bioihbjkbjnl/mcl2 huggingface dataset:
Pre-medication With Alfentanil vs Placebo During ECT
Condition: Blood Pressure; Electroconvulsive Therapy
Intervention: Alfentanil; Placebos
Intervention description: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed; Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Intervention MeSH terms: Alfentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Masking description: study med prepared by a provider not involved in the anesthesia care of the subject
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anesthesia

Summary:

      Hemodynamic changes associated with the conduct of electroconvulsive therapy may be minimized
      with the administration of alfentanil as part of their anesthetic regimen. This study
      proposes to compare the effects in a blinded fashion. Currently alfentanil is an FDA approved
      drug used on a daily basis by anesthesiologists on other surgeries so this is not a new
      indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > /=18 years

          -  Males or females

          -  Anticipating electroconvulsive therapy to treat refractory depressive disorder

        Exclusion Criteria:

          -  Under the age of 18

          -  Allergy to alfentanil

          -  Allergy to other standard anesthetic medications utilized in the course of ECT
             (glycopyrrolate, methohexital, and succinylcholine)

          -  History of malignant hyperthermia

          -  History of severe airway obstruction, bronchospasm or laryngospasm

          -  History of recent myocardial infarction, ventricular arrhythmia

          -  Adverse reaction to ECT requiring premedication with lidocaine or atropine

          -  Non-English speaking

          -  Patients unable to consent for themselves

          -  Current pregnancy
Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing
Condition: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Intervention: Rituximab
Intervention description: re-dosing dependent on interventional arm parameter.
Intervention MeSH terms: Rituximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 82 Years
Healthy volunteers: No
Keywords: rituximab; maintenance; remission

Summary:

      The purpose of this study is to determine the best management strategy to maintain remission
      in patients with ANCA vasculitis who have been treated with rituximab induced B cell
      depletion for at least two years. This study will compare intermittent B Cell depletion upon
      B cell return or intermittent B cell depletion upon serologic relapse.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients must be able and willing to give written informed consent and comply with
             the requirements of the study protocol.

          2. Diagnosis: ANCA vasculitis as defined by a positive MPO- and/or PR3-ANCA test together
             with clinical features characteristic of ANCA-positive diseases as detailed in the
             2012 Chapel Hill Consensus Conference Definitions(18).

          3. eGFR ≥ 73 cc/min/1.73m2

          4. Age: 18-82 years old

          5. Treated with rituximab-induced continuous B cell depletion at regularly scheduled
             interval with a goal of undetectable B cells for at least 24 months

          6. In sustained remission (defined by a modified BVAS-WG=0 AND a prednisone dose of ≤ 7.5
             mg) for at least 12 months.

          7. Undetectable (<10mm3) B cells (quantified by CD20+ number) on day 0

          8. Urine Hcg negative for women of child bearing potential and not planning to become
             pregnant for at least 12 months from enrollment and at least 12 months after any study
             related rituximab dose

          9. Judged to be otherwise healthy by the Investigator, based on medical history and
             physical examination (no known active disease process for which life expectancy is
             less than 36 months)

        Exclusion Criteria:

          1. Secondary Disease: disease suspected to be induced by levamisole-adulterated cocaine

          2. All transplanted patients

          3. Treatment: additional immunosuppressive agents other than rituximab and/or total daily
             prednisone dose ≥ 7.5 milligrams

          4. Hypogammaglobulinemia: IgG level < 300 mg/dL

          5. Terminal cancer or other primary illness with life expectancy of less than 36 months

          6. Active anti-GBM disease and other known autoimmune disease for which the need for
             additional immunosuppression is likely

          7. Pregnancy or breastfeeding
Spinal Cord Stimulation for Low Back Pain
Condition: Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Intervention: Precision Spinal Cord Stimulation System
Intervention description: Stimulation on throughout study
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Back Pain; Low Back Pain; Chronic Pain; Spinal Cord Stimulation

Summary:

      The purpose of this study is to assess the acute and chronic effectiveness of the Advanced
      Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery
      syndrome and associated low back axial pain.

      Subjects will undergo a temporary or permanent trial to assess their candidacy for placement
      of an implantable pulse generator. Those who demonstrate a significant clinical reduction in
      pain will be enrolled in the chronic study. Subjects will be followed for 12 months post
      implantation to assess the long-term effectiveness of the therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Eligible for spinal cord stimulation as labeled in the FDA approval for the
             Precision(R) Spinal Cord Stimulator by Advanced Bionics;

          2. Age ≥18 years;

          3. Have pain of neuropathic origin;

          4. Have chronic pain secondary to surgical spine procedure or intractable low back pain
             with or without leg pain for at least 3 months and not responding to less invasive
             clinical procedures.

