bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)
Condition: Invasive Candidiasis
MeSH terms: Candidiasis; Candidiasis, Invasive
Intervention: Caspofungin; Normal Saline
Intervention description: 50 mg IV daily; 100 cc IV daily
Intervention MeSH terms: Caspofungin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Candida; Prophylaxis; High risk adults; Intensive care unit (ICU)

Summary:

      Adults admitted to intensive care units are at risk for a variety of complications.
      Infections due to the fungus called candida are of particular concern. The study will test
      the possibility that caspofungin, a new therapy for fungal infections, can successfully
      reduce the rate of candida infections in subjects at risk. It will also test if caspofungin
      is useful in treating subjects for this disease when diagnosed using a new blood test that is
      performed twice weekly, permitting earlier diagnosis than current practice standards.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-pregnant >18 yrs of age

          -  Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU
             for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.

          -  Subjects meeting the clinical prediction rule

        Exclusion Criteria:

          -  Subjects with an allergy/intolerance to caspofungin or echinocandin analog

          -  absolute neutrophil count <500/mm3 at study entry or likely to develop such a count
             during therapy

          -  acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease

          -  moderate or severe hepatic insufficiency

          -  subjects who are pregnant or lactating

          -  unlikely to survive < 24 hours

          -  subjects who have received systemic antifungal therapy within 10 days prior to study
             entry

          -  Documented active proven or probable invasive fungal infection upon enrollment

          -  previously enrolled in this study

          -  Currently on another investigational agent or have received an investigational agent
             within 10 days prior to study entry.
The Effects of Dexmedetomidine Dose on Motor Evoked Potentials
Condition: Spinal Fusion
Intervention: Dexmedetomidine
Intervention description: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Masking description: The anesthesiologist administering anesthetic agents will have knowledge of their doses. The technologist performing motor evoked potential testing and other participants will not.
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: motor evoked potentials

Summary:

      This a parallel group, two-arm, randomized superiority trial that will compare the effect of
      two different doses of dexmedetomidine on motor evoked potentials during spine surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing multi-level posterior spine fusions requiring motor evoked
             potential monitoring

        Exclusion Criteria:

          -  Allergy to dexmedetomidine, propofol

          -  Conditions knows to make recording of motor evoked potentials difficult, including
             poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or
             previous surgery during which motor evoked potentials were difficult to obtain

          -  Hepatic disease
Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery
Condition: Chest Pain; Surgery
MeSH terms: Chest Pain; Pain, Postoperative
Intervention: Intercostal block Bupivacaine based
Intervention description: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post surgical pain

Summary:

      It is well known that chest surgery patients suffer from high level pain in the perioperative
      period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain
      control technique for thoracoscopic approaches is still under debate. One of the most popular
      methods for pain control is these procedures is the Intercostal block. The Intercostal block
      is usually based upon topical analgesic. In this study the investigators will try to examine
      the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The
      study is a prospective comparative study. The cohort will be divided into two groups. In the
      control group patients will have Intercostal block after surgery and in the study group the
      intercostal block will be given in the beginning of the surgical procedure. All other
      analgesic treatment during and post-surgery will be the same in both groups. The study will
      evaluate pain level in the days after the surgery, analgesic medication consumption and
      relevant morbidity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Thoracoscopic surgery candidate.

          -  Over 18 years old.

          -  No known allergy to Bupivacaine.

          -  Patient is able to read understand and singe an inform consent.

