bioihbjkbjnl/mcl2 huggingface dataset:
Sub-dissociative Dose Ketamine Dosing Study
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Ketamine
Intervention description: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate
      to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to
      Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ages 18-59

          -  Weight 45 - 115 kg

          -  Acute abdominal, flank, back, musculoskeletal pain, or a headache

          -  Onset of pain within 7 days

          -  Pain score of 5 or more

          -  Requiring intravenous analgesia

          -  Hasn't been enrolled in this study previously

        Exclusion Criteria:

          -  Pregnancy

          -  Breast-feeding

          -  Altered mental status rendering the patient unable to consent to the study

          -  Allergy to ketamine

          -  Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or
             >150 beats/minute, and respiration rate <10 or >30 breaths/minute)

          -  History of acute head or eye injury, seizure, intracranial hypertension

          -  Chronic pain

          -  Renal or hepatic insufficiency

          -  Known alcohol or drug use disorder

          -  Currently under influence of alcohol/opiates

          -  Acute psychiatric illness
HCV Positive Heart Donors
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Transplant with HCV positive donor, followed by surveillance and treatment of viremia
Intervention description: Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Healthy volunteers: No

Summary:

      Study subjects active on the waiting list for a heart transplant at the NYU Langone
      Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from
      a donor who tests positive for HCV. The study will entail surveillance for the development of
      HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated
      with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are
      treated with Mavyret will be monitored for clearance of viremia and for sustained virologic
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Listed for an isolated heart transplant at NYU Langone Health

          -  Able to travel to the NYU Langone Health for routine post-transplant visits and study
             visits for a minimum of 6 months after transplantation

          -  No active illicit substance abuse

          -  Weight at least 50kg

          -  Women of childbearing potential must agree to use birth control in accordance with
             Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to
             the increased risk of birth defects and/or miscarriage

          -  Both men and women must agree to use at least one barrier method after transplant to
             prevent any secretion exchange

          -  Able and willing to provide informed consent

        Exclusion Criteria:

          -  HIV positive

          -  HCV RNA positive or history of previously treated HCV

          -  Hepatitis B surface antigen positive or on active antiviral treatment for HBV

          -  Pregnant or nursing (lactating) women

          -  Use of strong CYP3A inducers
A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain
Condition: Pain
MeSH terms: Musculoskeletal Pain
Intervention: Aspirin and Ketamine; Oral Ketamine
Intervention description: Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin; Proprietary oral formulation of 0.5mg/kg of ketamine
Intervention MeSH terms: Aspirin; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Emergency Medicine, Pain, Pain Management, Musculoskeletal; Emergency Medicine; Pain; Pain Management; Musculoskeletal

Summary:

      Acute Pain is one of the most frequent chief complaints and the main reason for visiting the
      Emergency Department (ED). The acute pain in the ED is largely prevalent across the country
      with recent literature demonstrating that 61-91% of patients are admitted to the ED due to a
      variety of acute painful syndromes. There is a lack of good options for pain control in such
      settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 and older

          -  acute musculoskeletal pain

          -  initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating
             scale.

          -  awake, alert, and oriented to person, place, and time

        Exclusion Criteria:

          -  altered mental status,

          -  allergy to aspirin and ketamine,

          -  pregnant

          -  unstable vital signs (systolic blood pressure <90 or>180 mm Hg, pulse rate <50 or >150
             beats/ min, and respiration rate <10 or >30 breaths/min)

          -  inability to provide consent

          -  consumption of Aspirin or NSAID's within 6 hours of arrival to the ED

          -  active PUD

          -  history of GI Hemorrhage

          -  history of renal and hepatic insufficiency

          -  past medical history of alcohol or drug abuse

          -  schizophrenia
The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals
Condition: Healthy
Intervention: Olanzapine
Intervention description: All subjects will take a single 2.5 mg dose of olanzapine (Zyprexa Zydis) followed by a 5 mg dose for 14 days. (2.5 mg/d for 1 day, 5 mg/d for 14 days).
Intervention MeSH terms: Olanzapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers; antipsychotic drugs; brain metabolism

Summary:

      The primary aim of this study is to investigate antipsychotic drug effects on healthy brain
      metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 21-50 years old

          -  Male or female

          -  Without psychiatric diagnosis according to a structured psychiatric interview (SCID)

          -  Without history of a psychotic disorder among parents, siblings, or children

        Exclusion Criteria:

          -  Significant medical or neurological illness

          -  Diagnosis diabetes mellitus, uncontrolled hypertension, severe hypotension, coronary
             artery disease, metabolic syndrome, glaucoma, liver impairment, decreased renal
             function, respiratory disorders, peptic ulcer disease (absolute and relative
             contraindications to use of antipsychotic drugs)

          -  Body mass index (BMI) over 30

          -  Taking any other medications, including over the counter supplements with the
             exception of oral contraceptives for women

          -  Pregnancy. Females of child-bearing age must be using an effective contraceptive
             method

          -  History of smoking, substance abuse or dependence

          -  Contraindication to MR scan (claustrophobia, cardiac pacemakers, metal clips and
             stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc.,
             brain stimulator devices, implanted drug pumps, ear implants, eye implants or known
             metal fragments in eyes, exposure to shrapnel or metal filings, other metallic
             surgical hardware in vital areas, certain tattoos with metallic ink, certain
             transdermal patches, metal-containing IUDs)

          -  Medical condition that would prevent blood draws
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Intervention: Esomeprazole 40 mg
Intervention description: Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 408.0
Sex: All
Minimum age: 15 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole
      (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with
      symptomatic erosive esophagitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients between the ages of 15 and 80 years

          -  with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the
             stomach,

          -  who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are
             recruited.

