bioihbjkbjnl/mcl2 huggingface dataset:
Adductor Canal Block for Medial Compartment Knee Arthroplasty
Condition: Postoperative Analgesia; Medial Unicompartmental Knee Arthroplasty
Intervention: Adductor canal block; Lumbar plexus block
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Partial knee replacement

Summary:

      This study will evaluate the affects of a single injection ultrasound-guided adductor canal
      block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee
      arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia
      provided by the adductor canal block with that provided by single injection lumbar plexus
      blockade. The working hypothesis is that the analgesia provided by the adductor canal block
      will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome
      will be a comparison of verbal numerical pain scores at rest and with movement over the first
      24 hours following nerve blockade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-85

          -  Undergoing unilateral robotic-assisted (MAKOplasty) medial compartment knee
             arthroplasty at Wake Forest University Baptist Medical Center.

          -  Must give written informed consent for anesthesia including subarachnoid blockade and
             peripheral nerve blockade of both the lumbar plexus and adductor canal.

          -  Must consent to the performance of a sham block at the site to which they are not
             randomized.

          -  Must also be reliable to give accurate verbal pain scores postoperatively.

        Exclusion Criteria:

          -  Contraindication to adductor canal blockade or lumbar plexus blockade (including
             significant coagulation abnormalities)

          -  History of opioid addiction or current chronic pain therapy for pain other than at the
             surgical site that is being treated with high-dose opioids (extended release opioids
             or > 40mg oxycodone equivalents per day)

          -  Allergy to study medications

          -  Failure to adequately place either the adductor canal or lumbar plexus blocks.

          -  Patients who decline or have a contraindication to subarachnoid blockade will also be
             excluded from the study.

          -  Pregnancy.
HIV Non Occupational Post-Exposure Prophylaxis (PEP)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: TRUVADA + Raltegravir
Intervention description: TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV Prevention; Non-occupational post-exposure prophylaxis; HIV seronegativity

Summary:

      This study will evaluate how safe and tolerable a combination of taking three-drugs will be
      for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in
      HIV uninfected adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a
             negative HIV-1 RNA assay

          -  Possible non-occupational exposure to HIV-1, recent enough to permit receiving the
             first dose of study medication within 72 hours from the end of the exposure.

          -  Able to understand the study procedures and willing to sign informed consent

        Exclusion Criteria:

          -  Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of
             the investigator, could prevent compliance with study procedures.

          -  Pregnancy.

          -  Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive
             serum HBV DNA; or prior lamivudine therapy for hepatitis B.

          -  Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.

          -  Unwillingness to participate in study procedures, including Mental Health referral and
             intervention.

          -  Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.

          -  Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which
             cannot be used with raltegravir.
Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
Condition: Eyelash Hypotrichosis
MeSH terms: Hypotrichosis
Intervention: bimatoprost 0.03%
Intervention description: One drop of bimatoprost 0.03% (LATISSE®) applied evenly to each upper eyelid in the evening. Treatment is once daily for up to 40 weeks.
Intervention MeSH terms: Bimatoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the
      augmentation of eyelashes in Korean women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eyelash prominence assessment of minimal or moderate

          -  Of Korean ethnicity

        Exclusion Criteria:

          -  Any eye disease or abnormality

          -  Any ocular surgery or use of any eyelash extension or eyelash growth products within 3
             months

          -  Any permanent eyeliner within 5 years

          -  Eyelash implants of any kind

          -  Eyelash tint or dye application within 2 months

          -  Use of any treatment that may affect hair growth within 6 months
Opioid Analgesia for MAB
Condition: MAB; Pain
Intervention: Oxycodone 10mg oral; Placebo
Intervention description: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion; Placebo given in addition to standard of care medications in women undergoing medical abortion
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 172.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose
      recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared
      to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study
      will help future providers understand whether prescribing opioids are an important adjunct
      for pain control in women undergoing MAB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older

          -  Seeking elective medical abortion

          -  In good health

          -  Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound

          -  Able and willing to receive text messages via phone

          -  Literate in English

          -  Able and willing to give informed consent and agree to the study terms

          -  Have assistance at home; no motor vehicle use while taking study medications

        Exclusion Criteria:

          -  Lack of access to cell phone and texting capabilities

          -  Early pregnancy failure

          -  Contraindications to the study medications: Oxycodone, Ibuprofen

          -  Contraindications to medical abortion with Mifepristone or Misoprostol

          -  History of methadone or heroin use

          -  Used alcohol in the past 24 hours

          -  Used marijuana >4 times per week

          -  Any opioid in the past 30 days

          -  Using additional pain medications
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Condition: Diabetes, Type 1; Diabetes, Type 2; Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: Bacitracin; AmeriGel®; Vitamin C
Intervention description: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.; Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.; Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
Intervention MeSH terms: Ascorbic Acid; Bacitracin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adult

Summary:

      The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic
      wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health
      Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will
      be done to evaluate impact on time to wound closure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years of age

          -  Diabetic (Type I and Type II)

          -  Ulceration of the foot at least one centimeter in width/length

          -  Ulceration at least 0.2 centimeters in depth

        Exclusion Criteria:

          -  Ulceration width/length > 7.5 centimeters

          -  Wound depth > 1.25 centimeters

          -  Purulent, excessive drainage and/or other signs of infection (i.e. erythema, edema,
             warmth)

          -  Inability to provide informed consent

          -  Inability to swallow pills (vitamin C supplement)

          -  Patients with concurrent renal problems

          -  Patients with medication contraindications to Vitamin C and/or topical wound dressings
Comparing a Virtual vs. Face to Face Weight Management Program Using Phentermine for Patients With Overweight or Obesity
Condition: Obesity
MeSH terms: Obesity; Overweight
Intervention: Phentermine 37.5 Mg; Dietary program; Exercise program
Intervention description: Patients will receive 37.5 mg of phentermine daily for a 12 week duration; Patients will be able to select either the Mediterranean diet or the Ketogenic diet and will work with a dietician; Patients will be provided with a personalized exercise program
Intervention MeSH terms: Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Single-center, Parallel-group trial comparing the use of virtual visit for prescription of phentermine versus standard face-to-face visits for weight management
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will study the effects associated with the prescription of phentermine in a
      virtual setting, comparing with prescription of phentermine via a standard face-to-face visit
      for patients with obesity or overweight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years old

          -  Body mass index (BMI) greater than or equal to 27 with 1 or more comorbidities
             (hypertension, diabetes, sleep apnea, fatty liver disease, PCOS, dyslipidemia,
             congestive heart failure, osteoarthritis) OR a BMI or 30 or greater

          -  Able to log into an online platform or have a smartphone

          -  Willing to join a virtual weight management program

        Exclusion Criteria:

          -  Contraindication for use of phentermine

          -  Female who is pregnant, breast-feeding, or intends to become pregnant or is of
             child-bearing potential and not using adequate contraceptive methods

          -  Participation in another clinical trial within 30 days of screening

          -  Cardiovascular disease including uncontrolled hypertension or history of arrhythmias

          -  Treatment with any medication with the intention of weight loss within 180 days before
             screening

          -  Use of Topiramate within 180 days of screening

          -  Previous history of bariatric surgery or use of minimally invasive weight loss devices
Mortality Reduction After Oral Azithromycin: Mortality Study
Condition: Childhood Mortality
Intervention: Azithromycin; Placebo
Intervention description: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.; Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
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: 190238.0
Sex: All
Minimum age: 1 Month
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Childhood mortality; Azithromycin; Mass treatment; Infection; Verbal Autopsy

Summary:

      Our long-term goal is to more precisely define the role of mass azithromycin treatments as an
      intervention for reducing childhood mortality. We propose a single multi-site
      (multi-country), cluster-randomized trial comparing communities randomized to oral
      azithromycin with those randomized to placebo. We hypothesize that mass azithromycin
      treatments will reduce childhood mortality.
    

Eligibility criteria:

        Inclusion Criteria:

        Communities

          -  The community location in target district.

          -  The community leader consents to participation in the trial

          -  The community's estimated population is between 200-2,000 people.

          -  The community is not in an urban area.

        Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as
        assessed via biannual census.

