bioihbjkbjnl/mcl2 huggingface dataset:
Sleep and Breathing in the General Population - Chemical Stimuli
Condition: Sleep-disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes
Intervention: Zolpidem; No Treatment
Intervention description: A nonbenzodiazepine hypnotic; The Control condition in which participants do not receive medication.
Intervention MeSH terms: Zolpidem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After an initial assessment to determine eligibility, participant complete two in-lab night studies in a randomized manner including one night with the administration of zolpidem and another without zolpidem.
Masking: Single (Outcomes Assessor)
Masking description: Personnel conducting assessment of outcomes and data analysis are blinded to treatment.
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sleep-disordered Breathing; central sleep apnea

Summary:

      Central sleep apnea (CSA) is a common condition and its treatment remains elusive. The focus
      of this proposal is to identify the role of the physiologic path involving cortical arousals
      in CSA by decreasing arousal frequency using the pharmacological agent zolpidem. The goal is
      to identify the acute effects of administering zolpidem on sleep and respiratory outcomes,
      and subsequently, its effect on the severity of CSA and propensity to develop CSA. This study
      will shed light on the mechanisms underlying CSA that involve cortical arousals and will
      guide future therapeutic interventions for CSA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index
             (AHI)>15/hour with CAHI>5/hour, will be included in the experiments.

        Exclusion Criteria:

          -  less than 18 years old

          -  pregnant or breastfeeding female

          -  have severe respiratory disease that require to be on oxygen

          -  recent health event that may affect the ability to participate in the study,

          -  Body Mass Index (BMI) is >40 kg/m2

          -  significant insomnia

          -  mental instability

          -  recent health event that may affect sleep

          -  if at any time the principal investigator (PI) identifies that a certain drug is not
             suitable, or are unable to use the device that is used to treat sleep apnea, will be
             not be allowed to participate in the study
No Drop Post-Op Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: Omidria
Intervention description: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal
      Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of
      Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post
      operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 55-90 years with visual significant cataracts in one or both eyes.

          -  Healthy individuals able to tolerate outpatient cataract surgery under local
             anesthesia via either phacoemulsification and/or femtosecond assisted cataract
             surgery. Well-controlled diabetes, hypertension will be included.

          -  Females of childbearing potential must agree to use a reliable method of birth control
             while participating in this study. Reliable methods of birth control are: abstinence,
             oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation or
             vasectomy of the partner (with confirmed negative sperm counts) in monogamous
             relationship (same partner). An acceptable, although less reliable, method involves
             the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge.
             A pregnancy test is required at least 10 days from the last normal menstrual period,
             if the patient is a sexually active female of childbearing potential.

        Exclusion Criteria:

          -  Allergy to Phenylephrine or NSAIDs.

          -  Inability to sit steady and upright for the Optical Coherence Tomography (OCT).

          -  Complications during surgery, including posterior capsular rupture, vitreous loss,
             zonular dialysis, or iris trauma.

          -  Macular thickness above 300 microns at baseline

          -  Currently taking a prostaglandin analogue

          -  Presence of an epiretinal membrane on the preoperative OCT.

          -  Retained lens fragment post-operatively.

          -  Inability to return for follow appointments

          -  Female patients who are pregnant, lactating or planning to become pregnant during the
             course of treatment.
Long Term Safety Study of PRALUENT
Condition: Heterozygous Familial Hypercholesterolemia; Non-familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Praluent
Intervention description: Subcutaneous (SC) administration
Intervention MeSH terms: Alirocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1389.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to evaluate the long term safety of PRALUENT in
      participants with heterozygous familial hypercholesterolemia (heFH) or non-familial
      hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed
      the neurocognitive function study R727-CL-1532 (NCT02957682).

      The secondary objectives of the study were:

        -  To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)

        -  To evaluate the effect of PRALUENT on other lipid parameters

        -  To evaluate the effect of PRALUENT on gonadal steroid hormones
    

Eligibility criteria:

        Key Inclusion Criteria:

        Participants randomized into the neurocognitive function study (R727-CL-1532) who completed
        treatment and the end of study (EOS) visit with no premature or permanent discontinuation
        of study drug.

        Key Exclusion Criteria:

          1. Significant protocol deviation in the parent study (neurocognitive function study
             R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as
             noncompliance

          2. Any participant who experienced an AE leading to permanent discontinuation from the
             neurocognitive function study R727-CL-1532 (NCT02957682).

