bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder
Condition: Insomnia; Bipolar Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Bipolar Disorder
Intervention: Suvorexant; Placebo
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: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of suvorexant, added to existing
      medications, for treatment-resistant insomnia in individuals with bipolar disorder. The
      investigators hypothesize that participants receiving suvorexant for one week will experience
      significantly greater improvement in sleep duration compared to participants receiving
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder (296.70),
             bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80),
             with concurrent insomnia related to bipolar disorder (307.42).

          2. Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents,
             anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for
             management of bipolar disorder.

          3. Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week.

        Exclusion Criteria:

          1. Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total
             score ≥ 12.

          2. Current (past 6 months) alcohol or substance use disorder.

          3. Current psychosis.

          4. Patients who are actively suicidal or evaluated as being a high suicide risk.

          5. Women who are currently pregnant or breastfeeding.

          6. Clinically significant abnormalities on baseline laboratory tests (comprehensive
             metabolic panel, fasting lipid panel, Complete Blood Count (CBC) with differential,
             thyroid stimulating hormone).

          7. Presence of any unstable and/or potentially confounding neurological and/or medical
             disorder.
Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
Condition: Leukemia-Lymphoma
Intervention: EMLA; Lidocaine
Intervention description: EMLA cream (lidocaine 2.5% and prilocaine 2.5%); lidocaine 1%
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      A common procedure in children with cancer is the spinal tap, or lumbar puncture (LP), in
      which a needle is inserted into the spinal canal. In this population, LPs are most commonly
      performed to collect cerebrospinal fluid (CSF, the liquid surrounding the brain and spinal
      cord) for diagnostic testing, and to inject medications including chemotherapy. Local
      analgesic (pain control medicine) during pediatric LP procedures is underutilized and not
      standardized. The first local analgesic routinely used for LP procedures was lidocaine
      injection. The discovery of the topical EMLA (lidocaine 2.5%/prilocaine 2.5%) cream, approved
      by the FDA for local skin use in pediatric patients, has provided an additional option for
      local LP analgesia. A comparison between topical EMLA vs lidocaine injection for LP pain
      control in the pediatric population has not been performed. Pediatric oncology patients often
      require serial LPs for diagnostics purposes and/or chemotherapy delivery. Due to a lack of
      standardization of LP analgesia in this population, the investigators have designed a
      prospective, single-blind, randomized control crossover trial to examine EMLA vs. lidocaine
      injection in reducing pain associated with LP in children being treated for leukemia or
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric cancer patients (aged 3-18) with a diagnosis of leukemia or lymphoma

          -  Patients are expected to receive serial (i.e. > 1) LP as outpatients in Charleston
             Area Medical Center Children's Cancer Center in the course of 12 months for diagnostic
             and/or treatment purposes

        Exclusion Criteria:

          -  Patients not in the age range

          -  Non-cancer patients

          -  Allergy to amide anesthetics

          -  Patients treated with class I and III anti-arrhythmic drugs (eg, amiodarone,
             bretylium, sotalol, dofetilide)

          -  Patients with congenital or idiopathic methemoglobinemia
Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes
Condition: Hypertension; Stage 2 Hypertension; Diabetes
MeSH terms: Hypertension; Diabetes Mellitus
Intervention: Valturna; Amlodipine; Chlorthalidone; Placebo of Valturna Tablet; Placebo Capsule
Intervention description: Valturna (aliskiren 150 mg/valsartan 160 mg) tablet; Amlodipine 5 mg and 10 mg capsule; Chlorthalidone 15 mg and 25 mg capsule; Matching placebo of valturna tablet; Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule
Intervention MeSH terms: Amlodipine; Chlorthalidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 975.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: High blood pressure; diabetes

Summary:

      This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and
      chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and
      diabetes mellitus 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stage 2 hypertension within protocol limits at randomization

          -  Patients with type 2 diabetes mellitus with HgA1c less than or equal to 9%

          -  Patients with newly diagnosed hypertension or patients who have not received
             antihypertensive therapy for at least 4 weeks prior to screening

        Exclusion Criteria:

          -  Patients taking 4 or more antihypertensive medications at screening visit

          -  Patients with uncontrolled BP (> 140/90 mmHg) while taking 3 or more antihypertensives
             at their maximum approved doses

          -  Type 2 diabetes mellitus requiring insulin treatment

          -  Patients with HgA1c > 9%

          -  Patients with known gout

          -  Known history of cancer within the past 5 years

          -  Patients who are pregnant or nursing mothers

          -  Patients who have participated in an investigational clinical trial within the 30 days
             prior to screening.

