bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
Condition: Idiopathic Small Fiber Neuropathy
MeSH terms: Neuralgia; Small Fiber Neuropathy
Intervention: Pregabalin; Placebo
Intervention description: Pregabalin will be given to the patients, starting at 75 mg BID and increased weekly to reach 225 mg BID for 8 weeks. During withdrawal phase, dose of pregabalin will be kept the same for patients who are randomized to the pregabalin withdrawal group.; Placebo will be given to the patients that are randomized to placebo during withdrawal phase.
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess safety and efficacy of treatment with pregabalin in
      patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched
      enrollment randomized withdrawal study that comprises 4 phases: a screening and selection
      phase, a washout period from previous pain medication for enriched enrollment, an 8 week
      single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with idiopathic predominate-small fiber neuropathy

          -  Subject must have chronic peripheral neuropathic pain for more than 3 months

          -  A score >3 and <8 on Pain intensity scale for pain in prior week at first visit;

          -  Show increase in pain intensity scores during the wash off period;

          -  Age older than 18 years;

        Exclusion Criteria:

          -  Subjects with large-fiber predominant neuropathy

          -  Subjects with HIV infection, trigeminal neuralgia (TGN), toxic neuropathy (e.g.
             chemotherapy exposure), paraneoplastic neuropathy, mono-gammopathy, inflammatory
             neuropathy, celiac disease, systemic lupus, peripheral vascular disease, connective
             tissue disorders, hepatitis C, Fabry disease, and diabetes;

          -  Subjects with uncontrolled thyroid or B12 disorders

          -  Subjects with Complex Regional Pain Syndrome

          -  Allergy to Pregabalin

          -  Subjects at risk of suicide or self harm

          -  Subjects with any clinically unstable cardiovascular, hematological, autoimmune,
             endocrine, renal, hepatic, renal, respiratory, or gastrointestinal disease; epilepsy,
             symptomatic peripheral vascular disease including intermittent claudication,
             pernicious anemia, untreated hypothyroidism, venous insufficiency, or spinal stenosis.

          -  History of known analgesic, alcohol or illicit drug abuse within 12 months of first
             visit;

          -  Pregnant females; breastfeeding females.
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; ZPL389 3mg; ZPL389 10mg; ZPL389 30mg; ZPL389 50mg
Intervention description: once daily from baseline until week 16; ZPL389 3 mg oral powder; once daily from baseline to week 16; ZPL389 10 mg oral powder; once daily from baseline to week 16; ZPL389 30 mg oral powder; once daily from baseline to week 16; ZPL389 50 mg oral powder; once daily from baseline to week 16
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; AD; eczema; atopic eczema; itch, pruritus; histamine 4 receptor; antagonist; H4R; ZPL389; ZPL389A2203; dermatitis

Summary:

      This was a randomized, double-blind, placebo-controlled, parallel-group study to assess
      safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a
      total study duration up to 24 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must give a written, signed and dated informed consent

          -  Chronic atopic dermatitis present for at least 1 year before Baseline

          -  Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.

          -  Documented recent history (within 6 months before the screening visit) of inadequate
             response to treatment with topical medications or for whom topical treatments are
             otherwise medically inadvisable

          -  Candidate for systemic treatment

        Exclusion Criteria:

          -  Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis
             disease activity

          -  Use of other investigational drugs within 5 half-lives of enrollment, or within 30
             days or until the expected pharmacodynamic effect has returned to baseline, whichever
             is longer.

          -  History of hypersensitivity to any of the study drug constituents or to drugs of
             similar chemical classes.

          -  Participation in prior ZPL389 studies
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
Condition: Epilepsy; Dravet Syndrome; Lennox-Gastaut Syndrome
MeSH terms: Epilepsy; Brain Diseases; Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Syndrome
Intervention: TAK-935; Placebo
Intervention description: TAK-935 tablets or mini-tablets.; TAK-935 placebo-matching tablets or mini-tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 141.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Drug Therapy; Brain Diseases; Central Nervous System Diseases; Tuberous Sclerosis; CDKL5 deficiency disorder; Dup15Q syndrome; Anoxic brain injury; Infantile spams; West syndrome; Cortical dysplasia; SCN1A; OV-935; Cholesterol 24S-hydroxylase inhibitor; Seizure; Anti-epileptic drug; Anticonvulsants; Nervous System Diseases; Drop seizure; Atonic seizure

Summary:

      The purpose of this study is to investigate the effect on the frequency of all seizures
      (convulsive and drop) in participants treated with TAK-935 compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants aged greater than or equal to (>=) 2 and less than or
             equal to (<=) 17 years

          2. Clinical diagnosis of DS or LGS

          3. Weight of >=10 kilogram (kg) at the Screening visit

          4. Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose

          5. Failed to become and remain seizure free with trials of at least 2 AEDs

        Exclusion Criteria:

          1. Has been admitted to a medical facility and intubated for treatment of status
             epilepticus 2 or more times in the 3 months immediately prior to the screening visit