        Exclusion Criteria:

        1. Enrollment in any research that would conflict with study requirements.
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
Condition: Metastatic Renal Cell Carcinoma; Metastatic Melanoma
MeSH terms: Carcinoma; Melanoma; Carcinoma, Renal Cell
Intervention: Aldesleukin
Intervention MeSH terms: Aldesleukin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Renal Cell Carcinoma; Metastatic Melanoma; Aldesleukin; IL-2

Summary:

      This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic
      renal cell cancer or metastatic melanoma.
    

Eligibility criteria:

        Inclusion criteria:

          -  Performance Status Eastern Cooperative Oncology Group: 0 or 1.

          -  Adequate organ function.

        Exclusion criteria:

          -  Pregnancy or lactation.

          -  Prior treatment with any form of IL-2.

          -  Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: HeartMate II (HMII); Warfarin; acetylsalicylic acid (ASA) therapy
Intervention description: Left Ventricular Assist Device; (INR Target 2.0-2.5, median 2.25, per standard of patient care); (81mg/day)
Intervention MeSH terms: Aspirin; Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: HeartMate II (HMII); Left Ventricular Assist Device (LVAD)

Summary:

      This study is a prospective, multi-center, randomized, double-blind placebo-controlled study
      of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA
             approved indications for use

          -  Subject is ≥ 50 years of age

          -  Subject is receiving the HM II as their first LVAD

          -  Subject or legally authorized representative (LAR) has signed an informed consent form
             (ICF).

        Exclusion Criteria

          -  Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic
             balloon pump or Impella® devices

          -  Participation in any other clinical investigation(s) involving an MCS device, or an
             investigation(s) that is likely to confound study results or affect study outcome

          -  Antiplatelet therapy is mandated for other conditions, in particular: a) recent
             coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other
             conditions where the investigator is not comfortable leaving subjects off-ASA or
             starting ASA post LVAD implantation. In situations where the investigator is
             uncertain, the Steering Committee can provide recommendation to the investigator as
             needed.

          -  Subjects in whom heart transplantation is expected in ≤ 6 months

          -  Subjects with a known ASA allergy
QVA Mechanistic Efficacy Study (Receptor Effects, Etc)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Placebo
Intervention description: QVA149 110/50 μg o.d. capsules for inhalation, supplied in blisters via the Concept 1 inhalation device, a single dose dry powder inhaler.; Matching placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Smokers; Ex-smokers

Summary:

      The purpose of this study was to assess global ventilated lung volume in moderate to severe
      COPD patients using MRI lung imaging after treatment with QVA149 compared to placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Males and females with COPD aged 40 years and above, weighing ≥45 kg and ≤100 kg, who were
        smokers and ex-smokers who had a smoking history of at least 10 pack years, and diagnosed
        with moderate to severe COPD according to GOLD 2015 criteria were included in the study.
        Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC < 0.70 and by
        a post-bronchodilator FEV1 ≥ 30 % and <80 % were included in the study. Post-bronchodilator
        refers to 1 hr (+/- 5 minutes) after sequential inhalation of 84 µg ipratropium bromide (or
        equivalent dose) and 400 µg salbutamol/360 µg albuterol (or equivalent dose).

        Key Exclusion Criteria:

        Patients with conditions which could compromise patient safety and compliance (as judged by
        the investigator), as well as conditions that required oxygen therapy for chronic
        hypoxemia, ≥25% emphysematous changes on a scan within 6 months to screening, those with
        lower respiratory infections within 6 weeks of screening, and patients with concomitant
        pulmonary disease were excluded from the study. Patients with asthma were also excluded
        from the study.

        Pregnant or nursing (lactating) women, patients with poorly controlled Type I or Type II
        diabetes, patients with poor renal function, and those who were unable to use a dry powder
        inhaler or perform spirometry, and had contraindications to MRI were also excluded.
A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair
Condition: Pectus Excavatum
MeSH terms: Funnel Chest
Intervention: Hydromorphone; Morphine
Intervention description: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.; This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
Intervention MeSH terms: Morphine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 62.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling
      pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be
      the mean pain score during postoperative days 0-4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 8- 18 years 2) Patients undergoing minimally invasive pectus excavatum
             repair via Nuss procedure 3) American Society of Anesthesiology Status I-III

        Exclusion Criteria:

          -  1) Refusal of epidural catheter 2) Pregnancy 3) Bleeding History 4) Inability to
             understand how to use the PCA device 5) Medication interfering with blood coagulation
             6) Patients allergic to local anesthetics 7) Patient refusal to participate in study
             8) Developmental delay
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
Condition: Bronchospasm; Activity/Exercise Induced Bronchospasm
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Intervention: Fluticasone propionate/salmeterol; Fluticasone Propionate
Intervention description: Fluticasone propionate/salmeterol; Fluticasone Propionate
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 248.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: asthma; bronchospasm

Summary:

      During this study, your child will need to attend up to 5 office visits and maintain regular
      telephone contact with the clinic. Certain office visits will include physical exams, medical
      history review, exercise challenge test (walking/running on a treadmill), electrocardiogram
      (ECG) tests, and lung function tests. All study related medications and medical examinations
      are provided at no cost. All study drugs are currently available by prescription to patients
      4 years and older.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosed with persistent asthma for 3 months or longer.

          -  Experienced worsened asthma symptoms during physical activity.

          -  Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid,
             Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

        Exclusion criteria:

          -  Used systemic steroids as either liquids, pills, or injections to treat asthma within
             the previous 3 months.

          -  Have only intermittent, seasonal, or exercise-induced asthma, and not persistent
             asthma.

          -  Admitted to a hospital within the previous 6 months due to asthma symptoms.

          -  Any poorly controlled medical conditions that may make study participation unsafe or
             inappropriate in the opinion of the study physician (such as cystic fibrosis,
             congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.)

          -  The study physician will evaluate other medical criteria.
Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients
Condition: Opioid Use; Pain, Postoperative; Colectomy; Colorectal Surgery
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine; Bupivacaine liposome
Intervention description: Abdominal injection of bupivacaine into fascial layer.; Abdominal injection of bupivacaine liposome into fascial layer.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.
Masking: Double (Participant, Outcomes Assessor)
Masking description: The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bupivacaine; Exparel; TAP Block; Opioids; Narcotics; ERAS

Summary:

      The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get
      abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is
      to compare pain medication usage after surgery between two different types of local
      anesthetic: liposomal bupivacaine and standard bupivacaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

        Exclusion Criteria:

          -  Allergic to local anesthetics

          -  Unable to provide consent

          -  Pregnant

          -  On opioids at home chronically (Patients previously on a regular opioid regimen would
             need to be opioid-free for a period of 1 year for inclusion in the study)

          -  Undergoing emergent operations

          -  Undergoing loop ileostomy reversal

          -  Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal
             prolapse repairs
Dopamine Enhancement of Fear Extinction Learning in PTSD (1R21MH108753)
Condition: Stress Disorder, Post Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Placebo; Levodopa
Intervention description: Sugar pill packaged to resemble levodopa; EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Intervention MeSH terms: Levodopa
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: Female
Minimum age: 25 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Posttraumatic Stress Disorder; functional Magnetic Resonance Imaging; Levodopa (L-DOPA); Exposure Therapy; Fear Extinction

Summary:

      The purpose of this study is to investigate a new use for a medication called levodopa
      (L-DOPA). L-DOPA has been approved for use in Parkinson 's disease, but not for Posttraumatic
      Stress Disorder (PTSD). L-DOPA is thought to enhance certain cognitive abilities that the
      investigators believe may be affected among women with PTSD. It is hypothesized that L-DOPA
      may enhance fear extinction learning to a conditioned fear stimulus. If this is true, L-DOPA
      may improve outcomes for those undergoing certain types of therapy for PTSD, though that aim
      is beyond the scope of this project. Additionally, the investigators are testing whether an
      individual's genetic profile affects how well L-DOPA works to enhance cognitive abilities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25-50 years of age

          -  PTSD related to physical or sexual assault

          -  Medically healthy

          -  English speaking

        Exclusion Criteria:

          -  Claustrophobia, or the inability to lie still in a confined space

          -  Major medical disorders (e.g., HIV, cancer)

          -  Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips,
             artificial heart valves, inner ear (cochlear) implants, artificial joints, and
             vascular stents)

          -  Electronic or magnetic implants, such as pacemakers

          -  Permanent makeup or tattoos with metallic dyes

          -  Currently pregnant

          -  A self-reported history of loss of consciousness (greater than 10 minutes)

          -  Physical disabilities that prohibit task performance (such as blindness or deafness)

          -  Psychotic disorders (e.g., schizophrenia)

          -  Any other condition that the investigator believes might put the participant at risk