bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Pneumovax 23- pneumococcal polysaccharide; Blood draw
Intervention description: PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.; 6 ml blood draw at baseline and 6 months post immunization
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Will study immunological response to vaccination
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if children with type 1 diabetes have adequate
      immune response to PPSV23 vaccination and to assess factors affecting immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children ages 3-18 years old.

          -  Clinical diagnosis of Type 1 diabetes.

        Exclusion Criteria:

          -  Newly diagnosed with Type 1 diabetes with in the past month of study date.

          -  Contraindications to receiving 23 valent pneumococcal vaccines.

          -  Other conditions associated with compromised immunity and vaccine response.

          -  Primary or Secondary Immune deficiency.

          -  Previous receipt of PPSV-23 vaccination.
Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging
Condition: Obesity, Visceral
MeSH terms: Obesity, Abdominal
Intervention: [U-13C3] glycerol; Empagliflozin; Placebo (for Empagliflozin)
Intervention description: Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).; Active drug; Placebo tablet manufactured to mimic EMPA 10 mg tablet.
Intervention MeSH terms: Empagliflozin; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Visceral; Obesity; Adipose; Diabetes

Summary:

      This study is a clinical study to investigate the gluconeogenesis pathway related to visceral
      adipose tissue (VAT) in obese individuals without type 2 diabetes and the effects of
      empagliflozin (EMPA) on glucose homeostasis in viscerally-obese individuals using functional
      studies of glycerol metabolism in hepatic gluconeogenesis using a well-validated nuclear
      magnetic resonance (NMR) spectroscopy platform.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese, defined as BMI ≥ 30 kg/m2, at both time of abdominal fat imaging and at study
             entry.

          -  Ages 30-65

          -  No prevalent diagnosis of type 2 diabetes mellitus, either at the time of abdominal
             fat imaging or at study entry.

          -  Previous abdominal fat quantification by magnetic resonance imaging in the Dallas
             Heart Study or possible neck-to-knee MRI for VAT measurement may be performed.

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Incarcerated

          -  Chronic kidney or liver disease

          -  History of frequent (>2/year) urinary tract infections

          -  Non-obese either at time of abdominal fat imaging or at present.

          -  Greater than 10% change in body weight (kg) between time of abdominal fat imaging and
             present.

          -  Has donated blood within last 6 weeks

          -  Cannot give informed consent, understand the protocol, or tolerate any aspect of the
             protocol

          -  If undergoing MRI, persons with metal implants contraindicated for 3Tesla MRI exams
             will be excluded. Severe claustrophobia will also be assessed prior to an MRI exam.
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic
Condition: Trigger Finger
MeSH terms: Trigger Finger Disorder
Intervention: Corticosteroid with lidocaine with epinephrine; Corticosteroid with normal saline
Intervention description: Trigger finger injection; Trigger finger injection
Intervention MeSH terms: Lidocaine; Epinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Steroid injection is the first line treatment for trigger finger. Steroid injection is
      sometimes mixed with a local anesthetic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old with trigger finger

        Exclusion Criteria:

          -  Preference for open trigger finger release

          -  Not a candidate for corticosteroid injection

          -  Contraindication to lidocaine with epinephrine
Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Roflumilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 26.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Roflumilast; COPD

Summary:

      Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease
      surrogate markers of bone metabolism and early cardiovascular disease in individuals with
      moderate to severe airflow obstruction and a chronic bronchitis phenotype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco
             exposure, airflow obstruction (FEV1/FVC < 0.70) with an FEV1 < 70%

          -  baseline sputum production at least some of the time as reported on the Saint George's
             Respiratory Questionnaire, and at least one exacerbation within the past year

        Exclusion Criteria:

          -  Subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates,
             calcitonin, parathyroid hormone)

          -  Subjects with a body mass index less than 18 or greater than 34
A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Condition: Acute Bacterial Skin and Skin Structure Infection
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial
Intervention: Oritavancin; Warfarin
Intervention description: Administered intravenously; Administered as a concomitant medication at a standard dose and dosing schedule
Intervention MeSH terms: Oritavancin; Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: skin infection

Summary:

      This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV
      infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin
      and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive
      pathogens.

      An additional group of participants with ABSSSI, who were not on concomitant warfarin
      therapy, were also enrolled to obtain additional information following a single dose of
      oritavancin administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ABSSSI (wound infection, cellulitis/erysipelas, or cutaneous abscess)
             suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy

          -  Must be currently being treated with chronic warfarin therapy* *Participants in the
             non-warfarin group are not required to be on chronic warfarin therapy.

