bioihbjkbjnl/mcl2 huggingface dataset:
Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Condition: Alzheimer's Disease (AD)
MeSH terms: Alzheimer Disease
Intervention: Neuraceq (florbetaben 18F); PET
Intervention description: Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose.; A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: CSF; Alzheimer's Disease (AD) and related dementia; HAS recommendations

Summary:

      This phase 4 study will explore, in the context of the present French clinical practice, the
      impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for
      etiologic determination of the cognitive and functional impairment, but in whom:

        1. lumbar puncture was not feasible for medical conditions

        2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating
           physicians

        3. lumbar puncture (LP) was refused by the patient
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients being evaluated for Alzheimer disease and related dementias according to the
             HAS recommendations (atypical dementia, early onset and rapid progressive dementia)

          -  Patients who have previously been evaluated for AD and related dementias to whom a CSF
             examination was recommended in the last 12 months, but lumbar puncture was
             contraindicated or refused or CSF results were ambiguous, or

          -  Patients currently being evaluated for AD and related dementias to whom a CSF
             examination is recommended but lumbar puncture is contraindicated or refused

          -  Patients have a study partner who is willing and able to accompany him/her to all
             clinic visits for the duration of the protocol

          -  Patients able to complete all clinical visits according to the protocol

          -  Patients able to tolerate a 20-minute FBB PET scan

          -  Patient or legal representative to provide informed consent for study participation,
             visits and data source verification.

        Exclusion Criteria:

          -  The subject had a previous beta amyloid imaging scan

          -  Any significant systemic illness or unstable medical condition which could lead to
             difficulty complying with the protocol

          -  Is currently receiving any investigational pharmaceutical product or has participated
             in a clinical trial with an investigational pharmaceutical product within 30 days
             prior to screening and/or was administered a radiopharmaceutical within 10 radioactive
             half-lives prior to study drug administration in this study

          -  For females of childbearing age, a positive pregnancy test
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Acthar Gel; Placebo Gel
Intervention description: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection); 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is to study Acthar Gel in participants with active systemic lupus erythematosus
      (SLE).

      The doctor will assign eligible patients to one of two groups (like flipping a coin).

      Participants will receive the treatment assigned to their group for 24 weeks:

        -  Acthar Gel

        -  Placebo Gel, which looks like Acthar Gel, but has no medicine in it.

      The doctor or his staff will take measurements and ask questions to:

        -  see how well the gel is working

        -  see how safe it is for patients with SLE
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible to participate in this trial, a patient must:

          -  Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised
             criteria

          -  Have active SLE

          -  Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or
             B in the mucocutaneous and/or musculoskeletal body systems at both Screening and
             Randomization Visits

          -  Have a documented history or screening result of

               1. positive antinuclear antibody (ANA), OR

               2. elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies

          -  Have been on prednisone (or prednisone equivalent) before the screening visit:

               1. at least 8 weeks, and

               2. at a stable dose of 7.5 mg to 30 mg for at least 4 weeks

        Exclusion criteria:

        A patient is not eligible to participate if he/she:

          -  Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or
             porcine products

          -  Has active lupus nephritis

          -  Has active central nervous system (CNS) manifestations of SLE
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Condition: Preterm Birth; Child Development; Child Behavior
MeSH terms: Premature Birth
Intervention: LCPUFA oil supplement; Canola Oil Placebo
Intervention description: 2.5mL per day for 90 days
Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg); 2.5mL per day for 90 days
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Months
Maximum age: 39 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to examine whether supplementation with certain polyunsaturated
      fatty acids can help development and behavior of children born preterm.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Child born at less than or equal to 29 completed weeks' gestation;

          2. Child between 18 months, 0 days and 38 months, 30 days old chronological age;

          3. Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled.

