bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: CHS-1420; Adalimumab
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 545.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PsO

Summary:

      This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults

          -  PsO diagnosis for 6 months

          -  Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment
             (PSGA) score greater than or equal to 3 (based on a scale of 0-5),

          -  Body Surface Area (BSA) involved with PsO greater than or equal to 10%

        Exclusion Criteria:

          -  Forms of psoriasis other than PsO

          -  Drug induced psoriasis

          -  Positive QuantiFERON-tuberculosis (TB) Gold Test

          -  Presence of significant comorbid conditions

          -  Chemistry and hematology values outside protocol specified range

          -  Major systemic infections
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Condition: Methamphetamine Use Disorder
Intervention: Naltrexone: Vivitrol®; Placebo (PLB) Injectable; Bupropion: Wellbutrin XL®; Placebo (PLB) Oral
Intervention description: Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks; Placebo: 4 intramuscular injections administered every 3 weeks; Bupropion: 450 mg oral dose daily; Placebo: once-daily oral placebo tablets
Intervention MeSH terms: Naltrexone; Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: During the study, participants may or may not be switched to another group due to the adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Methamphetamine; Methamphetamine Use Disorder; Naltrexone; Bupropion; Vivitrol®

Summary:

      This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy
      of extended-release naltrexone plus bupropion as a combination pharmacotherapy for
      methamphetamine use disorder. Participants will be randomly assigned to the active medication
      combination (AMC) group or matching placebo group and will receive medications over the
      course of 12 weeks. Follow-ups will occur in weeks 13 and 16.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 65 years old;

          -  Interested in reducing/stopping methamphetamine use;

          -  Speak English;

          -  Agree to use acceptable birth control (if applicable);

          -  Be opioid-free at randomization;

          -  Willing to comply with all study procedures and medication instructions;

          -  Agree to use a cell phone (or similar study device) to take videos of medication
             dosing.

        Exclusion Criteria:

          -  Medical or psychiatric condition which would make participation unsafe;

          -  Recently participated in a study of pharmacological or behavioral treatment for
             methamphetamine use disorder;

          -  Recently taken an investigational drug;

          -  Prescribed and taken naltrexone or bupropion ≤ 30 days from consent;

          -  Current or planned extended absence during study period (e.g., jail, surgery, pending
             legal action);

          -  Currently pregnant or breastfeeding.
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: adalimumab
Intervention description: Subcutaneous Injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: efficacy; safety; adalimumab; japanese participants

Summary:

      This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese
      subjects with moderate to severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have a diagnosis of HS;

          -  Participant must have any HS symptom at least 6 months prior to Baseline;

          -  HS lesions must be present in at least 2 distinct anatomic areas, one of which must be
             Hurley Stage II or Hurley Stage III;

          -  Participant must have stable HS for at least 2 months (60 days) prior to Screening and
             also at the Baseline visit;

          -  Participant must have a total abscess and inflammatory nodule (AN) count of greater
             than or equal to 3 at the Baseline visit.

        Exclusion Criteria:

          -  Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or
             participation in adalimumab trial;

          -  Any other active skin lesion or condition that may interfere with assessment of HS;

          -  Participants received antibiotic treatment for HS within 28 days prior to the Baseline
             visit other than those allowed per protocol. Participant on permitted oral antibiotic
             treatment (doxycycline or minocycline only) for HS who have not been on a stable dose
             for at least 28 days prior to the Baseline visit;

          -  Participants received prescription topical therapies for the treatment for HS within
             14 days prior to the Baseline visit;

          -  Participants received systemic non-biologic therapies with potential therapeutic
             impact for HS less than 28 days prior to the Baseline visit;

          -  Participants received oral concomitant analgesics (non-opioids and opioids) for
             HS-related pain within 14 days prior to the Baseline visit.
Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation
Condition: Pain Management, Cervical Preparation
MeSH terms: Dilatation, Pathologic
Intervention: Lidocaine Gel (2%); Lidocaine Paracervical Block (1%)
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study seeks to compare self-administered lidocaine gel for pain control during cervical
      preparation for dilation and evacuation (D&E) to paracervical block.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18 and older

          -  Intrauterine pregnancy ≥16 weeks gestation

          -  English speaking competency

          -  Willing and able to sign consent forms

          -  Agree to comply with study procedures

        Exclusion Criteria:

          -  Women less than 18 years of age

          -  IV conscious sedation

          -  Known allergy to study medication (lidocaine)

          -  Any women not meeting inclusion criteria above will be excluded from participation
Treatment of Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: botulinum toxin; Placebo
Intervention description: neuromodulator to be injected in the GL region; Placebo to be injected in the GL area
Intervention MeSH terms: Botulinum Toxins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to evaluate the efficacy and safety of a single dose of
      QM1114-DP compared to placebo for the treatment of moderate to severe GL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years of age or older.

          2. Moderate to severe GL at maximum frown as assessed by the Investigator.

          3. Moderate to severe GL at maximum frown as assessed by the subject.

        Exclusion Criteria:

          1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study
             treatment.

