bioihbjkbjnl/mcl2 huggingface dataset:
Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Virus Diseases; Respiratory Syncytial Virus Infections
Intervention: JNJ-53718678 250 mg; Placebo; JNJ-53718678 125 mg
Intervention description: JNJ-53718678 250 mg will be administered orally.; Matching placebo will be administered orally.; JNJ-53718678 125 mg will be administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 13 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of
      respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult
      hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using
             any conditioning regimen

          -  Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)

          -  Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization

          -  New onset of at least 1 of the following respiratory symptoms within 4 days prior to
             the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis
             (sore throat), and/or worsening of one of these chronic (associated with previously
             existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung
             disease) respiratory symptoms within 4 days prior to the anticipated start of dosing

          -  Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent
             (%) on room air

        Exclusion Criteria:

          -  Admitted to the hospital primarily for a lower respiratory tract disease of any cause
             as determined by the investigator

          -  Requires supplemental oxygen at Screening or any time between Screening and
             randomization

          -  Documented to be positive for other respiratory viruses (limited to influenza,
             parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus)
             within 7 days prior to or at the Screening visit, if determined by local SOC testing
             (additional testing is not required)

          -  Clinically significant bacteremia or fungemia within 7 days prior to or at Screening
             that has not been adequately treated, as determined by the investigator
A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Intervention: RIST4721; Placebo
Intervention description: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets; Matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      A 12-week Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to
      Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
      followed by an Open-label Extension Phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 6 months history of moderate or severe PPP, as defined by PPPASI ≥12 and
             PPPGA ≥3 at screening

          -  Males and females must be willing to use birth control as indicated

        Exclusion Criteria:

          -  Moderate to severe psoriasis covering ≥10% of total body surface area (BSA) at
             screening

          -  Breastfeeding or pregnant

          -  Known immunodeficiency or subject is immunocompromised

          -  Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB

          -  Any topical medications for PPP excluding emollients within two weeks of randomization
             and systemic therapies (including phototherapy) within 4 weeks of randomization
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.
Condition: Pain
MeSH terms: Acute Pain
Intervention: Hydromorphone
Intervention description: To be administered by intranasal route using mucosal atomization device.
Intervention MeSH terms: Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Intranasal; Hydromorphone; Pediatric; Emergency department

Summary:

      Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It
      has not been previously studied in children, but may be a viable option for effectively and
      safely reducing pain in children by administering an analgesic by the intranasal route.

      This study will be a prospective, open-label pilot study of intranasal hydromorphone in
      children with moderate to severe acute pain presenting to the pediatric emergency department.
      The investigators aim to describe the amount of pain reduction associated with intranasal
      hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with
      a clinically meaningful improvement in acute pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 4 to 17 years old, inclusive

          -  Moderate to severe pain (i.e. FPS-R or vNRS score of 4 or more)

          -  Requires parenteral opioid analgesic to treat their pain, as decided by treating
             physician

        Exclusion Criteria:

          -  Allergy or known contraindication to receiving opioids

          -  Receipt of any opioid or benzodiazepine within preceding 6 hours

          -  Presence of intranasal obstruction that cannot be cleared readily

          -  Cannot speak English or Spanish

          -  Patient unlikely to be able to complete self-report measures of pain or questionnaires

          -  Known liver or kidney problems

          -  Currently critically ill

          -  Chronic pain condition (e.g. sickle cell disease, fibromyalgia)
A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine; Botulinum Toxins; Analgesics
Intervention MeSH terms: Morphine; Narcotics; Analgesics; Bupivacaine; Botulinum Toxins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain; breast cancer; breast implant; breast reconstruction

Summary:

      The investigators hypothesize that in mastectomy patients with breast reconstruction, the
      addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the
      acute and chronic setting, compared to traditional pain management techniques which rely
      almost exclusively on opioid analgesics and sedatives like diazepam (valium). This
      expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will
      produce muscle relaxation, the combination of which will target different sites of pain
      generation, thus producing better analgesia. We also hypothesize that additional benefits may
      accrue from this regimen including decreased nausea and vomiting, sedation and constipation
      as a result of diminished opioid use1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing immediate unilateral or bilateral tissue expander breast
             reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy
             requiring postoperative expansions

          -  Women undergoing immediate bilateral tissue expanders breast reconstruction following
             risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy requiring
             postoperative tissue expansions.

