bioihbjkbjnl/mcl2 huggingface dataset:
Enoxaparin Dosing in Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: Enoxaparin
Intervention description: Twice daily dosing
Intervention MeSH terms: Enoxaparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Enoxaparin dosing; Obesity

Summary:

      The purpose of this study is to determine an effective enoxaparin dosing strategy in
      medically ill, morbidly obese patients. This study will include adult patients greater than
      18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable
      patients such as prisoners, children, and pregnant women will not be enrolled in the study.
      Study participants will be contacted in person by the study personnel once inclusion criteria
      are met. Written informed consent will be obtained in person while hospitalized. Once the
      patient is consented they will be given enoxaparin and blood samples will be drawn. The data
      collected will be from the electronic medical record which is accessed only with a username
      and password so it is not publicly available. The data will be identifiable upon collection
      and will be kept on a password protected file on a computer in a locked office. The data will
      be de-identified after data analysis and only the study personnel will have access to the
      code that links identifiers to subjects. A HIPAA waiver will be requested to access existing
      data in order to identify patients for enrollment. All data will be collected in an office in
      the hospital. The study participants' burden will be minimal and dependent only on time of
      consent process since morbidly obese patients would be receiving this blood sample collection
      regardless of their participation in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned treating with twice daily enoxaparin

          -  BMI >= 40 kg/m2

        Exclusion Criteria:

          -  < 18 years of age

          -  CrCl < 30 ml/min

          -  Pregnancy

          -  Prisoner

          -  Active bleeding

          -  Already received 3 consecutive doses of enoxaparin

          -  Use of therapeutic enoxaparin for more than 5 consecutive days within the last 3
             months
Comparability and Standardization of Controlled Allergen Challenge Facilities
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Cetirizine; Placebo
Intervention description: Participants will receive either cetirizine (10mg tablet, orally) or a placebo (sugar pill) at one of the two treatment visits.; Participants will receive either a placebo or cetirizine (10mg tablet, orally) at one of the two treatment visits
Intervention MeSH terms: Cetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Allergen challenge facilities have been utilized for many years in clinical drug trials
      studying onset of action, proof of concept, duration of action, and efficacy. Each facility
      has somewhat different design characteristics and pollen dispersal technologies. Facilities
      are located in disparate geographic areas and have populations of participants who are
      sensitized to allergens unique to that area. Therefore, facilities have operated as single
      sites with little effort to evaluate facility comparability or to attempt standardization
      across facilities. The purpose of this study is to compare the two sites and assess whether
      the sites are able to achieve similar symptom scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of rhinoconjunctivitis during ragweed season for a minimum of 2 years,
             including the previous 2 ragweed seasons.

          -  positive skin test to ragweed allergen.

        Exclusion Criteria:

          -  participant is pregnant, lactating or actively trying to conceive.

          -  has a history of receiving immunotherapy containing short ragweed within the last 3
             years.

          -  participant has current allergy symptoms.
Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery
Condition: Spine Surgery
Intervention: sugammadex; Neostigmine
Intervention description: once at the end of the surgery; once at the end of the surgery
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will receive (per a randomization schedule) either sugammadex, or neostigmine/glycopyrrolate to reverse neuromuscular blockade at the end of the surgery. The reversal agent will be prepared in a blinded fashion.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The surgeon, anesthesiologist, operating room staff, patients, personnel in the postanesthesia care unit (PACU) as well as the investigators collecting the postoperative data will be blinded to the group allocation.
Enrollment: 40.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: spine surgery; neuromuscular blockade; sugammadex; elderly; reversal; neostigmine; recovery

Summary:

      Spine surgery is one of the most common operative procedures in the United States. It is
      performed in the prone position (a patient laying on belly). Muscle relaxants are given for
      neuromuscular blockade often referred as paralysis for surgical exposure which is maintained
      until the patient is returned to the supine position (a patient laying on back) at the end of
      surgery. At the end of the surgery the paralysis is reversed with a drug (neostigmine). A new
      drug (sugammadex) has the ability to rapidly reverse the paralysis but it is not well
      investigated in elderly. This study will investigate speed of recovery and complications of
      the two reversal drugs in elderly patients (age ≥ 65 years) undergoing posterior spine
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Posterior spinal surgery

