bioihbjkbjnl/mcl2 huggingface dataset:
Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Condition: Pain
Intervention: Lidocaine; Sterile Saline
Intervention description: 5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes; 5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Essure sterilization; pain management; intrauterine lidocaine infusion

Summary:

      The purpose of this study is to assess the level of pain women experience with an Essure
      procedure and the effect that lidocaine might have on that pain. We will also assess the
      absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Age 18 or older

          -  Good general health, based on the opinion of the investigator

          -  Voluntarily requesting permanent sterilization

          -  Negative pregnancy test

          -  Agree to premedication with ibuprofen and ativan

          -  English speaking, or other language if an interpreter is available to be present at
             all points of the study procedure.

          -  Willing and able to sign an informed consent

          -  Willing to comply with the terms of the study

        Exclusion Criteria:

          -  Significant physical or mental health condition, based on the opinion of the
             investigator.

          -  Positive pregnancy test

          -  Request for IV/IM sedation prior to the start of the procedure

          -  Refusal of ibuprofen, ativan, or paracervical block

          -  Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium
             bicarbonate

          -  History of toxic reaction to local anesthetics

          -  Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)

          -  Weight less than 100 pounds. [Any patient weighing less than 100 pounds would receive
             more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)].

          -  Current participation in another research study which would interfere with the conduct
             of this study.
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: denosumab; teriparatide; Zoledronic acid
Intervention description: denosumab subcutaneous injection; teriparatide daily subcutaneous injection; zoledronic acid infusion
Intervention MeSH terms: Zoledronic Acid; Denosumab; Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of the study is to assess the effect of an antiresorptive medication in combination
      with standard dose or alternate dose teriparatide. The study extension will evaluate the
      effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women aged 45+

          -  postmenopausal

          -  osteoporotic with high risk of fracture

        Exclusion Criteria:

          -  no significant previous use of bone health modifying treatments
Anti-inflammatory Effects of Simvastatin
Condition: Inflammation; Atherosclerosis; Hypercholesterolemia
MeSH terms: Atherosclerosis; Hypercholesterolemia; Inflammation
Intervention: Simvastatin 40mg; Ezetimibe 10mg
Intervention description: Simvastatin administered daily for 6 weeks; Ezetimibe administered daily for 6 weeks
Intervention MeSH terms: Simvastatin; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this research study is to determine which of the two ingredients of Vytorin
      (Simvastatin or Ezetimibe) is responsible for the anti-inflammatory effects of Vytorin
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: 18 to 75 years of age.

          2. Obese (BMI ≥30 kg/m2)

          3. LDL cholesterol of ≥100 mg/dl

          4. Not taking any vitamins or antioxidants

        Exclusion Criteria:

          1. Currently using anti-hyperlipidemic therapies

          2. Triglycerides >500 mg/dl.

          3. Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery
             in the past 6 months.

          4. Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids

          5. Hepatic disease

          6. Renal impairment.

          7. History of drug or alcohol abuse

          8. Participation in any other concurrent clinical trial

          9. Use of an investigational agent or therapeutic regimen within 30 days of study.

         10. Smoker

         11. Pregnancy

         12. Premenopausal women who are not on birth control pills and have not had a hysterectomy
             or tubal ligation

         13. Anemia with hemoglobin <12 g/dl
Smartphone Intervention for Smoking Cessation and Adherence to Anti- Retroviral Therapy (ART) Among People Living With Human Immunodeficiency Virus (HIV)
Condition: Smoking; Smoking Cessation; HIV
Intervention: Nicoderm C-Q Transdermal Product; Adherence to Antiretroviral Therapy Counseling; Behavioral Smoking Cessation Counseling; "Crave-to-Quit" app; vDOT "emocha" app
Intervention description: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT); Brief counseling on adhering to antiretroviral therapy with self-help materials.; One time face-to-face smoking cessation counseling and 2 follow-up phone calls.; Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.; Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Intervention MeSH terms: Anti-Retroviral Agents; Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nicotine replacement therapy; antiretroviral; smartphone

Summary:

      The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app
      can help people quit smoking and stay on antiretroviral therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • ≥ 18 years old

          -  Diagnosed with HIV

          -  have been prescribed ART medication in the prior 6 months

          -  have smoked ≥ 5 cigarettes/day in the past year

          -  be interested in making a quit attempt in the next 30 days

          -  own a smartphone (apple/android)and plan to keep it active for the following 3 months

          -  read/speak English

          -  be able to provide consent

          -  have no plans to move in the next 3 months

          -  not pregnant or planning to be pregnant in the following 3 months

        Exclusion Criteria:

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Prisoners

          -  Those that regularly use tobacco products other than cigarettes

          -  Those that use drugs (methadone, alcohol, cocaine, marijuana) more than once-a-week.

