bioihbjkbjnl/mcl2 huggingface dataset:
Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: salsalate
Intervention description: open-label trial of salsalate 3g/day for 12 weeks.
Intervention MeSH terms: Salicylsalicylic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Cognition; Metabolism; Antipsychotics; Psychopathology

Summary:

      This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15
      schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive
      functioning, and metabolic parameters.

      Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or
      Massachusetts General Hospital. A total of 15 subjects will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years;

          -  Diagnosis of schizophrenia or schizoaffective disorder;

          -  Stable dose of the current antipsychotic drug for at least one month;

          -  Well established compliance with outpatient treatment per treating clinician's
             judgment;

          -  Able to complete the cognitive assessment battery (must be English speaking);

          -  Female subjects will be eligible to participate in the study if they are of
             non-childbearing potential or of child-bearing potential and willing to practice
             appropriate birth control methods during the study.

        Exclusion Criteria:

          -  Inability to provide informed consent;

          -  Current substance abuse;

          -  Psychiatrically unstable per treating clinician's judgment;

          -  Significant medical illnesses including uncontrolled hypertension, diabetes, seizure
             disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;

          -  Currently on immunosuppressant medication including oral steroids;

          -  Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);

          -  History of chronic infection (including, HIV and hepatitis), malignancy, organ
             transplantation, blood dyscrasia, central nervous system demyelinating disorder, and
             any other known autoimmune or inflammatory condition;

          -  Experienced asthma, urticaria or allergic type reaction after taking aspirin,
             salsalate, or other NSAIDS;

          -  Pregnancy or breastfeeding;

          -  Pre-existing chronic tinnitus.

          -  Known hypersensitivity to salsalate.
A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis
Condition: Conjunctivitis, Allergic
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Alcaftadine 0.25%; Olopatadine 0.2%; dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
Intervention description: One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.; One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.; One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Intervention MeSH terms: Olopatadine Hydrochloride; Dextrans; Alcaftadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 157.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™
      (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular
      itching associated with allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of ocular allergies within the past 24 months.

          -  Able to avoid wearing contact lenses for at least 72 hours prior to and during the
             study trial period.

        Exclusion Criteria:

          -  Any presence of active ocular infection or history of an ocular herpetic infection.

          -  Ocular surgery within 3 months prior to the first visit or refractive surgery within
             the past 6 months.

          -  Have any planned surgery during the study or 30 days after the study.
Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: Oxytocin; Saline as a nasal spray
Intervention description: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed.; A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed.
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Interstitial cystitis (IC); Oxytocin; Bladder; Void

Summary:

      Anecdotal evidence suggests female patients with painful bladder disorder interstitial
      cystitis (IC) can experience a significant attenuation of their systems while breastfeeding.
      Since it has been shown that postpartum lactation is a time associated with decreased levels
      of stress, and stress has been shown to exacerbate IC-related pain, the investigators have
      developed an interest in the effects of the hormones involved in postpartum lactation on
      stress and pain. Based on a series of pre-clinical experiments, the investigators believe the
      hormone oxytoxin has both analgesic and anxiolytic properties which make it a potentially
      useful agent for the treatment of stress-exacerbated chronic pain syndrome such as IC.
      Therefore, the investigators propose a double-blinded, placebo-controlled crossover trial of
      intranasal oxytocin vs. intranasal saline for bladder pain in a cohort of patients with IC
      and some degree of continuous, daily pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  19 - 65 years of age

          -  Must meet the current National Institute of Diabetes and Digestive and Kidney Diseases
             (NIDDK) diagnostic criteria for interstitial cystitis and have some degree of
             continuous daily pain

        Exclusion Criteria:

          -  Pregnancy

          -  Under the age of 19

          -  Older that the age of 65

          -  Breastfeeding women

          -  Uncontrolled hypertension

          -  History of significant cardiac or pulmonary disease (including arrhythmias)

          -  Known allergy to oxytocin

          -  Severe psychiatric disease

          -  Patients who have undergone procedural interventions within the past month related to
             their interstitial cystitis
Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients
Condition: Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Intervention: Chlorhexidine Gluconate 2% Wipe; Theraworx Bath Wipes
Intervention description: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery.; Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Intervention: This study will involve three different study arms with different interventions
      prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus
      chlorhexidine wipes

