDF

Summary:

      To assess the antibacterial effect of Nanosilver Fluoride (NSF) in relation to caries
      activity in dentin caries lesions of primary teeth in comparison to Silver Diamine Fluoride
      (SDF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The presence of at least one active carious lesion on a primary tooth.

          -  Completion of an informed consent to participate in the study.

        Exclusion criteria:

          -  Children reporting spontaneous or elicited pain from caries or showing any signs of
             pulpal infection, swelling, abscess, obvious discoloration of the tooth, or premature
             mobility.

          -  Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes
             within the last 2 weeks.

          -  Children presenting with special health care needs or undergoing medical treatment for
             chronic or acute diseases affecting salivary flow.

          -  Allergy or sensitivity to silver or any of the materials included in the study.

          -  Child weight less than 10 Kg (to avoid concerns for toxicity).
A Study to Assess the Long-term Safety of QVA149
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Placebo
Intervention description: capsules for inhalation, delivered by an SDDPI; capsules for inhalation, delivered by an SDDPI
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 339.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: QVA149; COPD; combination bronchodilator

Summary:

      The study is designed to provide long-term safety data for QVA149 in patients with moderate
      to severe chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged ≥40 yrs

          -  Smoking history of at least 10 pack years

          -  Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for
             Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)

          -  Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and
             post-bronchodilator FEV1/FVC (forced vital capacity) <70%

        Exclusion Criteria:

          -  Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular co-morbid conditions

          -  Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          -  Patients in the active phase of a supervised pulmonary rehabilitation program

          -  Patients contraindicated for inhaled anticholinergic agents and β2 agonists

          -  Other protocol-defined inclusion/exclusion criteria may apply
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 0.3% OPA-15406; 1% OPA-15406; Placebos
Intervention description: Twice daily; Twice daily; Twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 251.0
Sex: All
Minimum age: 2 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406
      ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for
      4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary
      endpoint in pediatric patients with Atopic Dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AD based on the Japanese Dermatological Association's criteria

          -  Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of
             body surface area (BSA, excluding scalp) at the screening and baseline examinations

          -  IGA score of 2 or 3 at the screening and baseline examinations

        Exclusion Criteria:

          -  Subjects who have an AD or contact dermatitis flare-up defined as a rapid
             intensification of AD, within 28 days prior to the baseline examination
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: telbivudine; adefovir dipivoxil
Intervention description: 600mg/day oral tablet for 96 weeks; 10 mg of adefovir by mouth once daily
Intervention MeSH terms: Adefovir; Adefovir dipivoxil; Telbivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: lamivudine resistance; Hepatitis B virus

Summary:

      This study is being conducted to compare the safety and effectiveness of the investigational
      medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently
      approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus
      [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination
      therapy will be compared to the results for patients taking adefovir alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented compensated chronic hepatitis B defined by a clinical history compatible
             with chronic hepatitis B.

          -  Previous or current lamivudine treatment

          -  HBV DNA > 6 log10 copies/mL

          -  Evidence of viral breakthrough

        Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Patient is pregnant or breastfeeding.

          -  Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.

          -  Patient has received any anti-HBV treatment for HBV infection other than lamivudine in
             the 12 months before Screening for this study.

        Other protocol-defined exclusion criteria may apply.
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Ketotifen/naphazoline; Ketotifen; Naphazoline; Vehicle
Intervention description: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.; One drop of Ketotifen in study eye at visit 3 and visit 4.; One drop of naphazoline in study eye at vist 3 and visit 4.; One drop of vehicle in study eye at visit 3 and visit 4.
Intervention MeSH terms: Ketotifen; Naphazoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline
      ophthalmic solution compared to vehicle and its individual components in alleviating the
      signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive history of ocular allergies and positive skin test reaction to cat hair, cat
             dander, grasses, ragweed, and/or trees within the past 24 months.

          -  Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as
             measured using the ETDRS chart.

          -  Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of
             instillation of the last titration of allergen at visit 1.

          -  Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.

        Exclusion Criteria:

          -  Known contraindications or sensitivities to the study medication or its components.

          -  Any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety or trial parameters.

          -  Use of disallowed medications during the period indicated prior to study enrollment or
             during the study.
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD
Condition: Diabetes Mellitus; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus
Intervention: Subcutaneous Insulin; Inhaled Insulin
Intervention description: Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.; Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 30 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics
      with Chronic Obstructive Pulmonary Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin

          -  Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC < 70%) and FEV1
             < 80% predicted and/or a history of chronic productive cough.

        Exclusion Criteria:

          -  Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active
             smoking
Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: eicosapentaenoic acid; docosahexaenoic acid; Placebo
Intervention description: 1 gram/day; 1 gram/day; 980 milligram/day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Depression; Omega-3; Boston

Summary:

      This study examines the difference in the effectiveness of two natural compounds,
      eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major
      depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is
      believed that a deficiency in these omega-3 fatty acids may lead to the development of major
      depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18-80 years old.

          -  Must meet criteria for current Major Depressive Disorder.

        Exclusion Criteria:

          -  Serious or unstable medical illness including cardiovascular, hepatic, renal,
             respiratory, endocrine, neurologic, or hematologic disease

          -  History of seizure disorder.

          -  Substance use disorders, including alcohol, active within the last six months (past
             history is OK).

