bioihbjkbjnl/mcl2 huggingface dataset:
Postmenopausal Pessary Users: Estrogen Versus Trimosan
Condition: Vaginosis; Vaginosis, Bacterial; Vaginal Discharge
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Vaginal Discharge
Intervention: Estrogen vaginal cream; Trimo-San vaginal gel
Intervention description: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.; Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
Intervention MeSH terms: Estrogens
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Pessary; Vaginal pH

Summary:

      The purpose of the study is to compare vaginally applied estrogen with the vaginal gel
      trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary
      users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal
             will be defined as: amenorrhea for a year or 3 months after surgical bilateral
             salpingo-oophorectomy

          -  Is a new pessary user, or has not had a pessary for a year

        Exclusion Criteria:

          -  Pregnancy

          -  Persistent Bacterial Vaginosis infection in the first two clinic encounters

          -  Currently on hormone replacement therapy

          -  Previously on hormone replacement therapy in the past 6 months

          -  Currently on antibiotics

          -  Patients with existing vaginal erosions/ulcerations
Influence of Escitalopram on Fear Conditioning
Condition: Fear Conditioning
Intervention: Escitalopram
Intervention description: Escitalopram 10mg/day or matched pill placebo
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to learn how differences in learning under mildly-stressful
      circumstances may be changed by taking an antidepressant medication. This medication is
      called Lexapro (Escitalopram). The investigators will also examine the impact of any anxiety,
      depression, and stress related symptoms on learning processes. The investigators will also
      look at the response of these symptoms to Lexapro.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients 18 to 75 years of age

          2. Must have no current DSM-IV Axis I diagnosis as measured by the SCID (Structured
             Clinical Interview for DSM-IV-TR axis 1 disorders) with a trained study investigator.
             Past history of anxiety disorders, major depressive episodes or substance abuse
             disorders at least six months prior to baseline are not exclusionary.

        Exclusion Criteria:

          1. Patients will be excluded from entry into the study for current serious medical
             conditions or other conditions deemed likely to result in surgery or hospitalization.

          2. Patients with a history of trauma resulting in head injury related seizures, or with
             epilepsy (except a prior history of febrile seizures of infancy which are not
             exclusionary).

          3. Pregnant or lactating women or those of childbearing potential not using medically
             accepted forms of contraception will be excluded.

          4. Concurrent use of other antidepressants, benzodiazepines or antipsychotic medications.

          5. Patients with a history of hypersensitivity to escitalopram are excluded.

          6. Individuals must have discontinued MAO inhibitors more than 14 days before starting
             study drug.

          7. Additional contraindicated drugs during the study are pimozide, furazolidine,
             isocarboxazid, lazabemide, and St. John's Wort.

          8. Participants meeting DSM-IV or SCID criteria for a substance use disorder in the last
             six months other than nicotine dependence and those with a positive toxicology screen
             at baseline consistent with evidence of current substance abuse or dependence as
             determined by clinical interview.

          9. A lifetime history of Bipolar or any psychotic disorder is excluded.

         10. Current claustrophobia is exclusionary.

         11. Patients currently taking any narcotic will be excluded.
Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding
Condition: Variceal Bleeding, Cirrhosis
MeSH terms: Hemorrhage; Fibrosis
Intervention: Terlipressin; Somatostatin; Octreotide
Intervention description: loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days; loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days; loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days
Intervention MeSH terms: Octreotide; Terlipressin; Somatostatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1034.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cirrhosis, Esophagus Disorders, Varicose Veins

Summary:

      This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide
      in patients with variceal bleeding for the control of variceal bleeding in combination with
      endoscopic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  liver cirrhosis

          -  age between 16 and 75 years

          -  Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours
             before enrollment

          -  Patients whose systolic blood pressure <100 mmHg or pulse rate >100/min at the
             enrollment

          -  Patients who were not performed endoscopic or pharmacologic therapy for varices

          -  Signed informed consent

        Exclusion Criteria:

          -  Pregnancy

          -  Positive anti-HIV Ab

          -  A history of severe side-effects or contraindications to study drugs

          -  Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive
             heart failure, ischemic heart disease, hypertension (systolic blood pressure >170 mmHg
             or diastolic pressure >100 mmHg)

          -  Chronic renal failure

          -  Hepatocellular carcinoma with protal vein thrombosis

          -  Coexisting malignancy except hepatocellular carcinoma
A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab; Methotrexate
Intervention description: Adalimumab in pre-filled syringes; Methotrexate capsule
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 309.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in
      combination with open-label adalimumab (ADA) in patients who have had an inadequate response
      to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two
      regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects with moderately to severely active rheumatoid arthritis

