bioihbjkbjnl/mcl2 huggingface dataset:
Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Condition: Contraception
Intervention: Subcutaneous depot medroxyprogesterone acetate
Intervention description: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 401.0
Sex: Female
Minimum age: 15 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraceptive Methods; Female Contraception; Contraceptive satisfaction; Injectable contraception; Birth control

Summary:

      This randomized clinical trial will study subcutaneous depot medroxyprogesterone acetate
      (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient
      populations. Prior studies demonstrate that DMPA self-injection is safe, effective, feasible,
      and acceptable for women and adolescents. A total of 400 female patients (ages 15-44)
      requesting DMPA will be randomized to self-administration of DMPA sc or clinic administration
      (usual care). Subjects will be followed for one year. The primary study outcome is DMPA
      continuation at one year by self-report in both study arms. Secondary outcomes include
      patient-reported satisfaction with treatment; satisfaction with home use; and costs
      associated with contraceptive care. The investigators hypothesize higher continuation rates
      among self-injection users compared to patients who receive standard care. Secondary
      exploratory hypotheses include higher patient satisfaction and lower costs associated with
      contraceptive care among self-injection users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females ages 15-44

          -  Current or past users of DMPA or desires initiation of DMPA for contraception

          -  Can understand spoken and written English or Spanish

          -  Willing to consider/attempt DMPA self-injection

          -  Willing to be randomized to either self- or clinic administration of DMPA

          -  Do not want to become pregnant in the next 12 months

          -  Willing to provide contact information and to complete three surveys at baseline, 6
             months, and 12 months

          -  Have consistent access to a working telephone, email, and Internet

          -  No contraindications to DMPA use

        Exclusion Criteria:

          -  Suspected or confirmed pregnancy

          -  Vaginal bleeding of unknown etiology

          -  Known or suspected breast cancer

          -  Acute liver disease

          -  High blood pressure (Systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg)

          -  Known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA

          -  Desire for pregnancy within one year
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease, COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Placebo
Intervention description: QVA149 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily; Placebo to QVA140 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: QVA149, cardiac function, ventricular enddiastolic volume, hyperinflated COPD patients

Summary:

      This mechanistic study is a single-center, randomized, double-blind, placebo-controlled,
      cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and
      lung function parameters in hyperinflated COPD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with airflow limitation indicated by a post-bronchodilator FEV1 <80% of the
             predicted normal value and a post-bronchodilator FEV1/FVC<0.7

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

          -  Able and willing to give written informed consent

          -  Hyperinflated patients with RVol>135% predicted

        Exclusion Criteria:

          -  Patients on LABA or LAMA treatment at Visit 1.

          -  History of one COPD exacerbation that required treatment with antibiotics, systemic
             steroids (oral or intravenous) or hospitalization 3 months prior to Visit 2.

          -  More than one COPD exacerbation that required treatment with antibiotics, systemic
             steroids (oral or intravenous) or hospitalization within 6 months prior to Visit 2.

          -  Patients who have clinically significant cardiovascular abnormalities, which could
             interfere with the assessment of the study treatment (such as but not limited to
             cardiac arrhythmias, heart failure with left ventricular ejection fraction <40% as
             determined by MRI scan, unstable ischemic heart disease, NYHA Class III/IV left
             ventricular failure, history of myocardial infarction 6 months prior to Visit 2)

          -  Patients with a known history or current atrial fibrillation to be confirmed by ECG.

          -  Patients with pacemaker, bypass or stent.

          -  Patients whose QTcF measured at Visit 3 is >450 ms for males and >470 ms for females

        Additional study-specific inclusion and exclusion criteria may apply
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
Condition: Immunosuppression
Intervention: Tacrolimus Extended Release Capsule; Mycophenolate mofetil; Prednisone; Mycophenolate Sodium
Intervention description: goal trough 5 - 12ng/mL; ≥500mg twice a day; goal dose 5mg daily; ≥360mg twice a day
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Compare the difference in dose-normalized trough and total daily dose necessary to reach the
      steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African
      American kidney transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age

          2. Signed informed consent

          3. African American race

          4. History of a solitary renal transplant

          5. Stable tacrolimus dose for at least 2 weeks prior to randomization

        Exclusion Criteria:

          1. A condition or disorder that, in the opinion of the investigator, may adversely affect
             the outcome of the study or the safety of the subject

          2. Currently enrolled in an investigational drug trial

          3. History of a non-renal organ transplant

          4. History of acute cellular rejection within 1 month prior to randomization

          5. An increase in serum creatinine by > 20% in the 2 weeks prior to randomization

          6. Maintenance immunosuppression that does not consist of tacrolimus IR given twice
             daily, mycophenolate mofetil > 1000mg TDD or mycophenolate sodium > 720mg TDD, and
             prednisone ≥ 5mg daily
Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing
Condition: Fluid Overload; Heart Failure Acute
MeSH terms: Heart Failure
Intervention: Metolazone 60 minutes prior to furosemide; Metolazone concurrently with furosemide
Intervention description: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.; All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.
Intervention MeSH terms: Metolazone; Furosemide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, open-label, active control pilot study
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: diuretic; metolazone; furosemide

Summary:

      The purpose of this study is to examine whether administering metolazone 60 minutes prior to
      furosemide increases urine output compared with administering metolazone and furosemide
      concomitantly. Participants will have equal chance of being assigned to each group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission within 48 hours for acute decompensated heart failure with at least one
             symptom and one sign of volume overload

          -  Receipt of loop diuretic prior to admission

          -  Plan to administer furosemide 120 - 160 mg IV bolus twice daily over the next 24 hours
             with additional diuresis deemed necessary

          -  If patient is concurrently administered intravenous vasodilator or inotrope, the dose
             of vasodilator or inotrope must be stable for 6 hours prior to enrollment with a plan
             to continue the same dose for the 24 hour duration of this study

        Exclusion Criteria:

          -  Metolazone prescribed prior to admission

          -  Receipt of continuous intravenous infusion of furosemide

          -  Cirrhosis or end stage renal disease

          -  Non-English speaking patients
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
Condition: Pain
Intervention: Lidocaine Cream 4%; Placebo
Intervention description: Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure; inactive placebo without LMX4
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 0 Days
Maximum age: 60 Days
Healthy volunteers: No
Keywords: pain; lumbar puncture; neonates; infants; emergency department; topical anesthesia; LMX4

Summary:

      The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of
      infants undergoing Lumbar Puncture (spinal tap).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Full term (>=37 weeks gestation)

          -  Age 0-60 Days

          -  Undergoing Lumbar Puncture

        Exclusion Criteria:

          -  Unstable

          -  Premature (<37 weeks gestation)

          -  Allergy to study medicine

          -  Parent refusal of consent
Subclinical Cardiovascular Disease in Psoriatic Disease
Condition: Cardiovascular Diseases; Myocardial Infarction; Atherosclerotic Cardiovascular Disease; Thrombotic Vascular Disease
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Vascular Diseases; Atherosclerosis; Infarction
Intervention: Aspirin and/or Atorvastatin
Intervention description: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
Intervention MeSH terms: Aspirin; Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cardiovascular disease; CVD

Summary:

      This study will look at how chronic inflammation seen in psoriatic disease translates into
      the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk.
      The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic
      disease and measures of vascular function. 2) Evaluate the association between moderate to
      severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional
      medications used in cardiovascular disease (CVD) prevention such as aspirin and statins
      affect vascular function and thrombotic risk in those with moderate to severe psoriatic
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a history of moderate to severe psoriatic disease

          -  Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease

        Exclusion Criteria:

          -  Unable to speak Spanish or English

          -  Active smoking (within the past year)

          -  Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic
             arthritis

          -  Known active cancer receiving treatment

          -  Pregnancy

          -  Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or
             thrombocytosis (Platelet count >600)

          -  A history of severe bleeding or bleeding disorders

          -  Current medication use which interact with either aspirin or atorvastatin

          -  Chronic kidney disease (CrCl < 30ml/min)

          -  Congestive heart failure

          -  Currently taking aspirin or a statin.

