bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons
Condition: Adverse Effects
Intervention: Drug: Benzodiazepine (listed out below)
Intervention description: The benzodiazepine (BZD) dose will be discontinued in 4 weeks by a weekly 25% reduction. BZD-derivative hypnotics will include brotizolam, flunitrazepam, etizolam, quazepam, estazolam, nitrazepam, flurazepam, and diazepam.
All psychotropic agents other than the BZD-derivative hypnotics will be kept constant throughout the study. In addition, the use of trazodone (25-100 mg/day) will be allowed anytime throughout the study period. Subjects will be observed for 8 weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: aged; benzodiazepines; hypnotics; cognition; posture

Summary:

      Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as
      cognitive functions, which in turn could result in lethal incidents including falls
      especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and
      benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail
      population. In this 8-week open-label study, we examined changes in motor and cognitive
      functions following the discontinuation of BZD hypnotics in older persons.

      OBJECTIVES & HYPOTHESES

        1. Primary Objective The primary objective is to examine the feasibility of discontinuing
           BZD-derivative hypnotics in older people.

        2. Secondary Objectives

             1. One of the secondary objectives is to examine the magnitude of discontinuing
                BZD-derivative hypnotics in the stability of body.

             2. Another secondary objective is to examine the magnitude of discontinuing
                BZD-derivative hypnotics in cognitive function.

      Hypotheses

      1. More than 80% of the participants will complete and tolerate all the study procedures.

      2a. Participants will show an improvement in the stability of body. 2b. Participants will
      show an improvement in the cognitive function globally as well as specifically in attention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants of any race or ethnicity with any psychiatric diagnosis

          -  Age of 50 and older

          -  Having been treated with an BZD-derivative hypnotic drug at a steady dose for at least
             4 weeks

        Exclusion Criteria:

          -  Incapacity to follow the instructions.

          -  Unstable physical illness or significant neurological disorder

          -  Psychiatric concerns raised by the physician of record regarding participation in the
             study.
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: bimatoprost 0.03% eye drops; latanoprost 0.005% eye drops
Intervention description: Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks; Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks
Intervention MeSH terms: Bimatoprost; Ophthalmic Solutions; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 586.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients
      with glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or chronic glaucoma

          -  Patient requires IOP-lowering therapy in both eyes

        Exclusion Criteria:

          -  Uncontrolled medical conditions

          -  Hypersensitivity to study medications
Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
Condition: Mammaplasty
Intervention: Bupivicaine HCL; Liposomal bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine
      (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in
      terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12,
      24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of
      stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead
      to greater patient satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or
             TRAM).

          -  At least 18 years of age.

          -  Female.

          -  Able to understand and willing to sign a written informed consent document.

        Exclusion Criteria:

          -  Cognitive impairment.

          -  History of abdominal surgery precluding free flap donor site.

          -  Allergy or intolerance to bupivacaine or "amide" anesthetics.

          -  Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain
             (requiring daily use of pregabalin or gabapentin) within the previous 3 months.

          -  Pregnant or breastfeeding.
The Effectiveness of Lubiprostone in Constipated Diabetics
Condition: Constipation; Diabetes
MeSH terms: Constipation
Intervention: Lubiprostone; Placebo
Intervention description: Lubiprostone will be given as 24 mcg orally twice a day.; A matched placebo pill will be given twice a day for 8 weeks.
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Constipation; Diabetes; Lubiprostone; Amitiza; African Americans

Summary:

      The investigators will recruit a total of 136 diabetic men and women with constipation into
      this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The
      investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours
      after initiation of study drug (SBMs) in all patients two weeks before treatment with
      lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule.
      Colon transit reflects that rate of colonic peristalsis and movement of stool through the
      large bowel.

      Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks
      or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic
      transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week will
      be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will
      over-sample African American patients to achieve approximately 50% enrollment of this group.
      In a subanalysis, the investigators will assess response to treatment between the general
      population and African Americans.

