bioihbjkbjnl/mcl2 huggingface dataset:
Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults
Condition: Obesity
Intervention: Tedizolid phosphate
Intervention description: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Intervention MeSH terms: Tedizolid; Tedizolid phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal
      body weight- matched non-obese subjects. Qualifying subjects who have completed an informed
      consent will receive a single intravenous dose of tedizolid with the collection of 11 blood
      samples over 72 hours post dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers

          -  Estimated CLcr (Cockcroft-Gault equation) ≥ 90 mL/min

          -  Female subjects of childbearing potential (CBP) either surgically sterilized, using
             hormonal contraceptives or an effective barrier method of contraception (diaphragm,
             cervical cap, condom) or agree to abstain from sex from the time of pre-study
             screening, during the entire study period and 4 weeks following the study period

          -  Platelets count ≥ 140,000/mL

          -  Absolute neutrophil count (ANC) ≥ 1800/mL

        Exclusion Criteria:

          -  History of hypersensitivity reaction to any oxazolidinone

          -  BMI < 18.5 kg/m2

          -  Any chronic medical condition requiring pharmacologic therapy

          -  Transaminases (AST or ALT) > 2.5 x upper limit of normal

          -  Total bilirubin > 1.5 x upper limit of normal

          -  Positive urine pregnancy test (if female)

          -  Abnormal electrocardiogram (ECG) as judged by the study physician

          -  Unable to tolerate venipuncture and multiple blood draws

          -  Clinically significant abnormal physical examination defined as a physical finding
             requiring further clinical work-up

          -  Unable to independently provide a written informed consent
MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
Condition: Stiffness Following Total Knee Arthroplasty
Intervention: Dexamethasone; Celecoxib
Intervention description: 8 mg of IV dexamethasone immediately before MUA.; 2 weeks per mouth of celecoxib (200 mg daily)
Intervention MeSH terms: Dexamethasone; Celecoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Compare the outcome following manipulation under anesthesia for stiffness in a randomized
      controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time
      of manipulation to a control group receiving manipulation alone.

      Outcomes will include pain, range of motion, as well as subjective outcome scores.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.

          2. MUA's scheduled between 6-10 weeks postoperatively

        Exclusion Criteria:

          1. Intolerance to NSAIDs

          2. Renal dysfunction

          3. Age < 18 or > 90 years

          4. Primary diagnosis of rheumatoid arthritis

          5. Patients with a Glomerular Filtration Rate (GFR) <60 as the cut off for Chronic Kidney
             Disease (CKD) (stage 3 CKD)
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Condition: Mixed Urinary Incontinence; Stress Urinary Incontinence; Urgency Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: OnabotulinumtoxinA (Botox ®) Injections; Saline Injections
Intervention description: OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.; Saline will be injected into the bladder so that investigators are masked to subject randomization.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This double-blind randomized controlled trial seeks to find a better treatment for women with
      mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to
      determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA
      (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary
      incontinence better than sling surgery alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing mid-urethral sling surgery

          -  Have symptoms of both stress and urgency urinary incontinence

          -  Able to consent, fill out study documents, and complete all study procedures and
             follow-up visits

          -  At least 18 years of age

          -  English speaking

          -  Be able and willing to learn clean intermittent self catheterization technique

        Exclusion Criteria:

          -  History of recurrent UTI (defined as three culture proven UTIs within last 12 months)

          -  Systemic neuromuscular disease known to affect the lower urinary tract

          -  Undergoing concomitant prolapse surgery

          -  Previous incontinence surgery

          -  Treatment with anticholinergic medication in the last 2 months

          -  Previous bladder injection with onabotulinumtoxinA

          -  Prisoner Status

          -  Pregnancy
Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: VIGAMOX
Intervention description: 1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 137.0
Sex: All
Minimum age: 1 Year
Maximum age: 13 Years
Healthy volunteers: No

Summary:

      Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in
             either or both eyes (for < 3 days duration) based on clinical observation; matched
             healthy controls

