bioihbjkbjnl/mcl2 huggingface dataset:
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Condition: Insomnia; Sleep Initiation and Maintenance Disorders; Alzheimer Disease
MeSH terms: Alzheimer Disease; Sleep Initiation and Maintenance Disorders
Intervention: modafinil
Intervention description: 100-400 mg daily for 4 weeks
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Mild Cognitive Impairment (MCI); Sleep; Fatigue; Memory

Summary:

      Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration
      for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work
      sleep disorder. Each of these problems is characterized by difficulty sleeping at night and
      excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this
      sleepiness. The idea behind this treatment is that sleepiness that leads to napping during
      the day prevents a patient from being tired or sleepy enough to get good sleep at night. This
      study is designed to determine if the medication can "reset" participants' sleep/wake rhythm
      to a more normal rhythm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment

          -  Subjective complaint of sleep disruption, unsatisfactory sleep, early morning
             awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made
             by either the potential participant or by the caregiver.

        Exclusion Criteria:

          -  Participation in any other clinical drug trial

          -  Liver failure

          -  Believed by the investigator to be unwilling or unable to follow the protocol

          -  Active liver or coronary disease
Increasing Naloxone Access for Persons Who Use Opioids
Condition: Naloxone
Intervention: Opioid Overdose Education with Naloxone Distribution; Opioid Overdose Education
Intervention description: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with a naloxone kit.; Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with information on where they can obtain a naloxone kit.
Intervention MeSH terms: Analgesics, Opioid; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid overdose; Naloxone distribution; Narcan; Online training

Summary:

      Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to
      the serious public health concern of the opioid epidemic, federal agencies recommend
      employing various harm reduction interventions. The implementation of Opioid Overdose
      Education and Naloxone Distribution (OEND) programs is effective in reducing opioid overdose
      mortality, yet these programs do not reach many high-risk individuals. Traditionally, OEND
      program venues are found in large, urban medical centers, drug treatment facilities, and
      needle exchange programs. Identifying unreached, high-risk individuals and providing training
      and naloxone kits through online recruitment could significantly expand access to this
      life-saving intervention. The primary goal of the current proposed project is to examine the
      acceptability and feasibility of online recruitment, online opioid overdose and naloxone
      administration education, and postal distribution of naloxone kits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Current or past six months illicit use of opioids

          -  Electronic device access for online survey completion

          -  Willing to provide email address to receive survey link and compensation

          -  Able to read and speak English

          -  Willing to provide their contact information and that of two friends/family members

          -  Permanent address for mailing of naloxone kit

          -  Does not currently have a naloxone kit in possession

        Exclusion Criteria:

          -  Contraindication for naloxone (known severe allergic reaction)

          -  Cognitive impairment or unstable psychiatric condition that interferes with the
             informed consent process
Oracea Soolantra Association in Participants With Severe Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Ivermectin 1% cream; Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules; Oral placebo capsules
Intervention description: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks; 1 Capsule once-daily for 12 weeks; 1 Capsule once-daily for 12 weeks
Intervention MeSH terms: Doxycycline; Ivermectin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream
      associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical
      cream associated with Placebo in the treatment of severe Rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject age ≥ 18 years or older;

          -  Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and
             pustules) of rosacea on the face at Baseline visit;

          -  Subject with severe rosacea with papulopustular lesions (according to the
             Investigator's Global Assessment (IGA) score rated 4);

          -  Female subjects of childbearing potential with a negative urine pregnancy test (UPT);

          -  Female subjects of childbearing potential must practice a highly effective method of
             contraception during the study.

