bioihbjkbjnl/mcl2 huggingface dataset:
Glucose Regulation in Acute Stroke Patients (GRASP) Study
Condition: Stroke; Hyperglycemia
MeSH terms: Stroke; Hyperglycemia
Intervention: IV glucose insulin and potassium, GIK; standard care
Intervention description: The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.; usual care
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stroke; acute ischemic stroke; hyperglycemia; glucose; insulin; insulin and potassium therapy; GIK

Summary:

      The purpose of this study is to assess the feasibility, safety and preliminary efficacy of
      the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older.

          -  Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring
             in one or more major vessels.

          -  Must arrive at hospital and be able to begin treatment within 2 hours of established
             eligibility and this must be within 24 hours of symptom onset. - - Patients unable to
             report symptom onset time or those awakening with symptoms must use the time last
             known to be well as the onset time.

          -  Admission plasma glucose of > 110 mg/dL.

        Exclusion Criteria:

          -  Renal dysfunction as defined by a serum creatinine of >/=2.5 mg/dL at enrollment.

          -  Substantial pre-existing neurological or psychiatric illness that would confound
             neurological assessment.

          -  Patients who have received experimental therapy for the enrollment stroke.

          -  Pregnant females.

          -  Patients with other severe life threatening conditions that makes them unlikely to
             survive 90 days.

          -  Patients who are unable to follow the protocol or come back for 90-day followup.

          -  Patient has condition for which insulin infusion is the usual practice or the treating
             physician feels that there is an indication for insulin infusion.
Evaluation of DEX-IN During Outpatient Procedures
Condition: Pain
Intervention: DEX-IN; Fentanyl; Placebo
Intervention description: IN Dexmedetomidine + IV placebo; IN Placebo + IV Fentanyl; IN Placebo + IV Placebo
Intervention MeSH terms: Fentanyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, double-dummy
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Peri-procedural pain; Pain; Anxiety; Analgesia; Anxiolysis

Summary:

      The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared
      with placebo and active control (fentanyl), in subjects undergoing painful outpatient and
      office based procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily provide written informed consent

          -  Be planned to undergo a selected office-based or outpatient procedure

          -  Be naïve to the planned procedure, i.e. no repeated or revision procedures

          -  Not pregnant or planning to become pregnant, or using appropriate contraceptive
             measures.

        Exclusion Criteria:

          -  Known allergy to any study treatment or excipient

          -  Have another painful physical condition or anxiety related diagnosis that may confound
             study assessments

          -  Evidence of a clinically significant finding on physical examination, laboratory
             assessment, or ECG

          -  Have signs or a history of significant nasal condition that may interfere with
             intranasal drug delivery
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
Condition: Alagille Syndrome
MeSH terms: Liver Diseases; Alagille Syndrome; Syndrome
Intervention: LUM001; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and
      tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus
      placebo on the biochemical markers and pruritus associated with Alagille Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of Alagille Syndrome

          2. Evidence of cholestasis

          3. Moderate to severe pruritus

          4. Ability to understand and willingness to sign informed consent/assent prior to
             initiation of any study procedures

        Exclusion Criteria:

          1. Surgical disruption of the enterohepatic circulation

          2. Liver transplant

          3. History or presence of other concomitant liver disease

          4. Females who are pregnant or lactating

          5. Known HIV infection
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
Condition: Bipolar Disorder I; Bipolar Disorder II; Major Depressive Episode
MeSH terms: Bipolar Disorder; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 capsule; SAGE-217 matching placebo capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and
      efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a
      current major depressive episode.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Participant had a documented history of hypomanic or manic episode and a diagnosis of
        bipolar I or bipolar II disorder with a current major depressive episode.

