bioihbjkbjnl/mcl2 huggingface dataset:
Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Intervention: Estradiol; Placebo
Intervention description: 17β-estradiol vaginal cream; Compounded placebo cream
Intervention MeSH terms: Estradiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postpartum, local estrogen

Summary:

      Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal
      laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between
      women using vaginal estrogen in the postpartum period with those using placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  females >18 years old with at least one prior prenatal care appointment affiliated
             with The Ohio State University Wexner Medical Center; nulliparous; 1-2 days status
             post >37 weeks and 0 day vaginal delivery with at least a second degree perineal
             laceration; English-speaking and able to provide informed consent.

        Exclusion Criteria:

          -  allergies to estradiol cream or its constituents; a vaginal delivery associated with a
             intrauterine fetal demise or neonatal death; inability to complete questionnaires in
             English or comply with study protocol; and inability to apply vaginal cream
             independently. The following medical conditions and diagnoses are also exempted:
             undiagnosed abnormal vaginal bleeding, known or suspected estrogen-dependent
             neoplasia, active or history of deep venous thrombosis or pulmonary embolism, active
             arterial thromboembolic disease, known liver dysfunction or disease, known protein C,
             protein S, or antithrombin deficiency, or other known thrombophilic disorders.
Liposomal Bupivacaine After Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Intervention: Liposomal bupivacaine; Placebo
Intervention description: Liposomal bupivacaine solution (Exparel) for injection; Inert solution created to appear as liposomal bupivacaine (Exparel) for injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Liposomal bupivacaine, a long-acting form of bupivacaine, has been found to be effective for
      postoperative pain control after total knee, total hip and total shoulder arthroplasty. We
      are conducting a randomized, controlled trial to evaluate pain control after arthroscopic
      rotator cuff repair in ambulatory patients, comparing standard care in the control group,
      with standard care plus the addition of injection of liposomal bupivacaine in the
      experimental group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients up to age 65 years, undergoing elective, ambulatory, arthroscopic
             rotator cuff repair.

        Exclusion Criteria:

          -  Pregnancy, coagulopathy, allergy to bupivacaine, renal failure, hepatic insufficiency,
             and/or inappropriate candidate for usual therapy (specifically, if unable to receive
             the usual preoperative interscalene nerve block: preexisting nerve injury on side of
             surgery, refusal of nerve block, infection at site of nerve block).
Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty
Condition: Intracapsular Fracture of Femur; Femoral Neck Fractures; Hip Hemiarthroplasty
MeSH terms: Fractures, Bone; Femoral Neck Fractures; Femoral Fractures
Intervention: Bupivacaine liposome; Saline
Intervention description: A long-acting liposomal bupivacaine; Saline injection used as control
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be a total of 50 patients enrolled in this randomized blinded prospective two arm study. The participants will be randomized into either the control or the EXPAREL treatment group, with 25 patients in each cohort.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participants, Investigator(s), outcome assessors will all be blinded throughout the duration of the trial. Care providers pre- and post- op will be blinded as well, the operative team will not be blinded.
Enrollment: 50.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Exparel; Bupivacaine; Intracapsular Fracture of the Femur; Femoral Neck Fracture; Hip Hemiarthroplasty

Summary:

      This study will examine the efficacy of Liposomal Bupivacaine (Exparel) in hip fracture
      patients undergoing hip hemiarthroplasty for femoral neck fractures through a posterior
      approach. Post-operative measures will be assessing pain, overall opiate use, delirium,
      time-to-ambulation and discharge status.
    

Eligibility criteria:

        Inclusion Criteria:

        Men and women sixty-five years of age and older with isolated intracapsular hip fractures
        undergoing hemi arthroplasty through a posterior approach with the ability to consent to
        the study.