          3. Any new condition or worsening of an existing condition which, in the opinion of the
             investigator or per the PRALUENT local label, would make the participant unsuitable
             for enrollment or could interfere with the participant participating in or completing
             the open-label extension (OLE) study

          4. Known hypersensitivity to monoclonal antibody or any component of the drug product

          5. Pregnant or breastfeeding women

        Note: Other inclusion/ exclusion criteria apply
Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Gabapentin; Placebo
Intervention description: Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.; Patient will receive placebo tab less than 1 hour before surgery
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 112.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: laparoscopy; postoperative pain; gynecology; gabapentin

Summary:

      The purpose of this study is to prospectively determine the influence of immediate
      pre-operative gabapentin administration on acute postoperative pain. The investigators
      hypothesize that immediate post-operative pain will be improved with pre-operative
      administration of gabapentin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient must be female and planning to have a laparoscopic or robotic assisted
             procedure for benign gynecologic indications.

          2. Patients must be treated in the department of Obstetrics and Gynecology in the
             division of Minimally Invasive Gynecologic Surgery.

          3. The patient must be in the age range of 18-80 years, in general good health and able
             to comply with study procedures.

        Exclusion Criteria:

          1. Male patients will be excluded from this study.

          2. Patients under 18 years old will be excluded from this study.

          3. Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude
             pregnancy.

          4. Patients having abdominal, vaginal or hysteroscopic procedures

          5. Allergy to gabapentin

          6. Chronic use of gabapentin (greater than 6 months)
Sculptra Aesthetic Post-Approval Study
Condition: Nasolabial Fold Contour Deficiencies; Wrinkles
Intervention: injectable poly-L-lactic acid Sculptra Aesthetic
Intervention MeSH terms: Mannitol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 867.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent
      subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and
      other facial wrinkles.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Subjects seeking correction of shallow to deep NLF contour deficiencies.

        Exclusion Criteria:

          1. Subjects seeking, at entry into the study, correction of other facial wrinkles with
             Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines,
             glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower
             lip lines, corner of the mouth lines and/or horizontal neck folds.

          2. Subjects that are less than 18 or greater than 75 years of age.
Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant
Condition: Posttransplant Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Sitagliptin; Placebo
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; transplant; kidney

Summary:

      The purpose of this study is to determine whether sitagliptin is effective in preventing the
      development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of
      previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and
      calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute
      to diabetes development through multiple mechanisms; including decreased insulin production
      by the pancreas. Sitagliptin is an oral medication that results in increased insulin
      secretion. We hypothesize that administration of sitagliptin to transplant recipients
      identified to be at risk for diabetes development will reduce the incidence and severity of
      NODAT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult (≥18 yo) recipient of living-donor or deceased donor kidney transplant

          2. Blood sugar ≥ 200 mg/dL in first 72 hours after transplant

          3. No history of diabetes or prior treatment with insulin or oral hypoglycemic agents

        Exclusion Criteria:

          1. A1c of ≥6.5% measured immediately pre-transplant

          2. Recipient of simultaneous kidney-pancreas, kidney-liver, kidney-heart, or kidney-lung
             transplant

          3. Prior non-renal solid organ transplant
Suvorexant and Trauma Related Insomnia
Condition: Insomnia; Posttraumatic Stress Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic
Intervention: suvorexant; placebo
Intervention description: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia; Pill with inactive ingredients
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Problems sleeping are common after exposure to highly threatening experiences and can occur
      with and without a diagnosis of posttraumatic stress disorder (PTSD). Established treatments
      for PTSD are limited for addressing insomnia and many insomnia treatments appear to be
      limited in the context of PTSD. Suvorexant is FDA approved for insomnia and among approved
      drugs has a unique mechanism of action that may be well suited for targetting arousal at
      night dysregulated by trauma. The investigators will evaluate the efficacy of suvorexant for
      insomnia that developed in relation to trauma exposure, utilizing a placebo control, and
      polysomnography to identify biomarkers of response, in a six week trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physically healthy adults age 18-55 who meet DSM-5 criteria for insomnia and Criterion
             A (exposure to a traumatic event) for PTSD. The index trauma must have occurred within
             the past 5 years and at least 3 months before enrolling, and insomnia symptoms must
             have started or worsened after the exposure to the index trauma

        Exclusion Criteria:

          -  Psychiatric disorders other than insomnia, PTSD and specific phobias; including
             bipolar and psychotic disorders and meeting criteria for DSM-5 moderate alcohol or
             drug use disorders within the past year.