          -  Subjects must have a DAS28(CRP) (Disease Activity Score using C-Reactive Protein)
             greater than or equal to 3.2 at baseline (there is no minimum CRP score required to
             qualify)

          -  Subjects must have at least 5/68 tender joints plus 5/66 swollen joints assessed at
             screening or baseline

          -  Subject must treated with and MTX (methotrexate) dose (oral and/or injectable) of 15
             mg or more per week (no upper limit on dose) for at least 12 weeks prior to screening

          -  Subject is either biologic-naïve or has only one prior biologic disease-modifying
             antirheumatic drug (i.e. abatacept, anakinra, certolizumab, etanercept, golimumab,
             infliximab, or tocilizumab)

        Exclusion Criteria:

          -  Previous exposure to adalimumab (Humira), rituximab (Rituxan), natalizumab (Tysabri),
             efalizumab (Raptiva)

          -  Subject has been treated with intra-articular or parenteral administration of
             corticosteroids within 4 weeks of screening

          -  Subject has diagnosis or history of gout or pseudogout

          -  Subject has undergone joint surgery within 12 weeks of screening (at joints to be
             assessed by ultrasound)

          -  Subject has history of chronic arthritis diagnosed before age 16 years
Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Condition: Pain; Fever
MeSH terms: Fever
Intervention: Intravenous ibuprofen
Intervention description: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Fever

Summary:

      The primary objective of this study is to determine the safety of a single dose of
      intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in
      the hospital setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pain: Patients with baseline Visual Analog Scale assessment >3, -and/or- Fever:
             Patients with temperature >101°F.

        Exclusion Criteria:

          1. Patients with inadequate IV access

          2. Patients <18 years of age

          3. History or allergy or hypersensitivity to any component of intravenous ibuprofen,
             aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)

          4. Active hemorrhage or clinically significant bleeding

          5. Pregnant or nursing

          6. Patients in the peri-operative period in the setting of coronary artery bypass graft
             (CABG) surgery

          7. Inability to understand the requirements of the study, be willing to provide written
             informed consent (as evidenced by signature on an informed consent document approved
             by an Institutional Review Board [IRB]), and agree to abide by the study restrictions

          8. Refusal to provide written authorization for use and disclosure of protected health
             information
Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Condition: Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Intervention: Gefitinib
Intervention description: 250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met
Intervention MeSH terms: Gefitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1060.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Gefitinib; EGFR TKI; efficacy; Caucasian patients; EGFR mutation positive advanced NSCLC; safety

Summary:

      This study is carried out to see how Caucasian patients with lung cancer which has EGFR
      mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also
      be collected and analysed to confirm that treatment with gefitinib is safe and well
      tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic non-small cell lung cancer (i.e. cancer that has spread
             from where it started) which is EGFR mutation positive

          -  Caucasian female or male patients aged 18 years or over

          -  Measurable disease, i.e. at least one lesion, not previously irradiated, as ≥ 10 mm in
             the longest diameter (≥ 15 mm in short axis for lymph node )

        Exclusion Criteria:

          -  Prior adjuvant chemotherapy or other systemic anti-cancer treatment less than 6 month,
             or palliative radiotherapy less than 4 weeks prior to start of study treatment.

          -  Brain metastases or spinal cord compression, unless treated and stable without
             steroids

          -  Any clinically significant illness, which will jeopardize the patients' safety and
             their participation in the study.
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
Condition: Healthy
Intervention: Oxymorphone ER; Oxycodone CR; Placebo; Hydromorphone
Intervention description: 15mg or 30mg; 30mg or 60mg; The placebo was a sugar pill.; 8 mg
Intervention MeSH terms: Oxymorphone; Oxycodone; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioid; Recreational; Oxymorphone; Oxycodone; Extended Release; Healthy NonDependent Recreational Opioid Users

Summary:

      The purpose of this study is to compare the subjective and objective effects of Oxymorphone
      ER (Opana ER) versus Oxycodone CR (Oxycontin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recreational opioid use.

          -  At least 3 lifetime occasions of recreational use of an oral intact modified-release
             opioid product.

          -  BMI within range of 19.0 to 29.9 kg/m2, inclusive, minimum weight of 50.0 kg at
             screening and Day 0 of treatment period 1

        Exclusion Criteria:

          -  Self-reported history of drug or alcohol dependence in the past 2 years or presence of
             drug or alcohol dependence in the past 12 months as defined by the DSM-IV, including
             subjects who have ever been in a drug rehabilitation program.

          -  Unwillingness or inability to abstain from recreational drug use as required for the
             study.

          -  History of acute asthma or other obstructive airway disease or any condition that may
             increase the risk for respiratory depression, judged as clinically significant by the
             investigator or designee.

