bioihbjkbjnl/mcl2 huggingface dataset:
Determine the Clinical Advantage of IV vs PO Acetaminophen
Condition: Inguinal Hernia
MeSH terms: Hernia, Inguinal
Intervention: Acetaminophen IV Soln; Oral Acetaminophen; Placebo Pills; Saline
Intervention description: 1000mg of IV acetaminophen; oral acetaminophen 975mg pills; placebo match to acetaminophen; Intravenous saline
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acetaminophen; Tylenol; Intravenous versus oral

Summary:

      There is limited research on the clinical outcome differences between intravenous (IV)
      acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen
      sometimes being almost 100 times the cost of PO acetaminophen, it is not only important
      fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The
      proposed research study is to determine the clinical advantages of IV vs PO acetaminophen
      during the post-operative recovery time for ambulatory surgery patients by analyzing
      differences in time to first opioid delivery, pain scores, and patient satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA scores I-III

          -  Ambulatory surgery patients

          -  Ages 18-75

          -  Surgeries requiring general anesthesia for hernia surgery

        Exclusion Criteria:

          -  Patients with contraindications to acetaminophen (history of end organ liver
             dysfunction)

          -  Known allergy to acetaminophen

          -  Emergency surgery

          -  Patients who were not fasted

          -  Patients who cannot tolerate PO

          -  Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen

          -  Pregnancy

          -  Weight less than 50kg

          -  Chronic daily narcotic use

          -  Patients who's anesthetic plan requires regional anesthesia

          -  Patient refusal to participate or do not have capacity to provide consent.
Biomarker Study of Acamprosate in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Acamprosate
Intervention description: Acamprosate 333mg, ii tablets PO tid x 2 weeks
Intervention MeSH terms: Acamprosate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: schizophrenia; schizoaffective disorder; glutamate; NMDA receptor; magnetic resonance spectroscopy; acamprosate

Summary:

      NMDA receptors are brain receptors that are stimulated by glutamate. Poorly functioning NMDA
      receptors are thought to be involved in the pathology of schizophrenia. This hypothesis is
      based on the observation that PCP, which blocks the NMDA receptor, produces symptoms and
      cognitive impairments similar to schizophrenia. Efforts to enhance the function of the NMDA
      receptor with glycine and D-cycloserine have met with limited success. An alternative
      approach would be to use the drug acamprosate.

      Acamprosate, FDA-approved for maintenance of sobriety after detoxification from alcohol,
      seems to act through modulation of the NMDA receptor. In the lab, acamprosate has been noted
      to act as an antagonist when the NMDA receptors are maximally stimulated but as an agonist
      when NMDA receptor stimulation is minimal. This "smart drug" action makes acamprosate
      appealing for use in schizophrenia. If acamprosate works as a smart drug in patients, then we
      would predict that it would enhance the function of NMDA receptors in schizophrenia and
      improve cognition and the symptoms of the illness. Additionally, acamprosate seems to
      modulate the NMDA receptor in novel ways distinct from glycine and D-cycloserine.

      We will also see if the response to acamprosate differs based on whether participants do or
      do not have a past history of alcohol use disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of schizophrenia/schizoaffective disorder

          -  Age 18-55 years

          -  Male or female

          -  Any Race/ethnicity

          -  Participants will be analyzed separately depending on whether they do or do not have a
             history of an alcohol use disorder

        Exclusion Criteria:

          -  Pregnant/nursing females or females not using adequate birth control

          -  Documented history of mental retardation/severe neurological disorder/head injury with
             loss of consciousness

          -  DSM-IV diagnosis of substance dependence in previous six months/abuse in the previous
             three months (except nicotine)

          -  Serious suicidal risk in the previous six months

          -  History of renal failure/creatinine clearance of less than 50mL/min

          -  Current treatment with clozapine

          -  Contraindication to MRI scanning.
Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)
Condition: Attention Deficit Hyperactivity Disorder; Reading Disorder
MeSH terms: Hyperkinesis; Dyslexia; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine Hydrochloride; placebo
Intervention description: Atomoxetine, 1.2 mg/kg/day, by mouth (PO); Placebo, every day (QD), by mouth (PO)
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 8 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To test the hypothesis that a 4 week treatment with atomoxetine is more effective than
      placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD),
      patients with only Reading Disorder, and patients with combined type ADHD and Reading
      Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading
             Disorder

        Exclusion Criteria:

          -  Patients with Conduct Disorder

          -  Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive
             Development Disorder.

