bioihbjkbjnl/mcl2 huggingface dataset:
Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Passive enhanced safety surveillance
Intervention description: Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged <9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1060.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pilot study; Safety surveillance; Quadrivalent seasonal influenza vaccine; Influenza

Summary:

      The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on
      enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and
      aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination
      with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit
      Tetra in Germany, Fluarix Tetra in Spain).

      This study may help to inform decisions regarding future influenza vaccine safety
      surveillance for influenza vaccines in Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol (e.g., complete the ADR card, return for the next
             scheduled visit or return the ADR card by mail within a timely manner).

          -  A male or female subject vaccinated with GSK's quadrivalent seasonal influenza vaccine
             (one or two dose schedule) according to the routine medical practices between 01
             October 2018 and 31 December 2018.

          -  Subjects aged 6 months or above at the time of the vaccination according to the
             countries' specificities.

          -  Written informed consent/informed assent obtained from the subjects/subjects'
             parent(s)/Legally Acceptable Representative(s) (LARs).

        Exclusion Criteria:

        • Child in care.
Dose-response of Albuterol in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Intervention: albuterol
Intervention description: Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized)
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 8 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Albuterol; Forced expiratory volume in one second; Dose at fifty percent of maximum effect; Maximum effective dose; Metered dose inhaler; Nebulizer

Summary:

      The purpose of this study was to determine the lung function response after increasing doses
      of albuterol (a bronchodilator) in children and adults with asthma.
    

Eligibility criteria:

        Eligibility Criteria:

          -  Well-defined history of physician diagnosed asthma

          -  Any ethnic background

          -  8 to 65 years old

          -  Baseline pre-bronchodilator FEV1 of 40% to 80% predicted for age, height, and gender

          -  No oral corticosteroid use, emergency room visits, or hospitalizations within the
             previous 3 months

          -  Nonsmokers or less than a 5 pack-year history with no smoking in the previous year

          -  Normal physical exam and no confounding diseases were selected

          -  Able to withhold inhaled short-acting b2-agonists or inhaled anticholinergic drugs for
             8 hours, oral antihistamines for 5 days, theophylline for 24 hours, and cromolyn,
             nedocromil, and inhaled corticosteroids for 2 hours prior to the study.
The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ampicillin/Sulbactam
Intervention description: Ampicillin/Sulbactam 1 gr, once within onr hour before surgery
Intervention MeSH terms: Ampicillin; Sulbactam; Sultamicillin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 372.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; breast surgery; clean wound; overweight; prophylaxis; antibiotics

Summary:

      This is a single center trial to compare the rate of surgical site infection (SSI) in normal
      (BMI equal to or less than 25; Control Group)) and overweight (BMI over 25) women who are
      undergoing breast cancer surgery. The overweight patients are further randomized into two
      groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam;
      Prophylaxis Group), in the other they do not (No Prophylaxis Group).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women at any age with early stage breast cancer (stage I-II) and American Society of
             Anesthesiologists (ASA) score of I-II.

        Exclusion Criteria:

          -  Ductal carcinoma in situ (DCIS; stage 0 cancer),

          -  Advanced or distant metastatic stage,

          -  Receiving any neoadjuvant therapy,

          -  History of receiving any antibiotics within prior 3 months,

          -  History of immunodeficiency,

          -  Having a remote infection,

          -  History of reaction to study antibiotics,

          -  Denial of signing the consent form.
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Condition: Gingivitis
MeSH terms: Gingivitis
Intervention: Experimental Floss
Intervention description: Experimental Glide® floss with cetylpyridinium chloride (~13% dry weight CPC)
Intervention MeSH terms: Cetylpyridinium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, controlled, examiner-blind, parallel group, four week clinical study
      comparing brushing plus flossing to brushing alone in healthy adults with mild-to-moderate
      gingivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 18 years of age;

          -  physically able to floss his/her teeth;

          -  refrained from performing oral hygiene the morning of the Baseline visit;

          -  have measurable gingivitis on at least 5 test sites;

          -  in good general health.

