bioihbjkbjnl/mcl2 huggingface dataset:
Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
Condition: Alzheimers Disease; Postoperative Delirium; Post Operative Cognitive Dysfunction
MeSH terms: Alzheimer Disease; Delirium; Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Intervention: Total intravenous anesthesia with propofol; General anesthesia with isoflurane
Intervention MeSH terms: Anesthetics; Propofol; Isoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: isoflurane; propofol; total intravenous anesthesia; inhaled anesthetic; volatile anesthetic; anesthesia; delirium; Post Operative Cognitive Dysfunction; Alzheimer's Disease; Mild Cognitive Impairment

Summary:

      This study will examine the hypothesis that changes in the cognition (i.e. thinking and
      memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers
      Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF),
      and/or changes in brain connectivity. The investigators will also examine whether different
      types of anesthesia have different effects on these CSF markers of Alzheimers disease, or
      different effects on thinking and memory after anesthesia and surgery, or differential
      effects on the correlation between cognitive changes and CSF marker changes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Surgical patients 60 years of age or older

          -  Surgery scheduled to last at least 2 hours (including time for anesthesia induction,
             etc)

          -  English speaking ability.

          -  Ability to give informed consent

        Exclusion Criteria:

          -  Inmate of a correctional facility (i.e. prisoners).

          -  Pregnancy

          -  Documented or suspected family or personal history of malignant hyperthermia.

          -  Patient unable to receive either propofol or isoflurane due to allergy or other
             specific contraindication.
TAP Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery
Condition: Colorectal Surgery; TAP Blocks
Intervention: Exparel; Ropivacaine
Intervention description: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.; Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
Intervention MeSH terms: Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This is a prospective randomized study designed to compare the pain control from a single
      shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters
      with ropivicaine bolus in patients undergoing elective colorectal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for elective colorectal surgery with Dr. Linda Farkas

        Exclusion Criteria:

          -  Patients under 18 years of age

          -  Patient over 90 years of age

          -  Pregnancy

          -  Prisoners

          -  Patients unable to provide consent

          -  Patients on systemic anticoagulation therapy

          -  Patients with an allergy to local anesthetics
Vitamin D Deficiency in Patients With Hypertension
Condition: Vitamin D Deficiency; Hypertension
MeSH terms: Hypertension; Vitamin D Deficiency
Intervention: Aliskiren; Cholecalciferol; Placebo
Intervention description: 150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks; 3000 I.U. once daily for 6 weeks; Placebo for two weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Vitamin D; Hypertension

Summary:

      This study will evaluate the effects of Vitamin D replacement and the effects of an approved
      medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who
      have low levels of vitamin D in their blood. The study will compare the effects of vitamin D
      or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined
             as a seated diastolic BP ≥ 90 mmHg and < 110 mmHg in the untreated state).

          -  Patients under treatment for hypertension must be willing and able to discontinue any
             previous antihypertensive medications for the duration of the study.

          -  25-hydroxyvitamin D levels < 30 ng/ml and > 12 ng/ml.

          -  Women of childbearing potential must be using a medically acceptable form of birth
             control for the duration of the trial, must have a negative serum pregnancy test at
             screening, and must have a negative urine pregnancy test within 7 days before
             initiating aliskiren therapy.

        Exclusion Criteria:

          -  Vitamin D levels < 12 ng/ml

          -  Known hypersensitivity or allergy to aliskiren

          -  Clinic blood pressure > 180/110 mmHg

          -  Known forms of secondary hypertension

          -  Chronic atrial fibrillation

          -  Uncontrolled or unstable cardiovascular diseases

          -  Shift or night workers

          -  Mid-arm circumference > 42 cm in diameter

          -  Current or recent (<1 year) alcohol or drug abuse

          -  Pregnant or lactating women
Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Emergencies; Headache
Intervention: Metoclopramide; Haloperidol; Normal Saline; Diphenhydramine
Intervention description: Patients receive 10 mg of intravenous (IV) metoclopramide.; Patients receive 2.5 mg of IV haloperidol.; All patients receive a 1-liter bolus of normal saline (NS); All patients receive 25 mg of intravenous (IV) diphenhydramine.
Intervention MeSH terms: Diphenhydramine; Promethazine; Haloperidol; Metoclopramide; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metoclopramide (Reglan); Haloperidol (Haldol)

Summary:

      Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency
      department (ED).In this study the investigators seek to explore another option for treatment
      of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol),
      a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor
      in the brain.

      By exploring haloperidol as an option for treatment, the investigators hope to discover a
      more efficient and effective medication for the treatment of non-traumatic headaches, thereby
      decreasing a patient's length of stay in the department and decreasing the rate of return
      visits for continued discomfort from the same headache. This study could lead to the
      increased usage of haloperidol as a first line agent in the treatment of prolonged headaches
      presenting to the ED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who present with a headache or migraine with onset less than or equal to 72
             hours

        Exclusion Criteria:

          -  Known pregnancy

          -  Breast-feeding women

          -  Known history of arrhythmias or QT prolongation (450 ms)

          -  Known adverse effects to haloperidol, diphenhydramine (Benadryl) or metoclopramide

          -  Subarachnoid hemorrhage

          -  Headaches caused by trauma, meningitis

          -  Congestive heart failure

          -  Parkinson's Disease

          -  Dementia

          -  Pheochromocytoma

          -  History of glaucoma

          -  History of seizures

          -  Non-English speaking patients
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
Condition: Iron Deficiency Anemia Treatment; Chronic Kidney Disease(CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferumoxytol; Iron Sucrose
Intervention description: IV Ferumoxytol; IV Iron Sucrose
Intervention MeSH terms: Ferrosoferric Oxide; Ferric Oxide, Saccharated
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia (IDA); chronic kidney disease (CKD); hemodialysis; magnetic resonance imaging (MRI); ferumoxytol; Feraheme

Summary:

      The objectives of this study are to compare the efficacy and safety of repeat doses of
      intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with
      hemodialysis-dependent CKD.
    