        Exclusion Criteria:

          -  Cannot have had bacterial conjunctivitis symptoms as reported by parent for > 2 days
Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture
Condition: Pain
Intervention: Ropivacine and Chloroprocaine mixture; Ropivacaine only
Intervention description: Chloroprocaine is added to Ropivacaine; Ropivacaine diluted with normal saline instead of chloroprocaine
Intervention MeSH terms: Ropivacaine; Chloroprocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onset; Duration; Upper Limb Block; Ultrasound guided supraclavicular block; Ropivacaine; Chloroprocaine

Summary:

      A double blinded randomized controlled trial comparing the onset and duration of the Onset
      and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local
      anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic
      (Ropivacaine-Chloroprocaine Mixture).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who will be having a supraclavicular brachial plexus block as part of their
             anesthetic will be approached for possible inclusion in the study

        Exclusion Criteria:

          -  patients who are pregnant,

          -  have an ASA status of IV or greater,

          -  neuropathy,

          -  a cast or other impediment to performing a motor or sensory exam in the arm and hand,

          -  patients under the age of 18,

          -  long term opioid therapy (longer than 1 month),

          -  history of opioid abuse and pseudocholinesterase deficiency
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone; montelukast; Fluticasone plus salmeterol
Intervention description: fluticasone (100 microgram twice daily) treatment; Montelukast (5 or 10 mg each night).; fluticasone (100 microgram) plus salmeterol (50 microgram) each night
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 500.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Asthma; Asthma Control

Summary:

      This research study will compare the treatment effects of three different asthma medications
      in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled
      corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a
      combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone,
      montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are
      all approved for the treatment of asthma. We are looking at whether the three treatments are
      equally effective for reducing the number and the severity of asthma attacks in subjects with
      mild to moderately severe asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  physician-diagnosed asthma

          -  age 6 or older

          -  pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted

          -  beta-agonist reversibility OR airways hyperreactivity by methacholine challenge

          -  Juniper Asthma Control Score of 1.5 or greater if not on daily controller

          -  good current health

        Exclusion Criteria:

          -  current or past smoking (greater than 20 pack-years)

          -  chronic or current oral steroid therapy

          -  pregnancy, lack of effective contraception (when appropriate), lactation
Pharmacogenomic Evaluation of Antihypertensive Responses
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Hydrochlorothiazide; Atenolol
Intervention description: atenolol 50 or 100 mg hydrochlorothiazide 12.5 or 25 mg; atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
Intervention MeSH terms: Atenolol; Metoprolol; Hydrochlorothiazide; Trichlormethiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 1701.0
Sex: All
Minimum age: 17 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hypertension; pharmacogenetics; pharmacogenomics; beta-blocker; atenolol; diuretic; hydrochlorothiazide; blood pressure; metabolic adverse effects

Summary:

      There are many medications available for the treatment of high blood pressure (hypertension),
      but finding the right one for a specific patient can be challenging. In fact, it is estimated
      that only 34% of people with hypertension have their blood pressure under control. The
      hypothesis is that genetic differences between individuals influence their response to
      antihypertensive medications. This study is aimed at determining the genetic factors that may
      influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is
      that through this research, we may someday be able to use an individual's genetic information
      to guide the selection of their blood pressure medicine, leading to better control of blood
      pressure, and less need for the current trial and error process.
    

