bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Condition: Stem Cell Transplant Complications; Delirium
MeSH terms: Delirium
Intervention: Haldol
Intervention MeSH terms: Haloperidol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This research study proposes to conduct an open label, feasibility study administering
      prophylactic oral haldol to patients undergoing a hematopoietic stem cell transplant (HSCT).

      The study will address the following research aims: 1) To demonstrate the feasibility of
      enrolling HSCT patients in a prophylactic medication trial, 2) To determine the tolerability
      of oral haldol in HSCT patients and 2) To compare rates of delirium in HSCT patients who
      receive prophylactic haldol with an untreated historical control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant must undergo an autologous or allogeneic bone marrow or stem cell
             transplant

          -  The participant is 18 years of age or older

          -  The participant provides written consent

        Exclusion Criteria:

          -  The participant has a QTc of >450 msec at the time of enrollment

          -  The participant used any antipsychotic medications within the last 30 days

          -  The participant has any significant allergies or past intolerance to Haloperidol

          -  The participant has a history of major neurological, metabolic, psychiatric, or
             cardiovascular disease, cerebrovascular event, or substance abuse

          -  The participant has a history of mental retardation or learning disability that, at
             the discretion of the investigator, could affect their ability to complete study
             assessments.
Allopurinol Outcome Study
Condition: Gout
MeSH terms: Gout
Intervention: Allopurinol
Intervention description: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
Intervention MeSH terms: Allopurinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1735.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the
      safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy
      (ULT) for up to six months. Allopurinol will be dosed according to the local product label,
      at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for
      each patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets the diagnosis of gout according to the American Rheumatism Association (ARA)
             Criteria for the Classification of Acute Arthritis of Primary Gout.

          -  Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.

          -  If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.

          -  Must have had at least 2 gout flares in the past year.

        Exclusion Criteria:

          -  Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of
             wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).

          -  History or suspicion of drug abuse.

          -  History of autoimmune disease requiring systemic treatment.

          -  Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or
             hepatitis B antibody (HBsAg) infection.

          -  History of malignancy within the previous 5 years (with the exception of nonmelanoma
             skin cancer that has been treated with no evidence of recurrence, treated cervical
             dysplasia or treated in situ Grade 1 cervical cancer).

          -  Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or
             IV heart failure, or stroke within the last 12 months.

          -  Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure
             above 95 mm Hg).

          -  Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.

          -  Kidney or other organ transplant.

          -  Active peptic ulcer disease requiring treatment.

          -  History of xanthinuria, active liver disease, or hepatic dysfunction.

          -  If unable to take gout flare prophylaxis of either colchicine or nonsteroidal
             anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal
             function, use of contraindicated medications).

          -  Known hypersensitivity or allergy to allopurinol.
Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing
Condition: Acetaminophen Toxicity
Intervention: First Treatment Period; Washout; Second Treatment Period
Intervention description: (duration: 14 days) Subjects will be randomized to receive either of the 2 interventions (4 grams of solid acetaminophen formulation for two weeks vs. 4 grams of solid acetaminophen formulation + 70 mg/kg/day of liquid propylene glycol); (duration: 14 days) At the end of the First intervention period all participants will enter a washout period.; (duration: 14 days) At the end of the washout period, participants will receive the alternative intervention.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Eligible subjects will then be randomized at a 1:1 ratio to receive either acetaminophen (APAP) or APAP + propylene glycol for 2 weeks (Treatment Period 1). At the end of the Treatment Period 1 subjects will enter the Wash-Out period for 2 weeks. Study subjects will then receive the alternative treatment for 2 weeks (Treatment Period 2). Overall, the maximum duration of treatment is approximately 6 weeks.
RESPONDERS: Subjects whose transaminase levels rise to 3 times normal or greater during either of the Treatment Periods will be deemed responders and the intervention will cease.
If subjects are in the Treatment Period 1, they will enter the washout period and continue to return daily to ensure that liver function tests decline. After the 2 week washout-period, responders will cross over to Treatment Period 2.
If subjects are in the Treatment Period 2 phase, they will continue to return to the CRC and have their transaminases checked until they return to normal.
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acetaminophen; Propylene glycol

Summary:

      A purpose of this protocol is to is to compare the metabolites of the toxic bioactivating
      pathway after acetaminophen alone or acetaminophen followed by Propylene Glycol (PG) and to
      determine if it prevents the formation of the toxic metabolites of acetaminophen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers ages 20-40

          -  Patients not taking any chronic medications

        Exclusion Criteria:

          -  Any history of liver disease

          -  Frequent alcohol use (2 or more drinks more than 4 times per week)

          -  Pregnant women

          -  Chronic medical condition requiring daily pharmacotherapy or the use of any daily
             prescription medications.