Eligibility criteria:

        Key Inclusion Criteria include:

          1. Males and females ≥18 years of age

          2. Diagnosis of CKD

          3. Subjects on dialysis must have been on dialysis for at least 3 months prior to
             screening

          4. Female subjects of childbearing potential who are sexually active must be on an
             effective method of birth control for at least 1 month prior to screening and agree to
             remain on birth control until completion of participation in the study

        Key Exclusion Criteria include:

          1. History of allergy to either oral or IV iron

          2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3
             months postpartum, or have a positive serum or urine pregnancy test

          3. Parenteral iron therapy within 30 days prior to screening or red blood cell
             (RBC)/whole blood transfusion within 14 days prior to screening or planned during the
             study
Post-Op Lidocaine Patch
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Lidoderm 5 % Topical Patch; Sham Topical Patch
Intervention description: Lidocaine patch after cesarean section delivery.; Sham patch after cesarean section delivery.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cesarean section; Postoperative pain

Summary:

      Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative
      cesarean incision pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant patients who require a scheduled or non-urgent cesarean birth

          -  Patient able to receive neuraxial analgesia

          -  Patient able to give verbal and written consent for both cesarean birth and study

        Exclusion Criteria:

          -  Patients requiring emergent cesarean birth

          -  Patients allergic to lidocaine or adhesive

          -  Patients who have already received an epidural during this admission or requiring
             general anesthesia for cesarean birth

          -  Patients using chronic oral neuromodulators

          -  Patients with cardiac disease or using anti-arrhythmic agents

          -  Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis,
             osteoarthritis, or lupus.

          -  Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the
             study.
Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Lifestyle Intervention; Metformin
Intervention description: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.; At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patient Recruitment:
The investigators are targeting the highest risk pre-diabetic patients for this study. Patient recruitment will occur through the involved health clinics.
Control Participants Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited from the ECHORN Cohort Study (ECS).
ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups. These participants will be offered a delayed intervention at the end of 2.5years, given the evidence supporting behavioral modification for diabetes prevention.
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 40 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk
      pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.

      Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle
      intervention, with escalation to Metformin therapy will lower the incidence of diabetes among
      the highest risk pre-diabetic individuals of Caribbean-descent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI>25 or WC>88/102cm

          -  No history of type I or type II diabetes or gestational diabetes

          -  Not on blood sugar altering medication

          -  Ability to attend weekly sessions

          -  HbA1c 6-6.4%

        Exclusion Criteria:

          -  Pregnant

          -  eGFR<45 mL/min/1.73 m2

          -  Prescribed Metformin and randomized to the control arm
MEthylene Blue In Patients With Acquired Methemoglobinemia
Condition: Acquired Methaemoglobinaemia
MeSH terms: Methemoglobinemia
Intervention: Methylene Blue
Intervention description: Administration of Methylene Blue to treat acquired methaemoglobinaemia
Intervention MeSH terms: Methylene Blue
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Healthy volunteers: No
Keywords: Acquired Methaemoglobinemia; Methylene Blue

Summary:

      This is an open label, uncontrolled, Phase 4 study including 10 patients who present in
      hospital/urgent care setting with acquired methemoglobinemia. The population may include
      pediatric and adult patients (males and females of all ages are included).

      The study will run in both the EU and the US. The aim of the study is to confirm safety and
      efficacy of ProvayBlueTM for the treatment of acquired methemoglobinemia and has been
      requested by the US-FDA as a Post-Marketing requirements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric or adult patients (males and females of all ages are included) diagnosed
             with acquired methemoglobinemia and receiving treatment with ProvayBlue™ as per the
             treating physician's diagnosis and hospital standard of care.

        Acquired methemoglobinemia is defined as a level of methemoglobinemia >30% or ≤30% in case
        of clinical symptoms (e.g. sleepiness, cyanosis, dizziness, etc.).

          -  Written informed consent obtained prior to any data collection (retrospective and
             prospective) for this study and study specific assessments.

        Exclusion Criteria:

          -  Known severe hypersensitivity reactions to methylene blue or any other thiazine dye;

          -  Known deficiency in glucose-6-phosphate dehydrogenase (G6PD) due to the risk of
             hemolytic anemia as well as lack of therapeutic effect;

          -  Known deficiency in Nicotinamide Adenine Dinucleotide Phosphate Hydrogen (NADPH)
             reductase.

          -  Known use of selective serotonin reuptake inhibitors (SSRIs), serotonin and
             norepinephrine reuptake inhibitors (SNRIs), MonoAmine Oxidase (MAO) inhibitors or
             drugs metabolised via CYP isoenzymes anticipated during the treatment phase of the
             study.

          -  Women who refuse to stop breastfeeding for up to 8 days after receiving the last dose
             of ProvayBlueTM.
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