        Exclusion Criteria:

          1. Participant had a history of suicide attempt.

          2. Participant had current suicidal ideation with plans.

          3. Participant had a history of rapid cycling bipolar disorder.
The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Silibin-Phytosome
Intervention description: Subjects will take Silibin-Phytosome for 2-10 weeks. The dose of Silibin-Phytosome is 13 grams daily, in three divided doses. Patients will be asked to mix 1 level teaspoon and 1 heaping ¼ teaspoon of Silybin-Phytosome powder into 6 tablespoons of applesauce for each dose.
Intervention MeSH terms: Silymarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer

Summary:

      Silibinin has demonstrated anti-cancer activity in the laboratory for several different
      cancer types, including prostate cancer. Silibinin was originally obtained from milk thistle.
      Silybin-Phytosome, an oral form of silibinin, has been tested previously in prostate cancer
      patients to determine the safety of high-dose treatment. This study is for men with prostate
      cancer who are planning to have their prostate surgically removed. Participants will be given
      Silybin-Phytosome three times a day from enrollment in the study until the time of their
      surgery. Participation in this study will not affect the timing of surgery. We obtain blood
      and urine samples at the start and completion of the trial in addition to prostate tissue
      from the surgery. These samples will be analyzed for the effect of Silybin-Phytosome at the
      end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must sign an Institutional Review Board (IRB) approved informed consent

          2. Age greater than 18 years old

          3. Male patients with histologically documented adenocarcinoma of the prostate

          4. Life expectancy greater than three months

          5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          6. Adequate organ function including a total Bilirubin less than or equal to 1.5 mg/dl

          7. Planned prostatectomy as treatment for prostate cancer.

          8. No known metastatic disease

        Exclusion Criteria:

          1. Prior definitive treatment for prostate cancer with surgery or radiation therapy

          2. Use of an investigational medication or device within one month of initiating study
             therapy.

          3. Prior systemic chemotherapy for prostate cancer or any hormonal therapy for prostate
             cancer.

          4. Any use of hormonal therapy (i.e. luteinizing hormone-releasing hormone analog) or
             anti-androgen therapy.

          5. Any condition or any medication which may interfere with the conduct of the study as
             determined by the principal investigator.
Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Rivaroxaban/Placebo; Placebo; Rivaroxaban
Intervention description: 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.; 1 placebo tablet twice daily for 6 months.; 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3490.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndrome (ACS); Myocardial Ischemia; Rivaroxaban (BAY59-7939); Anti-platelet agents; Aspirin; Thienopyridine; Clopidogrel

Summary:

      The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent
      acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the
      occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions,
      stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring
             within 7 days of randomization

          -  Have a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial
             infarction/unstable angina (ie, chest pain or discomfort) (ST elevation is an abnormal
             finding from an ECG test) with at least 1 protocol-defined high risk feature

        Exclusion Criteria:

          -  Active bleeding or high risk of bleeding or intracranial hemorrhage (bleeding within
             the skull enclosing the brain)

          -  Need for continued anticoagulant therapy

          -  Significantly impaired renal (kidney) or hepatic (liver) function

          -  Severe concomitant diseases such as cardiogenic shock (heart damage that results in
             insufficient blood supply to other parts or organs of the body), refractory
             ventricular arrhythmias (irregular contractions of the heart unresponsive to
             treatment), or any severe condition that would limit life expectancy of the patient to
             less than 6 months
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: SOF; VEL; RBV
Intervention description: 400 mg tablet administered orally once daily; Tablet administered orally once daily; 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 379.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis; HCV Genotype 1; HCV Genotype 2; HCV Genotype 3; HCV Genotype 4; HCV Genotype 5; HCV Genotype 6; treatment naive

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)
      in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus
      (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HCV infection

          -  Body mass index (BMI) ≥ 18 kg/m^2

          -  HCV RNA ≥ 10000 IU/mL at screening

          -  Use of highly effective contraception methods if female of childbearing potential or
             sexually active male

          -  Must not have cirrhosis

        Exclusion Criteria:

          -  Current or prior history of clinically significant illness other than HCV

          -  Screening ECG with clinically significant abnormalities

          -  Prior exposure to HCV specific direct acting antiviral agent

          -  Prior treatment of HCV with interferon or ribavirin

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of non-HCV etiology

          -  Hepatitis B

          -  Active drug abuse

          -  Use of any prohibited concomitant medications
Evaluating Commercial Anti-Plaque Products and Oral Rinse
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Fluoride; Chlorhexidine digluconate; Fluoride, triclosan
Intervention description: Half mouth toothbrushing twice a day for four days.; Mouth rinsing with 15 ml for 30 seconds twice a day for four days.; Half mouth Brushing twice daily
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Triclosan; Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 23 Years
Maximum age: 81 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and
      an oral rinse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers at least 18 years of age.

          -  Good general health.

          -  Must sign informed consent form.

          -  Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.

          -  No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

        Exclusion Criteria:

          -  Subjects unable or unwilling to sign the informed consent form.

          -  Medical condition which requires pre-medication prior to dental visits/procedures.

          -  Moderate or advanced periodontal disease or heavy dental tartar (calculus).

          -  Two or more decayed untreated dental sites at screening.

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that are currently affect salivary function.

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

          -  Allergy to chlorhexidine.

          -  Pregnant or nursing women.

          -  Participation in any other clinical study within 1 week prior to enrollment into this
             study.

          -  Use of tobacco products.

          -  Subjects who must receive dental treatment during the study dates.

          -  Current use of Antibiotics for pre-medication for dental treatment or for any other
             purpose.

          -  Presence of an orthodontic appliance that interferes with plaque scoring.

          -  History of allergy to common dentifrice ingredients.

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: AGN-199201 ophthalmic solution; AGN-190584 ophthalmic solution; AGN-190584 vehicle; AGN-199201 + AGN-190584 Combination; AGN-199201 vehicle
Intervention description: 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.; Vehicle to AGN-190584; 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.; Vehicle to AGN-199201
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 40 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed
      in combination once a day for the improvement of uncorrected near visual acuity in
      participants with presbyopia (inability to focus on items close-up).
    

Eligibility criteria:

        Inclusion Criteria:

        -Normal vision at distance, either natural or post corneal laser refractive surgery, with
        presbyopia in each eye and complaints of poor near vision that impacts activities of daily
        living.

        Exclusion Criteria:

          -  Use of any topical ophthalmic medications, including artificial tears other than the
             study medications during the study

          -  Corneal abnormalities in either eye that interfere with visual acuity

          -  History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or
             any intraocular surgery

          -  Diagnosis of glaucoma or ocular hypertension.
Minimum Effective Concentration of Ropivacaine for Brachial Plexus Block Via the Supraclavicular and Infraclavicular Approach, Femoral Nerve Block, Sciatic Nerve Block Via the Popliteal and Parasacral Approach
Condition: Surgical Anesthesia
Intervention: Ropivacaine concentration
Intervention description: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block
Intervention MeSH terms: Ropivacaine
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a dose finding study to identify the minimum effective anesthetic concentration
      (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in
      supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and
      popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane
      (TAP) blocks in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists physical status I to III (patients may be
             healthy or have systemic disease, but any disease does not pose a constant threat to
             life, and patients are neither moribund, nor not expected to survive without the
             operation).

          -  Age 18 or above

          -  Undergoing elective ambulatory surgery of the upper limb (excluding the shoulder),
             lower limb (excluding the hip), or lower abdomen with sensory blockade as part of the
             pain management plan.

        Exclusion Criteria:

          -  Body mass index of >35 kg/m2 (higher chance of failure)

          -  Deformities of the leg (for patients in the parasacral, femoral, and popliteal
             groups), or the chest or shoulder (for patients in the supraclavicular,
             infraclavicular, and TAP groups)

          -  Preexisting infection at the injection site

          -  Existing neurologic disease

          -  Allergy to local anesthetic agents

          -  Severe respiratory disease

          -  Coagulopathy

          -  Any other contraindication to the block being considered

          -  Patients requiring total motor blockade as well as sensory blockade