          2. Age ≥ 65 years

          3. American Society of Anesthesiologists (ASA) grade I-III

        Exclusion Criteria:

          1. Inability to obtain written informed consent

          2. Allergy to rocuronium or anesthetic agents used in the protocol

          3. Known or suspected neuromuscular disorders

          4. Significant renal disease with a serum creatinine ≥ 2 mg/dl

          5. Significant liver disease

          6. A family history of malignant hyperthermia
C. Difficile and Ursodiol
Condition: Diarrhea
MeSH terms: Diarrhea
Intervention: Ursodiol
Intervention description: Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks.
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colitis; Bile

Summary:

      In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic
      acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators
      will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or
      Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile
      infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing
      the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid
      composition (80% deoxycholic acid) to maintain growth suppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with recurrent C. difficile colitis

          -  18 years of age and older

          -  Capable of giving informed consent

        Exclusion Criteria:

          -  Patients with other gastrointestinal problems prone to cause diarrhea if they cannot
             be controlled for the period of the study. Lactose intolerance or gluten enteropathy
             are not an exclusion provide that the potential subject is asymptomatic and can be
             expected to adhere to the appropriate dietary regimen.

          -  Patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets
             or components of the formulations.

          -  Patients not available for long-term follow-up (2 months) by their physician will be
             excluded from the study.
Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures
Condition: Epilepsy, Idiopathic Generalized
MeSH terms: Seizures
Intervention: Levetiracetam; Valproate
Intervention description: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred; Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Intervention MeSH terms: Levetiracetam; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and
      safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age≥16

          -  At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least
             one in last 6 months

          -  Normal brain MRI or MRI without epileptogenic lesion

          -  Normal electroencephalography(EEG) or existence of generalized epileptiform discharges
             without any focal epileptiform discharges.

          -  Signing consent form

        Exclusion Criteria:

          -  History of treatment by sodium valproate or levetiracetam

          -  History of treatment by any anti-epileptic drug in last 6 months

          -  Plan for pregnancy

          -  Using no certain contraceptive method

          -  History of past or current hepatic disease

          -  History of past or current renal disease

          -  History of past or current hematologic disease

          -  History of known psychiatric disease

          -  History of status epilepticus
Treatment of Bipolar Mania in Older Adults
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Intervention: Lithium (LI); Divalproex (DV)
Intervention description: The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L).; Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).
Intervention MeSH terms: Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This study will compare the benefits and side effects of lithium and divalproex in the
      treatment of older adults with bipolar mania.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic
             episodes

        Exclusion Criteria:

          -  Rapid cycling bipolar disorder

          -  History of substance abuse or dependence within last 3 months

          -  Diagnosis of schizophrenia or other chronic psychotic conditions

          -  Acute or unstable medical illness

          -  Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam

          -  Dementia

          -  Inability to communicate in English
The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.
Condition: Suicidal Ideation
MeSH terms: Suicidal Ideation
Intervention: Ketamine; Normal Saline
Intervention description: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.; IV infusion of 100 ml of normal saline over 45 minutes.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: ketamine; suicidal ideation; length of stay

Summary:

      This study will evaluate the effect of ketamine on the treatment of patients hospitalized
      with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein.
      The other half will receive a placebo. Because we think that ketamine will improve depression
      and suicidal thoughts, we expect that patients who receive ketamine will require less time in
      the hospital than patients who receive placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 18 and 64

          2. Patients admitted to the University of Mississippi Medical Center inpatient psychiatry
             service with suicidal ideations

        Exclusion Criteria:

          1. Lifetime history of schizophrenia or other primary psychotic disorder

          2. Current psychotic or manic symptoms

          3. Substance use disorder within one month of admission

          4. Positive urine toxicology at admission

          5. Any lifetime abuse of ketamine or phencyclidine

          6. Systolic BP >180 mmHg or diastolic BP >110 mmHg

          7. Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion
             or who has drank clear liquids within 2 hours prior to receiving the infusion

