bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Intervention: EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Intervention description: Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 404.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to
      tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and
             eligible for bilateral myringotomy and tympanostomy tube insertion.

          -  Suspected bacterial infection at time of surgery in at least 1 ear.

          -  Willing to refrain from water immersion of the ears following surgery without the use
             of adequate ear protection during swimming, bathing, showering and other water-related
             activities.

          -  Legally Authorized Representative (LAR) must read and sign the informed consent.

          -  Parent or caregiver must agree to comply with the requirements of the study and
             administer study medication as directed, complete required study visits, and comply
             with the protocol.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Previous otologic or otologic-related surgery within the past 30 days or ongoing
             complications.

          -  Middle ear pathology in either ear other than otitis media.

          -  Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions
             which could interfere with evaluation of the study drug.

          -  Any systemic disease or disorder, complicating factor or structural abnormality that
             would negatively affect the conduct or outcome of the study based upon assessment by
             the Investigator.

          -  Known or suspected allergy or hypersensitivity to quinolones or other active or
             inactive ingredients present in the medications to be used in the study.

          -  Other protocol-specified exclusion criteria may apply.
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165; Placebo
Intervention description: Specified dose on Specified Days; Specified dose on Specified days
Intervention MeSH terms: Deucravacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the experimental medication BMS-986165 compared
      to placebo in participants with moderate to severe plaque psoriasis in mainland China,
      Taiwan, and South Korea
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plaque psoriasis for at least 6 months

          -  Moderate to severe disease

          -  Candidate for phototherapy or systemic therapy

        Exclusion Criteria:

          -  Other forms of psoriasis

          -  History of recent infection

          -  Prior exposure to BMS-986165

        Other inclusion/exclusion criteria may apply.
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
Condition: Cataract
MeSH terms: Cataract; Uveitis; Inflammation
Intervention: Loteprednol etabonate; Prednisolones acetate
Intervention description: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.; 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Intervention MeSH terms: Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 107.0
Sex: All
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Pediatric cataract

Summary:

      The objective of this study is to compare the efficacy and safety for the treatment of
      postoperative inflammation following ocular surgery for childhood cataract.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a candidate for routine, uncomplicated surgery for childhood cataract

        Exclusion Criteria:

          -  Subjects who have a severe/serious ocular condition, or any other unstable medical
             condition that, in the Investigator's opinion, may preclude study treatment or
             follow-up.

          -  Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure
             (IOP) lowering therapy in either eye or systemically.

          -  Subjects with a history of steroid-induced IOP elevation in either eye.

          -  Subjects who have known hypersensitivity or other contraindication to the study
             drug(s) or any components in the drug formulation.
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
Condition: Allergic Rhinitis; Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis
Intervention: REGN5713; REGN5714; REGN5715; Placebo
Intervention description: Administered subcutaneously; Administered subcutaneously; Administered subcutaneously; Placebo that replaces REGN5713-5714-5715
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Birch Allergy

Summary:

      The primary objective is to assess the reduction of allergic symptoms as measured by combined
      symptom and medication score (CSMS) during birch pollen season after a single dose of
      REGN5713-5714-5715 versus placebo.
    

Eligibility criteria:

        Key Inclusion Criteria

          1. Documented or participant-reported history of birch pollen-triggered allergic rhinitis
             symptoms, with or without conjunctivitis, for at least 2 years

          2. Positive Skin prick test (SPT) with birch pollen extract in the screening period, as
             defined in the protocol

          3. Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the
             screening period, as defined in the protocol

          4. Willing and able to comply with clinic visits and study-related procedures

        Key Exclusion Criteria:

          1. Participation in a prior REGN5713-5714-5715 clinical trial

          2. Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or
             due to daily contact with other allergens causing symptoms that are expected to
             coincide with birch pollen season, as assessed by the investigator

          3. Participants who anticipate major changes in allergen exposure in their home or work
             environments that are expected to coincide with the study assessments as assessed by
             the investigator

