bioihbjkbjnl/mcl2 huggingface dataset:
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: Amoxicillin-Potassium Clavulanate; Placebo
Intervention description: Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.; Patients in this arm will receive 7 days of placebo after surgery.
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: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic rhinosinusitis; Sinus surgery; Antibiotics

Summary:

      Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery.
      There is minimal data to support this. The investigators' study will aim to demonstrate that
      patients' quality of life and rate of post operative infection is the same whether they
      receive or do not receive antibiotics post operatively. The investigators hypothesis is that
      the disease specific quality of life of patients taking post-operative antibiotics is not
      inferior to the quality of life of patients who do not take post-operative antibiotics, and
      the rate of post-operative infections are the same. The investigators' specific aim is to
      compare validated symptom scores between post-operative populations who are given or are not
      given antibiotics. Rates of infections in the first 10 days after surgery will be recorded.
      The investigators will also compare endoscopic grades of sinus cavities during the
      post-operative follow up exams as an additional outcome measure.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients eligible for surgery would be patients with chronic rhinosinusitis (defined by
        the AAOHNS 2007 consensus statement by Rosenfeld et al) and have been determined by their
        surgeons to have persistent symptoms after maximal medical therapy. Maximal medical therapy
        is defined as a course of broad spectrum or culture-directed antibiotics used in
        conjunction with a nasal steroid.

        Exclusion Criteria:

          1. Penicillin, cephalosporin, amoxicillin/clavulanate allergy

          2. Cystic Fibrosis

          3. Immunodeficiency

          4. Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery

          5. Odontogenic causes of sinusitis

          6. Fungal ball

          7. Infected mucocele

          8. Complication of sinusitis (meningitis, orbital complication, cellulitis, brain
             abscess)

          9. Non endoscopic sinus surgery (Caldwell luc, external approaches, etc)

         10. Age <18

         11. Pregnant women
Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: reteplase 10+10 U; primary PCI
Intervention description: comparison to primary PCI; comparison to thrombolysis
Intervention MeSH terms: Reteplase
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: thrombolysis; primary PCI; abciximab; ST-segment resolution; TIMI flow

Summary:

      The main objective is to compare a fibrinolytic strategy with an interventional strategy
      initiated as early as possible, preferably in the pre-hospital phase, with respect to
      resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In
      Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7
      days after inclusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting within 6 h after onset of chest pain lasting for more than 30 min
             and with significant ST-segment elevation on ECG.

        Exclusion Criteria:

          -  BP >180/110

          -  Known bleeding disorder

          -  Cardiogenic shock

          -  CPR>10 min

          -  Ongoing anticoagulant therapy

          -  Renal insufficiency

          -  Weight >120 kg
Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
Condition: Procedural Sedation
MeSH terms: Emergencies
Intervention: Propofol; 1:1 Propofol/Ketamine; 4:1 Propofol/Ketamine
Intervention description: 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation; Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation; Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 271.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Deep Procedural Sedation; Propofol; Ketamine; Emergency Department; Monitoring; Capnography; Procedural Sedation in the Emergency Department

Summary:

      This will be a randomized trial of propofol versus the combination of propofol and ketamine
      for procedural sedation for procedures in the Emergency Department (ED). Propofol produces
      sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County
      Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is
      also frequently used in the ED in children and sometimes in adults. It has been proposed that
      by combining the two agents, the negative side effects of respiratory depression and
      hypotension associated with propofol, and the negative effects of dysphoria and vomiting
      associated with ketamine, can be avoided.

      In the proposed study, patients seen in the ED who will require procedural sedation for a
      painful procedure will be randomized to receive either propofol or propofol and ketamine.
      During the procedure, patients will be monitored per the standard of care, including use of a
      cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample
      end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully
      completed and the patient has returned to his/her baseline mental status, the patient will be
      asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure,
      memory of the procedure, and overall satisfaction with the procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients undergoing procedural sedation for an urgent procedure in the Emergency
             Department

        Exclusion Criteria:

          -  Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical
             status score >2
A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Intervention: sertraline; Paroxetine
Intervention description: dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks; dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks
Intervention MeSH terms: Sertraline; Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Panic Disorder

Summary:

      To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with
      panic disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who meets diagnosis of Panic Disorder (with or without Agoraphobia) according
             to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV).

          -  Patients must have experienced at least 4 panic attacks within 4 weeks before
             screening.

          -  At baseline patients with Panic Disorder of total score of 18 or higher on the Panic
             and Agoraphobia scale (clinician rated version).