        Exclusion Criteria:

        Under sixty-five years of age, extracapsular hip fracture, suffer from any form of
        cognitive compromise that leaves them unable to consent, or if they are treated with any
        surgical modality other than hip hemiarthroplasty.
Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture
Condition: Pain
Intervention: Ropivacine and Chloroprocaine mixture; Ropivacaine only
Intervention description: Chloroprocaine is added to Ropivacaine; Ropivacaine diluted with normal saline instead of chloroprocaine
Intervention MeSH terms: Ropivacaine; Chloroprocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onset; Duration; Upper Limb Block; Ultrasound guided supraclavicular block; Ropivacaine; Chloroprocaine

Summary:

      A double blinded randomized controlled trial comparing the onset and duration of the Onset
      and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local
      anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic
      (Ropivacaine-Chloroprocaine Mixture).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who will be having a supraclavicular brachial plexus block as part of their
             anesthetic will be approached for possible inclusion in the study

        Exclusion Criteria:

          -  patients who are pregnant,

          -  have an ASA status of IV or greater,

          -  neuropathy,

          -  a cast or other impediment to performing a motor or sensory exam in the arm and hand,

          -  patients under the age of 18,

          -  long term opioid therapy (longer than 1 month),

          -  history of opioid abuse and pseudocholinesterase deficiency
Anti-HIV Medications for People Recently Infected With HIV
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Highly active antiretroviral therapy (HAART)
Intervention description: Regimens will be assigned by investigators
Intervention MeSH terms: Anti-Retroviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Acute/Early Seroconverters; Acute Infection; Treatment Naive; Primary HIV Infection

Summary:

      It is not known if anti-HIV treatment for recently infected patients improves long-term
      patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV
      medications slows progression of HIV disease in adults recently infected with HIV.

      Study hypothesis: A one-year course of HAART administered during acute or early
      seroconversion may slow the progression of HIV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented acute or recent HIV infection (infected in the past 12 months) as defined
             in the study protocol

          -  Antiretroviral naive. Participants who have taken antiretrovirals for postexposure
             prophylaxis are eligible for this study.

          -  Able to swallow tablets or capsules

          -  Willing to use acceptable forms of contraception

        Exclusion Criteria:

          -  Physician unable to design a potentially effective HAART regimen based on results of
             genotypic resistance testing

          -  Two CD4 counts of less than 350 cells/mm3 obtained at least 7 days apart within 30
             days of study entry

          -  Viral load less than 5,000 copies/ml within 30 days of study entry in participants who
             have been infected with HIV-1 for more than six months prior to study entry

          -  Use of systemic cancer chemotherapy, systemic investigational agents, specific
             antiretroviral medications, or immunomodulators (growth factors, systemic
             corticosteroids, HIV vaccines, immune globulin, interleukins, interferons) within 30
             days prior to study entry

          -  Current alcohol or drug use that, in the opinion of the investigator, would interfere
             with the study

          -  Serious illness requiring systemic treatment or hospitalization until participant
             either completes therapy or is clinically stable on therapy for at least 7 days prior
             to study entry

          -  Currently involuntarily incarcerated for treatment of either a psychiatric or physical
             (e.g., infectious disease) illness

          -  Pregnancy or breastfeeding
Study of Memantine to Treat Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: Memantine
Intervention description: 10 mg BID x 3 months
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in
      patients with Huntington's disease (HD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18 or older.

          -  Diagnosis of HD with current complaints of memory or concentration difficulties.

          -  Dementia Rating Scale score of <129, to ensure that patients have sufficient cognitive
             impairment.

          -  Adequate visual and auditory acuity to allow neuropsychological testing.

          -  Good general health with no additional diseases expected to interfere with the study.

          -  Patient is not institutionalized.

          -  Sufficient English skills to complete all testing without assistance of an English
             language interpreter.

          -  Availability of a responsible caregiver who agrees to supervise administration of
             study drug, monitor the patient's compliance and adverse events, and accompany the
             patient to all clinic visits.

        Exclusion Criteria:

          -  1. Any significant neurologic disease other than HD.

          -  Severe psychotic features or other severe psychiatric problems within the last three
             months which could lead to difficulty complying with the protocol.

          -  History of alcohol or substance abuse within the past two years (DSM IV criteria).

          -  Any significant systemic illness or unstable medical condition which could lead to
             difficulty complying with the protocol.

          -  History of MI in the past year or head trauma with loss of consciousness greater than
             20 minutes.

          -  Insulin-requiring diabetes.

          -  Use of any FDA approved cognitive enhancing prescription medications or
             investigational drugs within 30 days.

          -  Use of ginkgo biloba or DHEA within four weeks prior to baseline.

          -  Use of narcotic analgesics within 4 weeks prior to baseline.