          -  Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive
             Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder,
             and certain other learning disorders.
Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Kidney Failure, Chronic; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Placebo; Everolimus
Intervention description: placebo comparator; experimental
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 431.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: end-stage renal disease, ESRD, autosomal dominant polycystic kidney disease, ADPKD, everolimus

Summary:

      This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney
      expansion as well as worsening of renal function in patients with ADPKD and whether the
      application of 5 mg/day everolimus as monotherapy is safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria

          1. Clinical diagnosis of autosomal dominant polycystic kidney disease ADPKD

          2. Chronic kidney disease (CKD) stage II / III

          3. Females capable of becoming pregnant must have a negative serum pregnancy test within
             7 days prior to or at baseline, and are required to practice an approved method of
             birth control for the duration of the study and for a period of 6 weeks following
             discontinuation of study medication, even where there has been a history of
             infertility

        Exclusion Criteria

          1. ADPKD patients with normal renal function

          2. ADPKD patients with CKD stage IV

          3. Patients with a history of subarachnoid bleeding

          4. Patients with a history of severe infections

          5. Patients with life-threatening urinary tract or cyst infection in the past

          6. Patients who have received any investigational drug within four weeks prior to
             baseline

          7. Patients who have been treated with any non-protocol immunosuppressive drug or
             treatment within one month prior to baseline

        Other protocol-defined inclusion/exclusion criteria may apply
Ketamine for Pain in the Emergency Department
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Intervention: Ketamine Injectable Product
Intervention description: Three different doses of ketamine will be administered.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 arms each arm getting a different dose of ketamine
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded study (only the pharmacist supervisor that has no other involvement with the study will know the dose)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: moderate to severe pain; emergency department patient; ketamine

Summary:

      This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score
      reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2
      mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also
      examine the frequency of adverse events secondary to ketamine including fatigue, dizziness,
      nausea, headache, feeling of unreality, changes in hearing or vision, mood changes,
      generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory
      analysis based on the need for rescue analgesia within two hours of ketamine administration,
      adequate pain relief, previous opioid tolerance, and age (adults < 65 years old and > 65
      years old).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute pain (including acute on chronic pain)

          -  Pain score of moderate to severe (> 4/10) on the Numerical Rating Scale

          -  Provider determines the patient requires intravenous ketamine for analgesia

        Exclusion Criteria:

          -  History of hypersensitivity to ketamine

          -  Altered mental status

          -  Psychiatric illness

          -  Known history of renal or hepatic insufficiency

          -  Acute head or eye injury

          -  Suspected intracranial hypertension or mass

          -  Headache as the chief complaint

          -  Alcohol or drug abuse

          -  Received an analgesic within the last four hours

          -  History of congestive heart failure

          -  History of aortic or brain aneurysm

          -  Active Chest Pain

          -  Porphyria

          -  Active methadone treatment

          -  Pregnant or breastfeeding

          -  Signs of respiratory, hemodynamic, or neurologic compromise

               -  Systolic blood pressure < 90 mmHg or > 180 mmHg

               -  Heart rate < 50 beats per minute or > 150 beats per minute

               -  Respiratory rate < 10 breaths per minute or > 30 breaths per minute

               -  Glasgow Coma Score < 15

          -  Previously received ketamine < 0.3 mg/kg IV for acute pain in the emergency department
RNS® System LTT Study
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: RNS® System
Intervention description: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epilepsy; Responsive neurostimulation; RNS System; NeuroPace; Brain stimulation; Seizures

Summary:

      The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the
      long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of
      seizures in individuals 18 years of age or older with partial onset seizures that are
      refractory to two or more antiepileptic medications. Candidates will continue to receive
      their epilepsy medications while participating in the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has completed either the RNS® System Pivotal or Feasibility study

          2. Subject has an implanted RNS® System

          3. Subject has elected to continue to receive responsive neurostimulation therapy after
             completion of the RNS® System Pivotal or Feasibility study

          4. Subject is able to attend scheduled appointments for the RNS® System LTT study

        Exclusion Criteria:

          1. Subject has active psychiatric or medical illness that makes it inadvisable for the
             subject to continue to receive responsive neurostimulation therapy with the RNS®
             System

          2. Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily
             generalized seizures during the RNS® System Pivotal or Feasibility study