Eligibility criteria:

        Inclusion Criteria:

        An average seated home diastolic blood pressure (DBP) > 85 mmHg and home systolic blood
        pressure (SBP) < 180 mmHg. Subjects must also have an average seated (> 5 minutes) clinic
        DBP between 90 mmHg and 110 mmHg and SBP < 180 mmHg

        Exclusion Criteria:

        secondary forms of HTN, patients currently treated with three or more antihypertensive
        drugs, isolated systolic HTN, other diseases requiring treatment with BP lowering
        medications, heart rate < 55 beats/min, known cardiovascular disease (including history of
        angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial
        infarction or revascularization procedure, or cerebrovascular disease, including stroke and
        TIA), diabetes mellitus (Type 1 or 2), renal insufficiency (serum creatinine > 1.5 in men
        or 1.4 in women), primary renal disease, pregnancy or lactation, liver enzymes > 2.5 upper
        limits of normal, current treatment with NSAIDS, cyclooxygenase-2 (COX2) inhibitors, oral
        contraceptives or estrogen.
Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: liposomal bupivacaine; bupivacaine
Intervention description: patients will receive a tap with liposomal bupivacaine; patients will receive a tap with bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is whether one local anesthetic, liposomal bupivacaine,
      provides improved pain control and decreased opioid use compared to bupivacaine when injected
      during a transversus abdominis plane block for donor nephrectomy patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  presenting for donor nephrectomy

        Exclusion Criteria:

          -  non english speaking

          -  chronic pain condition

          -  taking chronic opioids
Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
Condition: Adenoids
MeSH terms: Hypertrophy
Intervention: mometasone furoate nasal spray
Intervention description: One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      To document the short term & long term effect of treatment with Nasonex (mometasone furoate
      nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the
      posterior choanae).
    

Eligibility criteria:

        Inclusion Criteria:

          -  2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of
             posterior choanae.

        Exclusion Criteria:

          -  adenoids hypertrophy < 50% of posterior choanae

        recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal
        atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic
        otitis media, cystic fibrosis, acute infection.
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Ropinirole Prolonged release
Intervention description: Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Intervention MeSH terms: Ropinirole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson disease; Ropinirole

Summary:

      1. In order to compare the benefit, side effects, and patient preference of Ropinirole
           prolonged release when used in once-daily or twice-daily dosing

        2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged
           release
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: 30-80

          2. Parkinson disease

          3. On dopamine agonists (Ropinirole IR or Pramipexole IR) and are considering to change
             into Ropinirole PR

          4. On stable antiparkinsonian medication for at least 4 weeks

          5. Who signed consent to the study

        Exclusion Criteria:

          1. Who are on less than 2 mg of Ropinirole IR or 0.375 mg of Pramipexole IR

          2. Who have dementia, psychosis, major depression and other serious neurological or
             medical problems

          3. Who are allergic to the similar medications

          4. Who has history of heavy metal poisoning

          5. Who were on othe clinical trials of other medications within the last 4 weeks

          6. Whoa re pregnant or lactating

          7. Who are considered not eligible by the investigator
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Oral Risperidone; Risperidone in Long-Acting Injectable Form (Consta)
Intervention description: Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.; Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizoaffective Disorder, Depressed Type; Schizophreniform Disorder; First-episode Schizophrenia; Injectable Risperidone

Summary:

      This study will determine the effectiveness of oral risperidone versus long-acting injectable
      risperidone in treating people with first-episode schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of schizophrenia, schizoaffective disorder (depressed type), or
             schizophreniform disorder

          -  First major episode of psychotic symptoms occurred within 2 years prior to study entry

          -  Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia

        Exclusion Criteria:

          -  Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)

          -  Mental retardation (e.g., premorbid IQ less than 70)

          -  Significant alcohol or substance abuse within 6 months prior to study entry

          -  Inability to complete research measures in English

          -  Any condition that may make risperidone use medically inadvisable
Pregabalin In Adolescent Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: pregabalin
Intervention description: Oral capsule 75-450 mg/day
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the long-term safety of pregabalin in
      adolescent patients who participated in the previous fibromyalgia study (A0081180) and who
      wish to recieve open-label pregabalin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met the inclusion criteria for the preceding fibromyalgia Study
             A0081180, and have received pregabalin/placebo under double-blind conditions.

        Exclusion Criteria:

          -  Patients may not participate in the study if they experienced a serious adverse event
             during the previous fibromyalgia study A0081180 which was determined to be related to
             the study medication by the investigator or sponsor.