          4. Persistent chronic or recurring acute infection requiring treatment with antibiotics,
             antivirals, or antifungals, or any untreated respiratory infections (at the discretion
             of the investigator) within 4 weeks prior to screening visit. Participants may be
             re-evaluated for eligibility after symptoms resolve

          5. Documentation of active SARS-CoV-2 infection, as defined in the protocol

          6. A clinical history of asthma with 2 or more asthma exacerbations requiring
             hospitalizations or systemic corticosteroids in the previous year

          7. History of birch allergy immunotherapy as defined in the protocol

          8. Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6
             months prior to screening

        NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
Condition: Neurogenic Detrusor Overactivity; Pediatric
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin succinate
Intervention description: Oral suspension
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 6 Months
Maximum age: 4 Years
Healthy volunteers: No
Keywords: Solifenacin succinate suspension; Efficacy; Safety

Summary:

      The purpose of this study was to evaluate long term efficacy and safety of treatment with
      solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity
      after multiple dose administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Myelomeningocoele

          -  Documented diagnosis of NDO, confirmed by urodynamics

          -  DSD (detrusor sphincter dyssynergia)

          -  Practicing clean intermittent catheterization (CIC)

        Exclusion Criteria:

          -  Know genitourinary condition (other than NDO) that may cause incontinence

          -  Bladder augmentation surgery

          -  Current faecal impaction

          -  Electro-stimulation therapy within 2 weeks prior to visit

          -  Subjects with the following gastro-intestinal problems: partial or complete
             obstructions, decreased motility like paralytic ileus, subjects at risk of gastric
             retention

          -  Reflux grade 3 to 5

          -  Current urinary tract infection
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
Condition: Migraine; Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Intervention: Dihydroergotamine
Intervention description: Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Intervention MeSH terms: Dihydroergotamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: dihydroergotamine; dihydroergotamine mesylate; migraine

Summary:

      Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to
      evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute
      treatment of migraine.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or females, 18-65 years of age at the time of Screening Visit

          -  Subject has at least 1-year history of migraines (with or without aura), according to
             the

          -  International Classification of Headache Disorder, 3rd Edition (ICHD3)

        Key Exclusion Criteria:

          -  Pregnant or breast-feeding women

          -  Women of child-bearing potential not using or not willing to use highly effective
             contraception.

          -  Diagnosis of headache conditions other than migraine with or without aura, including
             diagnosis of basilar or hemiplegic migraines or cluster headache.

          -  History of coronary artery disease, coronary artery vasospasm (including
             Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular
             disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina
             pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary
             intervention, or cardiac surgery.

          -  History of cerebrovascular disease, including but not limited to stroke, transient
             ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.

          -  Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or
             dependence, drug abuse or dependence, major psychiatric conditions (e.g.
             schizophrenia, psychosis or Bipolar disorder), dementia. Other significant
             neurological or psychiatric disorders (including other pain syndromes or risk of
             suicide) that in the opinion of the investigator might interfere with study
             participation and assessments or subject safety.

          -  Any clinically significant symptoms or conditions, including but not limited to
             central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic
             or gastrointestinal conditions or history of such conditions that, in the opinion of
             the investigator might interfere with study assessments or safety of participant.
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder
MeSH terms: Tourette Syndrome
Intervention: Aripiprazole
Intervention description: Aripiprazole tablets orally once daily.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Tourette's Disorder; Tic Disorders

Summary:

      The goal of the current trial is to obtain long term efficacy, safety and tolerability data
      of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participants successfully completed the final assessment visit in either Study
             31-10-272 (NCT01418339) or 31-10-273 (NCT01418352). The participants completed all
             required assessments for the Week 8/Early Termination Visit to be eligible for
             rollover in to this open-label trial.

          -  Written informed consent form (ICF) obtained from a legally acceptable representative
             & informed assent at Baseline as applicable by trial center's Institutional review
             board/independent ethics committee (IRB/IEC).

