bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: Cyclosporine 0.05% Ophthalmic Emulsion
Intervention description: Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of Restasis® in participants with dry eye disease who
      engage in electronic visual tasking.
    

Eligibility criteria:

        Inclusion:

          -  Has Eye Symptoms when using video display terminals

          -  Has a reported history of dry eye in both eyes.

        Exclusion:

          -  Diagnosed with eye infection or active inflammation.

          -  Has worn contact lenses within the past 7 days or anticipated use during the study.

          -  Has used any eye drops within 2 hours.

          -  Has had laser-assisted in situ keratomileusis (LASIK) within 12 months.

          -  Has used Restasis® within 90 days.

          -  Has had any eye and or/lid surgeries within 6 months.

          -  Has had cataract surgery in either eye.

          -  Has current punctal occlusion or anticipate a change in punctal occlusion status at
             any point during the study.

          -  Is currently taking any topical ophthalmic prescriptions or over-the-counter
             solutions, artificial tears, gels or lid scrubs that cannot be discontinued for the
             trial duration.

          -  Use of medication known to cause ocular drying that is not on a stable dose for at
             least 30 days.
Ablation of the Pulmonary Veins for Paroxysmal Afib
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: RF Ablation procedure
Intervention description: Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: atrial fibrillation

Summary:

      The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency
      of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal
      atrial fibrillation. (PAF)
    

Eligibility criteria:

        Inclusion Criteria:

        History of symptomatic paroxysmal atrial fibrillation defined as:

          -  Self terminating AF lasting no more than 7 days

          -  AF events demostrating spontaneous conversion back to sinus rhythm

          -  Documentation of one or more events with PAF tracings by ECG, event recordings,
             pacemaker strips or monitor rhythm strips within the past year

          -  AF symptoms defined as the manisfestation of any of the following: Palpitations,
             Fatigue, Exertional dyspnea, effort intolerance

          -  Age between 18 and 70

          -  Willingness, ability and commitment to participate in baseline and follow-up
             evaluations for the full length of the study

        Exclusion Criteria:

          -  Structural heart disease of clinical significance

          -  Prior ablation for arrhythmias other than AF within the past three months

          -  Prior left sided AF ablation

          -  Enrollment in any other ongoing arrhythmia study protocol

          -  Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the
             management may interfere with this study

          -  Active infection or sepsis

          -  Any history of cerebral vascular disease including stroke or TIAs

          -  Pregnancy or lactation

          -  Untreatable allergy to contrast media

          -  Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid
             disease, or any other reversible or non-cardiovascular causes

          -  History of blood clotting (bleeding or thrombotic) abnormalities

          -  Known sensitivities to heparin or warfarin

          -  Severe COPD (identified by an FEV1 < 1)

          -  Severe co morbidity or poor general physical/mental health that, in the opinion of the
             investigator, will not allow the patient to be a good study candidate (i.e. other
             disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: memantine hydrochloride
Intervention description: tablet, 5-20 mg, twice daily, by mouth, 12 weeks
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: ADHD; Namenda

Summary:

      The primary objective of the study is to assess the efficacy and tolerability of a 12-week
      trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD
      and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the
      investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a
      questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening
      in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine
      hydrochloride will be associated with improving ADHD symptoms and associated deficits in
      executive functions. We also expect that memantine will be well-tolerated with predictable
      adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female outpatients 18-55 years of age

          2. Subjects with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by
             DSM-IV or ADHD NOS (late onset; >7 years), as manifested in clinical evaluation and
             confirmed by structured interview.

          3. Subjects must score at least 14 on inattentive symptom questions on the DSM-IV based
             ADHD Rating Scale.

          4. Subjects who have an ADHD specific CGI Severity score of 4 or more (> moderately
             impaired).

        Exclusion Criteria:

          1. Subjects with a medical condition or treatment that will either jeopardize subject
             safety or affect the scientific merit of the study, including:

          2. History of Renal or Hepatic Impairment.

          3. Organic brain disorders.

          4. History of Seizure disorder.

          5. Any clinically unstable psychiatric conditions including the following: psychosis,
             suicidality, bipolar disorder, current substance use disorders (alcohol or drugs) or
             current tic disorder.