          -  Unable to provide informed consent
Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Levetiracetam
Intervention description: Pharmaceutical form: oral tablets
Concentration: 500 mg
Route of administration: Oral use
Intervention MeSH terms: Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial Onset Seizures; Keppra; Levetiracetam

Summary:

      Community based study assessing safety and efficacy of levetiracetam in partial onset
      seizures.

      The optimal dose in daily clinical practice will be used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with epilepsy experiencing partial seizures, whether or not secondarily
             generalized.

          -  Subjects must present between 3 and 42 partial seizures over the three months prior to
             protocol Visit 1.

          -  Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs
             (AEDs) at the time of trial entry.

        Exclusion Criteria:

          -  Subjects on vigabatrin, whose visual field has not been assessed as per recommendation
             of the manufacturer, i.e. every 6 months.

          -  Presence of known pseudoseizures within the last year.

          -  Presence of progressive cerebral disease, any other progressively degenerative
             neurological disease, or any cerebral tumors.

          -  Uncountable seizures (clusters) or history of convulsive status epilepticus within the
             last five years.
Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Superparamagnetic Iron Oxide Magnetic Resonance Imaging
Intervention description: Two MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SPIO MRI; Feridex

Summary:

      The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall
      Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an
      FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise
      undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for
      surgical resection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally resectable pancreatic mass present on one or more pre-operative imaging
             modalities

          -  Must demonstrate no evidence of distant metastases as assessed by chest/abdomen/pelvis
             CT scan

          -  Deemed eligible for resection with curative intent by a treating surgeon who is listed
             as an investigator on this study

          -  18 years of age or older

          -  No uncontrolled serious medical or psychiatric illness

          -  Women of childbearing potential must not be pregnant or lactating

        Exclusion Criteria:

          -  Known allergy to iron or dextran

          -  Pregnant or lactating

          -  Counter-indication to MRI, such as the presence of metallic prostheses or implanted
             metal device

          -  Sickle cell disease or hemoglobinopathy
Antidepressant Treatment of Melancholia in Late Life
Condition: Depression; Melancholia
MeSH terms: Depression; Depressive Disorder
Intervention: Sertraline; Nortriptyline
Intervention description: 12 week trial dose up to 200mgs; 12 week trial dose adjusted to therapeutic level
Intervention MeSH terms: Sertraline; Nortriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 60 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Aged; Antidepressive Agents, Tricyclic; Depression; Female; Human; Male; Middle Age; Nortriptyline; Sertraline; Serotonin Uptake Inhibitors; Antidepressive Agents, Tricyclic -- *therapeutic use; Antidepressive Agents, Tricyclic -- adverse effects; Depression -- *drug therapy; Nortriptyline -- *therapeutic use; Nortriptyline -- adverse effects; Sertraline -- *therapeutic use; Sertraline -- adverse effects; Serotonin Uptake Inhibitors -- *therapeutic use; Serotonin Uptake Inhibitors -- adverse effects

Summary:

      The purpose of this study is to compare the safety and effectiveness of a select serotonin
      re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in
      outpatients over the age of 60 who have major depression.

      SSRIs are effective in the treatment of major depression. However, there is also evidence
      that SSRIs may be significantly less effective than TCAs for patients with late-life major
      depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more
      widely prescribed, it is important to determine which of these types of antidepressants works
      best to treat these patients.

      Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a
      TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of
      life. If a patient responds to treatment, he/she will participate in a 6-month continuation
      phase in which he/she will continue to receive the same medication.

      An individual may be eligible for this study if he/she:

      Has unipolar major depression (with some exceptions) and is over 60 years old.
    

Eligibility criteria:

        Inclusion Criteria:

        -

        Patients must have:

        Unipolar major depression (per Diagnostic and Statistical Manuel-IV criteria) with or
        without melancholia.

