bioihbjkbjnl/mcl2 huggingface dataset:
Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment
Condition: Fatigue
MeSH terms: Brain Injuries; Fatigue
Intervention: Modafinil; Placebo
Intervention description: single dose of 200 mg. a day of modafinil for four weeks; daily dose of placebo for four weeks.
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fatigue; TBI; brain injury; Modafinil; traumatic brain injury

Summary:

      Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.
    

Eligibility criteria:

        Inclusion Criteria:

        - Individuals who sustained a TBI with a documented loss of consciousness or evidence of a
        TBI on neuroimaging studies and who are at least 12 months post-injury, who complain of
        fatigue and who have scores of 22 or above on the Barroso Fatigue Scale will be eligible to
        participate in this study. Subjects must not meet criteria for alcohol or substance abuse
        using the Structured Clinical Interview for DSM-IV (SCID) for at least six months prior to
        study enrollment.

        Exclusion Criteria:

        - Diagnosis of chronic neurological disease (including Lyme disease), narcolepsy, current
        infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not
        adequately controlled with medication, blood pressure greater 150/100 mm Hg, or clinically
        significant major systemic disease. In addition, individuals taking medications which are
        known to cause fatigue will be excluded from participation in the study.
A 48-Week, Open Label, Study to Evaluate the Efficacy and Safety of AMONDYS 45, EXONDYS 51, VYONDYS 53 in Subjects With DuchenneMuscular Dystrophy Carrying Eligible DMD Duplications.
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Amondys 45; Exondys 51; Vyondys 53
Intervention description: This drug is used to target skipping of exon 45 of the dystrophin gene.; This drug is used to target skipping of exon 51 of the dystrophin gene.; This drug is used to target skipping of exon 53 of the dystrophin gene.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 6 Months
Healthy volunteers: No
Keywords: DMD; Exon Skipping

Summary:

      This is an 48-week open-label study to determine the efficacy and safety of AMONDYS 45,
      EXONDYS 51, VYONDYS 53 for the treatment of boys with duchenne muscular dystrophy who have a
      single exon duplication of either exon 45, 51 or 53, respectively. There will be weekly
      infusions and two muscle biopsies at baseline and at month 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a male with DMD and has an out-of-frame duplication of either exon 45, 51, or 53,
             with a normal copy number of all other DMD exons.

          -  Is above age 6 months of age.

          -  Has sufficient muscle mass in a pair of bilateral muscles that will allow for pre- and
             post-treatment muscle biopsies per PI discretion.

          -  If the subject is ambulant and 4 years old or greater and has been on a stable dose or
             dose equivalent of oral corticosteroids for at least 12 weeks prior to Week 1 the dose
             is expected to remain constant (except for modifications to accommodate changes in
             weight) throughout the study.

        Exclusion Criteria:

          -  Any additional missing exon for DMD that cannot be treated with study drugs.

        Other inclusion/exclusion criteria apply
Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: EPI-589
Intervention description: An immediate release film-coated table at a 250 mg dosage strength will be administered per dose and schedule specified in arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is an open label study with 30-day run in phase to establish baseline parameters, 90-day
      treatment phase, and a 90-day withdrawal phase to determine long-term effects, duration of
      treatment response, and potential effects of EPI-589 therapy on known trajectory.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of possible, probable, laboratory supported probable, or definite ALS by E1
             Escorial Criteria

          -  Forced vital capacity (FVC) ≥ 70% of predicted

          -  Weakness onset within 3 years

          -  Agreement to use contraception if within reproductive years

          -  Willingness and ability to comply with study procedures

          -  Stable regimen of dietary supplements and /or riluzole for at least 30 days prior to
             enrollment

          -  Abstention from use of other investigative or non-approved drugs

          -  Participants must be able to swallow 0.375 * 0.700 inch tablets

        Exclusion Criteria:

          -  Allergy to EPI-589

          -  Use of ventilation

          -  Participation in other intervention studies

          -  Diagnosis of any other neurologic disease

          -  Malignancy within the past 2 years

          -  History of stroke

          -  History of brain surgery

          -  Hepatic insufficiency with liver function tests (LFTs) greater than 3 times upper
             limit of normal (ULN)

          -  Renal insufficiency requiring dialysis

          -  End stage cardiac failure

          -  Participation in a trial of a device, drug, or other therapy for ALS within 3 months
             of screening or during the trial
Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Condition: Acute Wounds
MeSH terms: Wounds and Injuries
Intervention: Procellera™ Antimicrobial Dressing; Mepilex® Border Lite; Adhesive Bandage
Intervention description: Dressing indicated for partial and full-thickness wounds.; Self-adherent foam dressing; Adhesive bandage
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Curettage and electrodesiccation; acute wounds; partial thickness wounds

Summary:

      The purpose of this pilot clinical study is to compare healing rates, pain levels, and
      incidence of wound complications including infection with the use of a moist PROCELLERA™
      Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite,
      following curettage and electrodesiccation of skin lesions.
    

