bioihbjkbjnl/mcl2 huggingface dataset:
Intercostal Nerve Cryoablation for Postoperative Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Intercostal Nerve Cryoablation; Bupivacaine liposomal injectable suspension; Patient-controlled analgesia (PCA)
Intervention description: Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.; Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).; Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cryoablation

Summary:

      The purpose of the study is to assess the efficacy of intercostal nerve cryoablation on the
      magnitude and duration of postoperative pain control both in patients undergoing
      thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Descending/thoracoabdominal incision is planned

          -  There is reasonable expectation that the patient will be extubated within 48 hours
             after surgery

        Exclusion Criteria:

          -  The patient has a known allergy to morphine or any opioid

          -  The patient has a known chronic pain disorder or takes daily opioid medication > 1
             month prior to surgery

          -  The surgeon/anesthesiologist concludes that the period for intubation will be likely
             be for more than 48 hours after surgery There is anticipated difficulty communicating
             pain status due to language or other barriers at the investigator discretion.
Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
Condition: Postoperative Delirium
MeSH terms: Delirium; Emergence Delirium
Intervention: Isoflurane; Desflurane
Intervention MeSH terms: Desflurane; Isoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Postoperative delirium; spine surgery; isoflurane; desflurane

Summary:

      Postoperative delirium (POD) is a known complication of inhalational agents used to
      anaesthetise patients for surgery with potential long term implications.The incidence of
      postoperative delirium in spine surgery is 3.3% to 3.8%.The purpose of this study is to
      compare the occurrence of postoperative delirium with inhalational anaesthetics namely
      isoflurane and desflurane in spine surgery patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for spine surgery.

          -  Age between 18-65 years

          -  American Society of Anaesthesiologists (ASA) Grade I and II patients

          -  Patients with Glasgow Coma Scale (GCS) of 15

          -  Postoperative Aldrette score > 9

        Exclusion Criteria:

          -  Cardiorespiratory disorders

          -  Associated cerebral disease

          -  Psychiatric illness

          -  Electrolyte and hormonal imbalance

          -  History of drug abuse

          -  Postoperative meningitis

          -  Administration of high dose steroids
Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
Condition: Healthy
Intervention: Fluoxetine; Bupropion
Intervention description: Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.; Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.
Intervention MeSH terms: Bupropion; Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gonadal Steroid Hormones; Healthy Volunteers; Antidepressant Side Effects; Fluoxetine; Bupropion; Prolactin; Testosterone; Estradiol; Progesterone; Sexual Function; Serotonin Reuptake Inhibitors; 17-OH Pregnenolone

Summary:

      This study will evaluate the effect of antidepressants on sex hormone levels in women and if
      the potential changes in sex hormone levels are related to sexual side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to
             study entry

          -  Willing to engage in sexual activity, alone or with a partner, at least weekly for the
             duration of the study

          -  Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal
             ligation, nonhormonal intrauterine device,, partner with vasectomy) for the duration
             of the study

        Exclusion Criteria:

          -  Medical illness that may contribute to sexual dysfunction or affect steroid hormone
             levels

          -  Body mass index (BMI) greater than 30

          -  Elevated testosterone at screening

          -  History of seizure disorder

          -  Consumes more than 10 alcoholic beverages per week
Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
Condition: Intubation; Difficult
Intervention: dexmedetomidine group; remifentanil group
Intervention description: 1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine; target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dexmedetomidine; remifentanil; awake nasotracheal fibreoptic intubation; oral maxillofacial surgery; difficult airway; adult

Summary:

      The purpose of this study is to compare the sedation effect of dexmedetomidine and target
      controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing
      oral maxillofacial surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA grade I-III adult patients with difficult airway, who were undergoing elective
             oral maxillofacial surgery

        Exclusion Criteria:

          -  pregnant or lactating female,

          -  long-term opioids or sedative medication,

          -  patients < 18 years of age,

          -  severe bradycardia (HR < 50 beats/min),

          -  hypotension (systolic pressure < 90mmHg),

          -  any type of atrioventricular block on the ECG
Predicting, Understanding and Speeding Recovery After TKA
Condition: Pain; Total Knee Replacement; Total Hip Replacement
Intervention: Gabapentin; Placebo
Intervention description: Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. Subjects randomized to gabapentin will receive 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week.; Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. Subjects randomized to gabapentin will receive 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week.
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The objective of this research study is to better understand patterns of recovery after Total
      Knee Arthroplasty (TKA) amd Total Hip Replacement (THA). The study will evaluate how pain,
      activity and cognitive (i.e., thinking style) responses determine patterns of recovery, and
      the study will evaluate the efficacy of gabapentin versus placebo for improving recovery
      after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults scheduled for elective total knee or hip replacement

          -  American Society of Anesthesiologists physical status 1-3

          -  Participants must be able to read and write English

        Exclusion Criteria:

          -  Inability to complete questionnaires

          -  Pregnancy

          -  Litigation or workers compensation related to joint surgery

          -  For 250 subjects in primary analysis - taking < 100 mg morphine equivalents/day. For
             50 subjects to test gabapentin's effect on pupil diameter - taking >100 mg morphine
             equivalents/day

          -  history of Raynaud's disease of the feet

          -  suffering from a psychotic disorder or a recent psychiatric hospitalization

          -  history of eye surgery or topical eye medications that would render pupillometry
             unreliable or would directly affect pupil diameter.

