bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: standard dose amoxicillin/clavulanate; high dose amoxicillin/clavulanate
Intervention description: amoxicillin/clavulanate 875/125 + placebo bid x 7 days; Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acute sinusitis; amoxicillin/clavulanate; adults; outcomes

Summary:

      The aim is to determine if high-dose amoxicillin/clavulanate is more effective than
      standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at
      a primary care office.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult 18 or over

          2. Meets definition of acute sinusitis by Infectious Disease Society of America (2012)

          3. Clinician and participant chose to start antibiotic treatment

        Exclusion Criteria:

          1. Previously enrolled in the study

          2. Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate

          3. Specific medication concerns: lactating (since safety of clavulanate unknown); taking
             allopurinol (increased risk of rash); concurrent mononucleosis (increased risk of rash
             with amoxicillin); chronic kidney disease with glomerular filtration rate < 30;
             significant hepatic impairment; history of antibiotic-associated colitis

          4. Cognitive impairment so that unable to give informed consent or give reliable
             assessment of improvement

          5. Need to use high-dose amoxicillin/clavulanate: treatment with amoxicllin or penicillin
             within the past month (risk of penicillin-resistant pneumococci), very ill patient
             (though not ill enough to send to hospital); immunocompromise

          6. Need to hospitalize the patient
Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: opioid pain pills
Intervention description: patient will receive their pain pill prescription
Intervention MeSH terms: Analgesics, Opioid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioids

Summary:

      The United States constitutes <5% of the world's population but over 80% of the opioid supply
      and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug
      overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids.
      Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood
      of readmission for pain. Available data suggests that orthopaedic surgeons are the most
      likely physicians to prescribe opioids to Medicare patients, whose opioid prescriptions are
      over 7 times more likely to come from an orthopaedic surgeon than another type of physician,
      but orthopaedic surgeons also had the highest readmission rate for post-operative pain. Many
      studies have investigated the utilization of opioids after surgery to assess surgeon's
      tendencies to overprescribe, demographics of those likely to overuse, and adverse events of
      opioid abusers.

      The primary purpose of this randomized controlled trial is to determine whether prescribing
      fewer opioid pills per prescription reduces the total amount of opioids taken, even while
      allowing equal total opioid availability via increased frequency of prescription
      availability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  any patient > 18 years of age scheduled for primary total hip or knee arthroplasty who
             is not consuming opioids during the 4 weeks prior to surgery

        Exclusion Criteria:

          -  patients consuming opioids during the 4 weeks prior to surgery

          -  patients who are allergic to oxycodone or refuse to take oxycodone

          -  patients with a history of opioid dependence or illegal or "off-label" opioid use

          -  patients undergoing a revision total knee or total hip arthroplasty

          -  any patient less than 18 years of age
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure; Atrial Fibrillation
Intervention: Dual (atrial and ventricular) implantable defibrillator; Dual (atrial and ventricular) implantable defibrillator; Dual (atrial and ventricular) implantable defibrillator
Intervention description: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.; In hospital application of anti arrhythmic therapies via the device; Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and
      fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and
      to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared
      to an in-hospital approach for treatment of symptomatic AT/AF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic symptomatic HF despite stable, optimal drug therapy

          -  indication for a cardiac resynchronisation device with defibrillator backup according
             to current guidelines

          -  patients implanted with cardiac resynchronization device with dual (atrial and
             ventricular) defibrillation capabilities

        Exclusion Criteria:

          -  Chronic atrial fibrillation

          -  Valvular disease

          -  patients who underwent or are planned for ablation of atrial fibrillation

          -  cerebral vascular accident/transient ischemic attack within 12 months from implant
             which lead to relevant impairment

          -  preexisting unipolar pacemaker
Vaginal Preparation Prior to Hysterectomy
Condition: Hysterectomy
Intervention: Chlorhexidine; Iodine
Intervention description: Chlorhexidine preparation solutions; Iodine-based preparation solutions
Intervention MeSH terms: Chlorhexidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized controlled trial to determine the influence of chlorhexidine gluconate
      surgical/topical antiseptic solutions on the bacterial environment of the vagina during
      hysterectomy and compare that to the effect of standard iodine-based preparations on the
      same.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing total vaginal, laparoscopic assisted vaginal, total laparoscopic, or
             robotic-assisted laparoscopic hysterectomy by a physician at Cincinnati Urogynecology
             Associates or Tri-State Gynecology Oncology TriHealth Inc.