        Exclusion Criteria:

          -  Known or suspected bacteremia, sepsis or refractory shock

          -  Participants who are likely to need treatment with IV heparin within 48 hours

          -  Significant or life-threatening condition

          -  Women who are pregnant or nursing

          -  Receiving chronic systemic immunosuppressive therapy such as chemotherapy or
             prednisone

          -  CD4 count <200 cells/mm^3 in participants with known human immunodeficiency virus or
             acquired immune deficiency syndrome

          -  Neutropenia
Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Condition: Perforated Appendicitis; Postoperative Infection
MeSH terms: Appendicitis
Intervention: Piperacillin, Tazobactam Drug Combination
Intervention description: Single drug therapy
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: 162.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      After appendix has been removed for perforated appendicitis, patients will receive
      postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3
      -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug
      therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a
      single-drug therapy, there are additional benefits of simplicity, compliance, and lower
      infectious complications. Currently surgeons are already using both 2-drug regimen
      (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA
      approved and regulated antibiotics for intra-abdominal infection. There is a clear need to
      compare outcomes between these two options.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postoperative Perforated Appendicitis (documented by intraoperative photo)

          -  Postoperative Laparoscopic Appendectomy

        Exclusion Criteria:

          -  Nonperforated Gangrenous Appendicitis

          -  Nonperforated Purulent Appendicitis

          -  Open Appendectomy
Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy
Condition: Obesity; Bariatrics; Sleep Apnea Syndromes; Gastric Bypass; Endoscopy
MeSH terms: Sleep Apnea Syndromes
Intervention: Ketofol; Propofol; Saline
Intervention description: 50mg of Ketamine mixed with 100mg of Propofol; 100mg of Propofol; 1mL of saline
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ketamine; Propofol; Ketofol; Obese; Upper gastrointestinal endoscopy; Sedation; Bariatric

Summary:

      Propofol is one of the most popular anesthetic drugs used for sedation during upper
      gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms allowing
      patients to leave the hospital sooner. However, when administered it can also slow the
      breathing of patients and cause others to have upper airway obstruction (such as snoring)
      which can impede proper spontaneous breathing. Ketamine is an agent that is capable of
      providing both pain control and sedation while having either minimal effect on breathing or
      promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to reduce
      the total amount of Propofol used resulting in a procedure being performed under the same
      level of sedation but without the downside of reduced spontaneous breathing. Patients who are
      obese (defined as body mass index greater than 35) tend to be even more susceptible to this
      effect of Propofol. The researchers are investigating whether the addition of Ketamine will
      indeed allow for this continued comfortable level of sedation while promoting continued
      spontaneous breathing in obese patients undergoing upper gastrointestinal endoscopies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI > 30

          -  Undergoing an upper gastrointestinal endoscopy

        Exclusion Criteria:

          -  History of schizophrenia/schizoaffective disorder

          -  History of bipolar disorder

          -  History of dementia

          -  Non-English Speaking

          -  History of Glaucoma

          -  Craniofacial Abnormalities

          -  Epilepsy

          -  Allergy to Propofol

          -  Allergy to Ketamine

          -  Current known intracranial mass/lesion
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
Condition: Skin Infection
MeSH terms: Cellulitis; Skin Diseases, Infectious
Intervention: Medicinal honey; Bacitracin
Intervention description: Treat healing surgical site with medicinal honey; Treat healing surgical site with bacitracin
Intervention MeSH terms: Bacitracin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Postoperative medicinal grade honey in post-operative care may prevent bone anchored hearing
      aid associated skin breakdown better than standard care of bacitracin ointment alone in adult
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients undergoing bone-anchored hearing aid implantation surgery.

        Exclusion Criteria:

          -  patients who are undergoing revision bone-anchored hearing surgery, history of
             radiation to the implantation site.
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
Condition: Gout
MeSH terms: Inflammation
Intervention: Magnetic Resonance Imaging; Febuxostat; Colchicine
Intervention description: An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).; All subjects in the sub-study will be started on febuxostat 40mg daily at baseline. If their serum urate level is > 6.0 at months 1 or 3, then the febuxostat dose will be increased to 80mg daily.; Colchicine will be dosed at 0.6mg by mouth BID for the first three months then 0.6mg daily from months 3 to 6, and then discontinued at month 6.
Intervention MeSH terms: Colchicine; Febuxostat
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gout; Synovial pannus; Magnetic resonance imaging

Summary:

      The purpose of this study is to show that patients with gout suffer from chronic inflammation
      of their joints, observable by MRI, even in the absence of symptomatic gouty attacks.
      Secondary end-points of this study will include analyzing the effects of uric acid-lowering
      therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients,
      checking for the presence of inflammatory markers to see if there is any correlation with the
      proposed chronic inflammation, and evaluating for other characteristic findings of gout on
      MRI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age > or = 18 - Open ended to both males and females.