          3. Subject has been noncompliant with scheduled appointments during the RNS® System
             Pivotal or Feasibility study

          4. Subject has been noncompliant with maintaining seizure diaries during the RNS® System
             Pivotal or Feasibility study

          5. Informed consent cannot be obtained from subject or caregiver
Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)
Condition: Blood Loss
MeSH terms: Hemorrhage
Intervention: Tranexamic Acid; Aquamantys System; Control
Intervention description: see arm/group descriptions; see arm/group descriptions; Standard Electro-cautery and Saline
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tranexamic Acid; Blood Loss; Aquamantys System; TKA

Summary:

      The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the
      postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the
      simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The
      assumption is that the combination of iv TXA and Aquamantys system will enable an improvement
      in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated
      by the use of Aquamantys system alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients over age of 18 undergoing elective total primary knee arthroplasty
             under spinal anesthesia.

        Exclusion Criteria:

          -  Previous adverse reaction to tranexamic acid

          -  Congenital or acquired coagulation disorders

          -  Preoperative platelet count of less than 100,000/microliter or INR> 1.4

          -  History of deep venous thrombosis, pulmonary embolism or cerebrovascular accident

          -  Patients with acquired defective color vision

          -  Renal insufficiency (Glomerular filtration rate <20 ml/min)

          -  Severe liver disease

          -  Coronary stents

          -  Pregnant patients

          -  Main anesthetic other than spinal anesthesia
A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: amlodipine and olmesartan medoxomil tablets; hydrochlorothiazide tablets
Intervention description: amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks; hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 999.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The initial 12 week portion of this 20 week study will examine the ability of a combination
      of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high
      blood pressure who have not had sufficient blood pressure reduction using one
      anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine
      the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to
      lower blood pressure in the same patient population. All three medications being tested have
      been approved by the FDA for the treatment of high blood pressure, but only amlodipine and
      olmesartan are currently approved for use in combination form.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= to 18 years of age

          -  Hypertension uncontrolled on current monotherapy

          -  Females:

          -  negative serum pregnancy test at screening

          -  post menopausal or have had a hysterectomy or tubal ligation or practicing approved
             methods of birth control

        Exclusion Criteria:

          -  Pregnant females

          -  Uncontrolled hypertension with multiple drugs, except for
             hydrochlorothiazide/triamterene

          -  Diabetes requiring insulin

          -  Serious disorders that may limit the ability to evaluate the efficacy or safety of
             treatment

          -  History of myocardial infarction, bypass graft, angioplasty or heart failure within
             the past 6 months

          -  History of Class III or IV congestive heart failure

          -  History of stroke or transient ischemic attack within the last 1 year
Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Condition: Diabetic Neuropathies
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: Duloxetine
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from
      Diabetic Neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes
             with the pain beginning in the feet and present for at least 6 months.

          -  May not be pregnant and agree to utilize medically acceptable and reliable means of
             birth control during participation in the study.

          -  Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

        Exclusion Criteria:

          -  History of substance abuse or dependence within the past year, excluding nicotine and
             caffeine.

          -  Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or
             severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems
             with peripheral vascular disease, or other medical conditions or psychiatric
             conditions that would hinder your participation or be likely to lead to
             hospitalization during the course of the study.

          -  Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the
             potential need to take during or within 5 days after discontinuation from the study.

          -  Treatment with fluoxetine within 30 days of starting the study.

          -  Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
Exploration of Pupil Dilation in Horner's Patients Taking Flomax
Condition: Horner Syndrome
MeSH terms: Horner Syndrome; Mydriasis
Intervention: 10% phenylephrine
Intervention description: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: Single arm, intervention trial.
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alpha blockers; Tamsulosin

Summary:

      This study is evaluating the pupil dilation of Horner's Patients who have ever taken an alpha
      blocker such as Tamsulosin. Patients will undergo eye dilation as would occur at a yearly eye
      examination, but their pupil dilation measurements will be recorded.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Horner's Syndrome

          2. History of taking an alpha blocker (tamsulosin/
             terazosin/doxazosin/alfuzosin/silodosin) medication

        Exclusion Criteria:

          1. Subjects with untreated hypertension

          2. Subjects with thyrotoxicosis

          3. Pregnant women

          4. Prisoners

          5. Inability to consent

          6. Subjects with anatomical narrow angles who have never had a dilated exam