          2. Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          3. Known allergy or hypersensitivity to any component of the investigational product
             (QM1114-DP) or any botulinum toxin serotype.
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: Cilofexor; Placebo
Intervention description: 100 mg tablet administered orally once daily; Tablet administered orally once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 419.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate whether cilofexor reduces the risk of
      fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of large duct PSC

          -  Liver biopsy at screening that is deemed acceptable for interpretation and
             demonstrates stage F0 - F3 fibrosis in the opinion of the central reader

          -  Individual has the following laboratory parameters at the screening visit, as
             determined by the central laboratory:

               -  Platelet count ≥ 150,000/mm^3

               -  Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as
                  calculated by the Cockcroft-Gault equation

               -  Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)

               -  Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's
                  syndrome or hemolytic anemia

               -  International normalized ratio (INR) ≤ 1.4, unless due to therapeutic
                  anticoagulation

               -  Negative anti-mitochondrial antibody

        Key Exclusion Criteria:

          -  Current or prior history of any of the following:

               -  Cirrhosis

               -  Liver transplantation

               -  Cholangiocarcinoma or hepatocellular carcinoma (HCC)

               -  Ascending cholangitis within 30 days of screening

          -  Presence of a percutaneous drain or biliary stent

          -  Other causes of liver disease

          -  Current or prior history of unstable cardiovascular disease

          -  Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative
             colitis, Crohn's disease, and indeterminate colitis)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
Buprenorphine Group Medical Visits in Primary Care
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: G-BMT; Treatment as usual; Buprenorphine
Intervention description: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.; Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.; All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid use disorder; group counseling; office-based buprenorphine treatment

Summary:

      The primary goal of this research is to improve the effectiveness of buprenorphine
      maintenance treatment (BMT) within primary care.

      Investigators propose that providing BMT as part of a group medical visit (instead of an
      individual visit) will improve treatment outcomes for patients with persistent opioid abuse,
      because members become accountable to the group, are exposed to beneficial habits of others
      (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly
      with medical management
    

Eligibility criteria:

        Inclusion Criteria:

          1. Currently receiving BMT at Montefiore community health center (CHC).

          2. Received BMT for 12 or more weeks.

          3. Persistent opioid abuse (positive toxicology for an unprescribed opioid at most recent
             test or in 50% or more of collected tests in the previous 6 months.)

          4. Fluent in English of Spanish

        Exclusion Criteria:

        1) Pregnancy
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Remdesivir; Standard of Care
Intervention description: Administered as an intravenous infusion; Standard of Care Treatment for COVID-19 Infection
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4891.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV)
      regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent, or with a legal representative
             who can provide informed consent, or enrolled under International Conference on
             Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the
             investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18,
             where locally and nationally approved) prior to performing study procedures

          -  Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg
             (where permitted according to local law and approved nationally and by the relevant
             institutional review board (IRB) or independent ethics committee (IEC))

          -  Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
             polymerase chain reaction (PCR) test ≤ 4 days before randomization

          -  Currently hospitalized

          -  Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen
             at screening

        Key Exclusion Criteria:

          -  Participation in any other clinical trial of an experimental treatment for COVID-19

          -  Concurrent treatment with other agents with actual or possible direct acting antiviral
             activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing

          -  Evidence of multiorgan failure

          -  Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane
             oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.

          -  Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit
             of normal (ULN)

          -  Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥
             18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of
             age

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus
Condition: Left Ventricular Thrombosis
MeSH terms: Thrombosis
Intervention: Apixaban 5 MG Oral Tablet [ELIQUIS]; Warfarin Sodium
Intervention description: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.; as controlled arm since warfarin is the standard therapy for LV thrombus
Intervention MeSH terms: Warfarin; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the novel oral anticoagulant apixaban with the
      standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus
      over 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 - 80 years old

          2. Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG
             1996), with regional wall motion abnormalities

          3. HASBLED score less than 3

          4. No episodes of major bleeding in the past 6 months a) Major bleeding defined as i.
             episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL
             - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion
             (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and
             lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits

        Exclusion Criteria:

          1. Patient with unstable arrhythmias and/or recurrent cardiogenic shock

          2. Patient with large ischemic stroke on recruitment-defined as involving >1/3 of
             cerebral hemisphere or deemed to have high chance of haemorrhagic transformation

          3. Patient with permanent pacemaker

          4. Patient who is post valve replacement therapy

          5. Patient who is pregnant.

          6. Patient with advanced kidney disease at stage V and not on dialysis (CrCl <15 mL/min)

          7. Patient with advanced liver disease with coagulopathy

          8. Patient with organized and old left ventricular thrombus
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Mirikizumab
Intervention description: Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Initially double-blind (until original, pivotal studies AMAK [NCT03482011] and AMAJ [NCT03535194] are locked and unblinded), then open-label.
Enrollment: 1936.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IL-23; Interleukin-23; Psoriasis

Summary:

      The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of
      mirikizumab in participants with moderate-to-severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have completed the last visit of an eligible study period of
             originating study.

          -  Participant must be willing to follow the birth control measures during and after
             study treatment if woman of childbearing potential.

        Exclusion Criteria:

          -  Participant must not have an unstable or uncontrolled illness, including but not
             limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal,
             endocrine, hematologic, or neurologic disease or abnormal lab results, that the study
             investigator thinks makes it unsafe or inappropriate for the participant to
             participate in this study.

          -  Participant must not have stopped taking mirikizumab during a previous study or if the
             study investigator thinks restarting mirikizumab would create an unacceptable risk to
             the participant.
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: TNX-102 SL; Placebo SL Tablet
Intervention description: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
Intervention MeSH terms: Cyclobenzaprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Sleep; Fibromyalgia; FM

Summary:

      This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week
      study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets)
      taken daily at bedtime for the treatment of fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is male or female 18 to 65 years of age, inclusive.

          -  The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the
             2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology
             Preliminary Diagnostic Criteria)

          -  The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit
             within protocol defined range.

        Exclusion Criteria:

        - History of or evidence for a diagnosis of borderline personality disorder (BPD).