          2. Non-epileptic events that cannot be reliably distinguished from epileptic seizures

          3. Participation in a clinical study involving another study drug in the previous month
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: CFZ533 active - Cohort 1; CFZ533 placebo- Cohort 1; CFZ533 active - Cohort 2; CFZ533 placebo - Cohort 2; CFZ533 active -Cohort 3; CFZ533 active - Cohort 3
Intervention description: multiple doses of CFZ533 s.c. injection; multiple doses of placebo s.c. injection; multiple doses of CFZ533 intravenous infusion; multiple doses of placebo intravenous infusion; multiple doses of CFZ533 s.c. injection; Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Sjögren's syndrome, CFZ533, ESSDAI

Summary:

      This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of
      multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary
      Sjögren's syndrome(pSS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary Sjögren's syndrome

          -  ESSDAI score ≥ 6

        Exclusion Criteria:

          -  Secondary Sjögren's syndrome

          -  Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab,
             belimunab, other immunosuppressives.

          -  At significant risk for thromboembolic event

          -  Clinically significant systemic infection

          -  Significant elevated risk for infection
Hyperbaric Oxygen Therapy for Lung Transplantation
Condition: Disorder Related to Lung Transplantation; Central Airway Stenosis; Airway Exudative Plaques; Airway Complications Post-Lung Transplantation
MeSH terms: Constriction, Pathologic
Intervention: Hyperbaric Oxygen Therapy; Endobronchial Biopsy of Airway Epithelium
Intervention description: 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at 2 ATA once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.; During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Hyperbaric Oxygen; Lung Transplantation; Central Airway Stenosis; Airway Exudative Plaques; Hyperbaric Oxygen Therapy; Post-Lung Transplantation; Airway Ischemia; Endobronchial Biopsy; Bronchoscopy

Summary:

      The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on
      airway complications in post-lung transplant recipients with evidence of restricted levels of
      blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage in
      the early post-transplant period will be randomized to HBOT or usual care and followed
      clinically for 12 months following randomization. The investigators hypothesize that HBOT
      will decrease the number of airway complications in the treated subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-lung transplant patient

          -  Extensive exudative plaques at 1 month bronchoscopy

          -  No sign of airway improvement, or showing worsening of plaques at follow-up
             bronchoscopy 2-3 weeks after 1 month bronchoscopy.

        Exclusion Criteria:

          -  Use of mechanical ventilation with fraction of inspired oxygen(FiO2) greater than 40%

          -  Use of extracorporeal membrane oxygenation

          -  Use of inhaled nitric oxide

          -  Presence of pneumothorax

          -  Pregnancy

          -  Inability to provide informed consent
Pentoxifylline Therapy in Biliary Atresia
Condition: Biliary Atresia
MeSH terms: Biliary Atresia
Intervention: Pentoxifylline
Intervention description: 20 mg/kg/day divided in 3 doses, given orally for 90 days
Intervention MeSH terms: Pentoxifylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Maximum age: 180 Days
Healthy volunteers: No
Keywords: Biliary Atresia; Pentoxifylline; Trental; Serum bilirubin; Conjugated bilirubin; Liver transplantation; Fibrosis

Summary:

      The purpose of this study is to determine whether pentoxifylline reduces liver damage in
      infants with biliary atresia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  0-180 days old

          -  Diagnosed with biliary atresia through liver biopsy and/or intra-operative
             cholangiogram

          -  No previous Kasai portoenterostomy performed at another institution

          -  Able to take medications orally

          -  Legal guardian signs consent after understanding risks and investigational nature of
             study

        Exclusion Criteria:

          -  Infants greater than 180 days old

          -  Infants receiving a Kasai portoenterostomy at another institution

          -  Infants unable to take medications orally
ET-01 in Subjects With Lateral Canthal Lines
Condition: Lateral Canthal Lines; Crow's Feet
Intervention: botulinum toxin, Type A; Vehicle
Intervention description: topical liniment; Vehicle Formulation
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: sequential, dose escalating study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  25 - 65 years of age

          -  minimal to moderate Crow's Feet wrinkles at rest

          -  moderate to severe Crow's Feet wrinkles on contraction

          -  willingness to refrain from any product affecting skin remodeling

          -  female subjects must be not pregnant and non-lactating-

        Exclusion Criteria:

          -  history of adverse reactions to any prior botulinum toxin treatments

          -  history of vaccination or non-response to any prior botulinum toxin treatments

          -  botulinum toxin treatment in the prior 6 months

          -  present or history of neuromuscular disease, eyelid ptosis, muscle weakness,
             paralysis, or "dry eye"

          -  history of peri-ocular surgery, brow lift or related procedures

          -  procedures affecting the lateral canthal region in the prior 12 months

          -  application of topical prescription medication to the treatment area

          -  female subjects who are pregnant or are nursing a child
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Ertapenem
Intervention description: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn
Intervention MeSH terms: Ertapenem
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 88 Years
Healthy volunteers: No
Keywords: ertapenem; pharmacokinetic; pharmacodynamics; hemodialysis; requires hemodialysis three times a week

Summary:

      The purpose of this study is to determine the amount of ertapenem in the blood over time
      between hemodialysis session.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and
             Medical Center during January 1, 2014 or date of Institutional Review Board (IRB)
             approval to December 1, 2015

          -  Diagnosed with end stage renal disease and requires hemodialysis three times a week

          -  No allergy to β lactam medications

          -  Existing IV access for parenteral ertapenem infusion

          -  Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and
             pre-hemodialysis for the following hemodialysis and immediately post hemodialysis
             session and 1 hour post.

