bioihbjkbjnl/mcl2 huggingface dataset:
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
Condition: Genital Herpes
MeSH terms: Herpes Simplex; Herpes Genitalis
Intervention: Famciclovir; Placebo
Intervention description: oral; two 500 mg tablets twice a day; single day treatment; oral; two tablets twice a day; single day treatment
Intervention MeSH terms: Famciclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent genital herpes; Black population

Summary:

      This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment
      in Black patients with recurrent genital herpes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Black men or women 18 years or older

          -  History of recurrent genital herpes with at least 4 recurrences in preceding 12 months
             or in preceding 12 months prior to using suppressive antiviral therapy

          -  Documented herpes simplex virus type 2 (HSV-2) seropositivity

          -  Willingness to discontinue suppressive therapy during study, if applicable

          -  Willingness and ability to comply with the study protocol

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Women of childbearing potential not using accepted methods of contraception

          -  Hypersensitivity to famciclovir or drugs with similar chemical structures

          -  Renal dysfunction

          -  Known or suspected to have decompensated liver disease

          -  Known to have gastrointestinal malabsorption

          -  Known to be immunocompromised

          -  Known to be hypersensitive to ingredients in study medication

          -  Other protocol-defined inclusion/exclusion criteria may apply
IV Acetaminophen as an Analgesic Adjunct
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: IV acetaminophen + 0.5 mg IV hydromorphone; Normal saline + 0.5 mg IV hydromorphone
Intervention description: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone; 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
Intervention MeSH terms: Acetaminophen; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Older adults; Elderly; Acute pain; IV acetaminophen; IV hydromorphone; Analgesia; Adjunctive analgesia

Summary:

      To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV
      hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED)
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV)
             opioids in the judgement of the treating attending physician

        Exclusion Criteria:

          -  Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly
             bias related to recent opioid use, since this may affect baseline levels of pain and
             need for analgesics.

          -  Prior adverse reaction to hydromorphone, morphine, or acetaminophen.

          -  Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months
             results in modulation of pain perception which is thought to be due to down-regulation
             of pain receptors. Examples of chronic pain syndromes include sickle cell anemia,
             osteoarthritis, fibromyalgia, and peripheral neuropathies.

          -  Alcohol intoxication: the presence of alcohol intoxication as judged by the treating
             physician may alter pain perception.

          -  Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation
             that may result in orthostatic hypotension.

          -  Heart Rate (HR) < 60/min: Opioids can cause bradycardia.

          -  Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or
             above on room air in order to be enrolled.

          -  Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been
             reported to intensify the effects of at least one opioid drug causing anxiety,
             confusion and significant respiratory depression or coma.

          -  Patients using transdermal pain patches
A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Dapsone plus Tretinoin Gel; Tretinoin Gel
Intervention description: Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks; Tretinoin gel applied once daily to the assigned side of the face for 2 weeks
Intervention MeSH terms: Dapsone; Tretinoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acne; Irritation

Summary:

      This study is to see if there's any difference in the amount of facial irritation when two
      acne products are used together on one side of the face, compared to one acne treatment
      product used alone on the other side of the face. All people participating in this trial will
      be required to return to the same study center every weekday for two weeks for the
      investigator to check for irritation on the face and to have the products applied - on
      weekends they will have to put them on at home. If one side of the face is more irritated
      than the other side, a picture will be taken as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fitzpatrick Skin Type I, II or III with healthy skin as judged by the investigator

          -  Bilateral skin is clear of any confounding irritation, rashes, acne, rosacea, etc.,
             prior to study start

          -  Subjects are willing to avoid applying emollients or cosmetics to the face 24 hours
             before they start, and during the study

          -  If subject is of childbearing potential, subject has been using a protocol-approved
             method of birth control for a certain amount of time, and is willing to continue using
             it throughout the study

        Exclusion Criteria:

          -  Subjects who are pregnant or nursing, or intend to be during the study

          -  Subjects with any condition or medical history, or using any drug or medication, that
             might negatively affect the subject's safety or the validity of study results, either
             as listed in the protocol or in the opinion of the investigator

          -  Subjects who have facial hair that may obstruct or hinder the evaluation of any
             reactions

          -  Subjects who use any known photosensitizing agents
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
Condition: Obesity; Contraception
MeSH terms: Emergencies
Intervention: UPA-ECx1; UPA-ECx2
Intervention description: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC; Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: obesity; body weight; BMI; emergency contraception; levonorgestrel; ulipristal acetate