      We hypothesize that lubiprostone will significantly increase the number of SBMs as well as
      decrease colonic transit time and improve quality of life in constipated diabetic patients
      compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetic patients with constipation.

          -  Patient must be on stable oral or subcutaneous hypoglycemic medication for 6 months.

        Exclusion Criteria:

          -  Acute infections

          -  Ischemic bowel syndrome

          -  Gastrointestinal obstruction
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Condition: Chronic Kidney Disease; End Stage Renal Disease; Coronary Artery Calcification; Vascular Calcification; Calcification; Cardiovascular Disease; Chronic Renal Failure; Hyperparathyroidism; Kidney Disease; Nephrology; Secondary Hyperparathyroidism
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Cardiovascular Diseases; Calcinosis; Vascular Calcification; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: cinacalcet
Intervention description: Low dose vitamin D with cinacalcet
Intervention MeSH terms: Vitamin D; Cinacalcet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: calcification; vascular calcification; coronary vascular calcification; chronic kidney disease; end stage renal disease; dialysis

Summary:

      The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates
      the progression of vascular calcification over one year, compared with a treatment regimen
      that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with
      chronic kidney disease receiving hemodialysis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with chronic kidney disease receiving hemodialysis.

          -  Lab tests required at screening include Parathyroid Hormone (PTH), calcium, and
             phosphorus.

          -  A screening coronary artery calcification score of at least 30.

        Exclusion Criteria:

          -  Subjects on non-calcium or aluminum containing phosphate binders (example: sevelamer
             HCl, lanthanum) 30 days prior to screening.

          -  Subjects on cinacalcet 30 days prior to screening.

          -  Current or previous use of some osteoporosis medications.

          -  Started or required change in cholesterol lowering medications within 30 days before
             screening.

          -  Abnormal rhythm of the heart.

          -  Parathyroidectomy done within 3 months prior to screening.

          -  Anticipated parathyroidectomy or kidney transplant.

          -  Current intolerance to oral medications, or inability to swallow.

          -  Unstable medical condition.

          -  Currently enrolled, or fewer than 30 days have passed since subject used another
             investigational device or drug.

          -  Pregnancy or breast feeding.
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Ibandronate
Intervention description: Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 308.0
Sex: Female
Healthy volunteers: No

Summary:

      This study will evaluate whether an early positive response to once-monthly oral ibandronate
      in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy
      later in treatment. The anticipated time on study treatment is 6 months, and the target
      sample size is 360 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women newly diagnosed with postmenopausal osteoporosis

          -  Naive to prior bisphosphonate therapy

        Exclusion Criteria:

          -  Inability to stand or sit upright for at least 60 minutes

          -  Inability to swallow a tablet whole

          -  Hypersensitivity to any component of ibandronate

          -  Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy
             within next 6 months

          -  Other osteoporosis drug within last 3 months

          -  Malignant disease diagnosed within previous 10 years, except resected basal cell
             cancer
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
Condition: Skin Infection
MeSH terms: Cellulitis; Skin Diseases, Infectious
Intervention: Medicinal honey; Bacitracin
Intervention description: Treat healing surgical site with medicinal honey; Treat healing surgical site with bacitracin
Intervention MeSH terms: Bacitracin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Postoperative medicinal grade honey in post-operative care may prevent bone anchored hearing
      aid associated skin breakdown better than standard care of bacitracin ointment alone in adult
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients undergoing bone-anchored hearing aid implantation surgery.

        Exclusion Criteria:

          -  patients who are undergoing revision bone-anchored hearing surgery, history of
             radiation to the implantation site.
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer; Ulcer
Intervention: TheraHoney HD; SkinTegrity
Intervention description: Honey; Hydrogel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No
Keywords: skin ulcers

Summary:

      Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer
      wounds
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects of any age

          -  Sacral wounds with necrotic tissue

        Exclusion Criteria:

          -  3rd degree burns

          -  know hypersensitivity to products
Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
Condition: Heart Failure; CHF
MeSH terms: Heart Failure
Intervention: IV loop diuretic; NxStage System One
Intervention description: Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.; Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Intervention MeSH terms: Diuretics; Sodium Potassium Chloride Symporter Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Failure; Congestive Heart Failure; CHF