          -  Concomitant procedures such as vaginal vault suspension, suburethral sling,
             cystoscopy, enterocele repair, anterior or posterior colporrhaphy, bilateral
             salpingectomy or salpingooophorectomy, staging procedures, lymph node sampling and
             other indicated procedures will be included

          -  English speaking

          -  Ability to provide consent

        Exclusion Criteria:

          -  Unwillingness to participate in the study

          -  Non English speaking

          -  Patients that do not undergo a hysterectomy

          -  Reported allergy to iodine or chlorhexidine preparation solutions

          -  Patients undergoing planned debulking surgery for ovarian, fallopian tube or primary
             peritoneal cancers

          -  Current infection necessitating hysterectomy

          -  Active sepsis, pelvic abscess or pelvic inflammatory disease
Surgical Debulking of Pituitary Adenomas
Condition: Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Intervention: Octreotide LAR; transsphenoidal surgery
Intervention MeSH terms: Octreotide
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, multicenter trial with stratification done by a single radiologist at
      the coordinating center (NYU), and patients with comparable disease will be randomized to
      Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before
      (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo
      transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to
      Sandostatin LAR will be evaluated.The primary objective of this trial will be to determine
      whether surgery (debulking of pituitary adenomas) improves the response of patients with
      acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Carry a diagnosis of de novo acromegaly with an elevated age and sex matched IGF-I and
             GH >1ng/ml at all time points during OGTT

          -  Have a pituitary macroadenoma

          -  Have clinical changes consistent with acromegaly

          -  Have a single random serum hGH of 12.5 ng/ml or greater

          -  Both the endocrinologist and surgeon must agree that the patient's health would not be
             compromised by a three-month period during which time Octreotide LAR is administered.

          -  Patients currently on dopamine agonist who agree to discontinue medication (2-6 week
             washout required)

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Documented loss of vision due to pituitary tumor

          -  Prior treatment for acromegaly other than dopamine agonists

          -  Inability to complete the protocol

          -  Intolerance to octreotide
Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Tramadol Hydrochloride/Dexketoprofen Trometamol; Tramadol Hydrochloride/Paracetamol; Placebo
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 654.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute pain; Acute moderate to severe pain; Postoperative pain; Dexketoprofen Tramadol; Dexketoprofen trometamol; Tramadol hydrochloride; Multimodal analgesia; Third molar extraction; Fixed drug combination; Paracetamol; Analgesics

Summary:

      The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral
      fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment
      of moderate to severe acute pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged more than 18 years. Females participating in the study
             must be either non-childbearing potential or routinely using an effective method of
             birth control resulting in a low failure rate.

          -  Scheduled for outpatient surgical extraction -under local anaesthesia of lower third
             molar teeth, with at least one partially impacted in the mandible requiring bone
             manipulation.

          -  Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS
             score ≥ 4).

        Exclusion Criteria:

          -  History of allergy or hypersensitivity to the study treatments, RM or to any other
             NSAIDs, opioids and acetyl salicylic acid.

          -  History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal
             bleeding or other active bleedings.

          -  History of any illness or condition that, in the opinion of the Investigator might
             pose a risk to the patient or confound the efficacy and safety results of the study.

          -  Patients using and not suitable for withdrawing the prohibited medications specified
             in the protocol.
Dynepo Long-Term Safety Study
Condition: Anemia; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Anemia
Intervention: Dynepo
Intervention description: Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in
      patients treated with Dynepo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who complete Dynepo study SPD490-301.

          2. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of
             10g/dL between Weeks 16 and 24 of study SPD490-301.