        Exclusion Criteria:

          -  Subjects who are unable to read or speak English;

          -  Breast reconstruction using the latissimus dorsi flap combined with a tissue expander;

          -  Documented diagnosis of chronic pain, chronic migraine, upper limb spasticity,
             cervical dystonia, axillary hyperhidrosis, strabismus or blepharospasm;

          -  Hypersensitivity to any botulinum toxin (BT) preparation or to any of the components
             in the formulation;

          -  Infection at the proposed site of injection;

          -  Pre-existing neuromuscular disorders (including diagnosed myasthenia gravis,
             Eaton-Lambert syndrome, or amyotrophic lateral sclerosis);

          -  Aminoglycosides intake at the time of surgery (these antibiotics can potentiate the
             effect of BT);

          -  Women who are pregnant or breast feeding.
Esmolol vs. Labetalol in Endoscopic Sinus Surgery
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Intervention: Labetalol; Esmolol
Intervention description: Aliquots of 20mg of Labetol
• Maximum Dose - 300mg total for case; Infusion - 0.1mg/kg/min
• Maximum Dose - after 30 minutes, 0.3mg/kg/min
Intervention MeSH terms: Labetalol; Esmolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative
      visibility scores in functional endoscopic sinus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of CRS with or without nasal polyps

          -  Undergoing FESS for CRS

          -  American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient
             with mild systemic disease).

        Exclusion Criteria:

          -  Pregnancy

          -  Asthma

          -  COPD

          -  Bradycardia

          -  Heart failure

          -  End stage renal disease

          -  Cerebrovascular accident

          -  Diabetes mellitus

          -  Preoperative use of NSAIDs, aspirin, or beta-blockers

          -  Body mass index (BMI) greater than 40 kg/m2.
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Condition: SARS-CoV 2
Intervention: SARS-CoV-2 convalescent plasma; Plasma from a volunteer donor
Intervention description: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.; Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19

Summary:

      To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the
      risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or
      oropharyngeal viral shedding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years of age

          -  Competent and capable to provide informed consent

          -  • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for
             antigen, oropharyngeal or nasopharyngeal swab

          -  Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F),
             cough, or other COVID associated symptoms like anosmia

          -  ≤ 8 days since the first symptoms of COVID-19

          -  ≤ 8 days since first positive SARS-CoV-2 RNA test

          -  Able and willing to comply with protocol requirements listed in the informed consent

        Exclusion Criteria:

          -  Hospitalized or expected to be hospitalized within 24 hours of enrollment

          -  Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion
             of the principal investigator, would affect subject safety and/or compliance

          -  History of prior reactions to transfusion blood products

          -  Inability to complete therapy with the study product within 24 hours after enrollment

          -  Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation
             (monoclonal antibodies, compassionate use or study trial related). Steroid treatment
             at any time does not affect study eligibility
Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: pazopanib eye drops; placebo; ranibizumab intravitreal injection
Intervention description: A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.; placebo eye drops; Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A
Intervention MeSH terms: Ranibizumab; Ophthalmic 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: 510.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: ranibizumab; wet AMD; MD7110852; age related macular degeneration; age-related macular degeneration; macular degeneration; pazopanib

Summary:

      The purpose of this study is to determine the safety and efficacy of different dosage
      regimens of pazopanib eye drops for the treatment of neovascular age-related macular
      degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged ≥50 years.

          -  Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study
             eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area.

          -  Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and
             in need of re-treatment.

          -  Best-corrected visual acuity of at least 24 letters (equates to approximately 20/320
             Snellen equivalents or better).

        Exclusion Criteria:

          -  Prior ocular investigational drug/device for choroidal neovascularization,
             photodynamic therapy, radiation, subfoveal or juxtafoveal focal laser
             photocoagulation.

          -  Prior failure to anti-VEGF intravitreal injection therapy.

          -  Recent ocular investigational drug/device for non-CNV condition.

          -  Prior ocular surgeries (vitrectomy, scleral buckle, or glaucoma filtering/shunt
             surgery). Cataract surgery permitted if ≥3 months and has posterior chamber
             intraocular lens.