          4. Child showing some autistic symptoms;

          5. Child between the 5th and 95th percentiles (per WHO growth chart) for weight at
             his/her most recent hospital visit;

          6. English spoken in the home, demonstrate ability to communicate in English well-enough
             to understand study, informed consent, and study questionnaires; and

          7. Have informed consent on file.

        Exclusion Criteria:

          1. Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x
             per week;

          2. Unable to tolerate venipuncture;

          3. Any major malformation that would preclude participation;

          4. Cerebral Palsy (quadriparesis only);

          5. Deafness;

          6. Blindness;

          7. Bleeding disorder;

          8. Type I diabetes;

          9. Fragile X Syndrome, Rett Syndrome, Angelman Syndrome, Tuberous Sclerosis;

         10. Non febrile seizure in the last month without a clear and resolved etiology;

         11. Feeding problem that may inhibit full participation;

         12. Known fish allergy;

         13. Known canola/rapeseed allergy or sensitivity; or

         14. Recorded score of <70 on Bayley Cognitive Section within the past year.
Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia
Condition: Healthy
Intervention: Functional Magnetic Resonance Imaging (fMRI)
Intervention description: Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations which will be maintained for 4 minutes each.
Four types of music, including Jazz, Rock, Pop and Country, will be presented in a pseudo-randomized order. During the behavioral test period, participants will be asked to squeeze an Magnetic Resonance Imaging (MRI) compatible grip dynamometer (a rubber ball) for every 10-second periods (96 cycles in total). The beginning of each cycle will be cued with the spoken word "squeeze".
Intervention MeSH terms: Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Music; Propofol

Summary:

      This study is to better understand the systems-level neuronal mechanisms by which general
      anesthetics produce loss of consciousness.The researchers believe that anesthetics suppress
      consciousness by disrupting the functioning of large-scale brain networks that support
      information integration in the brain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologist physical status of 1 (ASA-1), Healthy,
             non-smoking, no or minimal alcohol use

          -  Right-handed

          -  Body mass index (BMI) of less than 30

          -  English speakers

        Exclusion Criteria:

          -  Medical contraindication to Magnetic Resonance Imaging (MRI) scanning

          -  Unable to undergo MRI scanning because of possible pregnancy

          -  BMI over 30

          -  Tattoos in the head or neck region

          -  Unwilling to abstain from alcohol for 24 hours prior to dosing
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Condition: Vestibular
MeSH terms: Motion Sickness; Space Motion Sickness
Intervention: Promethazine; Hyper gravity training; Placebo; No hypergravity training
Intervention description: Subject receives promethazine; Subject receives hypergravity training before testing; Placebo; Subjects do not receive normal Earth gravity
Intervention MeSH terms: Promethazine; Diphenhydramine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The design includes three separate studies:
Arm 9&10 follows a crossover design. These results were reported in Diaz-Artiles et al 2017.
Arms 1-4 are a separate study which follow a factorial design, with arm 2 serving as the placebo, arms 1 and 3 assessing the effects of two separate interventions and arm 4 assessing the effect of two combined interventions.
Arms 5-8 are a separate study which follow a factorial design, with arm 6 serving as the placebo, arms 5 and 7 assessing the effects of two separate interventions and arm 8 assessing the effect of two combined interventions.
Masking: Double (Participant, Investigator)
Masking description: Double masking applies to arms 9&10. Other arms use participant masking only.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators will study adaptation of motion perception and manual control in altered
      gravity, including the effects of a drug (promethazine). The investigators will also study
      whether promethazine affects motion perceptual thresholds.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be in general good health

        Exclusion Criteria:

          -  Anyone who is not generally in good general health does not qualify

          -  Cardiovascular disease

          -  Severe diabetes

          -  Respiratory condition (e.g. asthma or emphysema)

          -  Narrow angle glaucoma

          -  Prostatic hypertrophy

          -  Gastrointestinal disorders
Safety Study of Analgesia After Craniotomy Surgery With End Tidal (ET) Carbon Dioxide (CO2) Monitoring
Condition: Pain
Intervention: Fentanyl; Fentanyl
Intervention description: 25-50 mcg every 20 minutes; 20mcg/demand dose with an 8 minute lock out
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pain management; opioid analgesic therapy; safety; craniotomy

Summary:

      This research is being done to compare two methods of giving fentanyl, a narcotic often given
      to patients following brain surgery and determine if one method has more side effects than
      the other. Both of these methods are available in the postoperative treatment of pain. This
      research also is being done to determine if patients receiving narcotic pain medicine will
      benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines
      can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide
      levels will help identify a slower breathing rate and improve safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female, English speaking patients undergoing supratentorial craniotomy
             for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for
             this study.

