bioihbjkbjnl/mcl2 huggingface dataset:
Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: nicotine patch; nicotine lozenge; nicotine patch + nicotine lozenge; bupropion; bupropion + lozenge; placebo
Intervention description: used according to FDA package label; used according to FDA-approved package directions; dosage of both according to FDA-approved dosing schedule; dosage according to FDA-approved instructions; dosage according to FDA approved standard instructions; dosage same as active drug conditions
Intervention MeSH terms: Bupropion; Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1504.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The proposed work will advance the understanding and effectiveness of tobacco dependence
      treatment and result in more smokers quitting successfully.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm -
             Motivated to quit smoking - Able to read and write English - Willing to complete
             required study assessments

        Exclusion Criteria:

          -  Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of
             bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem
             in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of
             Alcohol Dependence in the previous 6 months by participant self-report or drinking 6
             or more drinks on six or more days a week - History of seizure and/or serious head
             injury involving loss of consciousness - Use of contraindicated medications (MAO
             inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant
             or breast-feeding - Unwilling to use effective contraception during the treatment
             phase - More than one participant from the same household - Allergic reactions to 3 or
             more classes of drugs
Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Magnesium 400Mg; Ibuprofen 10 mg/kg; acetaminophen 15 mg/kg
Intervention description: magnesium 400 mg + conventional treatment; ibuprofen 10 mg/kg oral single dose; Acetaminophen 15 mg/kg oral single dose
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 160.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or
      acetaminophen for the acute treatment of primary migraine in children in or out prophylactic
      treatment with magnesium.

      Methods: The study had been approved by the Researchers Ethics Committee of the
      "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the
      children ranging from the ages of 5 to 18 years with at least four attack/month of primary
      migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the
      moment of admission to the study (start of the study) and every month up to 18 months later
      (end of the study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with migraine without aura (MoA) diagnosed according to the criteria for
             pediatric age of the International Classification of Headache Disorders (IHS-2)

          -  aged from 5 to 18 years

          -  at least four attacks /month

        Exclusion Criteria:

          -  mental retardation (IQ <70)

          -  genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome)

          -  hypothyroidism

          -  psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD),

          -  neuromuscular disorders,

          -  epilepsy,

          -  obesity (BMI>95 percentiles),

          -  liver or renal diseases,

          -  gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn;

          -  hypersensitivity to medication studies.
Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease
Condition: Increased Risk of SARS-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19
Intervention: Bromhexine Hydrochloride
Intervention description: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days
Intervention MeSH terms: Bromhexine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized controlled trial of the efficacy and safety evaluation of oral
      administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and
      COVID-19 disease in medical personnel assisting patients with a new coronavirus disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of 18 years or more;

          2. Negative test (PCR) for SARS-CoV-2 infection;

          3. The absence of clinical manifestations of a respiratory infection;

          4. Contact with patients with laboratory and / or clinically confirmed SARS-CoV-2
             infection;

          5. Signed informed consent to participate in the study.

        Exclusion Criteria:

          1. Intolerance to Bromhexine hydrochloride;

          2. Work out of contact with SARS-CoV-2 infection;

          3. Non-compliance with the rules for the use of personal protective equipment when
             working with SARS-CoV-2 infection (the rules for the use of personal protective
             equipment in accordance with the recommendations of the Ministry of Health of Russia
             and the internal orders of the Director General of Almazov NMRC, relevant to the dates
             of research);

          4. Pregnancy and the period of breastfeeding;

          5. Other circumstances that the researcher considers inappropriate to participate in this
             study
ADA Linagliptin in Long Term Care
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: linagliptin; insulin glargine
Intervention description: 5mg linagliptin tablets
Intervention MeSH terms: Insulin Glargine; Linagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nursing home facility; long-term care facility; older patients; elderly patients; hyperglycemia; type 2 diabetes

Summary:

      This is a study to determine whether glycemic control, as measured by change in HbA1c and
      frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and
      basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with
      poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with
      linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that
      treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement
      in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC
      residents with T2D. We will also determine differences in clinical outcome, resource
      utilization, and hospitalization costs between LTC residents with T2D treated with
      linagliptin and basal and correction insulin. We will compare differences in complications
      (infectious and non-infectious, neurological and cardiovascular events), emergency room
      visits and hospitalizations between groups during the 6 months of intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females with known history of type 2 diabetes, treated with diet, OADs as
             monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale
             insulin.

          2. Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

        Exclusion Criteria:

          1. Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis

          2. Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.

          3. Recurrent severe hypoglycemia or hypoglycemic unawareness.

          4. Subjects with history of gastrointestinal obstruction or gastroparesis.

          5. Patients with acute or chronic pancreatitis or pancreatic cancer.

          6. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage
             liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of
             normal, or significantly impaired renal function (GFR < 45 ml/min).

          7. Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.

          8. Mental condition rendering the subject unable to understand the nature and scope of
             the study.
Epiduo Pediatric Acne Study
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: adapalene/benzoyl peroxide; Topical Gel Vehicle
Intervention description: daily topical application for 12 weeks; daily topical application for 12 weeks
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 285.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and
      benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to
      11 years of age with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of acne vulgaris with facial involvement

          -  Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale

          -  A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or
             Inflammatory) on the face (including the nose) at Baseline

        Exclusion Criteria:

          -  Acne nodule or acne cyst

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
             or severe acne requiring systemic treatment

          -  Underlying diseases and/or dermatologic conditions that require the use of interfering
             topical or systemic therapy or that might interfere with study assessments

          -  Use of prohibited medications prior to the study and/or are unwilling to refrain from
             such use during the study
Study Evaluating The Safety Of Xyntha In Usual Care Settings
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Moroctocog alfa(AF-CC); Blood draw for laboratory testing
Intervention description: Dosing is at the discretion of the investigator during the study; Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No
Keywords: hemophilia; hemophilia A; ReFacto; Xyntha; moroctocog alfa; bleeding disorder

Summary:

      The purpose of this study is to collect safety information associated with the use of Xyntha
      in a usual care setting. Upon meeting eligibility criteria, patients will be required to have
      approximately 5 study visits over a 2 year period. Procedures completed throughout the study
      include collection of vital signs, physical exams, and laboratory assessments. Patients will
      be required to complete an infusion log for each Xyntha infusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients 12 years of age and older.