          8. Known central nervous system (CNS) mass

          9. CNS abnormalities

         10. Hydrocephalus

         11. Glaucoma

         12. Acute globe injury

         13. Porphyria

         14. Untreated thyroid disease

         15. Known coronary artery disease with poor functional capacity

         16. Pregnancy

         17. Currently breast-feeding
Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Oxymetazoline HCL 1.0% Cream; Energy-Based Therapy
Intervention description: Oxymetazoline HCl cream 1.0% once daily application; Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when
      used as an adjunctive treatment to energy-based therapy for participants with moderate to
      severe persistent facial erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

        -Documented clinical diagnosis of rosacea.

        Exclusion Criteria:

          -  History of any of the following conditions: Raynaud's syndrome, narrow angle glaucoma,
             orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis
             obliterans, scleroderma, Sjögren's syndrome, severe or unstable or uncontrolled
             cardiovascular disease, or any other current uncontrolled systemic disease

          -  Diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea
             fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis,
             demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus
             erythematosus, or chronic recurring facial acne

          -  Current treatment with monoamine oxidase (MAO) inhibitors

          -  Current treatment with niacin ≥ 500 mg/day

          -  Greater than 3 inflammatory lesions on the face

          -  History or current evidence of drug or alcohol abuse within 12 months prior to the
             screening visit.
Exparel in Minimally Invasive Cardiac Surgery
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Intervention: Exparel infiltration
Intervention description: Exparel infiltrated into wound and chest tube sites
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: minimally invasive cardiac surgery; Exparel

Summary:

      The investigators are presently using Exparel, a slow released local anesthestic, in patients
      undergoing minimally invasive cardiac surgery. The primary objective of this study is to
      assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to
      provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac
      surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the
      subject's overall postoperative pain scores and postsurgical analgesic use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-75 years inclusive and American Society of Anesthesiologists physical
             status 2-4.

          -  Undergoing minimally invasive cardiac surgery.

          -  Subjects must be physically and mentally able to participate in the study and complete
             all study assessments.

          -  Subjects must be able to give fully informed consent to participate in this study
             after demonstrating a good understanding of the risks and benefits of the proposed
             components of thoracotomy and chest tube sites infiltration.

        Exclusion Criteria:

          -  History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics

          -  Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator,
             might preclude the potential successful performance of a thoracotomy and chest tube
             sites infiltration.

          -  Any subject who in the opinion of the Investigator, might be harmed or be a poor
             candidate for participation in the study.

          -  Any subject, who in the opinion of the Investigator, is on chronic pain medicine,
             including large doses of nonsteroidal antiinflammatory drugs.

          -  Subjects who have received any investigational drug within 30 days prior to study drug
             administration, or planned administration of another investigational product or
             procedure during their participation in this study.
Mortality Reduction After Oral Azithromycin: Mortality Study
Condition: Childhood Mortality
Intervention: Azithromycin; Placebo
Intervention description: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.; Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 190238.0
Sex: All
Minimum age: 1 Month
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Childhood mortality; Azithromycin; Mass treatment; Infection; Verbal Autopsy

Summary:

      Our long-term goal is to more precisely define the role of mass azithromycin treatments as an
      intervention for reducing childhood mortality. We propose a single multi-site
      (multi-country), cluster-randomized trial comparing communities randomized to oral
      azithromycin with those randomized to placebo. We hypothesize that mass azithromycin
      treatments will reduce childhood mortality.
    

Eligibility criteria:

        Inclusion Criteria:

        Communities

          -  The community location in target district.

          -  The community leader consents to participation in the trial

          -  The community's estimated population is between 200-2,000 people.

          -  The community is not in an urban area.

        Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as
        assessed via biannual census.

        Exclusion Criteria:

        Individuals

        - Refusal of village chief (for village inclusion), or refusal of parent or guardian (for
        individual inclusion)