bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Pantoprazole and Ranitidine in Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Intervention: Pantoprazole; Ranitidine
Intervention description: 33 patients; 33 patients
Intervention MeSH terms: Pantoprazole; Ranitidine; Ranitidine bismuth citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dyspepsia; pantoprazole; ranitidine; emergency department

Summary:

      The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine
      in treating patients presented with dyspepsia to the emergency department.

      The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating
      patients presented with dyspepsia to the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Epigastric pain

          -  Older than 18 years old

        Exclusion Criteria:

          -  Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of
             the emergency deparment evaluation period.

          -  Pregnancy

          -  Patients with unstable vital signs

          -  Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last
             one hour.

          -  Allergy to H2 receptor blockers and proton pomp inhibitors.

          -  Patients denied to give inform consent and who are illiterate
An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Ethinyl estradiol/Norgestimate (EE/NGM); Ethinyl estradiol/Desogestrel (EE/DSG)
Intervention description: Ethinyl estradiol/Norgestimate encapsulated oral tablet will be administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.; Ethinyl estradiol/Desogestrel oral formulation will be administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
Intervention MeSH terms: Moxifloxacin; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Desogestrel; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Estradiol; Polyestradiol phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 201.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; Ethinyl estradiol; Norgestimate; Desogestrel; Tricilest; Oilezz

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and
      Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment
      of female participants with mild to moderate acne vulgaris (pimples).
    

Eligibility criteria:

        Inclusion Criteria: - Needs contraception in the family planning - Mild to moderate acne
        vulgaris - Agrees to take only the supplied study drug as treatment for acne during the
        6-month treatment phase of the study - Signs and dates an informed consent to participate
        in the study - female participants aged 18 to 45 years Exclusion Criteria: - Pregnant or
        nursing - Known hypersensitivity to any of the ingredients and currently having significant
        adverse experiences from ethinyl estradiol, norgestimate or desogestrel - Any coexisting
        medical condition or were taking any concomitant medication that is likely to interfere
        with safe administration of ethinyl estradiol/norgestimate and ethinyl
        estradiol/desogestrel, in the Investigator's opinion - Taking system retinoids, systemic
        antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to
        enrollment, respectively - Taking investigational medication or oral contraceptives within
        30 days prior to Screening
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
Condition: Dry Eye Syndromes; Cataract
MeSH terms: Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Sodium Carboxymethylcellulose; Levofloxacin; Prednisolone
Intervention description: Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.; Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.; Prednisolone 1 drop in the study eye 4 times a day for the 1st week post surgery, 3 times a day for the 2nd week post surgery, 2 times a day for the 3rd week post surgery, and 1 time a day for the 4th week post surgery.
Intervention MeSH terms: Levofloxacin; Prednisolone; Prednisolone acetate; Carboxymethylcellulose Sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the
      treatment of dry eye after cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of age-related cataract in the study eye

          -  Scheduled for cataract surgery and lens implant

        Exclusion Criteria:

          -  Diagnosis of ocular surface disease or glaucoma

          -  Ocular surgery in the past 3 months

          -  Wearing a corneal contact lens in the study eye
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.
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis; Inflammation
Intervention: Secukinumab 300 mg; Placebo
Intervention description: Secukinumab 300 mg was provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab consisted of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 48 inclusive.
The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occurred on days of study visits.
The injections not occurring on days of study visits were done by the patients (or caregivers) at home.; Placebo was provided in 1 mL prefilled syringe. Each placebo dose consisted of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3, 4), then after four weeks at Week 8. At Week 12, patients were switched to receive 300 mg secukinumab once weekly for five weeks (Weeks 12, 13, 14, 15, 16) followed by monthly dosing through Week 48 inclusive.
The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occured on days of study visits.
The injections not occurring on days of study visits were done by the patients (or caregivers) at home.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; plaque psoriasis; secukinumab; AIN457; biologic; monoclonal antibody; aortic vascular inflammation

Summary:

      This study evaluated the effect of secukinumab compared to placebo on aortic vascular
      inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly
      controlled by current psoriasis treatments.
    

