bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Atorvastatin; Atorvastatin
Intervention description: A single 10 mg dose of marketed 10 mg atorvastatin tablets; A single 10 mg dose of new formulation of 10 mg atorvastatin
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence, pharmacokinetics, atorvastatin

Summary:

      • To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial
      atorvastatin tablets (Lipitor®).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 18 and 55 years

          -  Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
             allergies at time of dosing) disease or clinical findings at screening.

          -  Treatment with an investigational drug within 30 days or 5 half lives preceding the
             first dose of study medication.
Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD
Condition: COPD
MeSH terms: Respiratory Aspiration
Intervention: Budesonide
Intervention description: After 4 weeks of inhalative therapy with tiotropium (all patients), patient get randomized to receive either inhalative budesonide (1600ug per day or placebo
Intervention MeSH terms: Budesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Inhaled corticosteroids; COPD; mannitol

Summary:

      Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD)
      are more likely to be responsive to additional inhaled corticosteroids if they have a
      positive response to hyperosmolar challenge with mannitol than if their response is negative.
    

Eligibility criteria:

        Inclusion Criteria:

          -  FEV1/FVC < 70%

          -  FEV1 % predicted > 60%

        Exclusion Criteria:

          -  Other major disease

          -  Asthma

          -  Currently taking inhaled corticosteroids

          -  oral corticosteroids in the last 3 month

          -  significant cardiovascular disease

          -  pregnancy/breast feeding

          -  current use of salmeterol or other long acting bronchodilator
Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles
Condition: OHSS (Ovarian Hyperstimulation)
Intervention: Buserelin and Pregnyl; Pregnyl; Buserelin and Pregnyl; Pregnyl
Intervention description: Subcutaneous injection 0.5 mg and 1500 IU; Subcutaneous injection 5000 IU; Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days; Subcutaneous injection 5000 IU
Intervention MeSH terms: Chorionic Gonadotropin; Buserelin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 384.0
Sex: Female
Minimum age: 20 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: GnRH antagonist; GnRH agonist; hCG; OHSS; In vitro fertilization; ovulation induction; Clinical pregnancy rate

Summary:

      The purpose of this study is to possibly further improve the clinical outcome and explore the
      incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in
      GnRH antagonist IVF/ICSI cycles
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient complying with the conditions for IVF or ICSI treatment

          -  Female age over 20 years and under 40 years

          -  Normal regular cycle and patients with oligomenorrhea

          -  BMI > 18 and < 35

          -  each patient contributes with one cycle only

        Exclusion Criteria:

          -  Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease,
             metabolic disorder)

          -  Patients with > 25 follicles on the day of triggering ovulation
Ketamine Versus Etomidate for Rapid Sequence Intubation
Condition: Airway Control; Anesthesia; Intubation; Complication
Intervention: Ketamine; Etomidate
Intervention description: Subjects will receive ketamine for sedation prior to rapid sequence intubation.; Subjects will receive etomidate for sedation prior to rapid sequence intubation.
Intervention MeSH terms: Ketamine; Etomidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intubation; Airway; Emergent intubation; Rapid sequence intubation; Rapid sequence induction; RSI; Ketamine; Etomidate; Sepsis; Sedative; Sedation

Summary:

      The purpose of this study is to compare the effectiveness and safety of ketamine and
      etomidate during rapid sequence intubation (RSI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

          -  Undergoing rapid sequence intubation (RSI) in the Emergency Department

        Exclusion Criteria:

          -  Known contraindication to ketamine or etomidate

          -  Patient has a condition in which an increase in heart rate or blood pressure would be
             hazardous, as judged by the treating physician

          -  Patient is known or suspected of having increased intracranial pressure, based on the
             history and physical examination performed by the treating physician.

          -  Females of child-bearing age, defined as 18-50 years, who do not have a documented
             pregnancy test in this institution confirming that they are not pregnant or who do not
             have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation,
             hysterectomy. The timing of the pregnancy test at which the investigative team will
             consider a subject to be non-pregnant is a documented negative test during current
             hospitalization or upon direct transfer from outside institution during current
             illness.

          -  Patient declines participation in the trial by wearing a bracelet marked "KvE
             declined"

          -  Prisoner
Kidney Damage In Patients With Severe Fall In eGFR
Condition: Coronary Artery Stenosis
MeSH terms: Coronary Stenosis
Intervention: Iopamidol 370; Iodixanol 320
Intervention description: one time administration for PCI; Iodixanol 320 single injection for percutaneous coronary injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study using a randomized, double blinded, comparison of two iodinated
      contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled
      must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical
      summaries will be presented to analyse the various laboratory tests for the two groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provides written Informed Consent

          -  Is at least 18 years of age;

          -  Is scheduled for or likely to undergo percutaneous coronary intervention;

          -  Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2
             calculated with the MDRD formula within 72 hours prior the enrolment.

        Exclusion Criteria:

          -  Is a pregnant or lactating female

          -  Has a history of severe congestive heart failure

          -  Has a history of hyperthyroidism

          -  Has unstable renal function

          -  Has a history of hypersensitivity to iodinated contrast agents
Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Effexor; SSRI
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1151.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is an open-label, randomized, multi-center study conducted in a typical
      psychiatric outpatient practice in China. This study is intended to collect data on the
      efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional
      antidepressants in depressed patients that previously failed antidepressant treatment. This
      data will be used to guide psychiatrists on recommendations for clinic use.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Males or females, 18 -65 years of age

          -  Outpatients

          -  Major depressive disorder based on DSM-IV criteria

          -  The baseline score of 17-item HAM-D³17

          -  Switchers from prior antidepressants, who have had no satisfactory improvement
             (normally after a minimum of 8weeks of treatment), with an approved antidepressant
             medication or have experienced intolerance due to side effects to their antidepressant
             medication based on clinical discretion

          -  Provide written informed consent

          -  If female is of childbearing potential, must be confirmed no pregnancy at baseline,
             and use a medically acceptable method of contraception throughout the study.

