bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Wound Bed Establishment in Facial Burns
Condition: Burns
MeSH terms: Burns
Intervention: Enzymatic agent; Bacitracin
Intervention description: Enzymatic agent
Intervention MeSH terms: Bacitracin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Participants received both the test drug and the standard of care, one on each side of the face.
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Facial; Partial thickness

Summary:

      Forty percent of patients admitted to the contributing regional burn unit over a five month
      period received facial burns (n=14). The purpose of this study is to examine if the time
      until a granulation bed is well established can be decreased be using an enzymatic agent,
      when compared to a second standard ointment, for patients with partial-thickness facial
      burns. The current study will use a prospective, experimental study design in which each
      individual will be their own matched control. That is, each individual will receive both the
      experimental ointment (one-side of the face) and the standard ointment (other-side of the
      face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation
      bed establishment) one ointment achieves in partial-thickness facial burns when compared to a
      second ointment. Exploratory analyses will examine the relationships among demographic
      variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That is,
      testing whether the time until granulation establishment may be associated with an
      individual's demographic variables, treatment type, pain, anxiety, itching levels, and
      scarring. Significance for all analysis will be at the 0.05 level. The investigators
      hypothesize that promoting rapid granulation bed establishment will decrease hospital length
      of stays, costs, risk of infection, and possibly associated appearance changes. The results
      from the current study will provide preliminary findings for a future, more sophisticated
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients (over the age of 18 years) admitted to the burn unit with a minimum of 1%
             partial-thickness burns each side of the face.

        Exclusion Criteria:

          -  patients with superficial or full-thickness facial burns;

          -  patients receiving facial grafts; patients with burns from chemical or contact
             sources;

          -  patients with wound infection;

          -  any patients starting treatment 24 hours after burn injury;

          -  patients with known sensitivity to either standard treatment; and

          -  any women by history who are pregnant or breast feeding.
Serratus Anterior Plane Block in Patients Undergoing Mastectomy
Condition: Pain, Post-operative
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine 0.35%
Intervention description: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized interventional prospective model to investigate effect of block placement in two treatment arms. Opioid consumption in the first 24 hours after the operation will be main outcome variable.
Masking: Single (Participant)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, interventional prospective study. Patients (n=66) undergoing
      mastectomies with or without tissue expander will be randomized to receive a supra-serratus
      or sub-serratus regional plane block prior to surgery. The main effect to be measured is
      total opioid consumption 24 hours after the operation. Secondary endpoints include measuring
      a change between pre-and post-operative pain scores, patient satisfaction of pain control
      during first 24 hours after the operation, presence of postoperative nausea and vomiting,
      duration of sleep on first postoperative night, and block performance time and length of
      stay, between the two treatment arms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients 18 years or older

          2. Individuals undergoing either a mastectomy or mastectomy with tissue expander for
             which the anesthetic plan includes a serratus anterior plane block.

        Exclusion Criteria:

          1. Any known sensory deficit of the anterolateral chest wall.

          2. Any local disorder of the skin or otherwise where blockade is to be performed which
             would prevent safe performance of the block

          3. Pregnancy

          4. American Society of Anesthesiology classification greater than 3

          5. Allergy to amide local anesthetic medications

          6. Chronic pain conditions

          7. Preoperative opioid use greater than 20 oral morphine equivalents per day

          8. Any coagulation abnormality which would be a contraindication for block placement

          9. Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum
             creatinine greater than 1.4 mg/dL

         10. Body mass index >50

         11. Incarceration

         12. Inability to understand study procedures including inability to understand the English
             language

         13. Inability to provide adequate informed consent

         14. Refusal to participate in the study
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth
Condition: PreTerm Birth
MeSH terms: Premature Birth
Intervention: Vaginal Progesterone; Placebo
Intervention description: 200 mg micronized vaginal progesterone suppository; Indistinguishable placebo vaginal suppository
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PreTerm Birth; HIV; Vaginal Progesterone; ART; Adherence; Feasibility

Summary:

      More than 1.5 million HIV-infected women become pregnant each year. Approximately half have
      access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB).
      Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that
      should be studied in this high-risk population. This pilot study will provide critical
      insight into the feasibility of a phase III trial by determining whether women are willing to
      participate, to adhere to study drug, and to complete follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. viable intrauterine pregnancy confirmed by ultrasound

