bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Condition: Chorioretinal Vascular Disease
MeSH terms: Vascular Diseases
Intervention: Intravitreal Aflibercept Injection (IAI)
Intervention description: IAI prepared and administered with a pre-filled syringe (PFS)
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to determine if the pre-filled syringe (PFS) supports
      successful preparation and accurate administration of an aflibercept injection.

      The secondary objective of the study is to assess ocular safety in the study eye.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants who have neovascular age-related macular degeneration (AMD), diabetic
             macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with
             diabetic macular edema (DME) in the study eye

        Key Exclusion Criteria:

          -  Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in
             either eye

          -  Any active intraocular inflammation or infection in either eye or history of
             intraocular inflammation or infection after past intravitreal injection treatment
             (IVT) injections with any agent in either eye

          -  History of or any current indication of excessive bleeding and recurrent hemorrhages,
             including any prior excessive intraocular (including subconjunctival) bleeding or
             hemorrhages after IVT injection or intraocular procedures in either eye

          -  Any intraocular surgery in the study eye at any time during the past 3 months

          -  Current systemic infectious disease or a therapy for active infectious disease

          -  Pregnant or breastfeeding women

        Note: Other inclusion/ exclusion apply
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: pegaptanib sodium (Macugen)
Intervention description: 0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart),
      of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in
      patients with exudative age-related macular degeneration and evidence of recent onset,
      subfoveal and/or juxtafoveal choroidal neovascularization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal
             neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc
             areas

          -  Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)

          -  Women must be using 2 forms of effective contraception

          -  Adequate hematological, renal and liver functions

        Exclusion Criteria:

          -  Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area

          -  Any extrafoveal choroidal neovascularization

          -  Any intraocular surgery or thermal laser to the study eye within 3 months of
             enrollment

          -  Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or
             subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external
             beam radiation, submacular surgery.

          -  Presence of other causes of choroidal neovascularization, including pathological
             myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and
             multifocal choroiditis
Preoperative IV Versus Oral Acetaminophen
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: IV Acetaminophen; PO Acetaminophen; PO Placebo; IV Solution Placebo
Intervention description: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively; Acetaminophen PO 1000mg once pre-operatively; PO placebo capsule compounded to match PO Acetaminophen capsule; This will serve as the placebo for the IV Acetaminophen intervention
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will use a randomized, double-blind, placebo controlled design with two arms.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current study proposes to examine whether there is a significant difference in patient
      outcomes related to the administration route of preoperative Acetaminophen. Specifically, the
      study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical
      patients who receive oral Acetaminophen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years old or older

          -  Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical
             procedure performed under general anesthesia

        Exclusion Criteria:

          -  Allergy to Acetaminophen

          -  Lactose intolerance or lactose allergy (placebo capsules contain lactose)

          -  Hepatic disease

          -  Having taken a product containing acetaminophen within 6 hours of scheduled surgery
             time

          -  Pregnant

          -  Weight less than 50kg

          -  Opioid addiction - admits to current opioid addiction and/or substance abuse disorder,
             and/or currently in treatment for opioid addiction or substance abuse

          -  Emergent or on-call procedures

          -  Inpatient surgery
Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery
Condition: Cesarean Delivery; Wound Infection; Obesity
MeSH terms: Wound Infection
Intervention: cefazolin; cefazolin
Intervention description: 2 gram dose for pre-operative prophylaxis; 4 gram dose for pre-operative prophylaxis
Intervention MeSH terms: Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cesarean Delivery; Wound infection; Obesity; Prophylactic antibiotics

Summary:

      Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater
      (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an
      antibiotic before surgery. The antibiotic is intended to prevent infection from the
      surgery.It is unknown what the best dose for large women is for the usual medicine used for
      this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the
      skin will be biopsied at the time the incision is made and at the time the cut is stitched or
      stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched
      closed after the delivery. Blood tests will be done at the start and end of surgery to test
      the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has
      been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be
      tested for the antibiotic level.These tests will be used to find out if the usual dose of
      medicine is enough or if more medicine is needed to prevent infection in large women
      undergoing c-sections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or above

          2. Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit

          3. Undergoing cesarean delivery

        Exclusion Criteria:

          1. BMI less than 35.

          2. Not undergoing Cesarean delivery.

          3. Age less than 18 years.

          4. Pre-existing infection.

          5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to
             penicillin.

          6. Cesarean delivery being performed under emergent circumstances.
Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
Condition: Pain
Intervention: Paracervical block technique with lidocaine
Intervention description: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 332.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain during first-trimester surgical abortion

Summary:

      The purpose of this study is to determine the level of pain women experience with a surgical
      abortion and the effect that varying paracervical block techniques might have on that pain.
      These different techniques involve wait time following the injection as well as the number of
      sites injected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 years or older

          -  voluntarily requesting pregnancy termination

          -  ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age

          -  generally healthy

          -  English or Spanish speaking

          -  able or willing to sign an informed consent and agree to terms of the study

        Exclusion Criteria:

          -  gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this
             gestational age at the study sites)

          -  incomplete abortion

          -  failed medical abortion

          -  required or requested IV sedation (prior to randomization)

          -  patient who declines Ibuprofen, Lorazepam or PCB

          -  medical contraindication or allergy to any of the study medications

          -  chronic use of narcotic pain medication or heroin

          -  significant physical or mental health condition

          -  adnexal mass or tenderness on pelvic exam consistent with inflammatory disease

          -  known hepatic disease

          -  women who, in the opinion of the investigator, are not suitable for the study protocol
Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: dapsone gel
Intervention description: Dapsone (ACZONE) 7.5% gel topically once daily.
Intervention MeSH terms: Dapsone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of
      ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with
      acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

        -Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions
        (noninflammatory and/or inflammatory).