Summary:

      Obese women are significantly more likely than their normal BMI counterparts to experience
      failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for
      testing a dose escalation strategy in an effort to provide improved efficacy from
      orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency
      contraception containing ulipristal acetate. The overall project will be focused on both
      levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but
      this protocol registration is for the UPA aspect of the study procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy women

          -  Aged 18-35 years old

          -  Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a
             progesterone level of 3 ng/mL or greater

          -  Subjects must have a BMI of >30kg/m2 and weight at least 80kg or more OR a BMI
             <25kg/m2 and a weight of less than 80kg.

        Exclusion Criteria:

          -  Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian
             Syndrome

          -  Impaired liver or renal function

          -  Actively seeking or involved in a weight loss program (must be weight stable)
             pregnancy, breastfeeding, or seeking pregnancy

          -  Recent (within last 8 weeks) use of hormonal contraception

          -  Current use of drugs that interfere with metabolism of sex steroids

          -  Smokers.
Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess
Condition: Cutaneous Abscess
MeSH terms: Abscess; Skin Diseases
Intervention: Chlorhexidine gluconate; Mupirocin
Intervention description: Scrubs applied once a day for 5 days; Nasal mupirocin applied topically to both nostrils twice a day for 5 days
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Mupirocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: abscess

Summary:

      In this study, the investigators will enroll patients who present to the emergency department
      with abscesses to the study. The patients will be randomly selected to either have the
      standard of care, which includes the standard drainage of the abscess and then usually a
      follow-up visit to recheck the wound, or to have the standard of care plus instructions to
      use a topical scrub of a soap called chlorhexidine once a day for five days and twice daily
      application of a topical antibiotic ointment called mupirocin to the nasal passages for five
      days.

      The investigators will then call back the patients at 7 days, 14 days (if in the treatment
      arm), 3 months and 6 months, to ask if they have had any recurrence of abscess formation. The
      study hypothesis is that the patients who have undergone the decontamination protocol will
      have fewer subsequent infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients aged 18 years of age or older who present to our emergency department
             with a skin abscess which has undergone incision and drainage in which pus was
             present, and for whom the attending emergency physician is planning on discharging the
             patient home.

        Exclusion Criteria:

          -  Abscesses resulting from insect or animal bites or intravenous drug use (both of which
             can be polymicrobial), chronic wounds (>2 weeks), wounds where no drainage was
             obtained in the course of the I&D, reported allergy to chlorhexidine or mupirocin,
             lack of ability to follow-up the patient (lack of phone number or stable address).
             Additionally, patients will be excluded who are of high acuity (unstable vital signs),
             in distress, with an insurmountable language barrier, intoxication (or other cause of
             altered mental status), presenting with acute psychiatric illness, are victims of
             possible sexual assault, or prisoners.
Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Rejuvesol; Blood transfusion
Intervention description: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this proposal is to test the feasibility of red blood cell (RBC)
      rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of
      RBC rejuvenation in this population to determine if a larger clinical trial powered to
      definitively characterize the benefits of rejuvenation is warranted.

      This is a small pilot study is to see if restoring important energy molecules (ATP and
      2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution
      (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects
      will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6
      transfusions (over approximately a 6-month period) in a pre-defined order to maximize
      detection of any signal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable, compliant, chronically transfused sickle cell disease (SCD) patients

          -  Currently maintained crisis-free with repeated RBC therapy for at least 3 consecutive
             sessions

          -  ≥18 years old

          -  Have Hb SS disease

          -  Have the capacity to give informed consent

        Exclusion Criteria:

          -  Baseline need for washed RBCs

          -  Pre-treatment SaO2 < 92%.
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Capecitabine; Bevacizumab
Intervention description: 1000 mg/m² PO BID on Days 1-15 of each 3-week cycle; 15 mg IV on Day 1 of each 3-week cycle
Intervention MeSH terms: Bevacizumab; Capecitabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus
      intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients
      received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg
      intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was
      until disease progression or unacceptable toxicity. The target sample size was <100
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women >=18 years of age

          -  HER2-negative metastatic breast cancer

          -  Previous adjuvant chemotherapy or hormonal treatment

          -  >=1 measurable target lesion

        Exclusion Criteria:

          -  Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy
             for advanced or metastatic cancer

          -  Radiation therapy within 4 weeks of study treatment start or insufficient recovery
             from the effects of prior radiation therapy

          -  Central nervous system metastases

          -  Other malignancy within last 5 years, except cured basal cell carcinoma of skin and
             carcinoma in situ of uterine cervix

          -  Serious concurrent infection
Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Condition: Perforated Appendicitis; Postoperative Infection
MeSH terms: Appendicitis
Intervention: Piperacillin, Tazobactam Drug Combination
Intervention description: Single drug therapy
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      After appendix has been removed for perforated appendicitis, patients will receive
      postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3
      -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug
      therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a
      single-drug therapy, there are additional benefits of simplicity, compliance, and lower
      infectious complications. Currently surgeons are already using both 2-drug regimen
      (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA
      approved and regulated antibiotics for intra-abdominal infection. There is a clear need to
      compare outcomes between these two options.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postoperative Perforated Appendicitis (documented by intraoperative photo)

          -  Postoperative Laparoscopic Appendectomy

        Exclusion Criteria:

          -  Nonperforated Gangrenous Appendicitis

          -  Nonperforated Purulent Appendicitis

          -  Open Appendectomy
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
Condition: Preterm Delivery
MeSH terms: Premature Birth
Intervention: Betamethasone or Dexamethasone (2nd course of ACS); Placebo
Intervention description: Course of Betamethasone or Dexamethasone; Course of Placebo (NS)
Intervention MeSH terms: Dexamethasone; Betamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 437.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Preterm Labor; Preterm delivery

Summary:

      The hypothesis is that administration of two courses of antenatal corticosteroids, compared
      to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in
      patients delivering prior to 34 weeks' gestation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25 to 32 6/7 weeks gestation

          -  Singleton or twin gestation

          -  Received 1st course of betamethasone prior to 30 weeks' gestation

          -  Began 1st course of betamethasone at least 14 days prior to randomization

          -  Risk of delivery in next 7 days due to either maternal or fetal complication (e.g.
             preterm labor, severe preeclampsia, IUGR, etc.)

          -  Intact membranes

        Exclusion Criteria:

          -  Known major fetal anomalies (eg: anencephaly, renal agenesis etc…)

          -  High order multiple gestation (triplets or higher)

          -  Cervical dilation > 5 cm

          -  Clinical chorioamnionitis prior to initiation of second course (two or more of the
             following; antepartum temperature > 38ºC (100.4ºF), uterine tenderness, foul smelling
             vaginal discharge or amniotic fluid, maternal tachycardia (>100beats/min), fetal
             tachycardia (>160 beats/min), or white blood cell count >20x109/L.define)

          -  Ruptured membranes prior to initiation of second course of betamethasone

          -  Already receiving corticosteroids for other conditions (e.g. Lupus, asthma)

          -  Maternal condition contraindicating the use of steroids (e.g. HIV, active
             Tuberculosis)

          -  Participation in conflicting study
Treatment of Zollinger-Ellison Syndrome With Prevacid
Condition: Zollinger-Ellison Syndrome; Multiple Endocrine Neoplasia
MeSH terms: Endocrine Gland Neoplasms; Multiple Endocrine Neoplasia; Zollinger-Ellison Syndrome; Gastrinoma; Syndrome
Intervention: Lansoprazole (Prevacid)
Intervention description: Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to study the safety and efficacy of high dose Prevacid in the
      long-term treatment of patients who secrete abnormally large amounts of gastric acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Zollinger-Ellison syndrome

        Exclusion Criteria:

          -  Pregnant or lactating females
Lidocaine Jelly for Pain Control During Mohs Surgery
Condition: Pain; Satisfaction, Consumer
Intervention: Lidocaine jelly; Surgilube
Intervention description: lidocaine 2% jelly applied during Mohs surgery; surgilube (placebo) applied during Mohs surgery
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Does the use of lidocaine jelly during Mohs surgery on the nose decrease the total amount of
      lidocaine used during surgery.

      Does patient satisfaction improve when lidocaine jelly is used during Mohs surgery of the
      nose?
    

Eligibility criteria:

        Inclusion criteria:

        Patients having Mohs surgery on the nose who are able to consent to the study >18 years old

        Exclusion criteria:

        unable to consent for themselves known allergy to lidocaine Mohs surgery in locations other
        than the nose