        Exclusion Criteria:

          -  Subjects with particular forms of rosacea or other concomitant facial dermatoses that
             may be confounded with rosacea;

          -  Subjects with more than 2 nodules of rosacea on the face;

          -  Subjects with any uncontrolled chronic or serious disease or medical condition that
             may either interfere with the interpretation of the clinical trial results, or with
             optimal participation in the study or would present a significant risk to the subject;

          -  Subjects with known or suspected allergies or sensitivities to any component of the
             investigational and non-investigational products, including the active ingredients
             doxycycline and ivermectin.
Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: opioid pain pills
Intervention description: patient will receive their pain pill prescription
Intervention MeSH terms: Analgesics, Opioid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioids

Summary:

      The United States constitutes <5% of the world's population but over 80% of the opioid supply
      and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug
      overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids.
      Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood
      of readmission for pain. Available data suggests that orthopaedic surgeons are the most
      likely physicians to prescribe opioids to Medicare patients, whose opioid prescriptions are
      over 7 times more likely to come from an orthopaedic surgeon than another type of physician,
      but orthopaedic surgeons also had the highest readmission rate for post-operative pain. Many
      studies have investigated the utilization of opioids after surgery to assess surgeon's
      tendencies to overprescribe, demographics of those likely to overuse, and adverse events of
      opioid abusers.

      The primary purpose of this randomized controlled trial is to determine whether prescribing
      fewer opioid pills per prescription reduces the total amount of opioids taken, even while
      allowing equal total opioid availability via increased frequency of prescription
      availability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  any patient > 18 years of age scheduled for primary total hip or knee arthroplasty who
             is not consuming opioids during the 4 weeks prior to surgery

        Exclusion Criteria:

          -  patients consuming opioids during the 4 weeks prior to surgery

          -  patients who are allergic to oxycodone or refuse to take oxycodone

          -  patients with a history of opioid dependence or illegal or "off-label" opioid use

          -  patients undergoing a revision total knee or total hip arthroplasty

          -  any patient less than 18 years of age
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM (Menveo)
Intervention description: One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3948.0
Sex: All
Minimum age: 2 Months
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: conjugate vaccine; phase IV clinical trial; Neisseria meningitidis

Summary:

      A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure
      requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety
      evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving
      MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible for enrolment in this study are those:

          1. male and female subjects from 2 months to 55 years of the age at the time of Visit 1
             (including all 55 years old subjects, up to one day before their 56th year birthday),
             who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according
             to the local prescribing information and routine clinical practice;

          2. to whom the nature of the study has been described and the subject or subject's
             parent/legal representative has provided written informed consent;

          3. whom the investigator believes that the subject can and will comply with the
             requirements of the protocol (e.g., completion of the Diary Card);

          4. who are in good health as determined by the outcome of medical history, physical
             assessment and clinical judgment of the investigator.

        Exclusion Criteria:

        1. Contraindication, special warnings and/or precautions, as evaluated by the
        investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing
        information. In particular, should not be included in the study a subject who has ever had:

          -  an allergic reaction to the active substances or any of the other ingredients of the
             study vaccine; an allergic reaction to diphtheria toxoid;

          -  an illness with high fever; however, a mild fever or upper respiratory infection (for
             example cold) itself is not a reason to delay vaccination. Special care should be
             taken for subjects having haemophilia or any other problem that may stop your blood
             from clotting properly, such as persons receiving blood thinners (anticoagulants).
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
5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
Condition: Major Depressive Disorder
MeSH terms: Hypoxia; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: 5-hydroxytryptophan and Creatine monohydrate
Intervention MeSH terms: 5-Hydroxytryptophan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators hypothesize that the administration of two widely available, naturally
      occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the
      severity of depression in individuals exposed to chronic hypoxia by living at altitude. The
      purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g
      creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms
      measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or
      SNRI-resistant depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female gender, ages 18-64 years inclusive

          -  Current diagnosis of Major Depressive Disorder identified by the SCID-5-CT

          -  Current HAM-D17 score of > 15

          -  Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks

        Exclusion Criteria:

          -  Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified
             by the SCID-5-CT

          -  History of or current diagnosis of renal disease, such as chronic renal failure, acute
             renal failure or end stage renal disease