          6. Mental retardation (IQ <75).

          7. Pregnant or nursing females.

          8. Known hypersensitivity to memantine.

          9. Any current psychotropic treatment, with the exception of stable regimen of SSRIs.
Effectiveness of Varenicline: Testing Individual Differences
Condition: Smoking Addiction
MeSH terms: Behavior, Addictive
Intervention: Placebo; Varenicline
Intervention description: 25mg look alike riboflavin tablets to match active study medication.; Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily
Intervention MeSH terms: Riboflavin; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The study will evaluate the effectiveness of smoking cessation using Varenicline versus
      placebo. Effectiveness will be measured by the average number of cigarettes smoked per
      smoking day for up to 36 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 yrs to 55 yrs

          -  smoker

        Exclusion Criteria:

          -  Medical Contraindications
TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Condition: Vaccine Responsiveness in Allergy; Vaccine Responsiveness During Allergy De-sensitization Treatment
MeSH terms: Encephalitis, Tick-Borne; Encephalitis; Hypersensitivity
Intervention: TBE booster vaccination
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Allergic patients especially those undergoing de-sensitization treatment have an altered
      immune responsiveness. The investigators aim to find out whether this influences immune
      responses to primary and booster vaccinations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  completed primary TBE immunization + at least one booster immunization

          -  adults of both sexes between 18 and 60 years of age

          -  willingness to sign written informed consent form

        Exclusion Criteria:

          -  age < 18 and > 60 years

          -  prior TBE infection

          -  Hepatitis A vaccination

          -  pregnancy and breast feeding

          -  acute infection on day of inclusion (day 0), body temperature >37,9°C

          -  concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive
             therapy 4 weeks prior to or during study

          -  administration of other vaccines 4 weeks before/after TBE vaccination

          -  planned surgery within 2 weeks before/after TBE vaccination

          -  Start of de-sensitization and the first 4 weeks of allergen dose escalation

          -  any contraindication to administration of FSME-Immun® vaccine according to
             manufacturer's instructions

          -  history of malignant disease within the last 5 years

          -  autoimmune diseases

          -  drug addictions

          -  plasma donors

          -  receipt of blood transfusions or immuno globulins within 3 month before study entry
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenzae vaccine
Intervention description: 0.5 mL Deltoid Intramuscular Injection X 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza prevention

Summary:

      We hypothesize that when offered influenza vaccine at little or no cost, in a setting where
      the value of the vaccine is connected to one's high risk child, vaccination rates for parents
      will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit
      environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parents or caregiver adults who accompany at-risk children to a Pediatric Care
             outpatient clinic appointment. High risk children are defined as those 0 to 5 years of
             age, or who have any of the following diagnoses:

               -  Sickle cell disease

               -  Asthma

               -  Cystic fibrosis

               -  Chronic renal disease

               -  Congenital heart disease

               -  Cancer

               -  Any immunodeficiency

        Exclusion Criteria:

          -  Caregivers of children residing in group homes

          -  Persons whose children do not meet the Center for Disease Control (CDC) definition of
             high-risk

          -  Persons who have had allergic reactions to influenza vaccination or any other
             vaccination in the past

          -  Persons who are allergic to eggs or egg products

          -  Persons who are allergic to thimerosol

          -  Previous diagnosis of Guillain-Barré syndrome (GBS)

          -  Persons who are moderately to severely ill at the time the vaccination is to be given
Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Intervention: FP; SFC; Placebo
Intervention description: Fluticasone Propionate 100 mcg BD; Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD; Matching Placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: asthma; allergen challenge; IL-5; eosinophils

Summary:

      The aim of the present study is to investigate whether the effects of salmeterol in
      combination with fluticasone propionate on blood markers of airway inflammation are
      maintained after chronic dosing and whether the effect is influenced by the time of allergen
      challenge relative to the time of dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent.

          -  Outpatient.

          -  Male or non-pregnant/non-lactating female.

          -  Aged 18-55.

          -  Diagnosis of asthma.

          -  Pre-bronchodilatory FEV1 > 75% predicted.

          -  Using inhaled short-acting beta-2-agonists (SABA) with no inhaled corticosteroids.

          -  Judged capable of withholding SABA for at least 6 hours prior to visits.

          -  Reversibility of >12% and 200mL or PC20 of <8mg/mL.

          -  Demonstration of atopy

        Exclusion Criteria:

          -  History of life-threatening asthma.

          -  Use of proscribed asthma medications.

          -  Use of anti-histamines or potent inhibitors of CYP3A4.

          -  Respiratory tract infection.

          -  Asthma exacerbation with 4 weeks of Visit 1.

          -  Subjects with exercise induced asthma only.

          -  Concurrent respiratory disease.

          -  Other clinically significant, uncontrolled condition or disease.

          -  Use of any investigational drug within 30 days.

          -  Allergic to beta-2-agonists, inhaled corticosteroids or excipients.

          -  Positive pregnancy test.

          -  Using immunosuppressive medications.

          -  Milk protein allergy.

          -  Factors likely to interfere with attendance.

          -  Current smokers or ex-smokers with a history of >10 pack years.

          -  Affiliation wih Investigator site.