        Exclusion Criteria:

          -  Previous thoracic operation in the same side.
Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Pregabalin; Vitamin Complex (placebo)
Intervention description: Pregabalin 150 mg orally; Vitamin Complex 150 mg orally
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 99.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: thyroidectomy; pain, postoperative; pregabalin

Summary:

      The investigators hypothesize that pregabalin will decrease post-operative pain scores and
      analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The
      primary outcome will be acute postoperative pain, measured by a verbal numerical rating score
      (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome
      will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months
      after operation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. American Society of Anesthesia physical status class I & II

          2. Age ≥ 20 and ≤ 65 years

          3. Robot- assisted endoscopic thyroidectomy

        Exclusion Criteria:

          1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of
             the standardized medications

          2. Body mass index ≥ 40 kg/m2

          3. History of seizure disorder

          4. Current therapy with pregabalin, gabapentin, or any opioid

          5. Any other physical or psychiatric condition which may impair their ability to
             cooperate with post-operative study data collection

          6. Insulin-dependent diabetes mellitus

          7. Renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2)
Effect of Dexamethasone on Duration of Lower Extremity Blocks With Bupivacaine in Subjects Having ACL Repair
Condition: Duration of Pain Relief
Intervention: dexamethsone; Bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: anterior cruciate ligament; block duration

Summary:

      Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic
      nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it
      in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief
      after surgery at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-75, no contraindication to regional anesthesia

        Exclusion Criteria:

          -  peripheral neuropathy
Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
Condition: Eyelash Hypotrichosis; Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Intervention: bimatoprost ophthalmic solution 0.03%; Vehicle Sterile Solution
Intervention description: One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.; One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily
      application to the upper eyelid margins compared with vehicle in treating eyelash loss or
      hypotrichosis (inadequate or not enough eyelashes) in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children who have inadequate eyelashes or have lost their eyelashes as a result of
             chemotherapy treatment, who completed their chemotherapy (intensive treatment) at
             least 4 weeks before starting the study, are considered to be at low risk for relapse
             of their cancer, and are well enough to complete the study

          -  Children who have minimal to moderate inadequate eyelashes due to alopecia areata

          -  Adolescents between the ages of 15-17 years who have minimal to marked inadequate
             eyelashes

        Exclusion Criteria:

          -  Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.

          -  Semi-permanent eyelash tint, dye or eyelash extension application within 3 months

          -  Use of over the counter eyelash growth products within 6 months.

          -  Use of prescription eyelash growth products (eg, Latisse®)

          -  Any eye condition that would prevent required ophthalmology exams
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
Condition: Primary Dyslipidemia; Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: pitavastatin; pravastatin
Intervention description: pitavastatin 4 mg once daily (QD); Pravastatin 40 mg once daily (QD)
Intervention MeSH terms: Pravastatin; Pitavastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg
      daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed
      dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who
             are ≥18 and ≤80 years of age at the time of consent

          -  Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter
             (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

        Exclusion Criteria:

          -  Homozygous familial hypercholesterolemia

          -  Any conditions which may cause secondary dyslipidemia

          -  Uncontrolled diabetes mellitus
Testosterone Patch's Effects on the Cardiovascular System and Libido
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Intervention: Intrinsa Transdermal testosterone patch
Intervention description: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hypoactive sexual desire disorder

Summary:

      The purpose of this study is to examine the effect of the testosterone patch, in addition to
      hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy postmenopausal women

          -  45 to 70 years of age

          -  on HRT and willing to continue the same HRT regimen for the next 6 months

          -  are in a stable relationship which was started at least 6 months ago

          -  continue on any concomitant medications without any change during the study

          -  give informed consent.

        Exclusion Criteria:

          -  have dyspareunia

          -  have received testosterone implants within the last 12 months or other androgen
             therapy within the last 6 months

          -  have received any medications which may interfere with the study (SSRI,
             anti-androgens, PDE5 inhibitors, DHEA, SERMS)

          -  have a significant psychiatric disorder

          -  have a history of breast cancer

          -  have diabetes, thromboembolic disorders, cardiovascular disease, any condition
             affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled
             hyperlipidaemia

          -  are on tibolone (due to its androgenic effect).
Dietary Impacts on Glucose-lowering Effects of Sitagliptin in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Glimepiride
Intervention MeSH terms: Sitagliptin Phosphate; Glimepiride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: DPP-4 inhibitor; sulfonylurea

Summary:

      In a prospective, randomized case-controlled study, the investigators hope to demonstrate a
      positive correlation of plasma levels of EPA and DHA as well as fish intake with the
      HbA1c-lowering effect of sitagliptin but not with the active comparator glimepiride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese T2DM patients, who are OAD naïve or receive 4-week wash out of one OAD
             (glinides, alpha-GI, metformin) before randomization.