        Exclusion Criteria:

          -  Patients who concurrently have bipolar disorder, schizophrenia, delusional disorder,
             epilepsy, Major Depression Disorder (MDD), Obsessive Compulsive Disorder (OCD),
             Seasonal Affective Disorder (SAD) or General Anxiety Disorder (GAD) according to the
             DSM-IV criteria.

          -  Patients who concurrently have depression/depressive state, anxiety disorder and
             generalized anxiety disorder may be included in the study if the primary diagnosis is
             identified to be panic disorder

          -  Patients with the total score of at least 18 on the Hamilton Depression Rating Scale
             (HAM-D) (Items 1 to 17) at the start of Screening (Visit 1)

          -  Patients who require concomitant drug therapy with psychotropic agents (including
             benzodiazepines) and monoamine oxidase inhibitor during the period of the study.
Somatuline Autogel Preference and Health Economy Study
Condition: Neuroendocrine Tumour With Carcinoid Symptoms
MeSH terms: Neuroendocrine Tumors
Intervention: lanreotide (Autogel formulation)
Intervention description: 90 mg or 120 mg once every 28th day
Intervention MeSH terms: Lanreotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary aim of this study is to assess which method of lanreotide Autogel administration
      patients with neuroendocrine tumours prefer - self/partner administrations or healthcare
      provided administrations. The study will also assess if self/partner administration can be
      performed without loss of efficacy and with a preserved safety profile. The impact of
      self/partner administration on resource utilisation and costs will be studied. In addition,
      we will also assess the healthcare provider's experience of the two administration practices.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent from the patient and their partner (if the
             partner will be administering the lanreotide Autogel injections during the self
             administration period)

          -  Male or female aged 18 years of age or older

          -  Treated with lanreotide Autogel 90 or 120 mg every 28th day for carcinoid symptoms on
             a stable dose for at least 3 months prior to inclusion. The patient is presumed to be
             clinically stable during the coming months

          -  Neuroendocrine tumour confirmed by biopsy and visible on radiology

        Exclusion Criteria:

          -  Has a history of hypersensitivity to the Investigational Medicinal Product or drugs
             with a similar chemical structure

          -  Has abnormal baseline findings, any other medical condition(s) or laboratory findings
             that, in the opinion of the Investigator, might jeopardise the patient's safety or
             decrease the chance of obtaining satisfactory data needed to achieve the objective(s)
             of the study

          -  Has a life expectancy less than a year, as judged by the Investigator

          -  The patient or their partner is not considered competent in injection technique, as
             judged by the Investigator
Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.
Condition: Anesthetic Effectiveness
Intervention: Articaine Hydrochloride + Epinephrine; Buffered Articaine Hydrochloride + Epinephrine
Intervention MeSH terms: Epinephrine; Racepinephrine; Carticaine; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Degree of pulpal anesthesia obtained.; Primary infiltration in the lower first molar.; Buffered local anesthetic.

Summary:

      Infiltration (injecting next to the tooth) injections are common in dentistry and a number of
      studies have shown that articaine anesthetic, when injected next to a lower molar, is more
      effective than a local anesthetic injection of lidocaine. However success rates have not been
      as high as hoped for. No objective study has addressed the success rate of buffering
      articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the
      purpose of this prospective, randomized, double-blind, crossover study is to compare the
      degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine
      solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary
      infiltration in the mandibular first molar. The investigators will also record the pain of
      injection and postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the age of 18-65 years.

          -  in good health (ASA classification II or higher).

          -  able to provide informed consent.

        Exclusion Criteria:

          -  allergy to articaine.

          -  history of significant medical problems (ASA classification of III or worse).

          -  diagnosed depression (taking tri-cyclic antidepressant medications to control).

          -  have taken central nervous system (CNS) depressants (including alcohol or any
             analgesic medications) within the last 48 hours prior to testing.

          -  lactating or pregnant.

          -  inability to give informed consent.
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection
Condition: Calcific Tendinitis
MeSH terms: Tendinopathy
Intervention: Barbotage; Dexamethasone
Intervention description: Administered as per standard of care; 4 mg of dexamethasone
Intervention MeSH terms: Dexamethasone; Cortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of barbotage therapy by comparing the
      clinical and sonographic changes in patients that solely receive barbotage to patients
      receiving the standard of care, barbotage with cortisone injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age and younger than 90 years of age

          -  Diagnosed with calcific tendonitis and ruled out other shoulder-related pathologies

          -  Failed 1st line therapy (physical therapy and cortisone injection)

               -  Intention to receive barbotage with cortisone as standard of care

               -  3 or more months of shoulder pain

               -  Finding of one or more calcifications ≥5 mm in size on either sonogram or
                  radiograph, located on the supraspinatus tendon

               -  Positive Hawkin's test or Neer's sign for impingement

        Exclusion Criteria:

          -  Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia,
             etc.)