        Exclusion Criteria:

        Individuals

        - Refusal of village chief (for village inclusion), or refusal of parent or guardian (for
        individual inclusion)
Dexamethasone and Lower Extremity Block Duration
Condition: Analgesia Duration
Intervention: Dexamethasone; Bupivacaine
Intervention description: Control
Intervention MeSH terms: Dexamethasone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: popliteal block; analgesia duration

Summary:

      Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on
      lower extremity blocks. The study would evaluate that point.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-75

          2. foot surgery

          3. no contraindication to regional anesthesia

        Exclusion Criteria:

          1. opioid dependent

          2. chronic pain condition

          3. peripheral neuropathy
Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
Condition: Osteoporotic Fractures; Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Fractures, Bone; Osteoporotic Fractures
Intervention: Zoledronic acid; vitamin D; calcium; Saline
Intervention description: Annual intravenous 5.0 mg; 800 IU daily; approximately 1200 mg (dietary and supplement); Annual intravenous saline placebo
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 310.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Bone loss; Frail Geriatric Women; Nursing Home Patients; Long-term Care Patients; Osteoporosis; Osteoporotic Fractures

Summary:

      The goal of this study is to perform the first fracture reduction clinical trial with a
      potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term
      care population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women age ≥65 years including those using assistive devices to maximize
             generalizability if they:

               1. Reside in long-term care (LTC);

               2. Have:

                    -  osteoporosis by axial bone density (spine, hip or forearm bone mineral
                       density (BMD) T-score ≤ -2.5 SD); or

                    -  a previous adult fragility fracture of the spine or hip; or,

                    -  would be treated based on FRAX National Osteoporosis Foundation (NOF)
                       treatment thresholds of a 10 year risk of ≥ 20% for a major osteoporotic
                       fracture or ≥ 3% for hip fracture using femoral neck BMD.

        Exclusion Criteria:

          -  Men because osteoporosis is less common in men and our initial ZEST 1 study only
             included women.

          -  Institutionalized women with subacute illnesses surviving or discharged in < 3 years.

          -  Women currently on bisphosphonate, denosumab, or teriparatide therapy or who have been
             on a bisphosphonate for greater than 1 year during the previous 2 years because
             bisphosphonates are long acting.

          -  Patients with a calculated creatinine clearance < 35 ml/min or who have a
             contraindication for bisphosphonates (allergy, hypocalcemia).
TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment
Condition: Infertility
MeSH terms: Infertility
Intervention: GERI+ incubator; Conventional incubator
Intervention description: The embryo culture of consented participants were carried out in GERI+ incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade are transferred were followed up until the achievement of implantation and confirmation of pregnancy.; The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos are assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 408.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GERI+; TICON; EEVA; Embryo culture; In Vitro Fertilization; Intracytoplasmic Sperm Injection

Summary:

      The main purpose of the study was to evaluate the overall clinical value of GERI+ as an
      integrated embryo culture and assessment system, providing an undisturbed culture
      environment, continuous monitoring of embryo development and automated scoring using a
      predictive algorithm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Couples with less than or equal to (<= ) two failed fresh In Vitro
             Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) embryo transfer cycles

          -  Age greater than or equal to (>=) 18 and <= 40 years

          -  Body mass index (BMI): 18-30 kilogram per meter square (kg/m2)

          -  Normal uterine cavity under ultrasound

          -  Participant and her husband/partner must have read and signed the Informed Consent
             form (ICF)

          -  At least four normally fertilized oocytes (2Pronuclear stage (PN)) in the current
             cycle

        Exclusion Criteria:

          -  Male with non-ejaculated sperm

          -  Participants with abnormal, undiagnosed gynecological bleeding or with genitourinary
             malformations

          -  Participants with any contraindication to Controlled Ovarian Stimulation (COS) for
             Assisted Reproductive Technologies (ART) or to gonadotropins

          -  Planned "freeze all" cycle (oocytes or embryos)

          -  Planned preimplantation genetic screening (PGS) or Pre-implantation genetic diagnosis
             (PGD) cycle

          -  Concurrent participation in another clinical study
Barbed Suture vs Smooth Suture for Vaginal Cuff Closure
Condition: Closure of Vaginal Cuff at Laparoscopic Hysterectomy
Intervention: Closure of vaginal cuff
Intervention description: Closure of the vaginal cuff
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study compares outcomes among patients having a total laparoscopic hysterectomy. This
      involves removing the uterus and cervix using a laparoscopic or keyhole technique. The top of
      the vagina is routinely sutured closed after this procedure and this study is comparing two
      different suture materials for this purpose. One suture material is a barbed suture that has
      the advantage of maintaining good tension and closure on the wound. The other is a standard
      smooth suture that is commonly used for this procedure. The investigators are comparing the
      time it takes to close the vaginal cuff, as well as bleeding after surgery and the healing of
      the top of the vagina.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients having a total laparoscopic hysterectomy for benign conditions

        Exclusion Criteria:

          -  Malignancy