          2. Have a known history of gout diagnosed by current or previous documentation of
             intracellular MSU crystals in synovial fluid, a tophus proved to contain MSU crystals,
             or at least six of the twelve ACR diagnostic criteria for gout (see appendix with the
             12 diagnostic criteria of gout).

          3. English of Spanish speaking

          4. Able to give informed consent

        Exclusion Criteria:

          1. Age < 18.

          2. Unable to give informed consent.

          3. Do not speak or write in English or Spanish.

          4. History of any other inflammatory arthritis.

          5. History of another crystal induced arthritis.

          6. Serum creatinine >1.8 mg/dL

          7. Patients taking oral corticosteroids (any dose) [or within 4 weeks]

          8. Parenteral or intraarticular corticosteroids within 6 weeks

          9. Allergy to gadolinium contrast dye

         10. Any contraindication to receiving a MRI

         11. Pregnant women

         12. Allergy to febuxostat (Uloric) or colchicine [substudy subjects only]
Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching
Condition: Pruritus
MeSH terms: Pruritus
Intervention: Cetirizine; Placebo or sugar pill
Intervention MeSH terms: Cetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is determine if long acting antihistamine like cetirizine can help
      with itching induced by opioid pain medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children age 6-18yrs on opioids who develop pruritus and are willing to participate in
             the study

        Exclusion Criteria:

          -  Children with history of chronic urticaria

          -  Children with other chronic pruritic condition like eczema, contact dermatitis,
             psoriasis

          -  Children with known hypersensitivity to cetirizine/zyrtec

          -  Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine,
             loratadine, fexofenadine, chlorpheniramine within the last 7days prior to
             randomization

          -  Children who have received Ondansetron within 24hrs prior to randomization

          -  Children who are on Tricyclic antidepressants

          -  Children who are unwilling or unable to swallow the capsule.

          -  Children with chronic liver or kidney disease
Postpartum HPV Vaccination
Condition: HPV-Related Malignancy
MeSH terms: Neoplasms
Intervention: Gardasil9
Intervention description: Gardasil 9
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 195.0
Sex: Female
Minimum age: 16 Years
Maximum age: 26 Years
Healthy volunteers: No

Summary:

      Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore,
      greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer
      disproportionately affects women of color in both incidence and mortality. Due to low HPV
      vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are
      necessary in order to maximize the cancer prevention potential of this vaccine. The
      puerperium is a time period when women are engaged in the healthcare system and have almost
      universal access to affordable health care. Two prior studies have shown that postpartum HPV
      vaccination is acceptable to patients, and high rates of vaccination were achieved in these
      primarily Hispanic populations. However, data show that the immune response in young women is
      less robust than in adolescents, and no studies have examined immunogenicity in postpartum
      women specifically. We propose an HPV vaccination pilot study in women who receive postpartum
      care at University of Alabama at Birmingham (UAB) hospital. We will examine the
      acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital

        Exclusion criteria

          -  Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid
             use, preeclampsia, non-English speaking
Rectal Indomethacin to Prevent Post ESWL-pancreatitis
Condition: Pancreatitis
MeSH terms: Pancreatitis
Intervention: indomethacin suppository; Glycerin Suppository
Intervention description: 100mg rectal indomethacin 30min before ESWL; 30min before ESWL
Intervention MeSH terms: Indomethacin; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1370.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extracorporeal Shock Wave lithotripsy(ESWL); Prophylaxis; Indomethacin; Chronic pancreatitis

Summary:

      The purpose of the study is to determine whether rectal indomethacin reduces the incidence of
      post-ESWL pancreatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter)
             undergoing P-ESWL

          -  at least 18 years old

          -  provides informed consent

        Exclusion Criteria:

          -  readmitted to the hospital during the enrollment of the study

          -  contraindications to ESWL

          -  suspected or established malignancy

          -  pancreatic ascites

          -  receiving NSAIDs within 7 days

          -  contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or
             renal dysfunction with serum creatinine >120 μmol/L)

          -  presence of coagulopathy or received anticoagulation therapy within 3 days

          -  acute pancreatitis within 3 days

          -  known active cardiovascular or cerebrovascular disease

          -  pregnant or breastfeeding women

          -  without a rectum (ie, status post-total proctocolectomy)