          3. presentation to antenatal care prior to 24 weeks gestation

          4. antibody-confirmed HIV-1 infection

          5. initiating or continuing ART treatment in pregnancy

          6. ability and willingness to provide written informed consent

          7. willing to adhere to study visit schedule

        Exclusion Criteria:

          1. multiple gestation

          2. non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or
             cervical length <20mm on screening ultrasound)

          3. planned or in situ cervical cerclage

          4. evidence of threatened abortion, preterm labor, or ruptured membranes

          5. major fetal anomaly detected on screening ultrasound

          6. known uterine anomaly

          7. known or suspected allergy or contraindication to VP or placebo components
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
Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Zinc gluconate; Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]; Placebo
Intervention description: oral zinc gluconate 200mg; Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening; contains cornstarch
Intervention MeSH terms: Zinc; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 27 Years
Healthy volunteers: No
Keywords: acne vulgaris; zinc gluconate; inflammation; adapalene; benzoyl peroxide; Global Acne Grading System

Summary:

      Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term
      maintenance therapy. Promising results of oral zinc gluconate in improving acne vulgaris has
      been described.

      A randomized, double blind, placebo-controlled clinical trial was utilized for this study
      with the objective to assess the efficacy of oral zinc gluconate in the improvement of
      disease activity in acne vulgaris patients as measured by the inflammatory score and Global
      Acne Grading System (GAGS) score.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Filipino patients, aged 18-27 years old

          -  New patients diagnosed with Acne Vulgaris with a Global Acne Grading System score of
             at least 19

          -  Able to read and write in English or Tagalog

          -  Seen at the Dermatology out-patient clinic of East Avenue Medical Center

        Exclusion Criteria:

          -  Patients with other chronic dermatoses or systemic disease

          -  Taking oral supplements or medications within the past 4 weeks

          -  Patients who are pregnant or lactating
Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment
Condition: Anxiety Disorders; Parkinson Disease
MeSH terms: Parkinson Disease; Anxiety Disorders
Intervention: rotigotine transdermal patch; placebo
Intervention description: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily; Participants will receive a placebo transdermal patch to be worn daily
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 21 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Anxiety Disorders; Parkinson Disease; rotigotine

Summary:

      This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing
      anxiety in people with Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 Anxiety
             Disorder

          -  Stable medical history and general health

          -  On stable anti-parkinsonian therapy for 2 weeks before enrollment

        Exclusion Criteria:

          -  Unstable medical disease of comorbid psychiatric disease

          -  Dementia

          -  Subjects with less than one year duration of Parkinson's

          -  Current treatment with a dopamine agonist
Improving Post-Operative Pain and Recovery in Gynecologic Surgery
Condition: Postoperative Pain; Opioid Use; Acetaminophen
MeSH terms: Pain, Postoperative
Intervention: Rectal acetaminophen; Intravenous acetaminophen
Intervention description: Rectal 1300mg; Intravenous 1000mg
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative Pain; Minimally-invasive Hysterectomy; Opioid Use; Acetaminophen; Hysterectomy

Summary:

      This is a clinical investigation to determine the efficacy of rectal versus intravenous
      acetaminophen in patients undergoing a minimally invasive hysterectomy. All women will
      receive acetaminophen either rectally or intravenously immediately postoperative, prior to
      extubation. Patient's will be randomly assigned to either the rectal acetaminophen or the
      intravenous acetaminophen group. Patient outcomes will be measured through a Numeric Rating
      Scale (NRS) from 0-10 for pain scores, and total opioid consumption measured in morphine
      milligram equivalent (MME) for the first 24 hours following surgery, or upon discharge,
      whichever comes first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to consent

          -  Amendable to receive either rectal or intravenous acetaminophen

          -  Planned hospital stay for at least 24 hours.

