bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Olopatadine HCL Nasal Spray, 0.6%; Fluticasone Propionate Nasal Spray, 50 mcg
Intervention description: Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily; Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Intervention MeSH terms: Fluticasone; Xhance; Olopatadine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rhinitis; Seasonal Allergic Rhinitis; allergies

Summary:

      Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
    

Eligibility criteria:

        Inclusion:

          -  A history of spring/summer seasonal allergies.

          -  Positive skin prick test for the currently prevalent allergen of the area.

          -  Confirmed absence of significant anatomic abnormalities, infection, bleeding, and
             mucosal ulcerations on nasal examination prior to administration of test article.

          -  For pre-menopausal females, a negative pregnancy test prior to entry into the study,
             and, if sexually active, agreement to use adequate birth control methods throughout
             the study.

        Exclusion:

          -  History of chronic sinusitis.

          -  Asthma, with the exception of intermittent asthma.

          -  Smokers.

          -  Known non-responders to antihistamines.

          -  Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal
             potent or super-potent topical corticosteroids.

          -  Chronic use of long acting antihistamines.

          -  Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute
             sinusitis within 30 days of Visit 1.

          -  Relatives of study site staff or other individuals who had access to the clinical
             study protocol.

          -  Participation in any other investigational study within 30 days before entry into this
             study or concomitantly with this study.
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B Kinder
Intervention description: Intramuscular injection, 1 dose
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: All
Minimum age: 7 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B vaccine; Challenge dose

Summary:

      The purpose of this study is to assess the persistence of immunity to hepatitis B in children
      who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female of 7 to 8 years of age (from and including the 7th birthday up to but
             excluding the 9th birthday) at the time of enrolment.

          -  With documented evidence of previous vaccination with three consecutive doses of
             Engerix™-B in Germany

          -  Written informed consent obtained from the parents or guardians of the subject at the
             time of enrolment.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product

          -  Evidence of previous hepatitis B booster vaccination since administration of the third
             dose of Engerix™-B vaccine.

          -  History of or intercurrent hepatitis B disease.

          -  Hepatitis B vaccination at birth.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before HBV vaccine challenge and ending 30
             days after.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding HBV vaccine challenge or planned administration during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the HBV vaccine challenge.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination
IVUS Guidance to Reduce Contrast in Coronary Angioplasty
Condition: Contrast Media Reaction; Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Intervention: IVUS-guided PCI
Intervention description: Intravascular ultrasound guided percutaneous coronary intervention
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary; Angioplasty; Percutaneous coronary intervention; Stent; Contrast; Acute Renal failure; Intravascular ultrasound; Prevention

Summary:

      This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the
      procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Age >=18 years

          -  Coronary artery disease scheduled for percutaneous intervention

          -  Technical feasibility for intravascular ultrasound to guide coronary angioplasty

          -  Increased risk for contrast-induced acute renal failure (e.g. age > 80 years, female
             gender, diabetes, urgent or emergent procedure priority, diabetes, congestive heart
             failure, increased baseline serum creatinine, decreased calculated or measured
             creatinine clearance, intra-aortic balloon pumping, previous renal transplantation or
             single kidney)

        Exclusion Criteria:

          -  Anticipated technical impossibility for intravascular ultrasound

          -  Unknown baseline renal function

          -  Baseline end-stage renal failure needing dialysis

          -  Acute renal failure with dynamic change in renal function at the time of index
             procedure

          -  Iodine contrast administration <= 72 prior to index procedure

          -  Known allergy to iodine contrast
A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Aliskiren; Ramipril; Placebo to Ramipril; Placebo to Aliskiren
Intervention description: Aliskiren 300 mg once a day; Ramipril 10 mg once a day; Placebo capsules to match ramipril.; Placebo tablets to match aliskiren.
Intervention MeSH terms: Ramipril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 774.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Hypertension, aliskiren, ramipril, colonoscopy

Summary:

      This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren
      (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients, 50 years of age and older with a diagnosis of essential
             hypertension

          -  Successful high quality colonoscopy at baseline including visualization of the entire
             colon and the cecum as confirmed by a photograph and collection of the rectal and
             cecal mucosal biopsy samples

          -  All rectal, colon or cecal polyps found at baseline colonoscopy must be completely
             resected endoscopically at the time of the procedure.