          -  HbA1c:6.0-8.0 %

          -  BMI:18-30 kg/m2

          -  Age:20-75 years old

          -  CrCl: > 60mL/min

        Exclusion Criteria:

          -  Patients on DPP-4 inhibitors or glimepiride

          -  Patients treated with pioglitazone

          -  Patients with moderate/severe renal impairments

          -  Patients with insulin or GLP-1 receptor agonists
Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions
Condition: Undesired Intrauterine Pregnancy; First Trimester Pregnancy
Intervention: Intravenous moderate sedation versus oral medication
Intervention description: Intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: Female
Minimum age: 16 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: abortion; uterine aspiration; pain control

Summary:

      In the United States, the majority of first-trimester surgical abortions are performed in
      outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain
      control. The specific aim of this study is to evaluate the equivalency of intravenous
      moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis
      (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg) for
      first-trimester surgical abortions. The investigators hypothesize that oral moderate sedation
      and intravenous moderate sedation will be equivalent in controlling pain as measured by a
      difference of +/- 10 on a 100-point (range 0-100) visual analog pain scale.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Intrauterine pregnancy <12 weeks gestation (as confirmed by ultrasound)

          2. Ability to undergo outpatient abortion without an anesthesiologist

          3. Age ≥ 16 years old

          4. Informed consent prior to participation in study

          5. English or Spanish language capacity (or staff or professional translator available
             for all study procedures)

        Exclusion Criteria:

          1. Possible ectopic pregnancy

          2. Known allergy to study medications or misoprostol

          3. Current unstable psychiatric disorder

          4. Current alcohol/drug/narcotic/benzodiazepine/barbituate dependence within the previous
             2 months

          5. Weight < 50 kg
Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Ticagrelor; Clopidogrel
Intervention description: 180 mg loading dose; 600 mg loading dose
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS
      patients undergoing an Ad Hoc PCI
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures

          -  Male or female patients aged 18 years or older

          -  Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc
             percutaneous coronary intervention (PCI)

          -  Females must be post menopausal or surgically sterile

          -  Taking aspirin as an anti-platelet medication

        Exclusion Criteria:

          -  Use of any thienopyridine or ticagrelor within 7 days prior to randomization

          -  Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or
             prosthetic heart valve)

          -  Contraindication that ticagrelor or clopidogrel should not be administered Patient
             requires dialysis

          -  History of intolerance or allergy to aspirin
Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
Condition: Ossification, Heterotopic
MeSH terms: Ossification, Heterotopic
Intervention: Etoricoxib (Arcoxia)
Intervention description: Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
Intervention MeSH terms: Etoricoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Arthroplasty; Hip; Cemented; Heterotopic ossification; Selective Cyclooxygenase-2 Inhibitors; Arthroplasty, Replacement; Hip Prosthesis; Cyclooxygenase Inhibitors

Summary:

      The purpose of the study is to determine whether Arcoxia is effective in preventing
      heterotopic ossification after total hip arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with primary or secondary hip osteoarthritis who are scheduled for cemented
             total hip replacement at the Radboud University Nijmegen Medical Centre, Nijmegen, the
             Netherlands.

          -  Written informed consent is obtained from the patient or the legally accepted
             representative.

        Exclusion Criteria:

          -  Patients with rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures

          -  Patients with previous allergic reaction on non-steroidal anti-inflammatory drugs

          -  Patients with gastrointestinal complaints at admission, a history of gastrointestinal
             ulcers or perforations, inflammatory bowel-disease, hepatic dysfunction, renal
             dysfunction with a clearance below 30 ml/min and cardiac insufficiency.

          -  Patients with blood pressure consistently > 140/90 mmHg and who have not been
             adequately controlled.