        Exclusion Criteria:

          -  Has uncontrolled systemic disease(s)

          -  Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne,
             drug-induced acne)

          -  Has used topical dapsone within 1 month prior to the screening

          -  Has used oral dapsone within 2 months prior to screening.
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
Condition: Candidiasis; Vaginosis, Bacterial
MeSH terms: Candidiasis; Vaginosis, Bacterial; Vaginal Diseases
Intervention: Boric acid and probiotics; Antibiotic (Clindamycin); Antifungal (Clotrimazole)
Intervention description: Vaginal capsules administered once a day during 7 days.; Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.; Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
Intervention MeSH terms: Anti-Bacterial Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Clotrimazole; Miconazole; Antifungal Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether a formula of boric acid and probiotics for
      vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis
      in comparison to pharmacological reference controls (depending on the suspected diagnosis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age over 18 years and agreement to participate by signing the consent form.

          -  Women with clinical manifestations of acute infectious vulvovaginitis (burning,
             pruritus, erythema, oedema, and abnormal vaginal discharge).

        Exclusion Criteria:

          -  Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or
             Trichomonas vaginalis infection.

          -  Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to
             the study.

          -  Patients receiving other treatment (drug, probiotics or vitamin supplements) that can
             significantly interfere with study evaluations during the 3 months of follow-up.

          -  Pregnant or high risk for pregnancy.
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
Condition: Pain
Intervention: Acetaminophen; Placebo
Intervention description: administered every 6 hours by mouth up to 4 doses
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: labor pain; acetaminophen

Summary:

      The hypothesis is if administration of acetaminophen during labor will reduce the amount of
      neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo
      capsules will be administered at the time of neuraxial analgesia placement and then
      administered every 6 hours until delivery. Overall consumption of neuraxial pain medication
      will be determined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >/= 18 years of age not allergic to study medications

        Exclusion Criteria:

          -  pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme
             function changes non-English speaking subjects
Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: rosiglitazone; placebo
Intervention description: 6 months of treatment of blinded study drug; blinded treatment with matching placebo
Intervention MeSH terms: Rosiglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Congestive Heart Failure; Cardiopulmonary exercise testing; intracellular cardiomyocyte triglycerides; thiazolidinedione; rosiglitazone; nuclear magnetic resonance

Summary:

      The purpose of this study is to determine if rosiglitazone treatment improves integrated
      cardiovascular performance in patients at risk for congestive heart failure. A second aim of
      this study is to determine if treatment with rosiglitazone decreases intracellular (ectopic)
      triglyceride (TG) deposition in cardiomyocytes using nuclear magnetic resonance (NMR)
      techniques, and how changes in intra-myocardial lipid content relate to changes in cardiac
      structure and function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes mellitus (prior clinical diagnosis and current use of hypoglycemic
             medical therapy or by new diagnosis according to ADA criteria) with at least one of
             the following:

               -  prior diagnosis of cardiovascular disease (CAD, MI, revascularization, CVA/TIA,
                  carotid or peripheral arterial disease)

               -  at least one additional CVD risk factor (smoking, hypertension,
                  hypercholesterolemia, albuminuria, family history of premature CAD, or documented
                  hsCRP>3)

        Exclusion Criteria:

          -  treatment with a TZD within prior 6 months

          -  documented intolerance to TZD

          -  history or evidence of CHF

          -  AST/ALT>3X upper limits of normal

          -  creatinine >2.5
Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery
Condition: Knee Arthroscopy
Intervention: Sufentanil; Fentanyl
Intervention description: 30 µg tablet of sublingual sufentanil; 50 µg fentanyl
Intervention MeSH terms: Fentanyl; Sufentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A pilot study to evaluate the effect of incorporating sublingual sufentanil into our
      perioperative opioid regimen for ambulatory orthopedic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 18 years or older;

          -  Scheduled for elective knee arthroscopy without anticipated ligamentous repair;

          -  Planned general anesthesia without a regional block or wound infiltration with local
             anesthesia;

          -  Planned day-of-surgery discharge.

        Exclusion Criteria:

          -  Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of
             another opioid within 30 days of surgery;

          -  Known hypersensitivity to sufentanil or components of DSUVIA;

          -  Patients with an allergy or hypersensitivity to opioids;

          -  Pregnancy or actively breastfeeding;

          -  Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken
             MAOIs within 14 days of the first dose of study drug;

          -  Patients with a medical condition that, in the Investigator's opinion, could adversely
             impact the patient's participation or safety, conduct of the study, or interfere with
             the pain assessments, including chronic pain or active infection.
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
Condition: Partial Seizures
MeSH terms: Seizures
Intervention: Pregabalin
Intervention description: 150 to 600 mg/day during 21 weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lyrica; Epilepsies - Partial

Summary:

      The purpose of this study is to assess the clinical improvement by partial seizures
      reduction, safety and tolerability of subjects having partial epilepsy related to the
      adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED
      (Antiepileptic drugs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female who are diagnosed of partial seizure (simple partial, complex partial,
             partial seizure secondarily generalized) as defined in the international league of
             epilepsy classification of seizure.

        Exclusion Criteria:

          -  Patients having a treatable cause of seizure, currently receiving vigabatrin, having a
             progressive neurological or systemic disorder.