          -  Patients who, in the investigator's opinion, would not comply with study procedures.
Liposomal Bupivacaine in Vaginal Hysterectomy
Condition: Vaginal Hysterectomy
Intervention: Liposomal bupivacaine; Bupivacaine Hydrochloride
Intervention description: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.; We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: This will be a blinded study where investigators, patients, and care providers will be blinded to treatment assignment.
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The aim of this study is to compare the effects of preemptive analgesia using liposomal
      bupivacaine mixed with bupivacaine HCl, versus bupivacaine HCl alone for uterosacral ligament
      injection in patients undergoing vaginal hysterectomy. We hypothesize that the group
      receiving a combination of liposomal bupivacaine and bupivacaine HCl will report superior
      postoperative pain management. Enhancement in pain control should confer a decrease in opioid
      and other analgesic medication requirements, which may contribute to decreased nausea,
      vomiting, and higher overall patient satisfaction with pain control.
    

Eligibility criteria:

        INCLUSION CRITERIA

        1. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without
        concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona

        EXCLUSION CRITERIA

          1. Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater
             than normal values

          2. Known history of renal (kidney) disease as evidenced by a serum creatinine that is
             greater than normal values

          3. Known history of prolonged QT (QTc greater than 500 m/s)

          4. Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral
             equivalents per day for a minimum of 1 month prior to surgery

          5. Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs,
             acetaminophen, gabapentin, sulfa drugs, or ondansetron

          6. Allergy to both oxycodone and hydromorphone

          7. Patients with acute gastrointestinal bleed that has occurred less than 6 months prior
             to study enrollment

          8. Adults lacking the ability to consent
The Effect of Donepezil on Gait and Balance in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Donepezil; Placebo
Intervention description: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.; Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days.
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Healthy volunteers: No
Keywords: donepezil; parkinson's disease; balance; cholinesterase inhibitor

Summary:

      This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and
      muscle rigidity. Current medications for the treatment of PD do not improve gait and balance
      difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in
      individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The
      investigators study will look at what aspects of gait and balance are improved by the study
      drug. The study drug is not approved to treat PD in the United States or other countries
      because we do not know enough about it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's disease, defined by the UK Brain Bank criteria, with a Hoehn
             and Yahr score of 2 to 4

          -  Treated with levodopa for at least a year and on a stable antiparkinsonian regimen for
             at least one month

          -  Abnormal computerized dynamic posturography (CDP) on screening defined as a composite
             score below 65 (range 1-100)

        Exclusion Criteria:

          -  Dementia defined by MMSE less than 27

          -  Other medical conditions other than PD affecting balance or gait as determined by the
             investigators

          -  Unable to stand unassisted for 30 minutes

          -  Current use of an acetylcholinesterase inhibitors or drugs with known anticholinergic
             properties

          -  Medical or psychiatric co-morbidities that may interfere with compliance or might
             place subject in danger as determined by the investigators
Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
Condition: Pneumonia; Diarrhea; Malaria; Co-infection; Death; Malnutrition
MeSH terms: Coinfection; Malnutrition; Diarrhea
Intervention: Azithromycin; Placebo
Intervention description: oral administration of Azithromycin; 5 days of taste/appearance/bottle-matched inactive substance
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1400.0
Sex: All
Minimum age: 1 Month
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post-discharge mortality; morbidity and mortality prevention; azithromycin; linear growth

Summary:

      Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity
      and mortality following discharge from hospital. These children represent an accessible
      high-risk population in which targeted interventions to prevent morbidity and mortality could
      have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass
      drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated
      an almost 50% mortality benefit in children 1-9 years of age in treated communities. However,
      mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance
      within treated communities and is expensive. The targeted delivery of azithromycin to
      children at hospital discharge may be a novel and practical intervention to maximize benefit
      while minimizing risk of antibiotic resistance. This is a randomized, double-blind,
      placebo-controlled trial to determine the efficacy of azithromycin provided at discharge,
      compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59
      months in Kenya. The study will also investigate potential mechanisms by which azithromycin
      may reduce morbidity and mortality in this population and will assess the emergence of
      antibiotic resistance among treated individuals and their primary caregivers. A
      cost-effectiveness analysis of the intervention will also be conducted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 1-59 months,

          -  Plan to remain in study area greater than 6 months

          -  Discharged from hospital following non-trauma related admission

        Exclusion Criteria:

          -  Contraindication to azithromycin use and other prophylactic antibiotic use