bioihbjkbjnl/mcl2 huggingface dataset:
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Condition: Heart Failure; Myocardial Infarction
MeSH terms: Influenza, Human; Heart Failure; Myocardial Infarction; Infarction
Intervention: High Dose Trivalent Influenza Vaccine; Standard Dose Quadrivalent Influenza Vaccine
Intervention description: High Dose Trivalent Influenza Vaccine; Standard Dose Quadrivalent Influenza Vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5388.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: influenza vaccine; cardiopulmonary hospitalization; heart failure; myocardial infarction; clinical trial

Summary:

      INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce
      cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine
      in high-risk cardiovascular patients with a recent history of myocardial infarction or heart
      failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three
      additional influenza seasons. The primary endpoint will be a composite of all-cause mortality
      or cardiopulmonary hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= 18 years of age

          -  history of hospitalization for myocardial infarction within 1 year of enrollment OR a
             history of hospitalization for heart failure within 2 years of enrollment

          -  At least one of the following additional risk factors:

               -  Prior MI (if HF the index event above; or a second MI)

               -  Prior HF hospitalization (if MI the index event above; or a second HF event)

               -  Age ≥ 65

               -  Left ventricular ejection fraction (LVEF) < 40%

               -  Diabetes mellitus

               -  Obesity (BMI ≥ 30)

               -  Renal impairment (eGFR ≤ 60)

               -  History of ischemic stroke

               -  History of peripheral artery disease

               -  Current smoking

        Exclusion Criteria:

          -  Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barré Syndrome within 6
             weeks after influenza vaccine

          -  Any non-cardiac condition that in the opinion of the investigator would lead to life
             expectancy less than 9 months.

          -  Receipt of influenza vaccine during current influenza season

          -  Any illness requiring treatment with antibiotics or anti-inflammatory medication
             within the past 14 days.

          -  Any fever over 100 degrees Fahrenheit or 38 degrees Celsius within the past 7 days.
Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Condition: Moderate to Advanced Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Inflammation
Intervention: locally-applied minocycline HCl (1 mg); scaling and root planing (Sc/RP)
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of local application of minocycline
      microspheres on the periodontal inflammation and bone loss prevention in patients diagnosed
      with moderate-severe chronic periodontitis within a periodontal maintenance program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of moderate-severe chronic periodontitis

          -  attending regular periodontal maintenance visits at UNMC COD

          -  one quadrant with at least one > 5 mm interproximal pocket and 3 posterior teeth

        Exclusion Criteria:

          -  systemic diseases which impact periodontal inflammation and bone turnover

          -  drugs which significantly impact periodontal inflammation and bone turnover

          -  surgical periodontal therapy within the last year

          -  pregnant or breast-feeding females
A Comparison of 5 Low Volume Bowel Preparations
Condition: Bowel Preparation for Colonoscopy
Intervention: MiraLAX; Gatorade; MoviPrep; SUPREP
Intervention description: MiraLAX consumed as described in each arm.; Gatorade consumed as described in each arm.; MoviPrep consumed as described in each arm.; SUPREP consumed as described in each arm.
Intervention MeSH terms: Polyethylene glycol 3350
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 1079.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Colonoscopy; Bowel Preparation; MiraLAX; Gatorade; PEG-3350; MoviPrep; SUPREP; Chicago Bowel Preparation Scale; Boston Bowel Preparation Scale

Summary:

      The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and
      SUPREP to see which preparation cleanses the colon best and which preparation is best
      tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years old planning to undergo an elective colonoscopy will be
             eligible for inclusion in our study. We would prefer to exclude as few groups as
             possible since in clinical practice these less well studied groups often need a
             colonoscopy and will need to have a colonoscopy preparation.

        Exclusion Criteria:

          1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.

          2. Patients who are pregnant.

          3. Patients who required multiple day colon preparations (2 days prior and 1 day prior)
             in the past will be excluded.

          4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel
             perforation, toxic colitis or toxic megacolon would not be considered elective
             colonoscopies and are excluded.