        Exclusion Criteria:

          1. coexistence of peptic ulcer or gastrointestinal malignancies,

          2. pregnancy,

          3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis
             and uremia),

          4. previous gastric surgery,

          5. allergy to esomeprazole,

          6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and

          7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin
Condition: Anticoagulants and Bleeding Disorders; Surgery; Regional Anesthesia Morbidity
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Intervention: Enoxaparin; Enoxaparin
Intervention description: The intervention is the implementation of a 36-hour time period from the last dose of treatment dose Enoxaparin to the blood sampling for anti-Xa testing.; This is the historical control arm. 24 hours removed from their last dose (time period from the last dose of treatment dose Enoxaparin to the blood sampling for anti-Xa testing)
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After consenting to the study, patients will be randomized to one of two groups.
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: enoxaparin; thromboembolism; coagulation; factor Xa

Summary:

      The main objective of this study is to determine the time interval following the last
      treatment dose of enoxaparin at which the amount of anti-Xa level activity is reliably less
      than 0.2 international unit per milliliter (IU/mL) in patients presenting for elective
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        Eligible patients need:

          -  to be on treatment dose (1mg/kg twice daily or 1.5mg/kg daily) enoxaparin at the time
             of presentation for elective surgery

          -  and must be able to accurately report the timing of their last dose and the
             administered dosage.

          -  Patients must also be between the ages of 18-100 years of age

          -  and must be able to give written consent to participate.

        Exclusion Criteria:

          -  Patients with severe renal insufficiency (creatinine clearance <30ml/min) will be
             excluded from the study, as the elimination of enoxaparin is known to be affected in
             this patient population.

          -  Pregnant patients will also be excluded, as the elimination and metabolism of
             enoxaparin is known to be altered in this patient population, and dose adjustments are
             recommended if treatment dose enoxaparin is used during pregnancy.

          -  Patients who are receiving enoxaparin as a bridge from another anti-Xa inhibiting
             medication will be excluded as this could unpredictably affect the results of anti-Xa
             testing. These medications include: Apixaban, Edoxaban, Fondaparinux, and Xarelto.
Ripening Interventions: Prostaglandins vs EASI Catheter
Condition: Cesarean Section
Intervention: Misoprostol; Catheter
Intervention description: Misoprostol,25 micrograms every 4 hours.; A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregnancy; Extra amniotic saline infusion; Misoprostol; Labor induction

Summary:

      The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs
      extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion
      of patients delivered by cesarean section for fetal intolerance of labor versus vaginal
      delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI
      catheter are less likely to undergo cesarean section for fetal intolerance of labor when
      compared to women who receive misoprostol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Singleton pregnancy

          -  Cephalic presentation

          -  36 completed weeks of gestation

          -  Intact membranes

          -  Unfavorable cervix (defined as Bishop score < 5)

          -  Indication for induction of labor

          -  Fetal Station less than or equal to -3

        Exclusion Criteria:

          -  Clinically significant vaginal bleeding

          -  Evidence of spontaneous labor (3 contractions in 10 minutes)

          -  Contraindication to induction of labor or to use of prostaglandins

          -  Fetal station higher than -3
Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma; Low Tension Glaucoma
Intervention: brinzolamide 1%/brimonidine 0.2% fixed combination; Placebo; travoprost 0.004% ophthalmic solution
Intervention description: One drop applied topically to the affected eye(s) in the morning and evening; One drop applied topically to the affected eye(s) in the morning and evening; One drop applied topically to the affected eye(s) in the evening
Intervention MeSH terms: Brimonidine Tartrate; Travoprost; Ophthalmic Solutions; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy.
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: travoprost; brinzolamide 1%/brimonidine 0.2%; normal tension glaucoma; intraocular pressure; efficacy; safety

Summary:

      The purpose of this study was to determine the incremental intraocular pressure (IOP)
      lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with
      normal tension glaucoma that may benefit from further IOP lowering.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign written informed consent

          -  Diagnosed with normal tension glaucoma

          -  Intraocular pressure measurements in at least 1 eye as specified in the protocol

          -  Willing and able to attend all study visits

        Exclusion Criteria:

          -  History of hypersensitivity to any of the study drugs

          -  Use of medications prohibited by the protocol

          -  Pregnant or nursing

          -  Of child-bearing potential unless using contraception, as specified in the protocol

          -  Any form of glaucoma other than open angle glaucoma in either eye

          -  Chronic, recurrent or severe inflammatory eye disease

          -  Ocular trauma or surgery within the past 6 months in either eye; ocular infection or
             laser surgery within the past 3 months in either eye (all from screening)

          -  Conditions which would make the patient, in the opinion of the Investigator,
             unsuitable for the study.
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.