Eligibility criteria:

        Inclusion Criteria:

        - Males and females at least 18 years of age with moderate to severe plaque psoriasis

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque psoriasis

          -  Previous exposure to IL-17A or IL-17 receptor targeting agents.

          -  Other active or ongoing disease that may interfere with evaluation of psoriasis or
             places the patient at unacceptable risk

          -  Other protocol-defined inclusion/exclusion criteria may apply
The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
Condition: Healthy
Intervention: Sitagliptin; atorvastatin
Intervention description: sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
Intervention MeSH terms: Sitagliptin Phosphate; Atorvastatin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and
      drug-drug interactions of sitagliptin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and women between 21 to 60 years of age will be recruited to participate
             in this study.

          -  Subjects will be eligible if metabolic, renal, hepatic, and hematological laboratory
             tests are within normal limits.

        Exclusion Criteria:

          -  Subjects will be excluded from the study if they have a current or past history of
             cardiovascular, hepatic, endocrine (e.g., diabetes), renal, pancreatic,
             gastrointestinal, pulmonary, immunologic, hematologic, or neurologic disease.
Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis
Condition: Advanced Cancers; Malignant Pleural Effusions
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion
Intervention: Questionnaires; Fentanyl Patch; Fentanyl (IV); Saline; Doxycycline; Phone Calls
Intervention description: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.; Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.; Fentanyl 50 mcg given by vein prior to catheter draining.; Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.; Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.; After the IPC is removed, participant is called one time each month by study staff to check on their status.
Intervention MeSH terms: Doxycycline; Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancers; Malignant pleural effusions; MPE; Indwelling pleural catheter; IPC; Questionnaires; Surveys; Fentanyl patch; Fentanyl by vein; Sublimaze; Doxycycline; Vibramycin; Periostat; Doryx; :Phone calls

Summary:

      The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in
      combination with saline (the current standard of care) versus IPC in combination with
      doxycycline as treatment for pleural effusions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Outpatients with MPE undergoing IPC placement

          2. Age 18 or older

          3. Sufficient mental capacity to answer SF-6D and Borg score questions.

        Exclusion Criteria:

          1. Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)

          2. Inability or unwillingness to give informed consent

          3. Inability to perform phone call and clinical follow-up at MDACC

          4. Previous intrapleural therapy for MPE on the same side

          5. Chylous effusions associated with malignant disease

          6. ECOG of 4 and life expectancy </= 2 weeks

          7. Doxycycline allergy

          8. Contraindication to placement of an IPC (e.g., uncorrected coagulopathy)
Postpartum Depression: Transdermal Estradiol Versus Sertraline
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Transdermal Estradiol; Sertraline; Placebo
Intervention description: Estradiol patch ranging in dose from 50 to 200 mcg/day; Sertraline dose will range from 50 - 200 mg/day; Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
Intervention MeSH terms: Sertraline; Estradiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Postpartum depression; estradiol; Postpartum major depressive disorder

Summary:

      The purpose of this study is to determine whether estrogen patches are effective for the
      treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-45 years

          -  Had a baby within the last 3 months

          -  Experiencing depression or lasting sadness

        Exclusion Criteria:

          -  Current use of other therapies for depression, such as antidepressants, psychotherapy,
             bright light therapy, and herbal remedies such as Hypericum St. John's Wort

          -  DSM-IV diagnoses of bipolar 1 or 2 disorder or any psychotic episode; substance abuse
             within last 6 months

          -  Previous adverse reaction to sertraline or provera

          -  No pediatric care: No pediatrician with whom to coordinate breastfeeding and infant
             care

          -  Use of medications for medical disorders, except for treatment of hypothyroidism or
             inhalers for asthma or progestin-only contraceptives

          -  Heavy smoking (>10 cigarettes per day) or intent to resume heavy smoking (unless
             willing to cut down)

          -  personal history of thromboembolic event, hypercoagulability, or first degree
             relatives with thromboembolic events.

          -  Current or past personal history of breast, uterine, or ovarian cancer.

