bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric Tonsillectomy Pain Reduction Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: lidocaine (1%) + bupivacaine (0.5%); Normal saline; Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
Intervention description: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
B - lidocaine (1%) + bupivacaine (0.5%); Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
A - normal saline; Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Intervention MeSH terms: Lidocaine; Clonidine; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tonsillectomy; Postoperative Pain; Clonidine; Anesthetics, Local

Summary:

      Tonsillectomy is associated with a significant decrease quality of life in children secondary
      to pain, which is worsened with swallowing. The objective of the current study is to conduct
      a prospective, double-blind, placebo-controlled, randomized clinical trial using a
      pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in
      reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline
      injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) +
      clonidine (25 µg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3 - 17 years old

          -  BMI < 35

          -  Negative pregnancy test in female patients age 10 and older

          -  Diagnosed with adenotonsillar hypertrophy, recurrent adenotonsillitis or upper airway
             obstruction and will be undergoing tonsillectomy alone or adenotonsillectomy

        Exclusion Criteria:

          -  Diagnosis of obstructive sleep apnea

          -  Patient with peritonsillar abscess

          -  Allergy to study medication

          -  Any major systemic illness, genetic disorder or diagnosed syndrome

          -  Bleeding disorder
Stepping Stones and Creating Futures Intervention Trial
Condition: IPV; Sexual Violence
Intervention: Stepping Stones and Creating Futures
Intervention description: Stepping Stones consists of 10 sessions. It seeks to strengthen relationships and to transform views on gender and in the process impact on exposure to, or participation in, gender-based violence and HIV risk. These cover gender and peer influences our actions; sex and love; conception and contraception; STIs and HIV; safer sex and condoms; GBV; motivations for behaviour (including influences of alcohol and poverty); and communication skills.
Creating Futures is a facilitated group intervention of eleven sessions. It seeks to strengthen livelihoods. The key sessions include: setting medium term livelihood goals, the need for assets and coping with crises; social resources for livelihoods (trust and community participation); getting and keeping jobs; and savings and spending.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1351.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: informal settlements; poverty

Summary:

      This study evaluates whether the behavioural/structural interventions of Stepping Stones and
      Creating Futures can reduce the incidence of intimate partner violence in urban informal
      settlements amongst young people. Half the participants will receive the interventions, while
      the other half will be in a control wait-list, only receiving the intervention after final
      data collection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normally resident in informal settlement cluster

          -  Not formally employed

          -  Able to communicate in main study languages (English, isiZulu, iXhosa)

        Exclusion Criteria:

          -  Under 18

          -  Mental deficit (learning difficulty, mental illness or substance abuse)
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
Condition: Huntingtons Disease
MeSH terms: Huntington Disease
Intervention: RO7234292; Placebo
Intervention description: Intrathecal injection; Intrathecal injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 899.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HD, RG6042, intrathecal, ASO, antisense oligonucleotide

Summary:

      This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042)
      compared with placebo in participants with manifest Huntington's disease (HD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Manifest HD diagnosis, defined as a DCL score of 4

          -  Independence Scale (IS) score >= 70

          -  Genetically confirmed disease by direct DNA testing with a CAP score >400

          -  Clinical assessment to ensure individual has intact functional independence at
             baseline to maintain self-care and core activities of daily living (ADLs).

        Exclusion Criteria:

          -  Any serious medical condition or clinically significant laboratory, or vital sign
             abnormality or claustrophobia at screening that, in the investigator's judgment,
             precludes the patient's safe participation in and completion of the study

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             5 months after the final dose of study drug
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Upadacitinib; Dupilumab; Placebo to dupilumab; Placebo to upadacitinib
Intervention description: Extended release tablet; Dupilumab is administered as a subcutaneous (SC) injection; Placebo administered as a subcutaneous injection; Tablet
Intervention MeSH terms: Upadacitinib; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 692.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Upadacitinib; ABT-494; Dupilumab; Atopic Dermatitis

Summary:

      This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with
      moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema
             Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10%
             body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and
             Baseline weekly average of daily Worst Pruritus NRS ≥ 4.