          5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will
             need to be excluded due to the magnesium in SUPREP which is contraindicated in
             patients with significant renal disease.
Modafinil Effects on Cognition in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: modafinil (M1, M2, M4)
Intervention description: modafinil 100, 200, and 400 mg oral dose
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 54 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cognition, pharmacology, memory, attention

Summary:

      Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This
      includes many types of cognitive dysfunction, such as in attention, memory and language.
      These problems may explain why patients with schizophrenia think and act in unusual ways, and
      often have problems managing aspects of their lives that healthy adults take for granted.
      Unfortunately, the biochemical aspects of these dysfunctions are presently unknown, and it is
      not clear whether current psychiatric medications can improve these functions. A recent
      FDA-approved medication that may improve this function is modafinil. Studies in animals and
      healthy adults show that this medication can improve many of these cognitive functions. We
      plan to study the effects of modafinil on these cognitive processes, by giving various doses
      of this medication to patients before they perform tasks of these cognitive processes. We
      predict that when patients receive modafinil, they will perform better on a cognitive test,
      and that these benefits will depend on the dose given.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults age 18-54

          -  diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or
             family history of mental illness

          -  able to provide informed consent

        Exclusion Criteria:

          -  history of significant head injury or other neurological illness

          -  active psychiatric illness requiring significant acute care

          -  significant intellectual impairment (e.g. standardized full-scale IQ < 70)

          -  history of medical illness or treatment that is associated with significant increase
             in risk from modafinil treatment (e.g. cardiac disease)

          -  significant active substance abuse

          -  active pregnancy

          -  active treatment with medications that have drug interactions with modafinil
Addition of Excimer Laser to Treatment With Acitretin Tablets for Psoriasis of the Palms and Soles
Condition: Psoriasis, Skin or Nails
MeSH terms: Psoriasis
Intervention: Excimer laser; Acitretin
Intervention description: twice weekly treatments with the excimer laser for a total of 8 weeks.; 17.5mg/d
Intervention MeSH terms: Acitretin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; palmoplantar; acitretin; retinoids; laser treatment

Summary:

      Psoriasis is a common skin disease that can affect 1-3% of the population. For more severe
      psoriasis, oral medication such as acitretin is sometimes given. While acitretin may be
      sufficient for treatment of some patients, psoriasis of the palms and soles is particularly
      challenging to treat, and may not respond to acitretin alone.

      In this study, the focus is on patients who have psoriasis of the palms and soles, and are
      currently taking acitretin. The aim is to initially recruit 10 patients and offer them
      treatment with a laser, the excimer laser, to one palm and one sole. Patients will receive
      laser treatment twice weekly for a total of 8 weeks, while also taking their acitretin
      tablet. If the side treated with the excimer laser shows greater improvement compared to the
      other side, the second part of the study will be conducted.

      In this second part, another 15 patients will be included. These patients will receive twice
      weekly treatments with the excimer laser to one both palms and/or soles, for a total of 8
      weeks. The aim is to prove that the addition of excimer laser to treatment with acitretin
      will lead to greater improvement of psoriasis on palms and soles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject at least 18 years of age

          -  Diagnosis of psoriasis, with palmoplantar involvement

          -  Initiated on oral acitretin for treatment of their psoriasis by their physician

        Exclusion Criteria:

          -  Subjects less than 18 years old

          -  Subjects with any skin disease, disease state, or physical condition that would impair
             evaluation of the skin

          -  Additional systemic therapy for psoriasis in last 4 weeks

          -  Additional topical or photo-therapy in last 2 weeks

          -  Usage of any additional therapy except for emollients and keratolytic agents (5%
             salicylic acid ointment or 30% urea cream)

          -  Pre-existent or current cutaneous malignancy affecting the palms and/or soles

          -  History of photosensitive disorders

          -  Ingestion of drugs reported to cause photosensitivity reactions

          -  Presence of erythroderma or generalized pustular psoriasis

          -  Concomitant use of sunlamps
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: FS-67 Patch; Placebo Patch
Intervention description: One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days); One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 252.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Ankle Sprain

Summary:

      The objective of this study is assess the efficacy and safety of single and multiple
      applications of the FS-67 patch in the treatment of ankle sprain in pediatric population
      (ages 13-17).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Grade 1 or Grade 2 ankle sprain

        Exclusion Criteria:

          -  Pregnancy or lactation
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Condition: Parenteral Nutrition Associated Liver Disease
MeSH terms: Liver Diseases
Intervention: Omegaven
Intervention description: 1 gram/kg/day daily until on feeds
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Parenteral nutrition associate liver disease; TPN cholestasis; TPN Associated Liver Disease

Summary:

      Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a
      long period of time frequently develop liver damage. The fat used is called intralipid and is
      made from soybean oil. There is a suggestion in the literature that using fish oil based fats
      called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer
      babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver
      damage reverses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants in the newborn intensive care unit

          -  TPN cholestasis of at least 2.5 mg/dl

          -  Anticipated TPN treatment for at least one month

          -  signed informed consent

        Exclusion Criteria:

          -  Enrollment in another trial

          -  Lack of consent
Conditioned Pharmacotherapeutic Effects in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: carvedilol
Intervention MeSH terms: Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension

Summary:

      The proposed research is designed to determine if the application of classical conditioning
      operations could influence the clinical effects of a regimen of antihypertensive drug
      therapy. It will be determined if, capitalizing on conditioned pharmacotherapeutic effects,
      patients can be effectively treated with smaller cumulative amounts of drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  systolic blood pressure between 140-160 mmHG

          -  between 18-80 years old

        Exclusion Criteria:

          -  abnormal renal function

          -  currently pregnant, or trying to become pregnant

          -  being treated with a beta-blocker

          -  use of illicit drugs
Exparel for Postoperative Pain Management in Shoulder Surgery
Condition: Fracture of Shoulder and Upper Arm
MeSH terms: Pain, Postoperative; Shoulder Fractures
Intervention: 1.3% Liposomal Bupivacaine; 0.125% Bupivacaine
Intervention description: local tissue infiltration of Liposomal Bupivacaine during surgery; Continues nerve block with Bupivacaine during surgery and postoperatively
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into
      the shoulder to continues nerve block with Bupivacaine on postoperative pain control and
      functional outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing shoulder arthroplasty under general anesthesia

          -  Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus
             fracture under general anesthesia

          -  Patients with American Society of Anesthesiologist (ASA) physical status
             classification of 1-3

          -  Patients meeting criteria for standard of care continuous peripheral nerve block
             (CPNB) per anesthesia guidelines.

          -  Patients agreeing to be available for brief follow up telephone survey post-
             operatively and being mentally able to respond.

          -  Patients available for follow up routine post-operative clinic visits, per standard of
             care.

        Exclusion Criteria:

          -  Contraindications to regional anesthesia

          -  Significant peripheral neuropathy or neurological disorder affecting the upper
             extremity

          -  Contraindication to a component of multimodal analgesia

          -  Pregnancy

          -  Opioid tolerance

          -  Cognitive or psychiatric condition that might affect patient assessment and/or
             inability to provide informed consent.
Optimal Care of Complicated Appendicitis
Condition: Appendicitis; Perforated Appendicitis; Ruptured Appendicitis; Complicated Appendicitis
MeSH terms: Appendicitis
Intervention: Early Appendectomy; Interval Appendectomy; Antibiotics
Intervention description: Removal of the appendix within 24 hours of admission; Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.; Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Ciprofloxacin; Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the
      infection and inflammation get worse, the appendix can die or burst, leading to a larger
      infection or even pus pockets around the appendix. This is called complicated, or perforated,
      appendicitis. Three common treatments for complicated appendicitis are

        -  appendectomy (removal of the appendix) right away

        -  appendectomy several weeks after the diagnosis

        -  treating the appendicitis without performing an appendectomy

      This study seeks to determine which of these three approaches is most cost-effective in
      children with complicated appendicitis.
    

Eligibility criteria:

        Inclusion criteria

          1. At least 1 of the following CT or MRI findings:

               1. Peri-appendicular abscess

               2. Extruded appendicolith

               3. Visible hole in appendiceal wall

               4. Free peritoneal air

             OR

          2. CT or MRI read with phlegmon or diffuse/extensive inflammation/free fluid plus 1 of 3
             of the following (with CT) or 2 of 3 of the following (with MRI) *:

               1. White blood cell count (WBC) >15

               2. Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign,
                  percussion tenderness, and/or rebound tenderness)

               3. Temperature > 38.0 C *>90% specificity for complicated appendicitis based on
                  unpublished institutional data

        Exclusion Criteria

          1. Immunocompromized state

          2. History of major abdominal operation

          3. Previous appendicitis

          4. Major comorbidities that preclude safe operation

          5. Inability to follow-up or appropriately consent

          6. Pregnant women

          7. Allergy to penicillin plus any one of the following:

               1. Hypersensitivity to ciprofloxacin and/or metronidazole

               2. Pregnant/lactating women

               3. Patients taking theophylline

               4. Patient taking tizanidine