        Exclusion Criteria:

          1. Withdrawal, before Week 24, from study SPD490-301.

          2. Pregnant or lactating women.

          3. Uncontrolled hypertension.

          4. Thrombocytopenia (platelet count <75,000/mm3).

          5. Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or
             genitourinary tract bleeding).

          6. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic
             condition) in the 30 days immediately prior to enrolment in this study.

          7. Androgen therapy in the 30 days immediately prior to enrolment in this study.

          8. Known Human Immunodeficiency Virus (HIV) infection.

          9. History of hypersensitivity to Dynepo.

         10. Known to have Ab against EPO.
Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Dabigatran etexilate (Pradaxa)
Intervention description: 150mg bid or 75mg bid for a period of one year
Intervention MeSH terms: Dabigatran
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; MRI

Summary:

      This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an
      anti-coagulant for a period of one year to see if there are any significant changes in the
      degree of left atrial structural remodeling in these patients. The investigators hypothesize
      that there will be a significant decrease in the degree of left atrial structural remodeling
      (fibrosis) in AF patients treated with dabigatran.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with all types of non-valvular AF (includes paroxysmal, persistent and
             permanent AF)

          2. Candidate for anticoagulation therapy

          3. No contra-indication for LGE-MRI

          4. Patients age 18 and older

          5. Patients who are able to provide informed consent to participate in the study

        Exclusion Criteria:

          1. Patients who have already undergone an atrial fibrillation ablation procedure.

          2. Patients with active contra-indications to any anticoagulant agent.

          3. Other major bleeding disorders or risk factors that would place the patient at risk of
             bleeding.

          4. Recent surgery (within 30 days).

          5. Renal insufficiency, severe kidney disorders/diseases, GFR < 30mg/dL (Gadolinium
             contraindication).

          6. Advanced liver disease.

          7. Any health related Gadolinium/MRI contraindications: Pacemaker devices, etc.

          8. Pregnant, planning to be become pregnant or nursing women

          9. Individuals who are unable to provide informed consent

         10. Contraindicated for Pradaxa® .

         11. Patients the Investigators feel are inappropriate for the study

         12. Patients who cannot give informed consent
Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia
Condition: Spasmodic Torticollis
MeSH terms: Torticollis
Intervention: botulinum toxin type A; botulinum toxin type A
Intervention description: 200 Units at Visit 1 (Day 1); 500 Units at Visit 1 (Day 1)
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: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare two types of botulinum toxin type A to treat the
      involuntary muscle contractions in the neck
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months

          -  Successfully treated previously with botulinum toxin type A

        Exclusion Criteria:

          -  Breast feeding, pregnant, or could become pregnant

          -  Surgery or spinal cord stimulation for cervical dystonia

          -  Previous injections of phenol, alcohol for cervical dystonia
Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population
Condition: Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension; Systolic Murmurs
Intervention: Aliskiren; Hydrochlorothiazide
Intervention description: Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks; Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks
Intervention MeSH terms: Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 451.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Hypertension; older population; aliskiren; hydrochlorothiazide; systolic blood pressure; diastolic blood pressure; amlodipine, stage 2

Summary:

      The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed
      dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in
      older population with Stage 2 systolic hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients, ≥ 55 years old

          2. Patients with essential hypertension

          3. Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood
             Pressure ≥ 160 mm Hg and < 200 mm Hg

          4. Patients who are eligible and able to participate in the study, and who are willing to
             give informed consent before any assessment is performed

        Exclusion Criteria:

          1. Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at
             Visits 1-5

          2. History or evidence of a secondary hypertension of any etiology (e.g., uncorrected
             renal artery stenosis, pheochromocytoma).

          3. History of hypertensive encephalopathy or heart failure (New York Heart Association
             [NYHA] Class II-IV)

          4. Cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial
             infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI)
             within 1 year prior to Visit 1

          5. Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L
             (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or
             dehydration at Visit 1.

          6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test (> 5 mIU/mL)

          7. Use of other investigational drugs within 30 days of enrollment.

        Other exclusions may apply.