bioihbjkbjnl/mcl2 huggingface dataset:
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Filgotinib; Placebo to match filgotinib; Adalimumab; Placebo to match adalimumab; MTX
Intervention description: 200 mg or 100 mg tablet(s) administered orally once daily; Tablet(s) administered orally once daily; 40 mg administered via subcutaneous injection once every two weeks; Administered via subcutaneous injection once every two weeks; Commercially sourced tablet(s) administered orally
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1759.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effects of filgotinib versus placebo
      for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the
      percentage of participants achieving an American College of Rheumatology 20% improvement
      response (ACR20) at Week 12.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a diagnosis of rheumatoid arthritis (RA) [2010 American College of Rheumatology
             (ACR)/European League Against Rheumatism (EULAR) criteria] , and are ACR functional
             class I-III.

          -  Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥
             6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both
             screening and Day 1.

          -  Ongoing treatment with a stable dose of MTX

        Key Exclusion Criteria:

          -  Previous treatment with any janus kinase (JAK) inhibitor

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Arimoclomol in Amyotropic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Arimoclomol; Placebo
Intervention description: 2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily; 2 matched placebo capsules taken 3 times daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arimoclomol; ALS

Summary:

      A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate
      the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets revised El Escorial criteria for clinically possible, clinically
             probable / clinically probable ALS laboratory-supported, clinically definite ALS or
             clinically definite familial ALS laboratory-supported

          -  18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria,
             dysphagia, shortness of breath)

          -  ALS Functional Rating Scale-Revised (ALSFRS-R) equal to or above 35 and erect (seated)
             Slow Vital Capacity (SVC) % predicted equal to or above 70% at Screening

        Exclusion Criteria:

          -  Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking
             hours at the time of Screening and Baseline

          -  Pregnant or breast-feeding

          -  Current or anticipated use of diaphragmatic pacing

          -  Any other relevant medically significant condition which could present risk to the
             subject or interfere with the assessment of safety or has an increased risk of causing
             death during the trial
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B (thiomersal-free) 20µg; 10 μg Engerix™-B (preservative-free); placebo
Intervention description: In the primary study: 2 deep intramuscular injections (Months 0, & 6); In the primary study: 3 deep intramuscular injections (months 0, 1 & 6); In the primary study: 1 deep intramuscular injection (month 1)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 267.0
Sex: All
Minimum age: 13 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Persistence; Hepatitis B vaccine

Summary:

      To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months
      after the first dose of the hepatitis B primary vaccination course.

      Subjects were aged 11 to 15 years at the time of the primary vaccination course.

      At the time of enrollment in the present long-term follow-up study subjects were aged 13 to
      18 years.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects have participated in primary study HBV-280

          -  Written informed consent will be obtained from each subject and/ or parent or guardian
             of the subject before the blood-sampling visit of each year
Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
Condition: Surgery
Intervention: Neostigmine+glycopyrrolate; Sugammadex
Intervention description: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate; At the conclusion of surgery neuromuscular blockade reversed with sugammadex
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuromuscular blockade; sugammadex; SUG; neostigmine; NEO/GLYCO; 17-207

Summary:

      The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate
      and sugammadex) to see if one drug improves patient comfort regarding the return of muscle
      strength after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients age 18 years of age or greater who are capable of giving consent

          -  Undergoing surgical procedures of expected length 6 </= hours requiring NMB

        Exclusion Criteria:

          -  Pregnancy

          -  History of documented anaphylaxis or contraindication to any of the study medications

          -  Active coronary disease with a positive cardiac stress test

          -  History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 <
             50% of predicted

          -  Serum Creatinine >/= 2.0 mg/dL

          -  Severe hepatic dysfunction accompanied by coagulopathy

               -  Definition:

               -  Known liver Disease AND

               -  INR > 1.5 (except for patients on anticoagulants) AND

               -  Platelet count <100,00/ul without other obvious cause

          -  Chronic sustained release opioid for > 2 weeks duration pre op (in the 30 days prior
             to surgery)

          -  Use of toremifene

          -  Significant cognitive impairment or documented psychologic impairment

          -  Myasthenia gravis or other neuromuscular disease

          -  Patients who are not eligible for standard anesthetic induction, eg, those needing
             rapid sequence induction or awake fiberoptic bronchial intubation.