        Exclusion Criteria:

          -  Patients unable to provide informed consent

          -  Patients with a history of regular opioid use prior to surgery based on their current
             home medication list

          -  Patients who have required regular opioid intake for the 7 days preceding surgery

          -  Patients with known hypersensitivity to acetaminophen

          -  Patients with a baseline preoperative liver function enzymes (AST and ALT) that are
             greater than twice the upper limits

          -  Unable to complete procedure as planned.
Retinol on Human Skin Aging in East Asian Descent
Condition: Intrinsic Aging of Skin
Intervention: Retinol; Placebo
Intervention description: Retinol in the form of vitamin A lotion; Placebo of Retinol
Intervention MeSH terms: Vitamin A
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      There has been increasing evidence for different rates of natural aging in humans and one of
      the best organs to study human aging is skin. Studies have demonstrated anti-aging effects of
      topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or
      vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally,
      studies of retinol in humans have largely occurred in white populations and so this study
      aims to focus on skin aging in individuals of East Asian descent as they represent a majority
      of the world population. This study aims to better characterize the molecular basis of
      rejuvenation effects and to potentially discover new topical agents with similar and/or more
      effective preservation of skin youthfulness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  able to provide written informed consent

          -  older group: age between 50 and 75 years

          -  young group: age 18 to 25 years

          -  all four grandparents of Han Chinese, Japanese, Korean descent

          -  body mass index within normal or overweight range

          -  no history of weight loss of >20 lbs within past 5 years

        Exclusion Criteria:

          -  skin condition in the areas of skin biopsy that would obscure results of analysis

          -  topical creams or treatment to arms 2 weeks prior to study baseline visit

          -  individuals with known hypersensitivity to retinoid class of agents (older group only)

          -  prior anti-aging treatments to arms including retinol, microdermabrasion within 2
             weeks of baseline visit

          -  prior laser therapy or surgical procedure to arms

          -  prior radiation or other trauma (extensive burns or abrasions) to arm skin

          -  hormone-based therapy within 4 weeks of enrollment
Effects of Intranasal Oxytocin on Cigarette Smoking
Condition: Nicotine Dependence; Tobacco Smoking
MeSH terms: Tobacco Use Disorder
Intervention: Oxytocin; Placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural
      processes that encode, interpret, and respond to socially and emotionally relevant stimuli)
      have been implicated in tobacco smoking and relapse, however this potential target for
      medication development has not been systematically examined. Evidence from animal and human
      laboratories indicate that administration of intranasal oxytocin enhances socioemotional
      processing and may be efficacious for the treatment of drug addiction, including nicotine
      dependence. In order to evaluate the potential efficacy of intranasal oxytocin for smoking
      cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates
      smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular
      smokers following overnight abstinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-40

          -  Smoke >= 10 cig/day for the past year

          -  English fluency

        Exclusion Criteria:

          -  Current DSM-5 substance use disorder, excluding nicotine dependence (to minimize
             alcohol or drug withdrawal symptoms during the study sessions)

          -  Any medical condition that would increase risk for study participation (such as sinus
             infection or other condition blocking access to the olfactory epithelium)

          -  Women who are pregnant or nursing

          -  Current use of psychiatric medication

          -  Breath Carbon Monoxide (CO) levels < 10ppm measured during study intake (to exclude
             individuals who overreport smoking in order to participate in the study)

          -  Planning to quit or reduce smoking in the next 30 days

          -  Current regular use of other nicotine products
Smoking Cessation in Hospitalized Smokers
Condition: Smoking Cessation
Intervention: Nicotine Patches; Telephone Counseling; Brief Hospital Counseling
Intervention description: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.; Up to 5 proactive counseling sessions from California Smokers' Helpline.; All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 1270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tobacco cessation; smoking cessation; telephone; self-help; smoking abstinence; tobacco use disorder; hospital; cardiopulmonary diseases; disparity

Summary:

      When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of
      them, however, go back to smoking soon after discharge. This study will test an innovative
      approach which includes dispensing nicotine patches at discharge, providing proactive
      telephone counseling post discharge, or giving a combination of the two. The interventions
      are aimed at increasing the long term quit rate of these patients.

      The specific aims of the study are to demonstrate the effects of two interventions,
      dispensing nicotine patches at discharge and providing proactive telephone counseling soon
      after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Smoke >=6 Cigarettes per day

          -  English or Spanish speaking

          -  Valid phone number

          -  Valid address

          -  Gave consent to participate in study and evaluation

        Exclusion Criteria:

          -  Hospital stay of less than 24 hours

          -  Inability to communicate orally

          -  Hypersensitivity to nicotine

          -  Pregnant

          -  Hospitalized for psychiatric treatment