bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
Condition: Cellulitis; Skin Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Emergencies
Intervention: Daptomycin; Vancomycin
Intervention description: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.; • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Intervention MeSH terms: Vancomycin; Daptomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the
      Emergency Department (ED) treatment of complicated skin and skin structure infection in the
      Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who
      are admitted to the RDTC cellulitis protocol in the ED will be randomized to either
      vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or
      daptomycin, which is the experimental treatment in this study. The primary hypothesis is that
      daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to RDTC to the Cellulitis Protocol

          -  18 yrs old or greater

          -  Able and willing to give informed consent

          -  Hemodynamically stable (systolic blood pressure >90mmHg and heart rate <120 beats per
             minute)

        Exclusion Criteria:

          -  Antibiotics given prior to enrollment

          -  Suspected necrotizing infection

          -  Diabetic foot ulcer

          -  Genitourinary involvement

          -  Post operative infection (not including simple wound closure infection)

          -  Suspected gouty or septic arthritis

          -  Chronic Lymphangitis

          -  Requiring routine hemodialysis

          -  Patient reported allergy to Vancomycin

          -  Patient reported allergy to Daptomycin

          -  Participation in another investigational treatment study within 30 days prior to
             enrollment

          -  Prisoner

          -  Pregnant or breast-feeding

          -  Complicated skin and skin structure infection of the face
The Treatment of Glabellar Frown Lines
Condition: Glabellar Frown Lines
Intervention: IncobotulinumtoxinA; OnabotulinumtoxinA
Intervention description: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection; 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Glabellar Frown Lines; Frown Lines; Facial Wrinkles

Summary:

      The purpose of this study is to show that two FDA-approved botulinum toxin drugs called
      Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between
      the eyebrows (glabellar frown lines).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient females 18 to 50 years of age

          -  Moderate to severe glabellar frown lines

        Exclusion Criteria:

          -  Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale

          -  Previous treatment with botulinum toxin

          -  Previous treatment with biodegradable fillers in glabellar area within last 12 months

          -  Any severe or uncontrolled systemic disease, malignant tumor, or medical history of
             HIV infection

          -  Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their
             excipients

          -  Intake of any of the forbidden concomitant medication or other agents that might
             interfere with neuromuscular function or might interfere with the action of botulinum
             toxin type within 14 days prior to injection
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Condition: Appendicitis
MeSH terms: Appendicitis
Intervention: Piperacillin/Tazobactam; Surgical Treatment
Intervention description: 24 hours of IV antibiotic administration; Appendectomy
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Several prior studies have demonstrated that medical management of acute appendicitis in
      adults is a safe first-line therapy option. This study aims to determine whether
      non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior
      to operative management in a pediatric population. This study will be a randomized controlled
      trial comparing non-operative management with antibiotics to surgical management of
      uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than
      surgery for the treatment of uncomplicated appendicitis in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  first episode of appendicitis

          -  Pain < 48 hours

          -  White blood cell count < 18,000

          -  temperature < 103º F

          -  radiographic evidence of acute appendicitis on ultrasound or CT without evidence of
             perforation

          -  appendiceal diameter < 11 mm

          -  ability to take oral antibiotics

        Exclusion Criteria:

          -  Prior antibiotic treatment for appendicitis

          -  presence of medical condition prohibiting surgical therapy

          -  radiographic or clinical evidence of abscess or perforation

          -  appendiceal mass, positive pregnancy test

          -  other diagnosis equally as likely as appendicitis

          -  pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or
             appendiceal diameter ≥ 11 mm

          -  inability to take oral antibiotics.
Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Prednisone; Placebo; Ablation Procedure
Intervention description: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure; 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure; Atrial Fibrillation (AF) ablation
Intervention MeSH terms: Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Ablation

Summary:

      The primary purpose of this study is to assess the efficacy of oral prednisone in improving
      the outcomes of pulmonary vein isolation with radiofrequency ablation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to provide written informed consent;

          2. Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation

        Exclusion Criteria:

          1. History of heart failure (right or left or biventricular) or cardiomyopathy.

          2. Immunosuppressive disorders and systemic fungal infection

          3. Concurrent use of corticosteroids in one week prior recruitment.

          4. Allergy or prednisone or its components.

          5. Other medical conditions were use of corticosteroids is not recommended or
             contraindicated.

          6. Patients with chronic and permanent atrial fibrillation.

          7. Patients with established diagnosis of rheumatological and immunological disorders.
Salt Loading and Thiazide Intervention Study
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Salt loading; Hydrochlorothiazide (HCTZ)
Intervention description: Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 liters (L) of 0.9% sodium chloride (NaCl) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.; We will perform short-term HCTZ intervention on the same 120 subjects. After overnight fasting and having their height, weight, and BP measured, subjects are given seven 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure will be measured and blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will repeat the 7-day HCTZ intervention, taking 25 mg of HCTZ instead. Subjects with plasma potassium levels below 3.6 mmol/L on day 8 of 12.5 mg HCTZ will be given a daily supplement of 16 milliequivalents of potassium to prevent harmful loss of potassium while taking HCTZ.
Intervention MeSH terms: Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hypertension; hydrochlorothiazide; HCTZ; Salt sensitivity; Hydrochlorothiazide induced hyperglycemia

Summary:

      The investigators of this study propose to examine the relationships between STK39 (Serine
      Threonine Kinase 39) genotypes and responses to salt loading and to thiazide diuretics,
      hydrochlorothiazide. The investigators hypothesize that STK39 genotypes will be associated
      with the outcome of both interventions and can contribute to personalized care for
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Old Order Amish

          -  Age 18 to 65

          -  Have systolic blood pressure between 120 and 160 and diastolic blood pressure between
             80 and 100