          -  any disorder that would affect pupil responsivity or prevent accuracy of pupillometry
             such as movement disorders
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
Condition: Pelvic Organ Prolapse; Urogenital Prolapse; Vaginal Vault Prolapse; Cystocele; Uterine Prolapse; Vaginal Prolapse; Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders; Cystocele; Uterine Prolapse; Recurrence; Prolapse; Pelvic Organ Prolapse
Intervention: Conjugated Estrogens Cream; Placebo Cream
Intervention description: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.; 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: Female
Minimum age: 48 Years
Healthy volunteers: No
Keywords: Pelvic Organ Prolapse; Pelvic Floor Disorders; Therapy, Estrogen Replacement; Estrogens, Conjugated

Summary:

      This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning
      native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued
      postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic
      science investigation are designed to understand the mechanisms by which local estrogen
      treatment affects connective tissues of the pelvic floor and determine whether its use before
      and after prolapse repair will (i) improve success rates of the surgical intervention and
      minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor
      disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal: no menses for >1 year

          -  Minimum age: 48 years

          -  Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater

          -  No estrogen replacement within the last month (may come off current treatment, i.e.
             wash out, to join the study)

          -  Medically fit for elective surgery

          -  Physically able to apply/insert the study drug

          -  Available for clinic follow-up for minimum 1yr

        Exclusion Criteria:

          -  Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)

          -  BMI >35 kg/m2

          -  Recent history (within last month) of vaginal infection or vaginitis

          -  Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or
             endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)

          -  History of connective tissue disease

          -  Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu

          -  History of vaginal irradiation

          -  Allergy to Premarin or its constituents

          -  Prior apical repair or use of mesh for prolapse repair

          -  Current tobacco use
Are Opioids Needed After ACL Reconstruction
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Intervention: Oxycodone; Placebo oral tablet
Intervention description: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10; Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double-blind, randomized controlled clinical trial
Masking: Double (Participant, Investigator)
Masking description: Both participants and PI (orthopaedic surgeon) will be blinded. Placebo pills will be closely matched to oxycodone pills, so patients will not know to which group they are allocated. The PI will be blinded to group allocation.
Enrollment: 98.0
Sex: All
Minimum age: 14 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Opioids

Summary:

      As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons
      must revisit pain management protocols to reduce unnecessary opioid prescriptions. The
      long-term goal is to reduce opioid use and residual opioids in circulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females

          -  Aged 14-40 years

          -  Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps
             tendon autograft.

        Exclusion Criteria:

          -  Revision and/or contralateral ACL reconstruction procedures

          -  Allergies to local anesthetics

          -  Chronic pain medication use

          -  Weight <50 kg, local infections

          -  Known coagulopathies,

          -  Liver dysfunction or renal failure
Ripening Interventions: Prostaglandins vs EASI Catheter
Condition: Cesarean Section
Intervention: Misoprostol; Catheter
Intervention description: Misoprostol,25 micrograms every 4 hours.; A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregnancy; Extra amniotic saline infusion; Misoprostol; Labor induction

Summary:

      The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs
      extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion
      of patients delivered by cesarean section for fetal intolerance of labor versus vaginal
      delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI
      catheter are less likely to undergo cesarean section for fetal intolerance of labor when
      compared to women who receive misoprostol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Singleton pregnancy

          -  Cephalic presentation

          -  36 completed weeks of gestation

          -  Intact membranes

          -  Unfavorable cervix (defined as Bishop score < 5)

          -  Indication for induction of labor

          -  Fetal Station less than or equal to -3

        Exclusion Criteria:

          -  Clinically significant vaginal bleeding

          -  Evidence of spontaneous labor (3 contractions in 10 minutes)

          -  Contraindication to induction of labor or to use of prostaglandins

          -  Fetal station higher than -3
12-Month Stability of Diurnal IOP Control on Cosopt
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Cosopt
Intervention description: Cosopt twice daily in both eyes
Intervention MeSH terms: Timolol; Dorzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glaucoma; diurnal; intraocular pressure

Summary:

      To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with
      Cosopt
    

Eligibility criteria:

        Inclusion Criteria:

          -  bilateral open-angle glaucoma

        Exclusion Criteria:

          -  contraindications to Cosopt

          -  pathology affecting tonometry
A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rivastigmine transdermal patch
Intervention description: The study treatment was delivered as a patch sizes 5 and 10 cm^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
Intervention MeSH terms: Rivastigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 50 Years
Keywords: Alzheimer's disease; cholinesterase inhibitor; rivastigmine

Summary:

      This study is designed to confirm the efficacy, the tolerability, the patient compliance and
      the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with
      probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males, and females of at least 50 years old with a primary caregiver

          -  Probable Alzheimer's disease

          -  Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26

          -  Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor
             (patients prescribed both rivastigmine and memantine are allowed) or patients who
             failed to benefit from previous ChE inhibitor treatment

          -  Residing with someone in the community throughout the study or, if living alone, in
             contact with the responsible caregiver everyday

        Exclusion Criteria:

          -  Patients not treated according to the product monograph for capsules

          -  Current diagnosis of an active skin lesion/disorder that would prevent accurate
             assessment of the adhesion and potential skin irritation of the patch (e.g., atopic
             dermatitis, wounded or scratched skin in the area of the patch application)

          -  History of allergy to topical products containing any of the constituents of the
             patches

        Other protocol-defined inclusion/exclusion criteria may apply.