        Main Exclusion Criteria:

          -  Hypersensitivity to venlafaxine;

          -  Clinically significant renal or hepatic disease or any other medical disease that, in
             the opinion of the investigator, might compromise the study, including seizure

          -  Alcohol or drug abuse within the last year

          -  A recent history of myocardial infarction or unstable heart disease (within 6 months
             of baseline)

          -  Bipolar disorder

          -  For female, known or suspected pregnancy or breast feeding

          -  Use of a monoamine oxidase inhibitor (MAOI) within 14 days of baseline; use of any
             investigational drug within 30 days of baseline.

          -  Patients have prior use of venlafaxine or use of venlafaxine for the current episode.
Hepatic Xenetix-CT Perfusion
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Xenetix-CT perfusion imaging
Intervention description: Injection of 50 ml of Xenetix
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CT perfusion; Hepatocellular Carcinoma; Xenetix; Contrast agent

Summary:

      The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT
      perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC)
      and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the
      aim to cover the entire liver.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed for HCC and planned for surgery (lobectomy or transplantation)
             within a timeframe of 30 days between first imaging procedure used for the study and
             surgery.

        Exclusion Criteria:

          -  Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA
             (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one
             year before inclusion.
Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia
Condition: Asthma
MeSH terms: Asthma
Intervention: Symbicort Turbuhaler 160/4.5
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      The purpose of the study is to evaluate the satisfaction level of patients using the
      Symbicort SMART approach for their asthma management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of asthma for past 6 months and treated with inhaled glucocorticosteroids
             for at least 3 months.

          -  Patients who asthma is classified as uncontrolled or partially controlled as defined
             by GINA 2006 guidelines.

        Exclusion Criteria:

          -  Patients already on Symbicort SMART treatment.

          -  Patients who has respiratory tract infection 30 days before study enrolment.
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Oxymorphone ER
Intervention description: 40 mg qd twice
Intervention MeSH terms: Oxymorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: opioid tolerant; chronic pain

Summary:

      The purpose of the study is to determine whether extended-release oxymorphone hydrochloride
      taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts
      cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB)
      tests, to a greater extent than when taking under conditions of fasting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Man or woman, 18-65 years of age, inclusive

          2. Able to provide informed consent and comply with all study procedures

          3. Women of childbearing potential with a negative urine pregnancy test at screening and
             on adequate contraception

          4. Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone,
             OxyContin®, MS (Morphine Sulfate) Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)

          5. Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg
             of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch

          6. Dose of opioid treatment stable for at least 1 week prior to screening and expected to
             be stable from screening through end of second testing

          7. Weight at screening 100-300 pounds, inclusive

        Exclusion Criteria:

          1. Pregnant or breastfeeding

          2. Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of
             study medication (delayed gastric emptying, partial or complete gastrectomy)

          3. Alcohol or substance abuse within 2 years of screening

          4. Consumption of alcohol within 24 hours of a screening or testing visit

          5. Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a
             screening or testing visit

          6. Impaired kidney or liver function (transaminase levels more than 3 times elevated;
             estimated creatinine clearance less than 50 mL/min)

          7. Epworth sleepiness scale (ESS) score 16 or higher at screening

          8. Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness

          9. Any clinically significant illness that would interfere with study participation or
             put the subject at risk

         10. Exposure to investigational medication within 30 days of screening
EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: EXPAREL
Intervention description: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hysterectomy; analgesia

Summary:

      The primary objective of this study is to determine the optimal of two different volumes of
      EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP)
      for prolonged postoperative analgesia in subjects undergoing open total abdominal
      hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females, 18-75 years of age inclusive.

          -  American Society of Anesthesiologist (ASA) physical status 1-3.

          -  Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not
             sufficient) without any concurrent surgical procedure(s).

          -  Physically and mentally able to participate in the study and complete all study
             assessments.

          -  Able to give fully informed consent to participate in this study after demonstrating a
             good understanding of the risks and benefits of the TAP.

        Exclusion Criteria:

          -  Demonstrated 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 TAP.

          -  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.

          -  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.
Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
Condition: Spinal Anesthesia; Cesarean Section
Intervention: Low-dose epinephrine; High-dose epinephrine; No epinephrine
Intervention description: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications; 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications; 0.2ml of preservative-free saline will be added to the standard spinal medications
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: spinal anesthesia; epinephrine; bupivacaine; repeat cesarean

Summary:

      The purpose of this study is to investigate whether the addition of a medication called
      epinephrine to spinal medications prolongs the duration of the anesthesia. The medication
      standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain
      medication (morphine). These medications typically last about 2 hours. The investigators want
      to determine if adding epinephrine to the spinal medications prolongs the anesthetic without
      side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean
      section. Epinephrine is known to prolong the action of some local anesthetics, but the
      investigators want to specifically study combining it with the medications the investigators
      use regularly for cesarean section.

      You may qualify to take part in this research study because you are having a repeat cesarean
      section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want
      to determine if epinephrine will prolong the anesthetic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-emergent repeat cesarean section

          -  Neuraxial anesthesia as the planned primary anesthetic

          -  Informed consent obtained

          -  Females age 18-50

        Exclusion Criteria:

          -  Emergency cesarean section

          -  Anesthetic other than neuraxial

          -  Allergy to local anesthetics, morphine, or epinephrine

          -  Pre-existing sensory/motor deficit