          -  Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII
             replacement products.

          -  Treatment history of 150 or greater exposure days to any FVIII products prior to
             Enrollment visit.

          -  Negative inhibitor at screening or documentation of negative inhibitor titer within 6
             weeks or less prior to study entry except for patients entering the study on immune
             tolerance induction therapy.

        Exclusion Criteria:

          -  Bleeding disorder other than hemophilia A.

          -  Inhibitor titer greater than or equal to 0.6 BU during screening except for patients
             on immune tolerance induction therapy.

          -  Immunomodulatory therapy during screening period.

          -  Known hypersensitivity to hamster protein.
Comparison of Albuterol for Status Asthmaticus
Condition: Status Asthmaticus
MeSH terms: Status Asthmaticus
Intervention: preservative free albuterol
Intervention description: Preservative free albuterol for nebulization
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study is designed to compare the length of continuous albuterol administration between
      two different albuterol formulations, BAC containing albuterol versus preservative free
      albuterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be included in the study if they are admitted to the 5th floor of Norton
             Children's Hospital for the treatment of an acute asthma exacerbation, initiated on
             continuous albuterol inhalation therapy, and are between 5 and 17 years of age.

        Exclusion Criteria:

          -  Patients will be excluded from the study if they are transferred from the 5th floor to
             the Pediatric Intensive Care Unit (PICU), admitted for any indication other than acute
             asthma exacerbation, or removed from the inpatient asthma protocol for any given
             reason.
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: capecitabine [Xeloda]; Taxotere; Herceptin (HER2-neu positive patients only); capecitabine [Xeloda]; Taxotere
Intervention description: 825mg/m2 po bid on days 1-14 of each 3 week cycle; 75mg/m2 iv on day 1 of each 3 week cycle; 4mg/kg iv (loading dose) followed by 2mg/kg iv weekly; 825mg/m2 po bid on days 1-14 of each 3 week cycle; 75mg/m2 iv on day 1 of each 3 week cycle
Intervention MeSH terms: Capecitabine; Docetaxel; Trastuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study stratified patients into two treatment cohorts based on HER2-neu
      overexpression/amplification. Each cohort will be independently powered for the primary
      endpoint. The study will evaluate the efficacy, safety and impact on quality of life of
      treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu
      negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv)
      Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same
      chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will
      receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice
      daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will
      also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women >=18 years of age;

          -  newly diagnosed;

          -  infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.

        Exclusion Criteria:

          -  evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;

          -  previous systemic or local primary treatment.
Control of Pain in Intravitreal Injections Using Topical NSAIDs
Condition: Intravitreal Injections; IVI
Intervention: Bromfenac; Artificial tears
Intervention description: An NSAID used to treat eye pain and swelling; eye drops to lubricate the eye and maintain moisture
Intervention MeSH terms: Bromfenac; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain

Summary:

      Intravitreal injections (IVI) are a common form of treatment for multiple retinal
      pathologies. The investigators hypothesize that an intervention with a topical NSAID will
      alleviate pain experienced at intravitreal injection (IVI) and post-IVI. 46 participants will
      be recruited, randomized into 1 of 3 treatment arms, and can expect to be on study for a day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eyes with retinal pathology requiring anti-VEGF therapy

          -  Previously had an IVI

        Exclusion Criteria:

          -  History of previous eye surgery other than cataract extraction

          -  Herpetic eye disease

          -  Uncontrolled glaucoma

          -  Uveitis

          -  Acute conjunctivitis

          -  Pregnancy

          -  Known previous adverse response or contraindication to intravitreal injection,
             Bromfenac, or other NSAIDs.

          -  Keratitis including povidone-induced keratitis

          -  Bullous keratopathy

          -  Diagnosis of dry eye syndrome

          -  Uncontrolled diabetes

          -  NSAID use 3 days prior to IVI
Early Surgery Versus Conventional Treatment in Infective Endocarditis
Condition: Endocarditis
MeSH terms: Endocarditis, Bacterial; Endocarditis
Intervention: Valve surgery with removal of vegetations
Intervention description: Early valve repair or replacement with removal of vegetations within 48 hours of randomization
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 15 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Endocarditis

Summary:

      There have been no prospective clinical studies in infective endocarditis comparing early
      surgery with the conventional treatment strategy based on current guidelines. The purpose of
      this prospective randomized trial is to compare clinical outcomes of early surgery versus
      conventional treatment strategy in patients with high embolic risk of infective endocarditis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed as infective endocarditis based on modified Duke criteria
             fulfilling both conditions:

               -  severe mitral or aortic regurgitation

               -  vegetation length > 10 mm on mitral or aortic valve

        Exclusion Criteria:

          -  Patients with urgent and emergent indication of surgery based on current guidelines;
             aortic abscess, moderate to severe heart failure due to valvular regurgitation,
             periannular complications, fungal endocarditis

          -  Prosthetic valve endocarditis

          -  Patient without vegetations on echocardiography

          -  Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission

          -  Patients referred from other hospitals more than 7 days after the appropriate
             antibiotic treatment of infective endocarditis

          -  Patients who were not candidates for surgery based on age > 80 years and coexisting
             malignancies

          -  Patients who did not consent to participate