          -  Diabetes type I or II

          -  Colitis or diverticulitis

          -  History of pulmonary disease

          -  History of fibromyalgia, lupus, eosinophilia myalgia syndrome, dermatomyositis,
             polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue
             disease, ankylosing spondylitis, or other related rheumatological condition

          -  Seizure disorder

          -  Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale

          -  Current treatment with an antipsychotic, mood stabilizer, or non-SSRI antidepressant

          -  Positive pregnancy test

          -  Previous diagnosis of serotonin syndrome

          -  Use of any excluded drugs or medications including serotonergic drugs or medications
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Condition: Dysmenorrhea; Pain
MeSH terms: Dysmenorrhea
Intervention: Naproxen
Intervention description: Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Intervention MeSH terms: Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: cross-organ sensitivity; bladder pain; NSAID; visceral pain

Summary:

      The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea
      will improve pain report from baseline. In addition, we will determine whether cross-organ
      influences from the uterus on bladder pain sensitivity change from baseline after reduced
      menstrual pain experience over six months. Finally, a battery of quantitative sensory tests
      and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with
      improvements in menstrual and bladder pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Reproductive-age women (age 18-45) with dysmenorrhea

          -  Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least
             one day during menses or during withdrawal uterine bleeding from cyclic OCs without
             painkillers

          -  Menstrual pain in the region between the umbilicus and the perineum, above the level
             of the inguinal ligament

          -  Indication the participant has attempted to resolve pain by medical means (including
             NSAIDs and/or OCPs)

        Exclusion Criteria:

          -  Presence of active pelvic or abdominal malignancies (primary or metastatic)

          -  Absence of regular menses (including current pregnancy, recent pregnancy, or active
             breast feeding)

          -  Active genitourinary infection in the last four weeks

          -  Unable to read or comprehend the informed consent in English

          -  Unwilling to complete study procedures

          -  Presence of hypertension or risk for developing hypertension

          -  Unwillingness to take naproxen and/or placebo

          -  Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism,
             cardiovascular disease, stomach or intestinal ulcer or abnormal liver function)

          -  Formal urological diagnosis such as overactive bladder or bladder pain syndrome.
Deep Neuromuscular Block for Laparoscopic Surgery
Condition: Laparoscopy; Anesthesia Recovery Period
Intervention: Sugammadex; Neostigmine
Intervention description: Reversal of neuromuscular block Sugammadex dosage will be adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. Dosage will be 4mg/kg if TOF = 0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.; Neostigmine 50 micrograms/kg coupled with atropine 20 micrograms/kg or glycopyrrolate 5 micrograms/kg, to a maximum dose of neostigmine of 5.0 mg. The neostigmine should not be administered until the TOF has at least 3 twitches present.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Trial summary: deep neuromuscular block is proposed as a technique to improve operative
      conditions for laparoscopy. Early clinical data would suggest that there may also be patient
      benefits beyond the operative period related to lower intra-abdominal pressure, and improved
      surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential to
      use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide
      moderate neuromuscular block and reverse with neostigmine. It is not possible to safely
      reverse deep neuromuscular block using neostogmine, as the majority of block must have worn
      off for neostigmine to be effective. in order to identify whether deep neuromuscular block
      improves quality of recovery after surgery, the investigators will conduct a randomised trial
      of deep versus moderate neuromuscular block, whilst minimising variance in other anaesthetic
      techniques and drugs used. the outcome measured will be the post-operative quality of
      recovery over multiple time periods using the Postoperative Quality of Recovery Scale
      (PostopQRS). 350 patients will be enrolled over 4 centres.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult participants

          2. operative gynecological or abdominal surgery

          3. receiving general anesthesia

          4. Operation expected to exceed1 hour duration

          5. Participants must speak sufficient English to answer the survey questions

        Exclusion Criteria:

          1. Participants undergoing diagnostic laparoscopy only

          2. Participants <18 years of age

          3. Current pregnancy

          4. Known allergy to rocuronium, neostigmine or sugammadex, or desflurane