      Study Design: Single center RCT

      Sample Size: 500 patients, aged 18+

      Objectives: Primary Objectives:

        1. Monitor for safety and adverse effects.

        2. Evaluate for differences in peri-operative skin cultures between treatment groups;

        3. Compare surgical site infection rates between groups.

      Secondary Objectives:

        1. Assess for patient compliance for each different treatment arms.

        2. Measure patient satisfaction.

        3. Measure nurse satisfaction.

        4. Visual assessment of wound healing

      Expected Results: We expect no statistically significant difference in peri-operative
      cultures or surgical site infection rates between groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient between ages 18-64

          -  Scheduled and deemed healthy enough to undergo orthopaedic surgery

          -  Willing and able to comply with protocol

        Exclusion Criteria:

          -  Clinical signs of infection

          -  Contraindication to CHG or Theraworx

          -  Previous allergic reaction to CHG or Theraworx

          -  Surgeon's Discretion
Clinical Investigation of the Vision-R800 Device.
Condition: Myopia; Hyperopia; Astigmatism; Presbyopia
MeSH terms: Astigmatism; Presbyopia; Hyperopia
Intervention: Vision R-800 Phoropter; Standard Phoropter
Intervention description: Refraction utilizing the Vision R-800 Phoropter with resulting glasses; Refraction utilizing the standard phoropter with resulting glasses
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and
      associated spectacle lenses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current adaptated progressive addition lens wearer, if bifocal lens required

          -  wearable pair of glasses < 2 years old

          -  wear glasses at least 6 hours per day

        Exclusion Criteria:

          -  Eye Disease with an impact on visual acuity or binocular vision abnormalities (by
             self-report)

          -  Formal training in optometry, vision science or in the eyecare field
Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
Condition: Moderate-severe Pain
Intervention: ALO-02
Intervention description: Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
Intervention MeSH terms: Naltrexone; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric; pain indication; controlled release oxycodone

Summary:

      Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone
      hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 7-17 with moderate to severe pain requiring around the clock treatment with
             an opioid analgesic.

          -  Be an experienced opioid user, defined as any subject treated with opioid therapy,
             equivalent or equal to > 6 mg per day of oxycodone, for a period of 3 consecutive days
             immediately prior to first day of dosing.

        Exclusion Criteria:

          -  Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in
             past year.

          -  Hypersensitivity to morphine, naltrexone.

          -  A life expectancy (assessed by investigator) of less than 6 months or is no longer
             capable of taking medication orally.

          -  Undergone surgery within 3 days prior to the first day of dosing.
Neuroimaging of the Effects of Concerta in the Treatment of ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: methylphenidate-OROS; Placebo
Intervention description: The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of Concerta that are made to appear similar to placebo capsules. The subject will be administered their usual dose of Concerta the morning of the scan.; The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of placebo that are made to appear similar to Concerta capsules. The subject will be administered placebo the morning of the scan.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 9 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Attention Deficit Disorder with Hyperactivity; Attention Deficit Hyperactivity Disorder; ADHD

Summary:

      A number of brain regions have been down to be altered in both structure and function in
      patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum.
      Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions
      of brain while performing measures of inhibitory control during functional magnetic resonance
      imaging (fMRI). While stimulant medications robustly improve the clinical symptoms of ADHD,
      there are only a small number of studies examining the effects of these commonly prescribed
      medications on brain activity. We propose to obtain fMRI in patients with ADHD on placebo and
      on their individualized dose of OROS methylphenidate (Concerta). Our hypothesis is that
      Concerta will increase the activity of the brain in the frontal, cingulate and amygdala of
      the brain and that these brain changes will be associated with clinical improvement of
      symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for Attention Deficit Hyperactivity Disorder

          -  Current clinical responder to Concerta (OROS-methylphenidate)

        Exclusion Criteria:

          -  IQ < 95

          -  Presence of Learning Disorder

          -  Presence of an Affective or Psychotic Disorder

          -  Presence of a Substance/Alcohol Abuse/Dependence Disorder

          -  Presence of an Autism Spectrum Disorder

          -  Presence of a Tic Disorder

          -  Taking any psychotropic medication other than Concerta

          -  A medical condition requiring daily medication

          -  Previous adverse or non response to Concerta
ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
Condition: Herpes Zoster; Shingles
MeSH terms: Herpes Zoster
Intervention: Zoster Vaccine Live
Intervention description: Zoster vaccine live
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean
      adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be
      enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical
      hypothesis testing will be conducted in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No fever on day of vaccination

          -  Females have a negative pregnancy test and use an acceptable method of birth control,
             or are postmenopausal

          -  Underlying chronic illness must be stable

        Exclusion Criteria:

          -  History of hypersensitivity reaction to any vaccine component

          -  Prior history of herpes zoster

          -  Prior receipt of varicella or zoster vaccine

          -  Pregnant or breastfeeding

          -  Have recently received immunoglobulins or blood products other than autologous blood
             transfusion

          -  Received any inactivated other live virus vaccine within 4 weeks prior to vaccination,
             or is expected to received any other live virus vaccine during the duration of the
             study

          -  Received any inactivated vaccine within 7 days prior to vaccination, or is expected to
             receive any inactivated vaccine during the duration of the study

          -  Use of immunosuppressive therapy

          -  Known or suspected immune dysfunction

          -  Use of nontopical antiviral therapy with activity against herpes virus

          -  Known or suspected active untreated tuberculosis
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Teriparatide; Denosumab
Intervention description: teriparatide daily subcutaneous injection; denosumab subcutaneous injection
Intervention MeSH terms: Denosumab; Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 37.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: osteoporosis; histomorphometry; bone density; teriparatide; denosumab

Summary:

      The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of
      combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3
      months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women aged 45+

          -  postmenopausal

          -  osteoporotic with high risk of fracture

        Exclusion Criteria:

          -  significant previous use of bone health modifying treatments

          -  known congenital or acquired bone disease other than osteoporosis

          -  significant renal disease, liver disease, cardiopulmonary disease, or psychiatric
             disease

          -  abnormal calcium or parathyroid hormone level

          -  serum vitamin D <20 ng/mL or >60ng/mL

          -  serum alkaline phosphatase above upper normal limit with no explanation

          -  anemia (hematocrit <32%)

          -  history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or
             gouty arthritis

          -  history of urolithiasis within the last one year

          -  excessive alcohol use or substance abuse

          -  use of oral or parenteral glucocorticoids for more than 14 days within the past 6
             months

          -  extensive dental work involving extraction or dental implant within the past or
             upcoming 2 months

          -  known sensitivity to mammalian cell-derived drug products

          -  known contraindications to denosumab, teriparatide, or any of their excipients

          -  known contraindications to tetracycline, demeclocycline, or other antibiotics in this
             drug class

          -  continuous use of tetracycline for >1-month duration within the last 10 years
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Condition: Dupuytren's Contracture
MeSH terms: Dupuytren Contracture; Contracture
Intervention: Injectable clostridial collagenase
Intervention description: Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dupuytren; Dupuytren's Disease

Summary:

      This study will evaluate the efficacy and safety of clostridial collagenase injections for
      treatment of Dupuytren's contracture of the thumb and first web space. The investigators
      hypothesis is that clostridial collagenase will have safety not significantly different to
      that demonstrated in Phase III clinical trials, and will be effective in significantly
      reducing the degree of thumb contracture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects (> 18 years) of either gender with an MP and/or IP joint contracture
             and a palpable cord of > 20 degrees of the thumb

          -  First web space contracture with a palpable cord due to Dupuytren's contracture

        Exclusion Criteria:

          -  Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's
             contracture of the same thumb.

          -  Any subject using anti-coagulant therapy other than low dose aspirin (up to
             150mg/day).

          -  Any subject in the opinion of the MD investigators with chronic, severe or terminal
             medical illness which would make them unsuitable for study participation.

          -  Any subject with known allergy to Xiaflex (Clostridial collagenase).

          -  Pregnant or nursing female

          -  Any subject who cannot conform to the study visit schedule