bioihbjkbjnl/mcl2 huggingface dataset:
Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence
Condition: Medication Adherence
Intervention: Varenicline; Placebo
Intervention description: Participants will be provided varenicline medication; Participants will be provided placebo medication
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Balanced placebo design
Masking: Double (Participant, Investigator)
Masking description: double-blind
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The current study will use the double-blind balanced placebo design to examine differences
      between expectancies versus the pharmacological effects of varenicline medication
      administered for two weeks to cigarette smokers. The double-blind balanced placebo design
      includes medication administration (active medication v. placebo) and medication information
      (told truth v. deception) resulting in four groups of smokers: (1) told therapeutic dose (TD)
      medication + received TD medication; (2) told TD medication + received placebo; (3) told low
      dose (LD) medication+ received TD dose medication; (4) told LD medication + received placebo.
      Ecological momentary assessments (EMA) in the form of Daily Dairies delivered via smartphone
      will assess real-time side effects, withdrawal symptoms, cigarettes smoked, medication use,
      and reasons for medication non-adherence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Smoking at least 5 cigarettes per day (cpd) for the past year

          -  A carbon monoxide (CO) >10ppm

          -  English speaking

          -  Must own a cellphone with SMS text capacity with Internet access OR daily use of email

          -  Must be varenicline naïve

          -  Express a desire to quit smoking

        Exclusion Criteria:

          -  Living in a restricted environment (e.g., prison or jail facility, etc.)

          -  Pregnant or nursing

          -  Currently enrolled in a smoking cessation treatment program, using NRT products, or
             prescribed bupropion or varenicline

          -  Known allergy to varenicline

          -  History of kidney disease, dialysis or known kidney impairment

          -  Cognitive impairment or unstable psychiatric condition that interferes with the
             informed consent process (individuals stable on psychiatric medications will be
             included)

          -  Daily or exclusive use of other tobacco products

          -  Current suicidal or homicidal ideation or a suicidal attempt within the past 12 months

          -  History of stroke, heart attack, or seizures
Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
Condition: Kidney Transplantation
Intervention: Sirolimus+MMF or MPS or AZA+Steroid; Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid
Intervention description: Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.; The maintenance dose of:
MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day
AZA will not exceed 75 mg/day
Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be:
continued for the entire 104-week period of randomized therapy
subsequently discontinued
restarted after discontinuation
Intervention MeSH terms: Cyclosporine; Sirolimus; Tacrolimus; Cyclosporins; Calcineurin Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI)
      to sirolimus (SRL) results in improved long-term renal function without a negative impact on
      safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce
      the severity and/or progression of chronic allograft nephropathy (CAN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be at least 18 years of age.

          -  Subjects who are 6 to 60 months after renal transplantation.

          -  Subjects who have a stable graft function.

        Exclusion Criteria:

          -  Subjects with active major infection, including HIV, decreased platelets, elevated
             lipids, or multiple organ transplants.
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
Condition: Liver Transplantation
Intervention: mycophenolate mofetil [CellCept]; Tacrolimus; Cyclosporine; Sirolimus
Intervention description: 1-1.5 g orally or intravenously twice daily; As prescribed, for 12 months; As prescribed, for 12 months; 2-4 mg orally once daily for 9-11 months
Intervention MeSH terms: Cyclosporine; Sirolimus; Mycophenolic Acid; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This two-arm study will assess the efficacy and safety of a long-term calcineurin
      inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an
      orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g
      twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The
      anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients 18-74 years of age

          -  Single primary liver transplant from a deceased donor

          -  CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72
             hours)

          -  Patients with hepatitis C-positive status may be entered if they have had an
             intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at
             the time of randomization. This is not required for patients negative for hepatitis C.

        Exclusion Criteria:

          -  Liver allograft from a living donor or a split liver

          -  Multiple organ transplant

          -  Dialysis therapy for >14 days from transplantation to randomization

          -  History of malignancy in the last 5 years (except hepatoma or non-melanoma skin
             cancer)

          -  Previous sirolimus therapy
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fingolimod
Intervention description: Fingolimod 0.5 mg tablet
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: multiple sclerosis, fingolimod, adult, FTY720, inflammatory disease, demyelination, auto-inflammatory disease, relapsing-remitting MS, CFTY720D2406

Summary:

      This study will evaluate if patients who had a serious cardiovascular event upon initiation
      of fingolimod are at risk to delevop long term other cardiovascular events
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients participating in study FTY720D2406 who experienced a serious cardiovascular
             event during their fingolimod treatment initiation or re-initiation which led to
             overnight monitoring or met seriousness criteria.

          -  Patients still on fingolimod after the this first dose serious event

        Exclusion Criteria:

        -Treatment with any investigational drug unless it is received as part of a Novartis
        sponsored MS study lasting less than 1 month
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact
Condition: Advanced Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa-carbidopa intestinal gel (LCIG); CADD-Legacy® 1400 ambulatory infusion pump; percutaneous endoscopic gastrostomy tube (PEG tube); jejunal extension tube (J-tube)
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Health economics,Quality of life

Summary:

      The primary objective of this study is to collect health economic data depicting the initial
      levels and natural progression over time of resource usage, Parkinson's disease (PD)-related
      costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients
      treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about
      one-third were Duodopa-naïve prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

        - Advanced idiopathic Parkinson's disease

        Exclusion Criteria:

        - Other diseases which might influence compliance or participation in the study
Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
Condition: Cardiac Arrythmias
MeSH terms: Arrhythmias, Cardiac
Intervention: Carbetocin
Intervention description: 50 mcg or 100 mcg bolus of carbetocin
Intervention MeSH terms: Carbetocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Carbetocin; Myocardial repolarization

Summary:

      Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial
             anesthesia

          -  American Society of Anesthesiologists (ASA) class 2

          -  Patients ≥ 19 years of age

        Exclusion Criteria:

          -  Long QT syndrome

          -  Cardiac disease or rhythm abnormalities

          -  Family history of long QT syndrome or abnormal cardiac conduction

          -  Currently taking medication that is known to prolong the QT interval

          -  Women who are high risk for uterine atony as outlined in SOGC

          -  Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin
             homologue

          -  Patients who are unable to give informed consent because of a language barrier as the
             study team only speaks English and will be unable to complete consent process and
             study procedure appropriately.
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
Condition: Psoriasis; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Intervention: Pandel Cream 0.1%
Intervention description: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: No
Keywords: Psoriasis; Atopic Dermatitis

Summary:

      The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate
      cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult
      subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface
      area.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body
             surface area

          -  Good health with the exception of psoriasis or atopic dermatitis

        Exclusion Criteria:

          -  Any disease affecting the HPA-axis

          -  Subjects who are pregnant, nursing, or planning a pregnancy within the study
             participation period
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Intervention: RF energy delivery for treatment of Typical Atrial flutter
Intervention description: Navistar ThermoCool catheter
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 291.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Disease; Atrial Flutter; Typical Atrial Flutter

Summary:

      The primary objective is to provide additional corroborative safety and efficacy data for the
      Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during
             the one-year period prior to enrollment. This may include typical AFL occurring while
             receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including
             atrial fibrillation.

          -  At least one episode of typical (clockwise or counterclockwise) atrial flutter
             documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event
             monitor, telemetry strip, or implanted device within 6 months prior to enrollment.

          -  18 years of age or older

          -  Informed consent

        Exclusion Criteria:

          -  Intracardiac thrombus

          -  Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart
             failure

          -  Women who are pregnant

          -  Cardiac surgery (ventriculotomy or atriotomy) within the past two months

          -  Intra-atrial thrombus, tumor, or other abnormality that precludes catheter
             introduction and placement

          -  Unstable angina or acute myocardial infarction within 3 months

          -  Awaiting cardiac transplantation

          -  Heart disease in which corrective surgery is anticipated within 6 months

          -  Presence of condition that precludes appropriate vascular access

          -  Enrolled in any investigational device exemption (IDE) investigating study for a
             device or drug

          -  High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by
             the investigator or patient's physician)

          -  Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma
Condition: Melasma
MeSH terms: Melanosis
Intervention: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%; Cetaphil® Moisturizing Cream as Inactive Control
Intervention description: Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.; Applied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
Intervention MeSH terms: Fluocinolone Acetonide; Tretinoin; Hydroquinone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide
      0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense
      pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a
      10 week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with moderate to severe melasma on both sides of the face
             (Investigator's Global Assessment (IGA) at baseline must be 3 or 4.)

        Exclusion Criteria:

          -  Subjects with a diagnosis of skin cancer (Basal Cell Carcinoma (BCC), Squamous Cell
             Carcinoma (SCC), Melanoma) in the areas to be treated

          -  Subjects with prior facial Intense Pulsed Light (IPL), resurfacing, deep or chemical
             peels within 6 months of the date of study entry

          -  Subject has initiated treatment with hormones including estrogen, progesterone and/or
             oral contraceptives within 3 months of study entry, or who intend to discontinue
             hormonal therapy during the study
Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction
Condition: Ureteral Obstruction
MeSH terms: Ureteral Obstruction
Intervention: Tamsulosin; Tolterodine ER
Intervention description: 0.4 mg by mouth once per day.; 4 mg by mouth once a day.
Intervention MeSH terms: Tamsulosin; Tolterodine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tolterodine; Tamsulosin; Ureteral Obstruction

Summary:

      The purpose of this study is to determine whether combination therapy with Tolterodine ER and
      Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent
      symptoms. The second purpose is to determine if people have less stent discomfort if they
      take these medications starting 2 weeks before the stent is placed

      The investigators hope to show that the addition of Tolterodine ER to Tamsulosin will provide
      added benefits in reducing stent symptoms in patients who have had unilateral placement of a
      ureteral stent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with unilateral ureteral stent placement for urolithiasis

        Exclusion Criteria:

          1. Pre-existing lower urinary tract symptoms

          2. Active urinary tract infection

          3. Contraindication to anticholinergic medication

               1. Prior hypersensitivity or allergy to tolterodine

               2. Patients with severe hepatic impairment (Child-Pugh Class C)

               3. Patients with uncontrolled close (narrow) angle glaucoma

               4. Patients with urinary retention

          4. Current anticholinergic use

          5. Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis)

          6. Women who are pregnant or nursing

          7. Under 18 years of age

          8. Prior hypersensitivity or allergy to tolterodine

          9. Patients with severe hepatic impairment (Child-Pugh Class C)

         10. Patients with uncontrolled close (narrow) angle glaucoma

         11. Patients with urinary retention

         12. Unable to provide informed consent
Effects of LDX on Functioning of College Students With ADHD
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: lisdexamfetamine dimesylate; Placebo
Intervention description: 30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 28 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a
      prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college
      students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students
      with ADHD from two universities (University of Rhode Island and Lehigh University) completed
      a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral,
      psychosocial, and academic functioning were completed on a weekly basis across five
      conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic Statistical Manual of Mental Disorders 4th edition-text revision
             (DSM-IV-TR) criteria for ADHD based on self- and parent-report using questionnaires
             and clinical interview

        Exclusion Criteria:

          -  significant cardiac condition based on medical history and/or physical examination

          -  significant substance abuse based on self-report and toxicology screen at intake

          -  significant symptoms of major depressive disorder, bipolar disorder, or thought
             disorder based on initial diagnostic interview