        Exclusion Criteria:

          -  severe periodontal disease

          -  atypical discoloration or pigmentation in the gingival tissue;

          -  meaningful malocclusion of the anterior teeth;

          -  fixed facial orthodontic appliances;

          -  use of antibiotics within two weeks of the baseline visit and at any time during the
             study;

          -  any diseases or conditions that could be expected to interfere with the subject safely
             completing the study.
Long-Duration Stimulant Treatment Study of ADHD in Young Children
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: B-MPH
Intervention description: Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 4 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ADHD; Attention-deficit/hyperactivity disorder (ADHD)

Summary:

      This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in
      4-to-5-year olds.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Parents/guardians and children must speak English and/or Spanish; parents/guardians
             must sign consent form; children must verbally assent.

          2. Boys and girls from 4-5 years old (inclusive) at screening.

          3. Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or
             hyperactive subtype), with symptoms present for at least 9 months.

          4. Children who demonstrate adequate need for treatment due to ADHD symptom-severity and
             clinical impairment.

          5. Children with IQ of at least 70 confirmed by valid IQ test.

          6. Children who are in educational settings (pre-school, kindergarten, or elementary
             school program) with at least 8 same-age peers for at least two half days weekly.

          7. Parents and children who can attend weekly study visits.

          8. Children who are naïve to ADHD medications; received ADHD medications in the past but
             are not currently treated; or on ADHD medications but finding them inconvenient (due
             to short duration of action) or not very helpful

        Exclusion Criteria:

          1. Children and parents/guardians who do not understand or cannot follow necessary
             instructions; children and parents who are unwilling to comply with study procedures
             or cooperate with child psychiatrist.

          2. Children taking excluded medications.

          3. Children with history of intolerance to MPH/stimulant medications or no response to
             adequate stimulant trials.

          4. Children with current adjustment disorder, autism, psychosis, bipolar disorder,
             significant suicidality, or other psychiatric disorders.

          5. Children with history of physical, sexual, or emotional abuse, which lead to a
             significant impact on the clinical presentation and potentially some ADHD symptoms.

          6. Children with screening abnormalities deemed clinically significant by child
             psychiatrist.
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
Condition: Preeclampsia Severe
MeSH terms: Pre-Eclampsia
Intervention: Nifedipine 30 MG; Placebos
Intervention description: Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure.; At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
Intervention MeSH terms: Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: preeclampsia severe, Nifedipine 30MG, placebo controlled

Summary:

      This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to
      placebo in 110 patients after decision has been made to proceed with induction of labor for
      the diagnosis of preeclampsia with severe features.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7
             and 41 6/7 weeks gestation based on the best obstetric estimate by The American
             College of Obstetricians and Gynecologists (ACOG) criteria.

          -  Diagnosis of preeclampsia with severe features with decision made to induce labor. The
             patient may or may not have already received acute treatment for severe blood
             pressures.

        Exclusion Criteria:

          -  Known allergy or adverse reaction to Nifedipine or any medical condition where
             Nifedipine is contraindicated, such as galactose intolerance, severe gastrointestinal
             (GI) structure, and GI hypomotility disorder.

          -  Currently receiving Nifedipine XL as part of hypertension management prior to
             induction of labor

          -  Participation in another trial that affects the primary outcome without prior approval

          -  Physician/provider or patient refusal

          -  Participation in this trial in a prior pregnancy

          -  Triplet or higher order pregnancy
Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients
Condition: Immunosuppression; Stem Cell Transplant; Bone Marrow Transplant
Intervention: Tacrolimus; Tacrolimus
Intervention description: Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.; Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Researchers are trying to learn more about using sublingual (absorption under the tongue)
      tacrolimus in blood and marrow transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals will be identified from within the adult allogeneic BMT program at Mayo
             Clinic in Rochester, Minnesota

          -  Adults prescribed tacrolimus for treatment or prevention of Graft Versus Host Disease
             (GVHD)

        Exclusion Criteria:

          -  Vulnerable populations

          -  Patients with contraindications to tacrolimus, inclusive of hypersensitivity, history
             of posterior reversible encephalopathy syndrome or calcineurin-inhibitor induced
             thrombotic microangiopathy

          -  Lacking the capacity to consent in English and declining to participate in research
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
Condition: Endometriosis; Infertility
MeSH terms: Infertility; Endometriosis
Intervention: Leuprolide acetate in depot suspension; No intervention
Intervention description: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Female
Minimum age: 21 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Endometriosis,infertility,in vitro fertilization

Summary:

      This prospective randomized trial evaluates whether one can predict which infertile women
      with endometriosis who are candidates for in vitro fertilization will benefit from prolonged
      therapy with a GnRH agonist by the determination of the absence of endometrial expression of
      the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which
      all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for
      in vitro fertilization and then undergo randomization to a three month course of a depot
      preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian
      stimulation or standard therapy. prio
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infertility

