bioihbjkbjnl/mcl2 huggingface dataset:
Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Golimumab
Intervention description: Golimumab 50mg/0.5 mL in a single-use, ready-to-use autoinjector. Golimumab is a fully human anti-TNF (tumor necrosis factor) alpha monoclonal antibody that will be administered SC.
Intervention MeSH terms: Golimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for
      Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor
      superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic
      response to golimumab treatment in participants with moderate to severe UC who have failed on
      prior conventional therapies. The primary endpoints of this study are to correlate serum
      soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and
      histological activity (Geboes index) of disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inadequate response to conventional therapy including corticosteroids or are
             intolerant to, or have medical contraindications for conventional therapies

          -  UC diagnosed prior to screening, based on a biopsy collected at endoscopy

          -  Moderate to severe active UC with total Mayo score of 6 to 12, inclusive at baseline,
             and endoscopic Mayo sub-score, greater than or equal to 2

          -  Adenomatous polyps removed within last 5 years or at the screening visit prior to the
             first drug treatment

          -  Extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for
             ≥10 years should have a colonoscopy to exclude the presence of dysplasia within 1 year
             prior to study inclusion or a colonoscopy to exclude the presence of malignancy at the
             screening visit

          -  No history of untreated latent or active Tuberculosis (TB) prior to screening

          -  Negative stool results for enteric pathogens

        Exclusion Criteria:

          -  History of asthma

          -  History of autoimmune diseases

          -  History of hypertension
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
Condition: Intraoperative Bleeding
MeSH terms: Blood Loss, Surgical
Intervention: Epinephrin; 1% lidocaine with epinephrin 1:100,000; Saline
Intervention description: Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity; 4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site); 4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      In endoscopic sinus surgery a clear surgical field of view is a very important aspect for
      good surgical outcome. This study is to evaluate the preoperative preparation to acquire best
      surgical field of view by comparing between the use of topical adrenaline and the use of
      combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in
      patients scheduled for endoscopic sinus surgery for rhinosinusitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical
             treatment and scheduled for endoscopic sinus surgery

        Exclusion Criteria:

          -  Patients who have asymetrical disease on the two sides (Lund Mackay score difference
             more than 2)

          -  Patients who have endoscopic sinus surgery for treatment of tumor or disease other
             than sinusitis

          -  Patients with underlying uncontrolled hypertension

          -  Patients with bleeding disorder or are unable to discontinue antiplatelet or
             anticoagulant before the surgery

          -  Patients who are allergic to adrenaline or to xylocaine
Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation
Condition: Atrial Fibrillation; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Atrial Fibrillation
Intervention: apixaban; warfarin
Intervention description: oral anticoagulant; oral anticoagulant
Intervention MeSH terms: Warfarin; Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal dialysis

Summary:

      This is a prospective, randomized, open-label, blinded end-point evaluation trial. The
      patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and
      end-stage renal disease (ESRD) .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, age at least 18 years, or the local age of consent, whichever is
             greater.

          -  Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from
             separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor,
             event monitor or implantable loop recorder).

          -  CHA2DS2-VASc score of ≥ 2.

          -  End-stage renal disease treated with hemodialysis for ≥ 3 months.

          -  Considered by the treating physician(s) to be candidate for oral anticoagulation.

          -  If of childbearing potential, be willing to avoid pregnancy during the study.

        Exclusion Criteria:

          -  Not considered by the treating physician(s) to be candidates for oral anticoagulation
             (for example, hemoglobin < 8.5g/dL, history of intracranial hemorrhage, active
             bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic
             impairment, or anaphylactic reaction to apixaban)

          -  Moderate or severe mitral stenosis

          -  Conditions other than AF that require anticoagulation such as mechanical prosthetic
             valve, deep venous thrombosis, or pulmonary embolism

          -  Need for aspirin at a dose > 81 mg a day or need for P2Y12 antagonist therapy (for
             example clopidogrel, prasugrel, or ticagrelor)

          -  Life expectancy < 3 months

          -  Anticipated kidney transplant within the next 3 months

          -  Prisoners or others who are involuntarily incarcerated or detained

          -  Pregnant, breastfeeding, or considering pregnancy.

          -  Participation in a clinical trial of an experimental treatment within the past 30 days
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
Condition: Barrett's Esophagus; Obesity
MeSH terms: Barrett Esophagus; Esophagitis; Inflammation
Intervention: Omega-3 polyunsaturated fatty acids; Placebo
Intervention description: 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.; 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal.
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
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Omega-3 fatty acid

Summary:

      This study is being done to understand the effect of dietary omega-3 fats in decreasing
      tissue inflammation in Barrett's esophagus.
    