          -  Other protocol-defined inclusion/exclusion criteria may apply
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
Condition: REM Sleep Behavior Disorder; Parkinson Disease
MeSH terms: Parkinson Disease; REM Sleep Behavior Disorder; Mental Disorders
Intervention: Sodium Oxybate; Placebo
Intervention description: Sodium Oxybate will be titrated up weekly by 1.5g nightly dose increments from an initial 4.5g total nightly dose (which could be given in two unequal doses if needed, or one single dose no greater than 4.5g) to an optimal individual dose based on clinical response on RBD symptoms and tolerance, to a maximum nightly dose of 9g ("flexible dose" period lasting up to 8 weeks). The optimal dose will then be continued for at least 4 weeks ("stable dose").; Placebo will be similar in appearance, smell and flavor to the subjects, so that the investigators and participants will be unable to distinguish it from sodium oxybate.
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: sodium oxybate

Summary:

      This study is the first clinical trial using sodium oxybate for the treatment of REM sleep
      behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of
      narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has
      shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal,
      2016; Moghadam, 2017).
    

Eligibility criteria:

        Inclusion Criteria:

          -  40-85 years old

          -  With or without Parkinson's disease

          -  Experiencing RBD episodes on average at least 2x/week or 8x/month

          -  Able to report RBD episodes themselves or via a partner witness

        Exclusion Criteria:

          -  History of falls during ambulation in the last 6 months despite adequate neurologic
             treatment

          -  Requirement of an ambulatory device at home

          -  Inadequately treated symptomatic orthostatic hypotension

          -  BMI > 35

          -  Untreated or uncontrolled OSA (4%AHI>15)

          -  Cognitive impairment resulting in inability to comply with treatment instructions

          -  Pregnancy
Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients
Condition: Constipation
MeSH terms: Constipation
Intervention: MOVANTIK™ (naloxegol); Sugar Pill
Intervention MeSH terms: Naloxegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Constipation is a known complication of the postoperative period after spinal surgery, where
      prescription pain medicines called opioids are traditionally used in high doses for the
      treatment of surgery-related pain. The goal of this study is to determine the effectiveness
      of Movantik (naloxegol)-a FDA-approved drug used to treat constipation that is caused by
      opioids-in preventing constipation in patients undergoing spinal fusion surgery at MGH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients between the ages of 18 and 75 years undergoing non-urgent,
             elective spinal fusion at Massachusetts General Hospital who are admitted to the
             neurosurgery floor from the operating room

        Exclusion Criteria:

          -  Patients who are taken to the operating room from another inpatient floor or service
             (already hospitalized prior to surgery)

          -  Patients with evidence of bowel obstruction

          -  Patients unable to take oral medications by mouth or by enteric feeding tube
             (gastrostomy or jejunostomy)

          -  Patients with a documented or potential allergy or adverse reaction to Movantik
             (naloxegol) from outpatient use

          -  Patients currently taking Movantik (naloxegol) in the outpatient setting

          -  Patients with a preoperative diagnosis of irritable bowel syndrome (IBS) obtained via
             Rome III questionnaire on screening

          -  Patients with disruptions to the blood-brain barrier (eg, multiple sclerosis, recent
             brain injury, Alzheimer's disease, and uncontrolled epilepsy)

          -  Patients with a history of cancer.

          -  Patients concomitantly using strong CYP3A4 inhibitors (eg, clarithromycin,
             ketoconazole), strong CYP3A4 inducers and other opioid antagonists.

          -  Patients with severe hepatic impairment.

          -  Patients with a previous history of or risk of bowel perforation.

          -  Patients with a post-op regional anesthetic technique employed like a continuous
             epidural or spinal.

          -  Patients for which local anesthetics will be placed in the wound.
Impact of Propofol Reduction in Anesthesia Induction
Condition: Propofol Adverse Reaction; Anesthesia
Intervention: Propofol Injection
Intervention description: 1, 1.5 or 2 mg/kg of propofol according to the subgroup
Intervention MeSH terms: Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 time groups, divided into 3 dose groups
Masking: Single (Participant)
Masking description: aleatory assignation, time measured by nurses, drugs administrated by principal investigator
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: propofol synergy; fentanyl; anesthesia induction

Summary:

      Objective: Determine if, by reducing the dose of propofol and increasing the time elapsed
      between fentanyl and propofol administration, hemodynamic response is improved.