Summary:

      The purpose of this study is to assess the ability of Ultrafiltration to influence the rate
      of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion
      pressure, in patients with NYHA class III/IV Heart Failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to Heart Failure Unit (H-22) with NYHA class III/IV HF and pulmonary artery
             catheter in situ

          -  Left ventricular ejection fraction <40%

          -  Mean Pulmonary Artery Occlusion Pressure ≥20 mm Hg

          -  Able to give informed consent

        Exclusion Criteria:

          -  Currently on renal replacement therapy or determined to need renal replacement therapy
             at the time of enrollment

          -  Estimated glomerular filtration rate (GFR) <15 mL/min

          -  Systolic blood pressure (SBP) <80 mm Hg

          -  Acute coronary syndrome

          -  Hematocrit >50%

          -  Malignancy other than prostrate or skin

          -  Chronic edematous states other than HF, including nephritic syndrome and cirrhosis

          -  Chronic inflammatory or infectious condition

          -  Pregnancy

          -  Previous enrollment in this study

          -  Expectation of need for heart transplantation or cardiac assist device within one week

          -  Pulmonary failure requiring intubation and mechanical ventilation

          -  Known or suspected hypersensitivity to dialysis membranes

          -  Severe aortic stenosis or regurgitation

          -  Severe mitral stenosis
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: TTS-fentanyl
Intervention description: TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Transdermal Therapeutic System (TTS)-fentanyl; Durogesic

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic
      System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so
      the drug will enter the body through the skin) in participants with moderate (medium level of
      seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder,
      which is seen mostly in older persons, in which the joints become painful and stiff).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic (lasting a long time) primary osteoarthritis pain for more than 3 months with
             Visual Analog Scale (VAS) greater than or equal to 5

          -  Participants having moderate to severe pain (VAS greater than or equal to 5), which
             was not adequately controlled by weak opioids such as tramadol or codeine at optimal
             doses (at least 150 milligram [mg] per day for tramadol or 200 mg per day for codeine)
             for at least 7 consecutive days

          -  Participants who failed from other treatments such as operation or lack of efficacy of
             current treatment

        Exclusion Criteria:

          -  Skin disease that prevents the use of the transdermal system or which could affect the
             absorption of fentanyl or local tolerability

          -  History or suspicion of alcohol or drug abuse within the past 5 years

          -  History of cardiac, nervous system or respiratory disease which in the investigator's
             judgment precludes participation in the study because of the potential for respiratory
             depression

          -  Confusion, reduced level of consciousness, or concomitant (given at the same time)
             psychiatric disorder which, in the opinion of the investigator, could prevent
             participation in the trial

          -  Pregnant or breast-feeding female; female participants of child bearing potential
             without adequate contraception
Seizure Prophylaxis in Aneurysm Repair
Condition: Intracranial Aneurysms; Seizures
MeSH terms: Seizures; Intracranial Aneurysm; Aneurysm
Intervention: Levetiracetam
Intervention description: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
Intervention MeSH terms: Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Seizures are a potential complication of surgical repair of intracranial aneurysms. In order
      to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during
      the intra-operative and post-operative period, however, such practice is not supported by
      clinical data. Retrospective review found the incidence of postoperative seizures was higher
      in those who received anti-epileptics versus those who did not. The goal is to examine the
      utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical
      repair of unruptured intracranial aneurysms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult (≥18 years)

          2. Presence of intracranial aneurysm (without rupture)

          3. Treating surgeon has recommended surgical repair of the aneurysm.

        Exclusion Criteria:

          1. History of seizures within last 10 years

          2. History of epilepsy

          3. History of prior stroke

          4. Currently prescribed medication with anti-epileptic activity (keppra,dilantin,
             tegretol, lamictal, topamax, etc.)

          5. Brain tumor

          6. Pregnant or nursing woman

          7. Known levetiracetam allergy