          -  Surgical diagnosis of endometriosis

          -  Normal ovarian reserve testing

          -  Regular menses

        Exclusion Criteria:

          -  Irregular menses

          -  Undiagnosed abnormal uterine bleeding

          -  Pregnancy

          -  Prior adverse reaction to any GnRH agonist

          -  Ovarian cystic or solid mass > 3cm in mean diameter at study entry

          -  Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis
             within 6 months of study entry

          -  Current hepatic, renal, hematologic or psychiatric disorder
Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
Intervention description: OptiVol® Fluid status Monitoring with Cardiac Compass
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention: in the access arm the patiens had programmmed the audible OptiVol Fliud status alert "on". Control patienst had programmed the audible alert "off"
Masking: None (Open Label)
Enrollment: 335.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Failure, randomized, OptiVol® Fluid status monitoring

Summary:

      The DOT-HF trial is an international, prospective, multi-center, randomized, controlled
      trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of both genders with mild to severe HF as defined as NHYA Class II to IV who
             also have an indication for device implant according to ESC/AHA guidelines as well as
             having a HF hospitalization or Emergency Department visit necessitating therapy within
             the past 12 months and who meet all inclusion criteria and no exclusion criteria, are
             eligible for this study.

        Exclusion Criteria:

          -  Subject is post heart transplant or actively listed on the transplant list and
             reasonable probability (as defined by investigator) of undergoing transplantation in
             the next year

          -  Subject received a coronary artery bypass graft or valve surgery in last 90 days

          -  Subject with a myocardial infarction (MI) in the last 40 days.

          -  Subject's life expectancy is less than one year in the opinion of the physician

          -  Subject has severe Chronic Obstructive Pulmonary Disease (COPD), as determined by
             physician and documented in medical records

          -  Subject is listed for valve replacement/valve repair

          -  Subject has severe, primary pulmonary hypertension as determined by physician and
             documented in medical records

          -  Subject with serum creatinine ≥ 2.5 mg/dL measured within 14 days prior to enrolment

          -  Subject on chronic renal dialysis

          -  Subject on continuous or uninterrupted (≥ 2 stable infusions per week) infusion
             (inotropic) therapy for HF

          -  Subject has complex and uncorrected Congenital Heart Disease
Study of the Safety and Efficacy of Botox in Bruxism
Condition: Bruxism
MeSH terms: Bruxism
Intervention: Botulinum toxin type A; Placebo arm
Intervention description: Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.; Placebo comparator
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
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: 80 Years
Healthy volunteers: No
Keywords: bruxism, botulinum toxin, sleep study

Summary:

      The purpose of this study is to determine whether botulinum toxin helps patients with
      bruxism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Patients between the ages of 18 and 80 years old with a diagnosis of bruxism, based
             on the standard criteria.

          -  2. If the subject is a female of childbearing age, she must have had a hysterectomy,
             tubal ligation, or otherwise be incapable of pregnancy, or have practiced a method of
             contraception (hormonal contraceptives, spermicidal barrier, intrauterine device,
             partner sterility) at least one month prior to study entry. Any female of childbearing
             age will have a urine pregnancy test one week prior to the treatment (visit 2).

          -  3. Ability of the patient or guardian to sign and understand informed consent.

          -  4. Ability to follow and comply with study directions.

        Exclusion Criteria:

          -  1. Coexistence of active psychosis, other active psychiatric disease or cognitive
             impairment.

          -  2. Coexistence of serious co-morbid conditions.

          -  3. Exposure to any botulinum toxin preparation within the past 6 months.

          -  4. Participation in another experimental therapeutic protocol within 30 days.

          -  5. Any medical condition in which the administration of botulinum toxin is
             contraindicated, including myasthenia gravis, amyotrophic lateral sclerosis or other
             neuromuscular diseases.

          -  6. History of dysphagia.

          -  7. History of botulism.

          -  8. A condition or situation in which the investigators view will confound the ability
             of the subject to participate in the study.

          -  9. Patients or guardian who are unable to understand and sign informed consent.

          -  10. Pregnancy

          -  11. Patients who do not meet inclusion criteria.

          -  12. Patients in whom it is felt that a major portion of overall sleep morbidity is not
             related to bruxism.