Eligibility criteria:

        Inclusion Criteria:

        If female, must either be not of childbearing potential or if they are of childbearing
        potential must have a negative urine pregnancy test.

          -  Wound size greater than 1x1 cm

          -  Wounds must be ≥5 cm away from all other wounds

          -  Wound size must not be diminished in size greater than 10% between enrollment in study
             and the prescreening

          -  Participant agrees to participate in follow-up evaluation

          -  Participant must be able to read and understand informed consent, and sign the
             informed consent

        Exclusion Criteria:

          -  Concurrent participation in another clinical trial that involves an investigational
             drug or device that would interfere with this study

          -  Participant is to receive another topical antimicrobial agent other than the study
             dressing

          -  Participant with sensitivity or adverse reactions to silver or zinc

          -  Pregnancy or nursing an infant or child

          -  Immunosuppression

          -  Active or systemic infection

          -  Peripheral vascular occlusive disease

          -  Collagen vascular disease

          -  Connective tissue disease

          -  Diabetes

          -  Venous stasis ulcers

          -  Participant undergoing active cancer chemotherapy

          -  Chronic steroid use

          -  Decision impairment
Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: rMenB; rMenB+OMV
Intervention description: One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.; One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease, prevention, vaccination

Summary:

      To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B
      Recombinant Vaccine when administered to healthy infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy 6-8 months old infants

        Exclusion Criteria:

          -  previous receipt of any meningococcal B vaccine;

          -  previous ascertained or suspected disease caused by N meningitidis;

          -  history of any anaphylactic shock, asthma, urticaria or other allergic reaction after
             previous vaccinations or known hypersensitivity to any vaccine component;

          -  any present or suspected serious acute or chronic disease

          -  known or suspected autoimmune disease or impairment /alteration of immune function
Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers
Condition: Mood Disorder; Anxiety Disorders
MeSH terms: Anxiety Disorders; Mood Disorders
Intervention: Low dose NPY; High dose NPY; Placebo
Intervention description: 50nmol, administered intranasally; 100nmol administered intranasally; placebo comparator (0nmol)) administered intranasally
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Male
Minimum age: 25 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mood Disorder; Anxiety Disorders

Summary:

      There is growing evidence that neuropeptides act as neuronal messengers in the brain and have
      diverse functions that may include the regulation of mood and behavior. For example,
      neuropeptide Y (NPY) is thought to play a role in the adaptive stress response. The
      therapeutic application of neuropeptides for psychiatric disorders has been limited by
      difficult and unreliable penetration of the blood-brain barrier (BBB). However, recent data
      suggest that intranasal administration may provide a means of effectively delivering some of
      these neuropeptides to the brain. Thus far it is unclear if this is the case for NPY. The
      aims of this project are:

        1. To evaluate, in 15 healthy male volunteers aged 25-45, the effect of intranasal NPY
           administration (0, 50 and 100 nmol) on its levels in cerebrospinal fluid (CSF), measured
           by means of lumbar puncture using an intraspinal catheter between L4 and L5, and in
           plasma, measured using an intravenous catheter in the forearm. One of the three
           treatments will be administered to each participant in a double-blind fashion. The 0
           nmol condition will serve as the placebo control.

        2. To test the effect of intranasal NPY administration on mood and anxiety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men aged 25-45.

          -  No history of Axis I disorder as defined in the DSM-IV other than past nicotine abuse
             or dependence or adjustment disorder.

        Exclusion Criteria:

          -  Nicotine or caffeine abuse or dependence within the preceding 3 months.

          -  History or complaint of nasal disorders or allergies.

          -  Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory,
             cardiovascular, endocrinologic, neurologic, immunologic, or hematologic.

          -  Significant obesity (BMI > 30), scoliosis, spinal stenosis or a history of lumbosacral
             laminectomy.

          -  Clinically significant abnormal findings of laboratory parameters, physical
             examination, or ECG.

          -  Current use of any medications that have effects on CNS function.

          -  Prior sinonasal surgery, or significant nasal polyps as determined by nasal endoscopy.
Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis
Condition: Nephrogenic Systemic Fibrosis
MeSH terms: Nephrogenic Fibrosing Dermopathy; Fibrosis
Intervention: Imatinib mesylate
Intervention description: 400 mg p.o. daily for 4 months. Dosage was reduced to 200 mg if participants develop gastrointestinal intolerance or alopecia.
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment; Chronic kidney disease; Fibrosing disorders; Imatinib mesylate

Summary:

      The purpose of this study is to determine the efficacy of imatinib mesylate in reducing
      cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). The
      study will also work to assess the safety and tolerability of imatinib mesylate in patients
      with chronic kidney disease and NSF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Biopsy-proven NSF

          -  Ability to give consent

        Exclusion Criteria:

          -  Known sensitivity to imatinib mesylate or to any of its components

          -  Pregnant or lactating woman

          -  Bullous dermatologic disease

          -  Aspartate aminotransferase / alanine aminotransferase (AST/ALT) >3 x upper limit of
             normal