          -  The participant, designated guardian(s) or caregiver(s) are able to comprehend and
             satisfactorily comply with the protocol requirements, as evaluated by the
             investigator.

        Exclusion Criteria:

          -  The participants experienced adverse events (AEs) during the double-blind study
             31-10-272 (NCT01418339) or 31-10-273 (NCT01418352) that would, in the investigator's
             judgment, preclude further exposure to aripiprazole.

          -  The participants had protocol violations during the double-blind trial considered
             major in the judgment of the investigator which would deem the participant a poor
             candidate for the trial.

          -  A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which
             will result in early termination at Week 1.

          -  Sexually active patients who will not commit to utilizing 2 of the approved birth
             control methods or who will not remain abstinent during the trial and for 90 and 30
             days following the last dose of study drug for male and female respectively.

          -  Participants representing Risk of committing suicide.

          -  Body weight lower than 16 kg.

          -  Abnormal laboratory test results (Platelet, Hemoglobin, Neutrophils, Aspartate
             aminotransferase, Alanine aminotransferase, Creatinine) vital signs and
             Electrocardiogram (ECG) results.
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
Condition: Malaria
MeSH terms: Malaria
Intervention: Blood sampling; Malaria Vaccine 257049 (MALARIA-055 PRI); Meningococcal C Conjugate Vaccine (MALARIA-055 PRI); Cell-culture rabies vaccine (MALARIA-055 PRI); TritanrixHepB/Hib (MALARIA-055 PRI); Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Intervention description: Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered orally, during the MALARIA-055 study (NCT00866619).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3084.0
Sex: All
Minimum age: 42 Months
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infants; Efficacy; Children; Malaria; Plasmodium falciparum; Safety; Surveillance; Immunogenicity; RTS,S/AS01E; Africa

Summary:

      The purpose of this study is to conduct long-term surveillance for efficacy, safety and
      immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria
      vaccine in infants and children in Africa following a primary vaccination series
      (NCT00866619). No new subjects will be enrolled in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of
             the investigator, can and will comply with the requirements of the protocol.

          -  Subjects who were enrolled and who received at least one vaccine dose in the primary
             study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who
             moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product or planned use during the study
             period.
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Twinrix™ adult
Intervention description: Intramuscular administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined Hepatitis A and B vaccine; Hepatitis A; Hepatitis B

Summary:

      The aim of this study is to evaluate the long-term persistence of hepatitis A and B
      antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a
      3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting
      has been updated in order to comply with the FDA Amendment Act, Sep 2007.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      11 to 15.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects participating in this study should have received three-dose primary
             vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.

          -  Written informed consent will be obtained from each subject before the blood sampling
             visit of each year
Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery
Condition: Colorectal Surgery
Intervention: liposomal Bupivacaine; Bupivacaine Hydrochloride
Intervention description: 20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group; 40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: LB group (Liposomal Bupivacaine)
SB group (Standard Bupivacaine)
Masking: Double (Participant, Investigator)
Masking description: Both the patients and the research staff doing assessments will be blinded to the randomization.
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the difference between two different pain control
      methods in patients who will be having a colorectal surgery
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients undergoing colorectal surgery at Indiana University Hospital

          -  American Society of Anesthesiologists (ASA) class 1, 2, 3 or 4

          -  Age 18 or older, male or female

          -  Desires Regional anesthesia for postoperative pain control

        Exclusion criteria:

          -  Any contraindication for QL block.

          -  History of substance abuse in the past 6 months.

          -  Patients on more than 30mg morphine equivalents of opioids daily.

          -  Any physical, mental or medical conditions which in the opinion of the investigators,
             may confound quantifying postoperative pain resulting from surgery.

          -  Known allergy or other contraindications to the study medications (Acetaminophen,
             Gabapentin, Bupivacaine).

          -  Postoperative intubation.

          -  Any BMI greater than 40.0.