        Exclusion Criteria:

          -  History of myocardial infarction, stroke, congestive heart failure, liver disease

          -  Known cause of secondary hypertension

          -  Diabetes or Fasting glucose > 100 mg/dL

          -  Women who are pregnant, on oral contraceptives, or menstruating

          -  Used hydrochlorothiazide (HCTZ) in the last 8 weeks or known allergy to HCTZ

          -  Taking non-steroidal anti-inflammatory drugs

          -  Estimated glomerular filtration rate < 80 mL/m

          -  Intention to alter dietary habit during the study

          -  Abuse of alcohol or drug
ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ketorolac; Ketorolac and Ropivacaine
Intervention description: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day; Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      After surgery it is normal to experience some pain at the site of operation. In order to
      reduce the pain, medication such as Morphine is injected into a vein using a Patient
      Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient
      when needed. However, Morphine is an opioid drug, which can cause side effects such as
      sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid
      drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs
      (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects
      of morphine. Recently a portable device called ON-Q pump has been developed to continuously
      infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q
      Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses
      the drug through the catheters by elastic force. This pump is very safe and is attached to a
      bedside pole or the patient's hospital gown. This pump has already been approved by the FDA
      for clinical use, and has been reported to provide effective pain management after some
      surgical procedures.

      The primary aim of the present study is to evaluate the relative efficacy of the drugs
      Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following
      gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used
      for post operative pain relief. Our hypothesis is that these two drugs in combination will
      provide better analgesia than Ketorolac alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients belonging to ASA class I to II classification who are undergoing abdominal
             gynecologic surgery will be included in the study.

        Exclusion Criteria:

          -  Patients who are allergic to NSAIDs, Asthmatics, and those who have peptic ulcer,
             sepsis, or coagulation problems will be excluded from the study.
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin
Intervention description: oral, 5 mg once a day (Q.D.)
Intervention MeSH terms: Saxagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2165.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Type 2 DM

Summary:

      The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with
      type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures Diagnosed with
             type 2 diabetes

          -  Men or women who are >18 years of age at time of consenting upon Visit 1

          -  HbA1c >7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone
             on stable doses of for at least continues 8 weeks prior to Visit 1

          -  Drug naive patients are defined as patients who have not received medical treatment
             for diabetes (insulin and/or oral hypo)

        Exclusion Criteria:

          -  Pregnant or breastfeeding patients

          -  Insulin therapy within one year of enrolment (with the exception of insulin therapy
             during a hospitalization or use in gestational diabetes)

          -  Previous treatment with any DPP-IV inhibitors or GLP-1 analogue

          -  History of administration of any antihyperglycemic therapy (other than metformin)
             during the 8 weeks prior to Visit 1(12 weeks for previous TZD)

          -  Treatment with systemic glucocorticoids other than replacement therapy

          -  Inhaled, local injected and topical use of glucocorticoids is allowed
Subconjunctival Versus Direct Mitomycin C in Trabeculectomy
Condition: Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: Mitomycin-C injection; Mitomycin-C sponge
Intervention description: MMC delivered by preoperative subconjunctival injection; MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: trabeculectomy, mitomycin-C, glaucoma

Summary:

      Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of
      trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing,
      specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites,
      concentrations and times. This study aims to compare the two application routes that are
      commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral
      application in terms of IOP lowering effect, bleb appearance and complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  medically uncontrolled glaucoma

          -  healthy and freely mobile conjunctiva in superior bulbar region

        Exclusion Criteria:

          -  previous incisional glaucoma surgery

          -  no light perception vision

          -  pregnant or nursing women

          -  iris neovascularization or proliferative retinopathy

          -  iridocorneal endothelial syndrome

          -  chronic or recurrent uveitis

          -  steroid-induced glaucoma

          -  pathologic myopia or refractive error less than -6.00 diopters

          -  unwillingness or inability to give consent

          -  inability to return for scheduled protocol visits
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Morphine, Parecoxib; Morphine, Placebo
Intervention description: Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.; Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA
Intervention MeSH terms: Parecoxib; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 105.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to demonstrate the opioid-sparing efficacy of
      parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the
      24 hours after the end of surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,<10%) of
             developing an acute coronary event within the next 10 years according to the PROCAM
             risk assessment calculator.

          -  The patient is scheduled to undergo routine radical prostatectomy performed under a
             standardized regimen of general anesthesia, and is expected to experience moderate to
             severe postsurgical pain in the absence of postoperative analgesia.

        Exclusion Criteria:

          -  The patient has a history of uncontrolled chronic disease or a concurrent clinically
             significant illness or medical condition such as a diagnosed chronic pain condition,
             which, in the Investigator's opinion, would contraindicate study participation or
             confound interpretation of the results

          -  The patient has a history or current presence of congestive heart failure (NYHA
             II-IV), established ischaemic heart disease, peripheral arterial disease and / or
             cerebrovascular disease.
Using Saline for Myofascial Pain Syndromes (USAMPS)
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Intervention: Normal Saline; Lidocaine Hydrochloride; Triamcinolone acetonide
Intervention description: Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.; Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.; Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myofascial Pain Syndrome; trigger point injection

Summary:

      This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The
      purpose of this research study is to determine if there is a therapeutic difference between
      trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic +
      steroid) in treating MPS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus,
             iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the
             emergency department.

        Exclusion Criteria:

          -  Patients allergic to lidocaine and/or steroids.

          -  Pregnant women.

          -  Prisoners.

          -  Patients who are cognitively impaired and/or unable to consent for the study.

          -  Age < 18.

          -  Signs of localized infection or skin breakdown at the injection site.