          -  Participant is a candidate for systemic therapy or have recently required systemic
             therapy for AD.

        Exclusion Criteria:

          -  Participant has prior exposure to Janus Kinase (JAK) inhibitor.

          -  Participant has prior exposure to dupilumab.

          -  Participant is unable or unwilling to discontinue current AD treatments prior to the
             study.

          -  Participant has requirement of prohibited medications during the study.

          -  Participant has other active skin diseases or skin infections requiring systemic
             treatment or would interfere with appropriate assessment of AD lesions.

          -  Female participant who is pregnant, breastfeeding, or considering pregnancy during the
             study.
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
Condition: Primary Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: TNX-102 SL
Intervention description: TNX-102 SL 2.8 mg taken daily at bedtime.
Intervention MeSH terms: Cyclobenzaprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: TNX-102 SL; bedtime; sublingual; 12-month; long term safety; long term efficacy; Fibromyalgia

Summary:

      This was an open-label, extension trial designed to evaluate the long-term safety over 12
      months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia.
      Patients recruited into this trial were those who had successfully completed the double-blind
      study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they
      received during the double-blind study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient met all prior inclusion and exclusion requirements for Study F202
             (NCT01903265) originally, and has had no intervening medical conditions, increased
             suicidal ideation, or requirements for concomitant medications that preclude exposure
             to TNX-102 SL or enrollment in the extension study.

          2. The patient completed expected dosing in F202 (NCT01903265) defined as taking study
             medication up to Week 12, with at least 70% compliance with medication usage (based on
             responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no
             major protocol violations.

          3. The patient has provided written informed consent to participate in this extension
             protocol.

        Exclusion Criteria:

        None
A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tofacitinib; Tofacitinib
Intervention description: tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks; tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 209.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Tofacitinib, CP-690,550, Janis kinase, JAK inhibitor, modified release, Xeljanz

Summary:

      This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib
      modified release tablet taken once a day in patients with rheumatoid arthritis who continue
      taking methotrexate. Results for the modified release tablets will be compared to the
      efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in
      patients with rheumatoid arthritis who continue taking methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of rheumatoid arthritis

          -  currently taking a stable dose of methotrexate

          -  no evidence of active or latent or inadequately treated tuberculosis

        Exclusion Criteria:

          -  evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or
             allergic disease

          -  clinically significant infections within the past 6 months
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
Condition: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Evolocumab; Atorvastatin; Placebo
Intervention description: Administered by subcutaneous injection; Administered orally once a day; Placebo to evolocumab administered by subcutaneous injection
Intervention MeSH terms: Atorvastatin; Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 986.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous
      evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from
      baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with
      hyperlipidemia or mixed dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with type 2 diabetes (receiving pharmacologic treatment for at least
             6 months or longer) with stable diabetes therapy

          -  Lipid-lowering therapy must be unchanged for at least 4 weeks or more

          -  Subjects receiving statin therapy at screening must have a fasting LDL-C of greater
             than or equal to 100 mg/dL

          -  Subjects not receiving statin therapy at screening must have a fasting LDL-C of
             greater than or equal to 130 mg/dL

        Exclusion criteria:

          -  New York Heart Association (NYHA) class III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes or poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism.
IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: Ropivacaine injection
Intervention description: Total dose not to exceed 3 mg/kg of ropivacaine.
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral
      nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing
      arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor
      canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block
      involved with sciatic nerve block. The lack of motor block is important to facilitate
      postoperative ambulation and physical therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients less than 21 years of age

          -  American Society of Anesthesiologists physical status I and II

          -  Undergoing elective anterior cruciate ligament reconstruction

        Exclusion Criteria:

          -  They are unable or unwilling to take part in the study

          -  History of allergy to any of the medications administered for the nerve block

          -  Contraindication to peripheral nerve block

          -  Patients who are unable to understand instructions or questions related to the study
             or the families required language interpretation