          -  History of multiple adverse drug reactions or allergy to the study drugs.
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine 10 mg; Aliskiren 150; Amlodipine 300
Intervention description: Amlodipine 10 mg; Aliskiren/Amlodipine 150/10 mg; Aliskiren/Amlodipine 300/10 mg
Intervention MeSH terms: Amlodipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 847.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aliskiren; Amlodipine; Non-responder to Amlodipine

Summary:

      This study will assess the safety and efficacy of combination aliskiren/amlodipine in
      patients with hypertension not adequately controlled with amlodipine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed patients or patients who have not been treated for hypertension within
             the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1
             and 2

          -  Patients who have been treated for hypertension within the 4 weeks prior to Visit 1
             must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2

          -  All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization)

        Exclusion Criteria:

          -  Severe hypertension

          -  Pregnant or nursing (lactating) women

          -  Pre-menopausal women not taking accepted form of birth control

          -  Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1

          -  History of cardiovascular conditions

          -  Uncontrolled Type 1 or Type 2 diabetes mellitus

          -  Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with
             similar chemical structures

        Other protocol-defined inclusion/exclusion criteria may apply
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children
Condition: Spinal Puncture
MeSH terms: Wounds and Injuries
Intervention: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg; Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Intervention description: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.; Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
Intervention MeSH terms: Remifentanil; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Lumbar Puncture; Pediatrics; Propofol; Remifentanil; sedation; Oncology

Summary:

      The objective of this study is to compare intraoperative and recovery parameters in patients
      who receive two different dose combinations of propofol and remifentanil in patients
      undergoing a lumbar puncture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of a hemato-oncological disorder

          -  Scheduled to undergo a lumbar puncture

          -  Aged 3-12 years

          -  Unpremedicated

        Exclusion Criteria:

          -  children who are known or suspected to be difficult to ventilate by face mask

          -  children who are deemed medically unfit to receive either of the two study medications

          -  children who are obese (weight for height > 95th percentile)

          -  children who do not have an indwelling intravenous line
Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: PRO-148; Systane
Intervention description: Instill 1 drop in each eye four times a day, for 60 days; Instill 1 drop in each eye four times a day, for 60 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution
      PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with
      ophthalmic solution Systane®
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate dry eye patients based on the Report of International Dry Eye
             Workshop (DEWS)

          -  OSDI score between 12 and 45

          -  Provided informed consent

        Exclusion Criteria:

          -  Patients with one blind eye

          -  Visual acuity of 20/100 or worst in any eye

          -  Patients with any active ocular disease that would interfere with study interpretation

          -  Patients in treatment with any medication that could interfere with the study,
             contraindication of any medication used in the protocol

          -  Patients with history of hypersensitivity or contraindication for any drug used in the
             study

          -  Contact lens users

          -  Pregnant patients, at risk of pregnancy or breastfeeding

          -  Patients without birth control treatment

          -  Patients who had participated in any clinical trial in the last 90 days

          -  Legal or mentally disabled patients who could not give informed consent

          -  Patients who do not provide informed consent
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Carfilzomib; Bortezomib; Melphalan; Prednisone
Intervention description: Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1.; Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9.; Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.; Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.
Intervention MeSH terms: Prednisone; Bortezomib; Melphalan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 955.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective was to compare the progression-free survival of transplant ineligible
      patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan
      and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group
             [IMWG] diagnostic criteria)

          2. Transplant ineligibility

          3. Measurable disease, as defined by 1 or more of the following (assessed within 21 days
             prior to randomization):

               -  Serum M-protein ≥ 0.5 g/dL, or

               -  Urine M-protein ≥ 200 mg/24 hours, or

               -  In subjects without detectable serum or urine M-protein, serum free light chain
                  (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC
                  kappa lambda ratio < 0.26 or > 1.65)

          4. No prior treatment for multiple myeloma

          5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

        Exclusion Criteria:

          1. Multiple myeloma of IgM (immunoglobulin M) subtype

          2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a
             cumulative dose of 160 mg of dexamethasone

          3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
             skin changes)

          4. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard
             differential)

          5. Waldenström macroglobulinemia (WM)

          6. Known amyloidosis
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
Condition: Hypertension; Left Ventricular Hypertrophy; Overweight
MeSH terms: Hypertension; Essential Hypertension; Hypertrophy, Left Ventricular; Overweight; Hypertrophy
Intervention: Aliskiren 150/300 mg; Losartan 50/100 mg; Aliskiren placebo; Losartan 50/100 mg placebo
Intervention description: Aliskiren 150 mg tablets; Losartan 50 or 100 mg capsules; Aliskiren 150 mg placebo tablet; Losartan 50/100 mg placebo capsules
Intervention MeSH terms: Losartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To compare the efficacy and safety of aliskiren in combination with losartan compared to
      losartan on the regression of the increased size of the left ventricle in overweight patients
      with high blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with essential hypertension

          -  Patients with a BMI > 25 kg/m2

          -  Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO

        Exclusion Criteria:

          -  Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1)
             who are unable or unwilling to undergo the 3 month washout period.

          -  Patients treated with an ACE and ARB combination at study entry.

          -  Known secondary hypertension of any etiology (e.g., uncorrected renal artery
             stenosis).

        Other protocol related inclusion/exclusion criteria applied to the study.