          -  Patients who are eligible and able to participate in the study, and who consent to do
             so after the purpose and nature of the investigation have been clearly explained to
             them (written informed consent).

        Exclusion Criteria:

          -  Previously treated in an aliskiren study.

          -  Current evidence of inflammatory bowel disease, the presence of colonic ulcerations
             (or other indices of colitis of any type) or colorectal carcinoma including carcinoma
             in situ found at baseline colonoscopy.

          -  History of gastrointestinal carcinoma, Crohn's disease, ulcerative colitis,
             microscopic colitis.

          -  History of familial polyposis or hereditary nonpolyposis colorectal cancer.

          -  History of confirmed diverticulitis within 12 months of Visit 1.

          -  History of celiac disease (gluten intolerance).

          -  History of or current evidence on the baseline colonoscopy of melanosis coli.
Preventing Depression in People Receiving Mechanical Ventilation in an Intensive Care Unit
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Escitalopram; Placebo
Intervention description: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents; Placebo pills for 8 weeks
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Critical Illness; Intensive Care Unit; Acute Respiratory Failure; Prolonged Mechanical Ventilation

Summary:

      This study will determine the effectiveness of antidepressant medication in preventing
      depression and improving recovery in people who have been supported by mechanical ventilators
      in an intensive care unit (ICU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly mechanically ventilated via an endotracheal tube

          -  Expected to remain intubated for at least 48 hours

          -  Fluent in English or Spanish

        Exclusion Criteria:

          -  Depression before admission to the ICU, as determined by a proxy interview

          -  Use of antidepressant medication within the last 2 weeks or a monoamine oxidase (MAO)
             inhibitor in the previous month

          -  History of suicide attempt

          -  Ventricular arrhythmias or a seizure requiring medication in the last 6 months

          -  History of retinal vascular proliferation or bleeding

          -  Migraine headaches treated with 5-HT1 agonists

          -  Organ transplant within the last 6 months

          -  Score of less than 4 on the Glasgow coma scale, in the absence of drug effects, for 2
             days

          -  Acute brain hemorrhage

          -  Increased intracranial pressure

          -  Active bleeding or less than 20,000 platelets/ul

          -  Expected prolonged inability to enterally administer escitalopram

          -  Residence more than 75 miles from study facility

          -  Serum sodium less than 125 mEq/l

          -  Hypersensitivity to citalopram or escitalopram

          -  Pregnant, breastfeeding, or possibly becoming pregnant in the next 3 months

          -  Undergoing life-support withdrawal or very low likelihood of 2-month survival

          -  Cognitive or communication impairment severe enough to preclude a conversation with an
             interviewer present before admission to ICU
e-Cigarettes Versus NRT Gum for Smoking Cessation
Condition: Nicotine Addiction; Smoking Cessation
MeSH terms: Tobacco Use Disorder; Behavior, Addictive
Intervention: Nicotine polacrilex; STAM 1100mAh CE4 eGo Clearomizer
Intervention description: 2 mg and 4 mg gum will be used according to the FDA approved product labelling
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Nicotine Addiction; e-Cigarette; electronic nicotine delivery device; electronic cigarette; nicotine replacement therapy

Summary:

      This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for
      smoking cessation. Participants will be randomly assigned to either e-cigarette use or
      nicotine gum use during a quit attempt. All participants will have a one hour meeting with a
      tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be
      determined at 12 weeks after the quit date. Continued use of nicotine replacement (either
      e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be
      evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smokes at least five cigarettes per day

          -  No current or previous regular use of e-cigarettes

          -  Ready to quit smoking

        Exclusion Criteria:

          -  Use of smokeless or pipe tobacco

          -  Smoke more than 40 cigarettes per day

          -  Pregnant or breastfeeding

          -  Unable to chew gum due to dental or jaw problems

          -  Myocardial infarction (heart attack) within the previous 12 months

          -  Hypersensitivity to propylene glycol or nicotine gum
Effects of Fish Oil on Post Ablation Arrhythmias
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: LOVAZA Omega 3-acid ethyl esters; LOVAZA; placebo
Intervention description: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.; (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.; Control group will receive placebo before & after ablation.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Radiofrequency Ablation; atrial fibrillation

Summary:

      To determine if peri-operative treatment with omega-3 fatty acids is associated with a
      decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an
      improvement in probability of long-term maintenance of sinus rhythm after radiofrequency
      catheter ablation for Atrial Fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years and < 70 years old

          -  Left atrial size <55 mm

        Exclusion Criteria:

          -  Inability or unwillingness to provide informed consent

          -  Current therapy with omega-3 fatty acids

          -  Current therapy with a statin

          -  Active liver disease

          -  Significant comorbidity such as end-stage renal disease or cirrhosis

          -  Valvular prosthesis
A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients
Condition: Kidney Transplantation
Intervention: MMF; EC-MPS; Prednisone
Intervention description: 1 g per day b.i.d. p.o. for at least 1 month; 720 mg b.i.d. p.o. for at least 1 month; 5 mg per day p.o.
Intervention MeSH terms: Mycophenolic Acid; Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate
      sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based
      therapy. On the study day patients will take their prescribed medication (either CellCept or
      mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12
      hours after intake of the study medication. Anticipated time on study treatment is 12 hours
      and target sample size is 24.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/=18 years of age

          -  kidney transplantation >/=6 months ago

          -  on mycophenolic acid-based, calcineurininhibitor-free therapy for >/=3 months, >/=1
             month on stable dose

          -  co-therapy with 5mg prednisone for >/=1 month

        Exclusion Criteria:

          -  active gastrointestinal ulcus

          -  severe diarrhea od gastrointestinal disease

          -  severe impairment of renal function

          -  current malignancy

          -  Lesch-Nyhan- or Kelley-Seegmiller-Syndrome
Anesthetic Techniques in EP Patients
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Intervention: Propofol; Ketamine; Remifentanil; Sevoflurane
Intervention description: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
1 of 2 sedation groups for VT ablation and afib procedures.; 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
1 of 2 sedation groups for VT ablation and afib procedures.; 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.; 1 general anesthesia group for VT ablations and afib procedures.
Intervention MeSH terms: Ketamine; Remifentanil; Propofol; Sevoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Electrophysiology; Anesthetics

Summary:

      The purpose of this study is to compare different combinations of anesthetic drugs (cause
      loss of sensation) in terms of effectiveness, adverse effects, pain relief, and patient
      comfort for cardiac electrophysiology procedures. In addition, the investigators are studying
      the different anesthetic combinations to determine the best approach in terms of
      identification and treatment of arrhythmias.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for cardiac electrophysiology procedures

          -  Patients ≥18 years of age

        Exclusion Criteria:

          -  Gastroesophageal reflux disease (GERD),

          -  pulmonary hypertension,

          -  severe pulmonary disease,

          -  obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Intervention: Ablation of the Incompetent Greater Saphenous Vein; ClosureFAST radiofrequency catheter; EVLT 980nm diode laser system
Intervention description: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic venous insufficiency; varicose vein; greater saphenous vein

Summary:

      The aim of this study is to perform a randomized, prospective trial comparing the two current
      methods of treatment for chronic venous insufficiency, in an effort to evaluate complications
      and outcomes for each method, and ultimately, to see if one is superior to the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic chronic venous insufficiency.

          -  Patients in whom endovenous thermal ablation is clinically indicate.

          -  Have previously undergone at least 6 weeks of conservative treatment with compression
             stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).

          -  Have venous disease that meets CEAP clinical class 2 through 6.

          -  Have symptoms secondary to Greater Saphenous Vein insufficiency defined as reverse
             flow in the saphenous vein >0.5 seconds after calf compression or while standing.

        Exclusion Criteria:

          -  Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive
             of spider vein injections or other cosmetic surface procedures).

          -  Have a history of DVT.

          -  Have a history of hypercoaguability disorder.

          -  Are pregnant or breastfeeding.

          -  Are nonambulatory.
European New Texture Implant Clinical Experience With Shaped Breast Implants
Condition: Breast Augmentation
Intervention: new texture shaped breast implants
Intervention description: breast implant surgery
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to obtain clinical experience with the use of new texture,
      shaped breast implants in bilateral primary breast augmentation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or
             biplanar placement of the breast implants by inframammary approach only

          -  Be a candidate for the device styles and sizes available in the study

        Exclusion Criteria:

          -  Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome),
             or grade 3 ptosis

          -  Have undergone any previous breast surgery

          -  Have tissue covering determined inadequate or unsuitable by the surgeon