        Exclusion Criteria:

          -  pregnant women

          -  patients with post operative neurological changes

          -  patients who remain intubated post-operatively

          -  patients who require the use of concomitant administration of sedatives

               -  patients who are unable to initiate a PCA bolus

               -  patients who are unable to communicate verbally

               -  patients who are allergic to fentanyl

          -  patients who have a history of narcotic abuse

          -  patients who have a history of chronic pain requiring opioids

          -  patients who have been in any investigational drug trial within 1 month of the
             treatment day

          -  patients who have chronic respiratory insufficiency
Primary Tube Versus Trabeculectomy Study
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Tube shunt surgery; Trabeculectomy; Mitomycin C
Intervention description: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.; The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.; A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Tube shunt surgery; Trabeculectomy

Summary:

      The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the
      long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with
      mitomycin C in eyes that have not had previous ocular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-85 years

          -  Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular
             Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg

          -  No previous incisional ocular surgery

        Exclusion Criteria:

          -  Unwilling or unable to give consent, unwilling to accept randomization, or unable to
             return for scheduled protocol visits

          -  Pregnant or nursing women

          -  No light perception vision

          -  Active iris neovascularization or active proliferative retinopathy

          -  Iridocorneal endothelial syndrome

          -  Epithelial or fibrous ingrowth

          -  Chronic or recurrent uveitis

          -  Steroid-induced glaucoma

          -  Severe posterior blepharitis

          -  Unwilling to discontinue contact lens use after surgery

          -  Previous cyclodestructive procedure

          -  Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a
             superior trabeculectomy

          -  Functionally significant cataract

          -  Need for glaucoma surgery combined with other ocular procedures or anticipated need
             for additional ocular surgery
Arresting Vertical Transmission of Hepatitis B Virus
Condition: Hepatitis B; Vertical Transmission of Infectious Disease
MeSH terms: Hepatitis A; Hepatitis B; Communicable Diseases; Infections; Hepatitis
Intervention: Tenofovir Disoproxil Fumarate; Monovalent HBV vaccine
Intervention description: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.; Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.
Intervention MeSH terms: Tenofovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and
      treatment of pregnant women to the existing HIV PMTCT platform in order to prevent
      mother-to-child transmission of hepatitis B virus.
    

Eligibility criteria:

        Inclusion criteria:

          -  Pregnant women receiving care at Binza and Kingasani maternity centers presenting
             prior to 24 weeks gestation

          -  Infants born to HBV-positive women

        Exclusion criteria:

          -  Participants who are severely sick and who require prolonged hospitalization.

          -  Any women who do not intend to stay in Kinshasa for prenatal care through delivery
Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
Condition: Thermal Burns
MeSH terms: Burns
Intervention: Lidocaine; Placebo
Intervention description: Lidocaine infusion runs for a total of 24 hours; Normal saline runs for a total of 24 hours
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain management; Narcotic consumption; Skin graft

Summary:

      Thermal injury results in one of the most intense and prolonged forms of pain the body can
      experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and
      their use in the perioperative period has been the mainstay of treatment; although medication
      requirements in burn patients are often underestimated. More medication may not be the
      answer, as relatively large doses of short acting opioids in the operative theater are
      associated with greater postoperative opioid consumption and higher pain scores. Furthermore,
      extensive use of opioids has resulted in the development of by hyperalgesia and allodynia.
      Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic,
      and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used
      for perioperative pain management in a variety of surgical procedures. The design of this
      study will examine if lidocaine will reduce the pain scores and narcotic utilization in
      patients undergoing surgical procedures for burn injuries. The intervention group will
      receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The
      control group will get an equal volume of saline. The investigators will compare pain scores,
      opioid use, and narcotic equivalents based on body weight and burn surface area (BSA)
      grafted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Burn patient ≥ 18 years of age

          -  Burn patient scheduled to go to OR for excision and/or grafting procedure

        Exclusion Criteria:

          -  Burn patient < 18 years of age

          -  Intubated patient on sedation drip

          -  Prolonged hypotension defined as Systolic Blood Pressure (SBP) < 90 mm/Hg for greater
             than 30 minutes in the pre-op area

          -  Severe underlying cardiovascular disease (documented ejection fraction < 40%)

          -  Documented conduction block, bradycardia or active congestive heart failure

          -  Documented active gastritis or ulcers

          -  Previous steroid medication history if documented adrenal insufficiency

          -  Patient with documented liver disease

          -  Patient with epilepsy or known seizure disorder

          -  Pregnant Women