          -  Osteoarthritis of the glenohumeral joint of the affected shoulder

          -  Previous surgery or barbotage to the affected shoulder

          -  History of prior allergic/hypersensitivity reactions related to the study medication

          -  Shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy,
             fibromyalgia, frozen shoulder or cervical radiculopathy

          -  Sub-acromial injection with a corticosteroid or treatment by ESWT during the last 3
             months before inclusion

          -  Younger than 18 years of age or older than 90

          -  Any patient considered a vulnerable subject
Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis
Condition: Osteoporosis, Postmenopausal; Periodontitis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Periodontitis
Intervention: Phase 1 periodontal therapy; Bisphosphonate therapy
Intervention description: Scaling and root planning with ultrasonic and hand instruments under local anesthesia.; Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year
Intervention MeSH terms: Diphosphonates
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 43.0
Sex: Female
Minimum age: 51 Years
Maximum age: 66 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sclerostin; dickkopf-related protein-1

Summary:

      Symptoms of periodontal disease are tissue destruction and destruction of the alveolar bone
      which supports the tooth. Wnt way (wingless-type MMTV integration site family) plays a role
      in the regulation of bone homeostasis in periodontal disease-induced bone resorption. The Wnt
      / β-catenin signal is controlled by physiological antagonists, including dickkopf released
      from osteocytes-associated protein 1 (DKK-1) and sclerostin (SOST). Thus, Wnt inhibitors SOST
      and DKK-1 affect bone mass changes. Bisphosphonates used in osteoporous treatment are
      selective inhibitors of bone resorption. In the serum of postmenopausal osteoporotic women
      treated with bisphosphonate, short-term and decreased DKK-1 level during the treatment, and
      increased SOST in the late period were reported. Increased bone formation after
      bisphosphonate treatment in postmenopausal osteoporotic patients has been associated with
      increased serum SOST level. The aim of our study is to investigate the effect of
      bisphosphonate in patients with post-menopausal osteoporosis on the bone demolition
      metabolism in periodontally healthy and periodontally diseased tooth regions and gingival
      health with the clinical data by investigating the SOST and DDK-1 molecules that play role in
      bone destruction mechanism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with T scores less than -2.5 (groups A and C)

          -  The periodontitis patients were selected based on the radiographical evidence of bone
             loss, presence of four or more sites with bleeding on probing (BOP), ≥5 mm pocket
             depth (PD) and ≥6 mm clinical attachment loss (CAL).

          -  The clinically healthy control groups were selected on the basis of no radiographic
             bone loss or CAL and PD≤3 mm.

        Exclusion Criteria:

          -  Any known systemic disease rather than osteoporosis

          -  Smoking

          -  Antibiotic therapy within the last 3 months

          -  Periodontal treatment in the last 6 months
Clinical Trial of NAC in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: n-acetylcystine; 0.9% saline
Intervention description: NAC is a mucolytic drug.; Normal saline is a placebo agent.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma
      that is complicated by mucus in the airway, as determined by CT imaging. The study is a
      crossover design, which means that half the study participants will get 20% NAC in the first
      7-day treatment period and placebo in the next 7-day treatment period; and the other half
      will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to perform reproducible spirometry according to ATS criteria

          -  Clinical history consistent with moderate to severe asthma for 1 year or greater.

          -  Post-bronchodilator FEV1 <90% of predicted

          -  Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of
             beclomethasone or greater and a second asthma controller therapy.

          -  CT mucus score >3 (determined during the initial screening process, provided the prior
             two conditions are met)

          -  Written informed consent obtained from participant and ability for participant to
             comply with the requirements of the study.

        Exclusion Criteria:

          -  Pregnant, breastfeeding, or unwilling to practice birth control during participation
             in the study.

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data.

          -  History of intolerance to study medications.

          -  Current use of carbamazepine

          -  Angina which includes a treatment plan with PRN nitroglycerin or nitrites

          -  Smoking of tobacco or other recreational inhalants in last year and/or >10 pack-year
             smoking history

          -  Current participation in an investigational drug trial Concurrent Medications