          -  Diagnosis of a sleep disorder other than insomnia including PSG findings of
             apnea/hypopnea or periodic limb movement indices > 10/hour;

          -  Medical conditions that require consistent use of medication or compromise sleep;

          -  History of moderate to severe traumatic brain injury or mild traumatic brain injury
             with ongoing post-concussive symptoms;

          -  Suicidal ideation with intent to act or with specific plan and intent in the past 6
             months (Type 4 - 5 ideation on the Columbia Suicide Severity Rating Scale) or a
             concerning history of prior suicidal behavior.

          -  Caffeine use exceeding 5 cups of coffee per day or its equivalent;

          -  Habitual bedtimes after 3 AM, habitual rise times after 10 AM, or habitual napping >
             1hour/day;

          -  Pregnancy or breastfeeding, or expecting to conceive while in study;

          -  Positive urine toxicology.
Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis
Condition: Calcinosis Cutis
MeSH terms: Calcinosis Cutis; Calcinosis
Intervention: Sodium Thiosulfate; Saline Solution
Intervention description: A volume of 0.1 ml/cm2 of STS will be injected into each lesion.; A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Intervention MeSH terms: Sodium thiosulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel two-arm study comparing sodium thiosulfate and saline control.
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Calcinosis cutis; sodium thiosulfate; sodium chloride

Summary:

      The purpose of our research is to compare the effectiveness of 125mg/50ml sodium thiosulfate
      (STS) solution to normal saline (0.9% sodium chloride) when injected intralesionally for the
      treatment of calcinosis cutis. Our specific aim is to assess the response of dystrophic and
      idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult 18 years of age or older

          -  Must have health insurance will be eligible to participate

          -  Must have a current diagnosis of dystrophic or idiopathic calcinosis cutis

          -  Subjects must have at least 2 lesions of at least 2mm in size

        Exclusion Criteria:

          -  Unable to read and speak English

          -  Allergy to any component of the sodium thiosulfate solution

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Women who are breastfeeding

          -  Prisoners
Symptom Control Satisfaction With Proton Pump Inhibitor Regimen
Condition: Heartburn
MeSH terms: Heartburn
Intervention: Optimal Dosing of Omeprazole
Intervention description: Omeprazole 20 mg
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The overall aim of this study is to assess if patients with persistent gastroesophageal
      reflux disease (GERD) symptoms receiving sub-optimal omeprazole dosing experience improvement
      in GERD symptoms when prescribed an optimal dosing regimen. The optimal dosing regimen is
      defined as taking omeprazole 30 minutes prior to the first meal of the day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years old

          -  taking omeprazole 20 mg

          -  episodic heartburn at least 3 times per week

          -  provides consent and be willing to complete study questionnaires

          -  read, speak and write English

        Exclusion Criteria:

          -  weight loss (alarm symptom)

          -  normal esophagogastroduodenoscopy (EGD) in last one year

          -  pregnant or women planning on becoming pregnant at any time during the study

          -  history of Barrett's esophagus

          -  prior esophageal strictures

          -  intolerance/allergy to study medications

          -  patients on plavix or a history of upper gastrointestinal surgery

          -  investigators or their immediate family (spouse, children, sibling)
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine Extended Release; Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
Intervention description: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.; SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioid dependence; Buprenorphine; primary care treatment; extended-release buprenorphine

Summary:

      This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded,
      examining the feasibility and acceptability of Buprenorphine extended-release vs. daily
      sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at
      community re-entry.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults >18yo incarcerated in NYC jails with known release dates.

          -  DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).

          -  Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid
             treatment program.

        Exclusion Criteria:

          -  Individual not interested in XRB treatment. Current SLB patients are otherwise by
             definition appropriate for XRB.

          -  Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be
             administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine
             with a sensitivity/specificity of: 25 mIU hCG/ml, >99%. Time to result is four
             minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter
             to ensure that a participant is not pregnant

          -  No severe or acute medical or psychiatric disability preventing safe study
             participation or making follow-up unlikely.