          -  Have contraindication to NRT (past month myocardial infarction, history of serious
             arrhythmias/or unstable angina pectoris, dermatological disorder)

          -  Have cognitive/mental health impairment that inhibits mindfulness treatment

          -  Use other tobacco products regularly (which can interfere with biological verification
             of smoking cessation)

          -  Currently being treated for smoking cessation, alcoholism, or illicit drug use
Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease
Condition: Pompe Disease; Glycogen Storage Disease Type II (GSD II)
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease
Intervention: alglucosidase alfa
Intervention description: Intravenous (IV) infusion of 20mg/kg body weight every other week (qow)
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No

Summary:

      -  The primary objective of this study was to characterize the pharmacokinetics (PK) of
           alglucosidase alfa manufactured at the 4000 L scale in participants who had a confirmed
           diagnosis of Pompe disease.

        -  A secondary objective of this study was to evaluate and explore the relationship between
           anti-recombinant human acid alpha-glucosidase antibody titers and the PK of
           alglucosidase alfa.
    

Eligibility criteria:

        Inclusion Criteria:

        A participant was to meet all of the following criteria to be eligible for this study:

          -  The participant and/or the participant's parent/legal guardian was willing and able to
             provide signed informed consent.

          -  The participant had a confirmed acid alpha-glucosidase (GAA) enzyme deficiency from
             skin, blood, or muscle tissue and/or 2 confirmed GAA gene mutations.

          -  Infant and toddler Pompe disease participants could be included in the study only
             under condition (minimal body weight) that the trial-related blood loss (including any
             losses in the maneuver) would not exceed 3 percent (%) of the total blood volume
             during a period of 4 weeks and would not exceed 1 % at any single time.

          -  The participant, if female and of childbearing potential, must have had a negative
             pregnancy test (urine beta-human chorionic gonadotropin) at screening. Note: All
             female participants of childbearing potential and sexually mature males must have
             agreed to use a medically accepted method of contraception throughout the study.

          -  For participants previously treated with alglucosidase alfa the participant had
             received alglucosidase alfa for at least 6 months.

        Exclusion Criteria:

        A participant who met any of the following criteria was excluded from this study:

          -  The participant was participating in another clinical study using an investigational
             product.

          -  The participant, in the opinion of the Investigator, was unable to adhere to the
             requirements of the study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Condition: MRI Sedation
Intervention: dexmedetomidine; propofol
Intervention description: dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan; propofol IV administration will be given if needed to maintain sedation
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: procedural sedation; dexmedetomidine; propofol; MRI

Summary:

      This is a randomized, double-blind, dose-ranging study of the efficacy and safety of
      dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric
      subjects ≥1 month to <17 years of age undergoing MRI scans in the US and Japan.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female subject ≥1 month and <17 years of age.

          2. American Society of Anesthesiologists (ASA) Physical Status I, II or III.

          3. Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for
             a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or
             other proceduralist in attendance.

          4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3
             hours to complete

        Key Exclusion Criteria:

          1. Pregnant female subjects (including those with an indeterminate or positive pregnancy
             test); breastfeeding female subjects.

          2. Weight on Day 1 before randomization is less than the 10th percentile of weight for
             age and sex in the US and Japan or is greater than the 95th percentile of weight for
             age and sex in the US or greater than the 97th percentile of weight for age and sex in
             Japan based on sponsor-provided growth charts.

          3. Planned medical procedure during the MRI scan or post-MRI recovery period.

          4. Requires endotracheal intubation or laryngeal mask airway (LMA).

          5. Known allergy to eggs, egg products, soybeans or soybean products.

          6. SpO2 <93 % on room air -
Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine
Condition: Depression; Bipolar Disorder; Bipolar Depression; Melancholia; Lamotrigine
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lamotrigine; Placebos
Intervention description: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.; Placebo tablets
Intervention MeSH terms: Lamotrigine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if patients with melancholic bipolar II depression
      are more responsive to lamotrigine than patients with non-melancholic bipolar II depression.
      To do this, the investigators will re-analyze a previous clinical trial that evaluated
      lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must provide written and informed consent.