Eligibility criteria:

        Inclusion Criteria

          -  Presence of BE defined as ≥ 1 cm of visible columnar mucosa in the distal esophagus
             with intestinal metaplasia on histology.

          -  Absence of high grade dysplasia or EAC on baseline histology.

          -  BMI > 30 kg/m2 or waist circumference > 102 cm in men, > 88 cm in women.

          -  Ability to give informed consent.

        Exclusion Criteria

          -  Allergy to ω3 FFAs, fish or shellfish.

          -  Presence of high grade dysplasia or cancer on histology.

          -  Pregnant and or breastfeeding women

          -  Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn
             or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux.

          -  Inability to give informed consent.

          -  Currently taking Omega3 FFA as prescription.

          -  Anti-coagulant therapy (Plavix, Warfarin, Coumadin)

          -  AST or ALT level > three times upper limit of normal at baseline

          -  LDL > 200 mg/dl at baseline.

          -  INR > 2
Mexiletine for the Treatment of Muscle Cramps in ALS
Condition: Muscle Cramps in Amyotrophic Lateral Sclerosis
MeSH terms: Muscle Cramp; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Spasm; Sclerosis
Intervention: Mexiletine; Placebo
Intervention description: Sodium channel blocker; Placebo
Intervention MeSH terms: Mexiletine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 21 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Muscle cramps; Cramp; ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig's disease; Motor Neuron Disease; MND

Summary:

      The purpose of this study is to determine if mexiletine is effective for the treatment of
      muscle cramps in Amyotrophic Lateral Sclerosis (ALS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ALS diagnosed according to El Escorial criteria (Awaji version) as: Possible,
             Probable, or Definite.

          -  Experiencing cramps as a moderate or severe symptom as defined by willingness to take
             a medication for the symptom

          -  ≥2 cramps per week during run in week

          -  Life expectancy > 6 months, estimated by clinician

          -  Able to take drug capsule by mouth

          -  No significant EKG abnormality on screening

          -  aspartate aminotransferase / alanine aminotransferase <2x upper limit of normal
             measured at screening

          -  Having successfully filled out the cramp diary and cramp and fasciculation scales on
             six out of the last seven days of run in period

        Exclusion Criteria:

          -  Inability to communicate by telephone or email

          -  Allergy/ known sensitivity to mexiletine

          -  Prior use of mexiletine

          -  AV block unless subject has pacemaker

          -  Cardiac arrhythmia

          -  Prior myocardial infarction

          -  Other significant EKG abnormality

          -  Liver disease

          -  History of leucopenia (WBC <3,500/mm3)

          -  Epilepsy

          -  Other serious and unstable medical condition

          -  Pregnant woman

          -  Breastfeeding woman

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements

          -  Use of quinidine (alone or as a component of Nuedexta®) during the study

          -  Inability or unwillingness of subject to give written informed consent

          -  Woman of childbearing potential, not willing to use at least two approved methods of
             contraception

          -  Use of a prohibited medication during study
Citicoline for Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Placebo; Citicoline
Intervention description: Inactive ingredient matching the active comparator in appearance; Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body.
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: alcohol dependence; alcohol abuse

Summary:

      The purpose of this study is to determine if citicoline, as an add-on therapy, will help
      reduce alcohol use in outpatients with alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18-75 years old with diagnosis of alcohol dependence

          -  Average alcohol use of at least 28 drinks per week and at least 7 heavy drinking days
             (defined as 4 or more drinks/day for women, 5 or more drinks/day for men) in the past
             28 days

          -  No alcohol use within 72 hours of randomization (maximum abstinence 7 days)

          -  CIWA-Ar (withdrawal scale) score less than or equal to 8 at randomization (consistent
             with minimal or no withdrawal symptoms and medication probably not needed)

        Exclusion Criteria:

          -  Vulnerable populations including individuals with intellectual disability or dementia,
             prison or jail inmates, pregnant or nursing women, or women of childbearing age who
             will not use acceptable forms of birth control

          -  History of arrhythmias

          -  Myocardial infarction or coronary artery bypass graft surgery in the past 6 months

          -  Active angina or blood pressure >170/105

          -  High risk for suicide (defined as suicide attempt in past 6 months, or current
             suicidal ideation with plan and intent)

          -  High risk of violence toward others (defined as assault in past 6 months, or violent
             thoughts with evidence of plan and intent)

          -  Intensive outpatient treatment for substance abuse (AA, NA meetings or weekly
             therapy/counseling for substance use for at least 28 days prior to randomization will
             be allowed)

          -  Dependence (not just abuse) on substances other than alcohol or nicotine

          -  History of delirium tremens or other sever alcohol withdrawal symptoms, history of
             cirrhosis or AST or ALT >3 times normal, or other unstable medical condition (e.g.
             uncontrolled diabetes)