          -  American Society of Anesthesiologists (ASA) Status > 3
Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)
Condition: Breast Cancer
Intervention: Paravertebral Block; Pectoral Nerve Block
Intervention description: 20-30 mL 0.5% Ropivacaine; 20-30 mL 0.5% Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).
Masking: None (Open Label)
Enrollment: 89.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Surgery; Breast; Pectoral Nerve Block; Paravertebral Block; Analgesia; Mastectomy

Summary:

      The purpose of this study is to compare two standard methods of pain control management used
      at Spectrum Health for patients undergoing breast surgery. The two methods being compared are
      the paravertebral block (PVB) and the pectoral nerve block (PEC). Postoperative pain control
      is essential following any major operative procedure. A variety of methods have been used to
      ensure adequate pain control, each with its own advantages and risks. Increasingly, attention
      has focused on regional methods of analgesia, which may allow for reduction in systemic
      narcotic use and their associated complications. Proposed benefits of regional analgesia and
      a resultant reduction in narcotic use include decreased risk of cancer progression, decreased
      length of stay, and decreased risk of ileus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients ≥ 18 years of age

          -  Total mastectomy or partial mastectomy with or without reconstruction OR planned
             lumpectomy.

          -  Patient determined by their surgeon as medically able to receive a regional block for
             post-operative analgesia

          -  Patient agrees to participate in the study and signs informed consent

        Exclusion Criteria:

          -  Neoadjuvant radiation therapy

          -  Stage IV cancer

          -  Previous breast surgery (excluding percutaneous biopsies of all types)

          -  History of either PVB or PEC procedures

          -  Planned general anesthesia use during surgery

          -  Allergies to ropivacaine, midazolam, fentanyl, or propofol

          -  Pregnant women

          -  Prisoners

          -  Adults unable to consent

          -  Non-English-speaking patients
Cancer Venous Thromboembolism (VTE)
Condition: Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Cancer
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Edoxaban; Dalteparin; Low molecular weight heparin
Intervention description: After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.; Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.; Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.
Intervention MeSH terms: Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1046.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Active Cancer with Metastasis

Summary:

      The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short
      course of LMWH) compared with dalteparin for the prevention of the combined outcome of
      recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with
      cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will
      be compared with dalteparin for superiority.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects with age ≥ 18 years or the otherwise legal lower age according
             to the country of residence;

          -  Confirmed acute lower extremity proximal DVT or PE for which long term treatment with
             low molecular weight heparin (LMWH) is indicated;

          -  Cancer, other than basal-cell or squamous-cell carcinoma of the skin;

          -  Able to provide written informed consent.

        Exclusion Criteria:

          -  Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
             current (index) episode of DVT and/or PE;

          -  Treatment with therapeutic doses of an anticoagulant other than that used for
             pretreatment of the current (index) VTE episode prior to randomization;

          -  Active bleeding or high risk for bleeding contraindicating treatment with LMWH or
             edoxaban;

          -  Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or
             edoxaban;
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Condition: Sialorrhea
MeSH terms: Sialorrhea
Intervention: MYOBLOC; PLACEBO
Intervention description: MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
Intervention MeSH terms: rimabotulinumtoxinB; 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: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Sialorrhea; Parkinson's disease; Amyotrophic lateral sclerosis (ALS); stroke; neuroleptics

Summary:

      This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea
      (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected
      directly into the salivary glands. MYOBLOC has been shown in previous trials to safely
      decrease saliva production, thereby demonstrating its potential as a safe and effective
      treatment for troublesome sialorrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring
             secondary to any disorder or related to any cause

          -  Investigator sites will review entire list of inclusion criteria with potential
             subjects

        Exclusion Criteria:

          -  Any known prior exposure to botulinum toxin type B, or known adverse reaction or
             sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC
             solution components.