          -  History of neurologic conditions such as convulsive disorders or severe head injury,
             judged as clinically significant by the investigator or qualified designee.

          -  History of Addison's disease, hypothyroidism, pancreatitis, prostatic hypertrophy, or
             urethral stricture.

          -  Use of non-prescription or prescription medications or natural health products within
             7 days prior to first drug administration in the qualification phase and throughout
             the study, unless in the opinion of the investigator or designee, the product will not
             interfere with the study procedures or data integrity or compromise the safety of the
             subject.

          -  Uses of Monoamine oxidize inhibitors (MAOIs) within 14 days of first drug
             administration in the qualification phase and throughout the study.

          -  Current consumption of greater than 20 cigarettes (or 2 cigars) per day or inability
             to abstain from smoking (or use of any nicotine-containing sub stance) for at least 14
             hours.
Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Folic Acid; B12; Placebo
Intervention description: Folic acid 2mg po daily; B12 400 micrograms po daily; 1 capsule po daily
Intervention MeSH terms: Folic Acid; Vitamin B 12
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Cognition; Folic Acid; B12

Summary:

      This study will evaluate the effectiveness of folate and B12 supplementation in reducing
      negative symptoms in people with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia, any subtype

          -  Treated with an antipsychotic medication for at least 6 months at a stable dose for at
             least 6 weeks before study entry

          -  PANSS total score of at least 60, with a score of at least 3 (moderate) on one
             negative symptom item or on one positive symptom item

          -  Simpson Angus Scale (SAS) for Extrapyramidal Syndrome (EPS) total score of 12 or less

          -  A score of 2 (mild) or less on all items of the Calgary Depression Scale (CDS)

          -  Speaks English adequately enough to complete cognitive testing

        Exclusion Criteria:

          -  Serum B12 concentration less than 300 ug/L

          -  Complete blood count results consistent with megaloblastic anemia

          -  Serum creatinine concentration greater than 1.4

          -  Current use of folate or B12 supplementation

          -  Current use of any of the following medications: phenobarbital, phenytoin,
             carbamazepine, valproic acid, fosphenytoin, primidone, or pyrimethamine

          -  Alcohol or other substance abuse within 3 months before study entry (nicotine allowed)

          -  Positive baseline urine toxic screen

          -  Unstable medical illness

          -  Unstable psychiatric illness

          -  Seizure disorder

          -  Pregnant or breastfeeding
Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
Condition: Pharmacokinetics Study in de Novo Kidney Transplantation
Intervention: Prograf; Tacrolimus Hexal
Intervention description: Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.; Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,
1 mg and 1.5 mg.
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Pharmacokinetics Study; Tacroliums; GFR; kidney; transplant rejection; allograft rejection; xenograft rejection; host vs graft disease; renal transplant

Summary:

      The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic
      properties compared to Prograf® in de novo renal transplant patients and whether the
      comparable exposure resulted in similar renal function.
    

Eligibility criteria:

        Inclusion:

        primary or sec. kidney transplanted patiens, written consent, cold ischemia < 24 h

        Exclusion:

        multi organ, immunological risc pts., PRA >20%, Antibodys against HLA-type of donor organ,
        hypersensitivity against Tacro or MMF,

        Other protocol-defined inclusion/exclusion criteria may apply
"The Once A Day Protease Inhibitor Regimens"
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: ritonavir-boosted atazanavir; ritonavir-boosted fosamprenavir
Intervention description: 100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.; 100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Fosamprenavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1 infected people; Antiretroviral treatment-naïve; Atazanavir; Fosamprenavir; ARV Treatment Naive

Summary:

      Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be
      administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that
      both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to
      demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing
      fAPV/r, in ARV-naïve patients over a 96-week period.

      This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV
      therapy-naïve patients with HIV-1 RNA >1,000 copes/mL and CD4 cell count <350 cells/mm3.
      Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd)
      and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older.

          -  Patient agrees to participate in the study by giving written informed consent.

          -  Documentation of HIV infection.

          -  No prior treatment with any anti-retroviral agent.

          -  CD4 cell count < 350 cells x mm3 or with an AIDS defining condition.

          -  Viral load > 1,000 copies/mL

        Exclusion Criteria:

          -  Less than 18 years old.

          -  Current pregnancy or breastfeeding.

          -  Any previous antiretroviral regimen.

          -  Severe hepatic impairment that precludes the use of either study drug. This will be
             defined as any laboratory value of Grade 3 or 4 on the ACTG scale.

          -  Use of any contra-indicated medication as defined in the package insert for each drug.

          -  Any condition that, in the judgment of the investigator, precludes successful
             participation in the study.