          -  History of bipolar disorder or schizophrenia

          -  Current major depressive episode (past episodes and current milder depressive symptoms
             allowed) or other psychiatric disorder that should be a major focus of treatment
Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
Condition: Cardiopulmonary Arrest; Respiratory Arrest
MeSH terms: Heart Arrest; Emergencies
Intervention: Etomidate; Ketamine; Emergency Endotracheal Intubation; Mechanical Ventilation
Intervention description: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.; Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.; Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.; Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Intervention MeSH terms: Ketamine; Etomidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 801.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: etomidate; ketamine; endotracheal intubation; anesthesia induction medications

Summary:

      Patients who are having problems breathing sometimes require placement of a breathing tube in
      their mouth and windpipe. The purpose of this breathing tube is to save the patient's life.
      It is common to give the patient a medication to sedate him or her before the breathing tube
      is placed. For patients who are gravely ill two medications are commonly used: etomidate or
      ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical
      Center and Parkland Memorial Hospital would like to do a study to figure out which one is
      better for our patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient (male or female) requiring emergency endotracheal intubation.

        Exclusion Criteria:

          -  Children (<18 years old).

          -  Women who are known to be pregnant.

          -  Any patient who has been previously randomized in the EvK Trial.

          -  Patients who require endotracheal intubation without sedative medication. For example,
             patients in full cardiac arrest.

          -  Patients with a known allergy to ketamine or etomidate.

          -  Any individual wearing a MedAlert bracelet indicating that he/she has formally opted
             out of the EvK Trial.
Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery
Condition: Pain
Intervention: Bupivacaine; Placebo
Intervention description: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients > 50 kgs; Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients > 50 kgs
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bupivacaine; Cardiac Surgery; Pediatrics; Nerve Block

Summary:

      All pediatric patients who undergo cardiac surgery require analgesic medications for
      postoperative pain control and many require sedation to facilitate comfort with cares.
      Parasternal infiltration of local anesthetic for nerve blocks is a simple option to
      postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve
      block administered in pediatric patients undergoing cardiac surgery will reduce the
      requirement of Opioids and other pain medications as well as decrease postoperative pain
      scores. This is a prospective, double-blind, randomized controlled trial. Subjects are
      randomized to receive either 0.25% Bupivacaine or normal saline following their
      cardiothoracic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 0-17 years old at time of surgery

          -  Society of Thoracic Surgeons- European Association for Cardio-Thoracic Surgery (STAT)
             mortality categories 1-3

          -  Surgical intervention requiring median sternotomy

          -  Expected extubation within 24 hours of surgery

        Exclusion Criteria:

          -  Known allergic reaction or hypersensitivity to Bupivacaine or to any local anesthetic
             agent of the amide type

          -  Delayed sternum closure
Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole
Condition: Schizophrenia; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Schizophrenia
Intervention: Stayers; Switchers
Intervention description: Participants remain on their current antipsychotic.; Subjects are randomized to switch to aripiprazole from their current antipsychotic.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizophrenia; Obesity; Hyperglycemia; Dyslipidemia; Type 2 Diabetes Mellitus

Summary:

      This proposal aims to use well-validated methodologies such as dual energy x-ray
      absorptiometry (DEXA), frequently sampled oral glucose tolerance tests (fsOGTTs), and
      hyperinsulinemic euglycemic clamps to characterize the metabolic effects of 12 weeks of
      aripiprazole treatment following chronic pretreatment with olanzapine, quetiapine,
      risperidone or ziprasidone.

      We hypothesize that switching to aripiprazole treatment will induce improvements in total
      body adiposity, inflammation (e.g., high sensitivity C-reactive protein [hsCRP]), glucose
      metabolism (e.g., insulin sensitivity) and lipid metabolism (e.g., fasting plasma
      triglyceride), in comparison to chronic pretreatment with olanzapine, risperidone and
      quetiapine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets DSM-IV criteria for Schizophrenia

          -  18-60 years of age or older

          -  Able to give informed consent

          -  Treated with olanzapine, quetiapine, risperidone or ziprasidone for greater than or
             equal to 3 months prior to enrollment

        Exclusion Criteria:

          -  pregnant or breastfeeding women will be excluded

          -  Meets DSM-IV criteria for substance abuse or dependence within past 6 months

          -  involuntary legal status (as per Missouri law)

          -  any serious medical disorder that may confound assessment of symptoms

          -  subjects taking prescription medications except psychotropic meds

          -  meets DSM-IV criteria for Mental Retardation (mild or worse)

          -  Subjects taking tricyclic antidepressants or mood stabilizers