          -  Severe congestive heart failure [New York Heart Association (NYHA) Class III or IV]

          -  Patients who have received Gleevec in the past 12 months
Allopregnanolone for the Treatment of Traumatic Brain Injury
Condition: Traumatic Brain Injury; Posttraumatic Epilepsy
MeSH terms: Brain Injuries; Epilepsy; Brain Injuries, Traumatic; Epilepsy, Post-Traumatic; Wounds and Injuries
Intervention: Allopregnanolone injection; Placebo injection
Intervention description: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium; Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
Intervention MeSH terms: Pregnanolone; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Brain Injuries; Pregnanolone; Epilepsy

Summary:

      This study will provide initial data on the safety and effectiveness of allopregnanolone in
      improving neurobehavioral outcome and reducing mortality in adults with moderate and severe
      traumatic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaking person

          -  Moderate to severe closed or blunt traumatic brain injury [post resuscitation Glasgow
             Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12]

          -  Less than 8 hours from injury to study initiation

          -  Able to participate for the full term of the study

        Exclusion Criteria:

          -  Subjects with life expectancy of less than 24 hours

          -  Isolated epidural hematoma

          -  Hypoxia (pulse oximetry saturation ≤90% for 15 or more minutes before enrollment)

          -  Hypotension (systolic blood pressure ≤90 mm Hg on 2 or more reliable measurements
             before enrollment)

          -  Cardiopulmonary arrest prior to randomization

          -  Spinal cord injury with motor deficits

          -  Bilateral non-reactive pupils with Glasgow Coma Scale 3

          -  Body weight >120 kg

          -  Pregnancy

          -  Active breast or reproductive organ cancer

          -  Allergy to progesterone

          -  History of thromboembolic events

          -  Receipt of activated Factor VII before enrollment

          -  Any disease that is unstable or which could jeopardize the safety of the subject
             including severe renal impairment (creatinine clearance <50 ml/min)

          -  Prisoner/ward of the state

          -  Known treatment with another investigational drug therapy or procedure within 30 days
             of injury
MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: MK0249; Comparator: Placebo (unspecified)
Intervention description: MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.; MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the efficacy and safety of an investigational medication
      for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication
      or placebo for 28 days. Tests of memory, concentration will be included. Safety will be
      monitored using routine clinical and laboratory tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or females

          -  Age at least 55 years or older

          -  Mild-to-moderate Alzheimer's Disease, with Mini Mental State Examination (MMSE)
             between 18 and 26, inclusive, Modified Hachinski Ischemic Scale (MHIS) score =/<4,
             Global CDR score of 1 or 2, and who have a reliable informant/caregiver to accompany
             patient to all clinic visits

          -  If using symptomatic Alzheimer's Disease treatments, patients must be on the
             medication for 3 months and on a STABLE DOSE for at least 2 months

        Exclusion Criteria:

          -  Patients cannot be living in a skilled nursing facility

          -  Patients cannot have poorly-controlled hypertension

          -  Patients cannot have the following conditions within 6 months of screening:
             significant cardiovascular disorders, active major depressive disorder,
             gastroesophageal reflux disease (GERD), or clinically significant sleep disorder

          -  Various concomitant therapy restrictions
Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: MindFrame System
Intervention description: Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cerebral Infarction; Stroke; Vascular Diseases; Central Nervous System Diseases; Penumbra; Functional Outcome; Aphasia; Hemiplegia; Left sided weakness; Right Sided weakness

Summary:

      The primary study objective is to assess the feasibility of using the MindFrame System to
      safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients
      experiencing an ischemic stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          1. NIHSS 6 to 30 within 6 hours of symptom onset

          2. Pre-stroke Modified Rankin Score ≤ 2

          3. Large Vessel Occlusion

          4. Patient/patient guardian is willing to comply with the protocol requirements and
             return to the treatment center for all required clinical evaluation.

          5. Patients must meet at least one of the following criteria:

               -  Eligible for Intravenous rt-PA

               -  Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom
                  onset

               -  Patient presents within 6 hours of symptom onset

        Exclusion Criteria:

          1. Pregnancy

          2. Glucose <50mg/dL

          3. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant
             therapy with INR>3.0

          4. Patient received heparin within 48 hours with a PTT greater than 2 times the lab
             normal.

          5. Patient has baseline platelets < 30,000

          6. Evidence of rapidly improving neurological signs of stroke at time of enrollment

          7. Coma

          8. Pre-existing neurological or psychiatric disease that could confound the study results

          9. Known severe allergy to contrast media or nitinol

         10. Patient has severe sustained hypertension

         11. CT/MRI scan reveals significant mass effect with midline shift

         12. Patient's angiogram shows an arterial stenosis >50% proximal to the embolus.

         13. Patient's anticipated life expectancy is less than 3 months

         14. Participation in another clinical investigation that could confound the evaluation of
             the study device