          -  NSAID use within the past 48 hours
Botox Cosmetic and the Young Patient With Glabellar Furrows
Condition: Glabellar Furrows
Intervention: Botox
Intervention description: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 30 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glabellar lines of moderate severity at maximum frown

Summary:

      The purpose of this study is to see if consistent treatment with Botox will lead to longer
      lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug
      Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this
      study a different dosing schedule of Botox injections will be used to see if the effects of
      the Botox treatment last longer than the effects of the standard injection regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Fitzpatrick Skin Types I-III

          -  Between 30 and 50 years of age

          -  At least moderate severity at maximum frown

        Exclusion Criteria:

          -  Prior botulinum toxin treatment

          -  Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as
             aminoglycoside antibiotics) that might interfere with neuromuscular function

          -  Any other condition or situation that might put the subject at significant risk,
             confound the study results (such as significant pre-existing brow or eyelid ptosis)

          -  Allergy or sensitivity to any study component

          -  Participation in another clinical study within 30 days of the study start date

          -  Are planning other facial cosmetic procedures during the study period, or are
             pregnant, breastfeeding, or planning a pregnancy during the study.
Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
Condition: Reperfusion Injury
MeSH terms: Reperfusion Injury
Intervention: Ascorbic Acid; 5 % Dextrose Water or Normal Saline
Intervention description: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.; 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Free Radicals; Ascorbic Acid; Cardiac Surgery; Prevention of Reperfusion Injury

Summary:

      It has been shown that the stress that occurs during cardiac surgery leads to early decrease
      of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to
      complications after surgery.

      This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the
      outcome and complications after cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients 18 years or older undergoing elective or urgent (prior to hospital
             discharge) cardiac surgery.

        Exclusion Criteria:

          -  History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate
             dehydrogenase deficiency) or the chronic use of steroids.
Trial of Aripiprazole in the Treatment of CD in Adolescents
Condition: Conduct Disorder
MeSH terms: Conduct Disorder
Intervention: Aripiprazole
Intervention description: The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open label trial
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aripiprazole

Summary:

      The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment
      of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct
      disorder. The initial dose depending on the weight of the patient will be as follows: < 25 kg
      = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003,
      Bristol-Myers Squibb). For the first two weeks of the study, the dose will be flexible based
      on response and tolerance and thereafter will remain fixed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct
             disorder.

        Exclusion Criteria:

          -  Clinically significant laboratory and/or ECG abnormalities

          -  Pre-existing health conditions that would compromise patient safety

          -  Mental retardation

          -  Previous use of aripiprazole

          -  Active psychosis
Impact of Oral Antibiotic Treatment on C. Difficile
Condition: C. Difficile; Diarrhea; Enterocolitis
MeSH terms: Enterocolitis; Diarrhea
Intervention: Fidaxomicin; Metronidazole; Vancomycin
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Vancomycin; Fidaxomicin; Amebicides
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The overall aim is to characterize and to compare the extent and quantity of C. difficile
      stool shedding, perianal colonization and environmental contamination in patients who
      received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective,
      randomized, microbiologic and molecular, study of environmental contamination from patients
      with proven C. difficile associated diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients with microbiology-proven CDAD

          -  provides informed consent

          -  eligible to receive oral antibiotic therapy

        Exclusion Criteria:

          -  prisoners

          -  pregnant women

          -  children <18 years

          -  patients who have contra-indications for perianal swabs, those who has medical
             conditions that would invalidate the results of the swabs

          -  patients requiring intravenous therapy for treatment of CDAD

          -  patients who do not consent and those who withdraw consent
Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Benzoyl Peroxide
Intervention description: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to see how often benzoyl peroxide is applied for acne.
      Use of medication was monitored electronically.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any male or female 13 to 18 years of age with a diagnosis of mild to moderate acne
             vulgaris by a dermatologist will be eligible for participation.

          -  Verbal consent of participation must be given by parent or guardian and child.

        Exclusion Criteria:

          -  Age less than 13 or greater than 18 years of age.

          -  Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.

          -  Inability to complete all study-related visits.

          -  Introduction of any other prescription medication, topical or systemic, for acne
             vulgaris while participating in the study.

          -  Subjects should not be using topical retinoids or benzoyl peroxide products, including
             Proactive® or topical prescription medications for the treatment of acne vulgaris for
             at least 2 weeks prior to beginning the study. Oral medications for the treatment of
             acne should not have been used at least 4 weeks prior to beginning the study.

          -  Women that are actively trying to become pregnant or wish to become pregnant during
             the time frame the study is to take place will be excluded.