          -  No evidence of hepatic disease

          -  No history of alcoholism or drug abuse within pervious 2 years

          -  Not pregnant

        Exclusion Criteria:

          -  History of any form of epilepsy, seizure or convulsion

          -  Currently taking any forms of valproic acid or divalproex sodium for treatment of any
             disease states

          -  Currently taking probenecid

          -  Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1
             of receiving ertapenem for this study

          -  Currently receiving any antimicrobial agents for prophylaxis or treatment
A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
Condition: Brain Contusion
MeSH terms: Brain Contusion; Contusions
Intervention: BIIB093; Placebo
Intervention description: Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Intervention MeSH terms: Glyburide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96
      when compared to placebo.

      The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status,
      functional outcomes, and treatment requirements, to further differentiate the mechanism of
      action of BIIB093 on contusion expansion by examining differential effects on hematoma and
      edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to
      placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of brain contusion with lesions within the supratentorial brain
             parenchyma totaling >3 mL in volume per Investigator assessment of baseline
             non-contrast computed tomography scan (NCCT) at Screening.

          -  A score of 5 to 15 on the Glasgow Coma Scale (GCS).

          -  Functionally independent, in the opinion of the Investigator, prior to index head
             injury.

        Key Exclusion Criteria:

          -  In the judgment of the Investigator, participant is likely to have supportive care
             withdrawn within 24 hours.

          -  Indication for immediate evacuation of IPH or DC.

          -  Clinical signs of brainstem herniation, in the opinion of the Investigator.

          -  NCCT or magnetic resonance imaging (MRI) evidence of penetrating brain parenchyma.
             Cerebrospinal fluid leak in isolation is not exclusionary unless evidence of
             parenchymal penetration by an external force (e.g., blunt object, bullet, or depressed
             skull fracture).

          -  Any presence of midbrain or posterior fossa injury as assessed by imaging and clinical
             examination.

          -  Presence of concomitant spinal cord injury as assessed by imaging and clinical
             examination.

          -  Life-threatening or nonsurvivable polytrauma, per Investigator's judgment.

          -  Use of novel oral anticoagulants (NOACS; including direct thrombin inhibitors such as
             dabigatran, or Factor Xa inhibitors such as rivaroxaban or apixaban), in preceding 3
             days prior to the injury, if known.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Investigation of Naltrexone for Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Intervention: Naltrexone; Placebo
Intervention description: Targeted dosage of 50mg PO daily; Sugar pills daily PO
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Naltrexone; Pathological Gambling; Opioid Antagonist

Summary:

      The investigators plan to investigate the safety, tolerability, and efficacy of the opioid
      antagonist naltrexone in Pathological Gambling. We hypothesize that naltrexone will be
      superior to placebo in reducing gambling urges and behavior, when combined with adjuvant
      non-pharmacological treatment as usual.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women over age 18

          2. Current DSM-IV PG Diagnosis as determined by a score of ≥ 5A criteria and B criterion
             present on the SCI-PG and a score ≥ 5 on the SOGS

          3. Gambling behavior within 2 weeks prior to enrollment

          4. For women, stable use of a medically accepted form of contraception and negative
             results on urine pregnancy test at study onset

          5. Currently entering, enrolled, or interested in treatment for PG

        Exclusion Criteria:

          1. Gambling that does not meet DSM-IV criteria for PG

          2. Unstable medical illness or clinically significant abnormalities on laboratory tests,
             EKG, or physical examination at screen

          3. Past or current acute hepatitis or liver failure

          4. History of renal impairment

          5. Current or recent (within one week) treatment with an opioid agonist/opioid analgesic
             or current opioid withdrawal

          6. Opiate agonist maintenance therapy (e.g. methadone)

          7. Known sensitivity to opioid antagonists

          8. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          9. A need for medication with unfavorable interactions with naltrexone

         10. Clinically significant suicidality

         11. Lifetime history of dementia, schizophrenia, or any psychotic disorder determined by
             SCID

         12. Clinically significant cognitive impairment

         13. Previous treatment with naltrexone or nalmefene

         14. Treatment with investigational medication or depot neuroleptics within 3 months

         15. Lack of proficiency in written and spoken English

         16. Unable to travel to study sites for appointments