          -  Center-fovea involvement of any of the following: fibrosis, atrophy, serous retinal
             pigment epithelial detachment, or retinal pigment epithelial tear.

          -  CNV in either eye due to other causes.

          -  Clinical evidence of diabetic retinopathy or diabetic macular edema.

          -  Recent myocardial infarction or cerebrovascular accident.

          -  Uncontrolled hypertension in spite of antihypertensive medications.
Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial
Condition: HIV-1
Intervention: OZ1 transduced cells
Intervention description: Long term follow up of previously infused OZ1 transduced cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Healthy volunteers: No
Keywords: Gene Therapy; Anti-HIV-1 Ribozyme; OZ1; HIV-1 Infections

Summary:

      The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency
      Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1
      Ribozyme [OZ1]) as part of an earlier phase 2 trial. Patients are seen twice yearly until 5
      years from initial infusion of study drug has elapsed and then yearly until withdrawal or
      study completion. The study will monitor for and record any ill effects from the gene therapy
      product to provide long term safety information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who were enrolled (between 18 and 45 years of age) in the base study
             "OTH/OZ1-INT-1" (NCT00074997) will be invited to participate in this long term
             follow-up study

          -  Patients must have received the Final Cell Product infusion in base study
             "OTH/OZ1-INT-1"

          -  Have signed Informed Consent Form

        Exclusion Criteria:

          -  All patients who were enrolled in the OTH/OZ1-INT-1 study and received the final cell
             product will be invited to participate in this long term follow-up study. After
             unblinding of the OTH/OZ1-INT-1 study, any patients in the placebo arm will be
             withdrawn from this protocol
Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: pembrolizumab; Acalabrutinib
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with
      advanced head and neck squamous cell carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC
             of the oral cavity, oropharynx, hypopharynx, and larynx that that has either
             progressed during or after platinum-based chemotherapy administered for metastatic
             disease or has recurred during or within 6 months after the completion of
             platinum-based neoadjuvant or adjuvant therapy

          -  Presence of radiographically measurable disease as defined by RECIST 1.1

          -  ECOG performance status of 0 or 1

        Exclusion Criteria:

          -  Prior malignancy (other than HNSCC), except for adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
             subject has been disease free for ≥ 2 years or which will not limit survival to < 2
             years

          -  Known central nervous system metastases and/or carcinomatous meningitis

          -  A life-threatening illness, medical condition (including psychiatric conditions) or
             organ system dysfunction which, in the investigator's opinion, could compromise the
             subject's safety

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of starting study
             drug
Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients
Condition: Dyskinesia; Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: AVP-923-45; Placebo
Intervention description: One capsule twice daily for 14 days; One capsule twice daily for 14 days
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: levodopa; dyskinesia; parkinson's disease; AVP-923; dextromethorphan; quinidine

Summary:

      To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg
      dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of
      levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 30 to 80 years of age, inclusive.

          -  Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society
             Brain Bank criteria.

          -  Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.

          -  Dyskinesia of at least moderate severity as per MDS-UPDRS

          -  Amantadine and Monoamine Oxidase (MAO) inhibitors must be discontinued at least three
             weeks prior to randomization.

          -  Subjects currently receiving anti-parkinsonian medications, including all Levodopa
             preparations are eligible provided they have been on a stable dose of these
             medications for at least 1 month prior to randomization.

          -  Concomitant use of antidepressants such as selective serotonin reuptake inhibitors are
             allowed, provided the dose has been stable for at least 1 month prior to
             randomization.

        Exclusion Criteria:

          -  Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain
             Stimulation must not have been performed within one year of screening)

          -  Hoehn and Yahr score of 5 when "off".

          -  Subject with Cognitive impairment and/or history of psychiatric manifestations or
             active hallucinations.

          -  Subjects with any history of complete heart block, QTc prolongation, or torsades de
             pointes.

          -  Subjects with any family history of congenital QT interval prolongation syndrome.

          -  Subjects with history of postural syncope, or any history of unexplained syncope
             within the last 12 months.

          -  Subjects with a history of substance and/or alcohol abuse within the past 2 years.