bioihbjkbjnl/mcl2 huggingface dataset:
Study of Sulfasalazine in Treating Painful Neuropathy
Condition: Painful Neuropathy
MeSH terms: Pain
Intervention: Sulfasalazine; placebo
Intervention MeSH terms: Sulfasalazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid
      arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this
      study, the investigators will evaluate whether sulfasalazine improves pain due to painful
      peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Painful neuropathy

          -  Michigan Neuropathy Screening Instrument score of 3 or greater

          -  no obvious alternative explanation for neuropathy

          -  average baseline pain > 4/10

        Exclusion Criteria:

          -  other severe pain

          -  anticipated difficulty weaning off medications

          -  past or current psychiatric disorder as determined by Mini International
             Neuropsychiatric Interview

          -  medical contraindication to sulfasalazine

          -  not proficient in English (due to heavy use of questionaires)

          -  pregnant or breast feeding women
A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
Condition: Urothelial Carcinoma; Urothelial Carcinoma Bladder; Urothelial Carcinoma Ureter; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma Urethra
MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Urinary Bladder Neoplasms
Intervention: Sitravatinib; Nivolumab; Pembrolizumab; Enfortumab vedotin
Intervention description: Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases; Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody; Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody; Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
Intervention MeSH terms: Pembrolizumab; Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 9 cohorts (having 9-55 maximum patients enrolled in each; based upon response rate). Patients are assigned to cohorts based upon their prior treatments for urothelial carcinoma.
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MGCD516; Antineoplastic Agents; Immunologic Factors; Nivolumab; Tyrosine Kinase Inhibitor; VEGFR; TAM RTKs; PD-1; PD-L1; Pembrolizumab; Enfortumab vedotin; Checkpoint Inhibitors; Antibody Drug Conjugates; ADC

Summary:

      The study will evaluate the clinical activity of PD-(L)1 Checkpoint Inhibitor regimens in
      combination with the investigational agent sitravatinib in patients with advanced or
      metastatic urothelial carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of urothelial carcinoma

          -  Adequate bone marrow and organ function

        Exclusion Criteria:

          -  Uncontrolled tumor in the brain

          -  Unacceptable toxicity with prior checkpoint inhibitor

          -  Impaired heart function
A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Eteplirsen
Intervention description: Eteplirsen IV infusion once weekly.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: DMD; Duchenne; Eteplirsen; Dystrophy; Dystrophin; Exon Skipping; Exon 51; Ambulatory; Pediatric

Summary:

      The purpose of this extension study is to evaluate the ongoing safety and tolerability of
      additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in
      male participants with DMD who have successfully completed the 96-week eteplirsen Study
      4658-102.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant successfully completes 96 weeks of treatment in Study 4658-102.

        Exclusion Criteria:

          -  Participant has a prior or ongoing medical condition that, in the Investigator's
             opinion, could adversely affect the safety of the participant, or make it unlikely
             that the course of treatment or follow-up would be completed, or impair the assessment
             of study results.

        Other inclusion/exclusion criteria apply.
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114 Lot 1; V114 Lot 2; Prevnar 13™
Intervention description: Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1051.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety, tolerability, and immunogenicity of two
      different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The
      primary hypothesis of the study is that the proportion of participants receiving V114 who
      have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,
      6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for
      recipients of Prevnar 13™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infant approximately 2 months of age (42 days to 90 days), inclusive

          -  In good health

        Exclusion Criteria:

          -  Prior administration of any pneumococcal vaccine

          -  Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any
             diphtheria toxoid-containing vaccine

          -  Known or suspected impairment of immunological function

          -  History of congenital or acquired immunodeficiency (eg, splenomegaly)

          -  Mother has documented human immunodeficiency virus (HIV) infection

          -  Mother has documented hepatitis B surface antigen-positive test result

          -  Known or history of functional or anatomic asplenia

          -  History of failure to thrive

          -  History of a coagulation disorder

          -  History of autoimmune disease

          -  Known neurologic or cognitive behavioral disorder

          -  Expects to require systemic corticosteroids within 30 days after each vaccination
             during the trial

          -  Prior administration of a blood transfusion or blood products, including
             immunoglobulin