          -  Patients who consume opioid medications for more than three days per week for more
             than a month prior to surgery
BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: BRII-196; BRII-198; Placebo; Remdesivir
Intervention description: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.; BRII-198 is a fully human IgG-1 mAb derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.; Commercially available 0.9% sodium chloride solution; Antiviral agent
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; COVID 19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Infections; Nidovirales Infections; SARS-CoV-2; SARS Coronavirus; ACTIV-3; ACTIV3; TICO

Summary:

      This study looks at the safety and effectiveness of BRII-196/BRII-198 in treating COVID-19 in
      people who have been hospitalized with the infection. Participants in the study will be
      treated with either BRII-196/BRII-198 plus current standard of care (SOC), or with placebo
      plus current SOC. This is ACTIV-3/TICO Treatment Trial H3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Refer to the master protocol (NCT04501978)

        Exclusion Criteria:

          -  Refer to the master protocol (NCT04501978)

          -  Additional Exclusion Criteria:

               -  Pregnant women

               -  Nursing mothers

          -  In addition, prior to the initial futility assessment which is performed when
             approximately 150 participants have been enrolled on BRII-196/BRII-198 and 150 on
             placebo, patients on high-flow oxygen or non-invasive ventilation (category 5 of the
             pulmonary ordinal outcome) will be excluded. These patients may be eligible for the
             trial if the initial futility assessment is passed by this agent.
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: GED-0301; Placebo
Intervention description: Mongersen; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Crohn's Disease; GED 0301; Mongersen; Safety; Irritable Bowel Disease

Summary:

      The purpose of this study is to assess long-term safety data of GED-0301 for a period of up
      to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3
      GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of
      age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will
      receive active treatment, this study is double-blinded for the entire 208 weeks for the
      purpose of preserving the blind of the subject's treatment allocation in the initial, core
      Phase 3 GED-0301 study.

      The GED-0301-CD-003 trial was not initiated; see detailed description.
    

Eligibility criteria:

        Inclusion Criteria for Adult Subjects:

        Subjects must satisfy the following criteria to be screened and enrolled in the study:

          -  Male or female ≥ 18 years of age.

          -  Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.

          -  Subject must use protocol approved contraception.

        Inclusion Criteria for Adolescent Subjects:

        Adolescent subjects must satisfy the following criteria to be screened and enrolled in the
        study

          -  Male or female 12 to 17 years of age.

          -  Subject must have participated in the GED 0301 CD 003 study.

          -  Subject is able to swallow the IP tablets.

          -  Subject must use protocol approved contraception.

        Exclusion Criteria for Adult and Adolescent Subjects:

        The presence of any of the following will exclude a subject from screening and enrollment:

          -  Subject had experienced a serious adverse event (SAE) related to the investigational
             product while participating in the previous Phase 3 GED-0301 study.

          -  Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.

          -  Subject is pregnant or breastfeeding.

          -  Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any
             ingredient in the investigational product.
Treatment of Strongyloides Infection
Condition: Strongyloides Stercoralis Infection; Strongyloidiasis
MeSH terms: Infections; Communicable Diseases; Strongyloidiasis
Intervention: Ivermectin
Intervention description: Ivermectin is an anti-parasitic
Intervention MeSH terms: Ivermectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ivermectin; S. stercoralis; parasite; helminth; Filariform; larvae; Baermann technique

Summary:

      The aim of this study is to evaluate the serologic response in patients with S. stercoralis
      infection after treatment with a regimen of two single doses of 200 µg/kg of ivermectin given
      2 weeks apart versus a regimen of two single doses of 200 µg/kg of ivermectin given in two
      consecutive days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Positive for Strongyloides serology infection (as determined by ELISA)

        Exclusion Criteria:

          -  Severe intestinal Strongyloides infection

          -  Disseminated Strongyloidiasis infection

          -  Pregnant and breastfeeding women

          -  HTLV-1 co-infection

          -  Patients with indeterminate results on Strongyloides serology

          -  Patients who are immunosuppressed

          -  Unable to read and understand consent form