          2. Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8
             weeks, with a HAMD-17 score of at least 18 with scores of 3 or more on Items 1 or 7.

          3. For females, be of non-childbearing potential, or of childbearing potential with a
             negative pregnancy test at screening and agrees to one of (a) abstinence from sex two
             weeks prior and five days after drug continuation/discontinuation, (b) personal or
             partner sterilization, (c) one method of hormonal contraception, or (d) two barrier
             methods of contraception.

          4. Acceptable results (within two times the normal limit) on laboratory screening tests
             (e.g., thyroid function).

        Exclusion Criteria:

          1. Active suicidality.

          2. History of non-response to antidepressant treatment, or any previous treatment with
             lamotrigine.

          3. History of substance dependence in the past year, or abuse within the 4 weeks prior to
             study entry.

          4. Rapid cycling bipolar disorder.

          5. Receiving additional psychoactive medication (not including lorazepam for agitation),
             or has started a new course of psychotherapy within the last month.

          6. Received treatment for an anxiety or eating disorder within the last 12 months.

          7. Investigational drug use within the last month.

          8. History of epilepsy.
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
Condition: Sars-CoV2
MeSH terms: COVID-19
Intervention: Octagam
Intervention description: Standard of Care plus Octagam infusion for 3 days.
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus; IVIG; COVID-19

Summary:

      The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce
      respiratory complications (respiratory failure and need for a ventilator) caused by
      coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized
      IVIG for patients infected with the influenza virus. The investigator wants to find out if
      IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune
      system some help to clear the infection naturally.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed COVID-19 positive test result (including presumptive positive).

          -  Hospitalization

          -  Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not
             mechanically ventilated

          -  Age ≥18 years old.

          -  Access to a phone in the hospital room or an electronic device that is capable of
             receiving phone calls and/or video calls and/or e-mail.

          -  Able to read/write/speak English or Spanish fluently.

          -  Subjects must have the capacity to provide consent or an appropriate Legally
             Authorized Representative (LAR) to provide informed consent.

        provide informed consent, and provide authorization of use and disclosure of personal
        health information.

          -  Negative pregnancy test for women of childbearing potential.

        Exclusion Criteria:

          -  Severe allergy to any IVIG product formulation

          -  History of DVT, PE, thromboembolic stroke or other thrombotic events

          -  Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from
             corn.

          -  Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)

          -  Active participant in another research treatment study

          -  Mechanically ventilated patient

          -  Code status is Do Not Resuscitate or Do Not Intubate
Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients
Condition: Pain
Intervention: IV Ibuprofen; placebo
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: , randomized, double-blind, parallel-group, placebo-controlled study. Eligible patients who signed the informed consent were randomized to either IV Ibuprofen (Caldolor®) or Placebo via a computer-generated randomization list.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Staff, including the principal investigator, study coordinator, and trauma nurses and the patients were blinded as to the treatment they received. In order to maintain the double-blind protocol, all IV bags had identical appearance and label.
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ibuprofen; Caldolor; orthopedic trauma

Summary:

      STUDY OBJECTIVES:

        1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in
           decreasing pain in orthopedic trauma patients with fractures of the extremities, face,
           pelvis and/or ribs compared to patients not receiving the medication.

        2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in
           decreasing the use of opioid analgesics among orthopedic trauma patients with fractures
           of the extremities, face, pelvis, and/or ribs compared to compared to patients not
           receiving the medication.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Trauma patient admitted to Trauma ICU or Trauma Step-Down Units.

          2. Fracture of ribs, face, extremities and/or pelvis

          3. Age between 18 and 75 years old

          4. Adequate IV access

          5. Able to self report and communicate pain severity

        Exclusion Criteria:

          1. History of allergy or hypersensitivity to any component of IV Ibuprofen, aspirin (or
             aspirin related products) NSAIDs, or COX-2 inhibitors

          2. Any intracranial or spinal cord trauma

          3. History of clinically significant bleeding disorders including ITP, DIC or platelet
             dysfunction

          4. Recent history of intracranial surgery or stroke (within past 30 days)

          5. History of ulcers, gastritis or previous GI bleeding

          6. Renal Impairment (Creatinine > 3.0 mg/dL)

          7. Pregnant or breastfeeding

          8. Otherwise unsuitable in the opinion of the treating physician at time of
             randomization.