        Exclusion Criteria:

        -

        Patients with the following symptoms or conditions are excluded:

        Psychotic or atypical subtype of unipolar major depression.
Pilot Study: Preoperative Nicotine Lozenges
Condition: Smoking
Intervention: Nicotine Lozenge; Placebo Lozenge; Abstinence Advisement
Intervention description: Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day and a 2 minute behavioral intervention. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.; Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day and a 2 minute behavioral intervention.; A brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cigarettes, surgery; Smokers scheduled for elective surgery

Summary:

      The goal of this pilot study is to determine the feasibility and potential effect size of
      nicotine lozenges as an adjunct to maintain brief preoperative abstinence, defined as not
      smoking the day of surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current cigarette smoker, defined as >100 cigarettes lifetime consumption and self
             report of smoking every day

          -  Scheduled for elective non-cardiac surgery

        Exclusion Criteria:

          -  An inability to understand consent procedures

          -  History of an allergic reaction to nicotine replacement therapy

          -  History of sustained ventricular tachycardia

          -  Untreated hyperthyroidism or pheochromocytoma

          -  Currently utilizing pharmacologic agents specifically to treat nicotine dependence,
             including nicotine replacement therapy and bupropion (for a stop-smoking indication)

          -  Active (within the past 12 months) non-nicotine drug dependence

          -  Females who are pregnant or lactating

          -  Patients with phenylketonuria, because the lozenges contain aspartame, which is
             metabolized to phenylalanine.

          -  Lack of access to a telephone, as one follow-up will be performed using this means.
Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
Intervention: Arformoterol (Brovana); Placebo
Intervention description: twice daily via nebulizer added to maintenance daily tiotropium; Placebo twice daily for 1 week (added to maintenance tiotropium)
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 40 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: COPD; Bronchodilator; arformoterol; tiotropium

Summary:

      This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this
      study will provide proof-of-concept information on whether the (anticipated) additional
      bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in
      the patient-centered outcome, exercise capacity. This study will only evaluate the effects of
      short-term (1-week) administration of Brovana. If results are positive, it would provide
      preliminary data for further, multicenter investigations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent (Approval by the St. Francis Hospital Institutional Review Board
             (IRB) will be required before study initiation)

          2. Adults, age > 40 years

          3. A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator
             forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) ( < 0.70

          4. Moderate, severe and very severe airflow limitation by GOLD criteria.

          5. Clinically stable respiratory disease

          6. The perceived ability to participate in pulmonary testing and exercise testing

          7. COPD, stable state

        Exclusion criteria:

          1. Women of childbearing potential

          2. Asthma

          3. Supplemental oxygen use or anticipated oxygen desaturation < 85% at peak exercise
             (patients who desaturate below 85% on the incremental study will be excluded)

          4. Co-morbidity that would interfere with the patient participating in the study,
             including the exercise testing. Examples include unstable cardiac disease, arthritis,
             psychological problems that would interfere with participation

          5. An exacerbation requiring therapy or any change in maintenance COPD therapy within six
             weeks of testing

          6. A history of a prolonged QT interval

          7. Recent exacerbation of COPD
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia (TD)
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: Valbenazine; Placebo oral capsule
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the
      persistence of effect of valbenazine 40 mg and 80 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently during the screening,
             treatment, and follow-up periods of the study.

          2. Have one of the following clinical diagnoses for at least 3 months before screening:
             Schizophrenia, Schizoaffective Disorder, or Mood Disorder

          3. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before
             screening.

          4. Be on stable doses if using maintenance medication(s) for schizophrenia or
             schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on
             stable doses of a mood stabilizer.

          5. Be in general good health.

          6. Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month
             before screening.

          2. Have a known history of substance (drug) dependence, or substance or alcohol abuse.

          3. Have a significant risk of suicidal or violent behavior.

          4. Have been hospitalized for psychiatric disorder within 6 months before Day 1.

          5. Have a known history of neuroleptic malignant syndrome.

          6. Have a known history of long QT syndrome or cardiac arrhythmia.

          7. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

          8. Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine
             (INGREZA) within 30 days of screening.

          9. Have received an investigational drug within 30 days before Day 1 or plan to use an
             investigational drug (other than NBI-98854) during the study.

         10. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

         11. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg,
             tetrabenazine, deutetrabenazine).

         12. Are currently pregnant or breastfeeding.

         13. Have HIV or hepatitis B.