          -  Participated in another clinical trial of an investigational product

          -  History of invasive pneumococcal disease or known history of other culture-positive
             pneumococcal disease
Bolus of Saline in Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Normal saline
Intervention description: intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 110 Years
Healthy volunteers: No

Summary:

      This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral
      blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke
      within 96 hours of enrollment. The study intervention will be a one hour monitoring session.
      There will be a 15 minute baseline measurement period, followed by intravenous administration
      of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All
      study measurements will cease after 1 hour. Subjects will be followed during their
      hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse
      events and to collect clinical information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral
             artery territory on either side of the brain

          -  Study intervention can be initiated within 96 hours of symptom onset

          -  Willingness and ability to sign informed consent by patient or legally acceptable
             surrogate decision-maker

        Exclusion Criteria:

          -  Infarct limited to the brainstem and/or cerebellum with no involvement of the cerebral
             hemispheres

          -  Bi-hemispheric infarction or acute infarct in the contra-lateral hemisphere within the
             past 30 days

          -  Symptoms of active congestive heart failure (dyspnea, orthopnea, increased oxygen
             requirement)

          -  Exacerbation of congestive heart failure, requiring hospitalization, within the past
             30 days or severe systolic dysfunction with a known ejection fraction <20%

          -  End stage renal disease requiring hemodialysis or a creatinine clearance <20
             ml/min/1.73 m2

          -  Hemicraniectomy or other skull defect that would interfere with monitoring

          -  Pregnant women are excluded. Women of child-bearing age must have a negative pregnancy
             test prior to enrollment

          -  Participation in another clinical trial

          -  Any other illness or condition that the investigator feels would pose a hazard to the
             subject from participation in the study
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Roflumilast Cream 0.3%; Roflumilast Cream 0.15%; Vehicle Cream
Intervention description: Applied once daily for 12 weeks; Applied once daily for 12 weeks; Applied once daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group, double blind, vehicle-controlled study
Masking: Double (Participant, Investigator)
Masking description: Roflumilast drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of roflumilast cream.
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a parallel group, double blind, vehicle-controlled study in which roflumilast
      (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD)
      for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body
      surface area.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants legally competent to sign and give informed consent

          -  Males and females ages 18 years and older (inclusive)

          -  Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined
             by the Investigator

          -  Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at
             Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must
             agree to use at least one form of highly effective contraception throughout the trial.

          -  In good health as judged by the Investigator, based on medical history, physical
             examination, serum chemistry labs, hematology values, and urinalysis.

          -  Subjects are considered reliable and capable of adhering to the Protocol and visit
             schedule, according to the judgment of the Investigator.

        Exclusion Criteria:

          -  Planned excessive exposure of treated area(s) to either natural or artificial sunlight
             or tanning bed.

          -  Females who are pregnant, wishing to become pregnant during the study, or are
             breast-feeding.

          -  Previous treatment with roflumilast cream or its active ingredient

          -  Subjects with any serious medical condition or laboratory abnormality that would
             prevent study participation or place the subject at significant risk, as determined by
             the Investigator.

          -  Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation
             of study medication.

          -  Subjects who are unable to communicate, read or understand the local language, or who
             display another condition, which in the Investigator's opinion, makes them unsuitable
             for clinical study participation.
The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: HD IL2
Intervention MeSH terms: Aldesleukin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Kidney; Renal Cell; Metastatic; interleukin-2; select

Summary:

      High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug
      Administration (FDA) for the treatment of metastatic kidney cancer and is a standard
      treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer
      that can produce a remission of disease that lasts after treatment is completed. However,
      most patients who receive IL-2 do not benefit and all patients experience potentially
      dangerous side effects.

      Recent research has suggested that certain patients may respond better to IL-2 than others.
      The Cytokine Working Group is currently conducting a clinical trial that aims to identify and
      confirm this research and narrow the application of IL-2 to those patients most likely to
      benefit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed renal cell carcinoma that is metastatic or
             unresectable.

          -  If patients have measurable disease restricted to a solitary lesion, its neoplastic
             nature should be confirmed by cytology/histology.

          -  Patients must provide access to tissue blocks containing adequate tumor for
             interpretation and analysis.

          -  Patients must have measurable disease.