          -  Medications that may affect the course of asthma or interact with sympathomimetic
             amines.
Polidocanol Versus Glucose Treatment of Telangiectasia Trial
Condition: Varicose Veins; Telangiectasis
MeSH terms: Telangiectasis; Varicose Veins
Intervention: Glucose; Polidocanol with Glucose
Intervention description: Sclerotherapy of telangiectasis in one lower limb.; Sclerotherapy of telangiectasis in one lower limb.
Intervention MeSH terms: Polidocanol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 115.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: telangiectasis; varicose veins; veins; glucose; sclerotherapy

Summary:

      It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%
      hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only
      adult women with reticular veins on the side of the thighs and mild venous insufficiency
      (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  females

          -  with telangiectasis on thigh side

          -  clinical classification of chronic venous disease C1(mild venous disease),

          -  minimum age of 18 year-old and maximum age 65 year-old

          -  agreement with the study

          -  signing the free and informed consent ( IC)

          -  not use anticoagulant drugs .

        Exclusion Criteria:

          -  male

          -  varicose disease in any quantity or location with clinical classification of chronic
             venous disease different of C1(mild venous disease)

          -  restrict mobility

          -  arterial insufficiency

          -  be allergic to any substance that may be related to the study drugs

          -  any cause of dermatitis on application site

          -  don´t be free of comorbidities clinically serious as diabetes mellitus, heart failure,
             respiratory failure, uncontrolled hypertension with medication, and uncontrolled
             hypothyroidism

          -  pregnancy

          -  previous deep vein thrombosis (DVT)

          -  family history of DVT

          -  thrombophilia

          -  do not agree with the search terms
Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Nilotinib
Intervention description: A daily dose of 300 mg was given to all participants as two 150 mg capsules BID. The prescription of study drug was not study dependent and followed medical needs of the participant only. The study treatment was administered for 24 months.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Chronic Myeloid Leukemia; Nilotinib; Molecular Response; MR4.5

Summary:

      The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5)
      after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase
      chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for
      CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CML
             in chronic phase

          -  Patients must be previously untreated for CML with the exception of 6 months treatment
             with hydroxyurea and a maximum of 6 weeks treatment with imatinib

          -  Adequate end organ function

          -  Normal serum levels ≥ lower limit of normal (LLN) of potassium, magnesium, total
             calcium corrected for serum albumin or phosphorus, or correctable to within normal
             limits with supplements, prior to the first dose of study medication.

        Key Exclusion Criteria:

          -  Known impaired cardiac function like long QT syndrome, history of myocardial
             infarction or unstable angina in the past 12 months.

          -  Patients who are pregnant or breast feeding.

        Other inclusion/exclusion criteria might apply
Pain Increases After Shoulder Injection
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Methylprednisolone (MPA); Triamcinolone Acetonide (TA)
Intervention description: injection into subacromial or glenohumeral space with MPA; injection into subacromial or glenohumeral space with TA
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours
      following a shoulder injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subacromial or glenohumeral shoulder pain to be treated with steroid injection

          -  Fluent in written and oral English

          -  Willing and able to provide written consent

          -  Willing to complete follow up pain scores (visual analog score)

        Exclusion Criteria:

          -  Unable to provide written consent

          -  Chronic pain syndrome

          -  Unwilling to complete follow up pain scores (visual analog score)
Corticosteroid Dosage for Crohn's Disease Flare
Condition: Crohn's Disease; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Intervention: Corticosteroid
Intervention description: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
Intervention MeSH terms: Prednisone; Methylprednisolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Corticosteroid

Summary:

      Prospective randomized comparative effectiveness trial designed to compare fixed dosing and
      weight-based dosing of corticosteroids in patients with Crohn's disease flares.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18

          -  Established diagnosis of Crohn's disease

          -  Diagnosis of Crohn's flare

          -  Decision by treating gastroenterologist to start corticosteroid therapy

        Exclusion Criteria:

          -  Patients in whom corticosteroid therapy is contraindicated: immunocompromised (active
             cancer on chemotherapy or radiation treatment), severe liver disease (decompensated
             cirrhosis, active alcoholic hepatitis), end-stage renal disease on dialysis, AIDS or
             AIDS-defining illness; myocardial infarction within the past year; NYHA Class 4 heart
             failure

          -  Patients on systemic corticosteroid therapy currently or within the past 8 weeks

          -  Patients not on stable doses of immunomodulators or biologics for at least 8 weeks

          -  Infectious colitis (e.g., C. difficile, CMV, HSV)

          -  Systemic infections (bacteremia, fungal infections)

          -  Fulminant Crohn's disease

          -  Patients who require imminent surgery

          -  Abscess

          -  Pregnancy

          -  Weight <35 kg