      Methods: Patients were randomized into time groups (2 and 1 minute) and each subdivided into
      dose groups (1, 1.5 and 2 mg kg-1) obtaining six time-dose groups. After receiving 2 μg kg-1
      of fentanyl, propofol was administered after the predetermined time. Time to hypnosis
      (BIS<60) and hemodynamic parameters at pre-induction, pre-intubation and postintubation were
      registered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults who required general anesthesia

          -  General anesthesia with endotracheal intubation (no supraglottic devices)

          -  Signed informed consent

          -  Non-cardiac surgery

          -  Same anesthesiologist

        Exclusion Criteria:

          -  Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac
             output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60%
             with normal arterial saturation or lactate >3 mmol/l)

          -  Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal
             obstruction, pregnancy, etc.)

          -  Suspected difficult airway

          -  Known allergy to anesthetic drugs
A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: COPEGUS; peginterferon alfa-2a [Pegasys]
Intervention description: COPEGUS 800 mg or 1000-1200 mg po for 24 weeks; PEGASYS 180 micrograms sc once weekly for 24 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center study will evaluate the safety and tolerability and the effect
      on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic
      hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24
      weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified
      as slow virological responders will be enrolled in this study in order to receive additional
      24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS
      will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on
      study treatment is 24 weeks. The target sample size is 50-150 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >/= 18 years of age

          -  Chronic hepatitis C, genotype 1, 2, 3

          -  Compensated liver disease

          -  Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and
             COPEGUS and were identified as slow virological responders

        Exclusion Criteria:

          -  Decompensated liver disease

          -  Signs or symptoms of hepatocellular carcinoma

          -  Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Cognitive Protection - Dexmedetomidine and Cognitive Reserve
Condition: Postoperative Delirium; PD; Postoperative Cognitive Dysfunction; POCD
MeSH terms: Delirium; Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Intervention: Precedex (Dexmedetomidine); Placebo
Intervention description: Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.; Matching placebo given prior to surgery and continued for 24 hours postoperatively
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 27.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Postoperative delirium; PD; Postoperative cognitive dysfunction; POCD

Summary:

      This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium
      in non-cardiac surgical patients. The preliminary data regarding the effect of
      dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize
      fifty patients into two different protocols, one using dexmedetomidine until PACU discharge
      (hip replacement) and the other using dexmedetomidine for 24 hours in a monitored setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 65 years and older

          -  elective major hip replacement or peripheral vascular (major surgery is defined by a
             planned 2 day hospitalization)

          -  ASA physical status I-III

          -  capable and willing to consent

        Exclusion Criteria:

          -  Cardiac surgery

          -  Intracranial Surgery

          -  Emergency Surgery

          -  Patients with severe visual or auditory disorder/handicaps

          -  Illiteracy

          -  Patients with clinically significant Parkinson's Disease

          -  Patients not expected to be able to complete the 3 month postoperative test

          -  Sick sinus syndrome without pacemaker

          -  Hypersensitivity to drug or class

          -  Current 2nd or 3rd degree AV block

          -  History of clinically significant bradycardia

          -  Contraindication to the use of an 2A-agonist

          -  Presence of a major psychiatric condition such as bipolar disorder, major depression,
             schizophrenia, or dementia

          -  ASA physical status IV or V
Duloxetine in Osteoarthritis (OA) Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Duloxetine; Sugar pill
Intervention description: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.; Matching capsule given once a day for a total of 17 weeks.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: osteoarthritis; pain; brain; gray matter

Summary:

      This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after
      treatment with either duloxetine or placebo is associated with changes in brain anatomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 45-80 years

          -  ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV

          -  VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)

          -  Knee OA for a minimum of 12 months

          -  Need for daily pain medication to manage symptoms of OA

        Exclusion Criteria:

        Currently taking MAO inhibitors or any centrally acting drug for analgesia, depression

          -  Narrow angle glaucoma

          -  Uncontrolled hypertension

          -  Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state.

          -  If a female, pregnant, trying to become pregnant, or lactating

          -  Major depressive disorder

          -  Substantial alcohol use or history of significant liver disease

          -  Use of MAO inhibitors, triptans, serotonin precursors (tryptophan)

          -  Use of potent CYP1A2 inhibitors, Thioridazine, and anti-depressants

          -  Diabetes, type 1 or type 2

          -  Condition in which the Investigator believes would interfere with the subject's
             ability to comply with study instructions, or might confound the interpretation of the
             study results or put the subject at undue risk

          -  MRI safety necessitates the exclusion of subjects having one or more of the following:

               -  Metal fragments in the eye or face, or having worked previously in the metal
                  industry

               -  Implantation of any electronic devices such as (but not limited to) cardiac
                  pacemakers, cardiac, defibrillators, and cochlear implants or nerve stimulators.

               -  Surgery on the blood vessels of the brain

               -  Claustrophobia (fear of enclosed places)

               -  Piercings or tattoos

               -  More than 250 lbs in weight

               -  Obvious brain abnormalities