          -  BRCA-positive mother

          -  Arterial vascular disease and/or heart disease: increased risk of stroke.

          -  Liver disease: increased risk of biliary stones, cholestatic jaundice and benign
             hepatic lesions with E2 treatment.

          -  Diabetes

          -  Pregnancy

          -  Infants born <32 weeks of gestation

          -  Imminent suicidality and/or homicidality: in need of higher level of care than is
             provided in this study.
A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)
Condition: Drug Therapy, Combination
Intervention: Oseltamivir; Warfarin
Intervention description: Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5.; Warfarin once daily, at a dose determined through titration by participants' usual hematologist.
Intervention MeSH terms: Oseltamivir; Warfarin
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an open-label, randomized, 2-period crossover study, to evaluate the
      pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with
      Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized
      to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and
      warfarin followed by warfarin. The treatment periods will be separated by a washout period of
      at least 4 days. Participants will continue receiving warfarin once daily at a prescribed
      usual dose throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have been receiving warfarin once daily for at least 4 weeks prior
             to Screening

          -  Participants must have regular International Normalized ratio (INR) monitoring during
             warfarin therapy prior to study entry, and be willing to be trained in the use of
             CoaguCheck devices

          -  INR must fall within a target range of 2.0-3.5

          -  Body mass index (BMI) between 18-32 kg/m^2 inclusive

        Exclusion Criteria:

          -  An INR value between screening and Day -1 lower than 2.0 or greater than 3.5

          -  A change in prescribed daily warfarin dose between Screening and Day -1

          -  History of any coagulopathy

          -  Consumption of health products or supplements containing vitamin K

          -  Pregnant or lactating women

          -  Confirmed positive urine and/or blood test for drugs of abuse at Screening or Day -1
Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's
Condition: Alzheimer's Disease; Hypertension
MeSH terms: Alzheimer Disease; Hypertension
Intervention: Ramipril; Placebo
Intervention description: Ramipril 5 mg/day; Matching Placebo
Intervention MeSH terms: Ramipril
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alzheimer's Disease; Hypertension

Summary:

      Angiotensin converting enzyme inhibitors (ACE-I) are a group of blood pressure-lowering
      medicines. Some studies suggest that ACE-I, such as ramipril, may help prevent Alzheimer's
      disease (AD). The purpose of the research is to see how ramipril affects a substance in the
      body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the
      brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of
      getting Alzheimer's disease. This study will see if ramipril can lower the amount of
      beta-amyloid in the spinal fluid. This study will also see if ramipril affects blood vessel
      function and memory and thinking. The investigators hope that future studies will show
      whether ramipril might prevent memory loss and decrease the chance of developing Alzheimer's
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 40 and 65

          -  Mean resting blood pressure between 130-160 systolic and 85-100 diastolic

          -  Parent with Alzheimer's Disease

        Exclusion Criteria:

          -  Current involvement in another investigational drug trial.

          -  Potassium > 5.0

          -  Dementia based on DSMIV criteria

          -  Mini-Mental State Exam (MMSE) score < 27

          -  Current blood pressure medication (< 4 months from screening)

          -  Weight loss medication

          -  Contraindications for LP

          -  Know diagnosis or history of hospitalization due to congestive heart failure

          -  Elevated creatinine (females > 1.3 mg/dL or males > 1.4 mg/dL at baseline)

          -  Diabetes Type I and II

          -  Know adverse reaction to an ACE-I or an angiotensin receptor blocker

          -  Pregnant of nursing women
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
Condition: Inflammation
MeSH terms: Atherosclerosis; Inflammation
Intervention: Atorvastatin
Intervention description: atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to test whether atorvastatin (also known as Lipitor) has
      anti-inflammatory effects in people with no known heart disease or high cholesterol. We also
      are investigating whether or not genetic differences between people plays a role in the drug
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18+ years old

          -  Normocholesterolemic

        Exclusion Criteria:

          -  Cardiovascular disease or risk equivalents

          -  Malignancy

          -  Active alcohol abuse

          -  Contraindications to statins

          -  Interacting drugs

          -  Chronic anti-inflammatory drugs