          -  Patients must have good performance status (ECOG 0 or 1; Karnofsky PS 100-80%).

          -  Patients must have adequate organ function.

          -  Patients must have no contraindication of vasopressor agents.

          -  Patients must be ≥ 18 years of age.

        Exclusion Criteria:

          -  Patients who have received systemic therapy for metastatic disease.

          -  Patients with organ allografts.

          -  Patients who require or are likely to require systemic corticosteroid therapy for
             intercurrent illness.

          -  Patients with any significant medical disease other than the malignancy (e.g. COPD,
             patients with ascites or pleural effusions), which in the opinion of the investigator
             would significantly increase the risk of immunotherapy.

          -  Patients with a history of another malignancy within the past 5 years other than
             surgically cured non-melanoma skin cancer, carcinoma-in-situ or Stage I carcinoma of
             the cervix.
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
Condition: Complicated Urinary Tract Infection; Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: levofloxacin; plazomicin; placebo
Intervention MeSH terms: Levofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: urinary tract infection; UTI; cUTI; pyelonephritis; AP; ACHN-490

Summary:

      This was a multi-center, multi-national, double-blind, randomized, comparator-controlled
      study of plazomicin administered intravenously compared with levofloxacin, a standard
      approved intravenous therapy for complicated urinary tract infection (cUTI) and acute
      pyelonephritis (AP).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented or suspected cUTI/AP with clinical signs and symptoms

          -  Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using
             Cockcroft-Gault formula

        Key Exclusion Criteria:

          -  Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis

          -  Gross heanaturia requiring intervention other than study drug

          -  Urinary tract surgery within 7 days of randomization or during the study period

          -  A known nonrenal source of infection diagnosed within 7 days of randomization

          -  A corrected QT interval > 440 msec

          -  History of hearing loss with onset before the age of 40 years, sensorineural hearing
             loss, or family history of hearing loss

          -  Pregnant or breastfeeding women
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
Condition: RSV Infection
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Intervention: EDP-938 Dose 1; EDP-938 Dose 2; Placebo; EDP-938 Dose 3; EDP-938 Dose 4; Placebo
Intervention description: Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: challenge study; RSV; antiviral; RSV-A Memphis 37b

Summary:

      A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety,
      pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in
      healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the
      antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus
      challenge model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An informed consent document signed and dated by the subject

          -  Age 18 to 55 years, inclusive

          -  In good health with no history of major medical conditions

          -  A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m^2 and ≤ 30kg/m^2

        Exclusion Criteria:

          -  Pregnant or nursing females

          -  Acute or chronic medical illness

          -  Abnormal lung function

          -  Positive for human immunodeficiency virus (HIV), active hepatitis A, B or C test

          -  Nose or nasopharynx abnormalities

          -  Receipt of any investigational drug within 3 months prior to the planned date of viral
             challenge/first dose of study drug
Kinematic-guided BoNT-A Treatment for ET and PD Tremor
Condition: Tremor
MeSH terms: Tremor
Intervention: BoNT-A
Intervention description: A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
Intervention MeSH terms: incobotulinumtoxinA; Botulinum Toxins, Type A; Botulinum Toxins; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Kinematics; Botulinum toxin type A

Summary:

      The present study attempts to fill a critical knowledge gap of BoNT A in tremor management by
      studying the efficacy of IncobotulinumtoxinA (Xeomin®) injection for hand tremor in essential
      tremor and idiopathic Parkinson disease using data regarding composition of tremor obtained
      through sophisticated, yet clinically accessible multi-sensor based kinematic information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consenting male and female participants, aged 18 years to 80 years

          -  PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease or ET
             with hand tremor in their motor dominant hand

          -  Stable IPD/ET medication management for the 6 month duration prior to their enrollment
             in the study

          -  Individuals with IPD will be eligible for the study only if tremor is their primary
             and most bothersome symptom as determined by clinical exam and patient report

          -  Participants who are botulinum toxin naïve for tremor management

        Exclusion Criteria:

          -  History of stroke

          -  Muscle weakness or any related compartmental muscle syndrome

          -  Smoking

          -  Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic
             agonists (e.g. salbutamol))

          -  Contradictions per the Xeomin® drug monograph

          -  Patients prescribed zonisamide