          -  Prior botulinum toxin treatment to the salivary glands at any time

          -  Investigator sites will review entire list of exclusion criteria with potential
             subjects
Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: glycopyrronium Topical Wipes; Vehicle
Intervention description: Topical wipes containing glycopyrronium; Vehicle (placebo) topical wipes
Intervention MeSH terms: Glycopyrrolate
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: 9 Years
Healthy volunteers: No

Summary:

      The study is a randomized, double-blind, vehicle controlled, parallel group study, designed
      to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to
      vehicle in subjects with axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 9 years of age.

          -  Primary, axillary hyperhidrosis of at least 6 months duration.

          -  Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline.

          -  Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline.

          -  Sweat production of at least 50 mg over 5 minutes in each axilla assessed
             gravimetrically.

        Exclusion Criteria:

          -  Prior surgical procedure for hyperhidrosis.

          -  Prior axillary treatment with an anti-hyperhidrosis medical device (approved or
             investigational).

          -  Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within
             1 year of Baseline/Day 1.

          -  Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.

          -  Axillary use of nonprescription antiperspirants within 1 week or prescription
             antiperspirants within 2 weeks of Baseline.

          -  Subjects on new or regimens of psychotherapeutic medications that have changed within
             2 months of baseline.

          -  Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless
             dosing has been stable for at least 4 months.

          -  Other treatment with glycopyrrolate within 4 weeks prior to Baseline.

          -  Secondary axillary hyperhidrosis or presence of a condition that may cause secondary
             hyperhidrosis.

          -  History of Sjögren's syndrome or Sicca syndrome.

          -  History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.

          -  Men with a history of urinary retention requiring catheterization due to prostatic
             hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

          -  History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.

          -  Other systemic diseases or active uncontrolled infections, or any other condition
             which, in the judgment of the Investigator, would put the subject at unacceptable risk
             for participation in the study.
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis (SAR)
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: GSP 301 NS; GSP 301 Placebo NS
Intervention description: 1 spray in each nostril twice daily for 14 days; 1 spray in each nostril twice daily for 14 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 446.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis

Summary:

      Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared
      with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic
      Rhinitis (SAR).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects aged ≥6 to <12 years

          2. Clinical history of SAR (at least 2 years) with exacerbations during the study season
             for the relevant seasonal allergen (e.g., tree/grass pollen)

          3. Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick
             test within 12 months prior to screening

          4. A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening

          5. Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

        Exclusion Criteria:

          1. Females of childbearing potential or pregnant

          2. Plans to travel outside the known pollen area for the investigational site for 24
             hours or longer during the last 7 days of the run-in period.

          3. History of anaphylaxis and/or other severe local reaction(s) to skin testing

          4. History and evidence of acute or significant chronic sinusitis or chronic purulent
             post nasal drip

          5. Subjects with an active pulmonary disorder or infection.

          6. Subjects with posterior subcapsular cataracts or glaucoma
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Condition: Bipolar I Disorder
Intervention: SM-13496
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 495.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I
      disorder.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who completed the D1002001 study

        ・Patients who completed the D1002001 study and who are considered by the investigator to be
        eligible and without safety concerns.

        Patients who did not participate in the D1002001 study

          -  Patients who were fully informed of and understand the objectives, procedures, and
             possible benefits and risks of the study and who provided written voluntary consent to
             participate in the study.

          -  Outpatients aged 18 through 74 years at the time of consent

          -  Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode manic,
             hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood
             disturbance, but < 8 episodes in the previous 12 months prior to screening).

        Exclusion Criteria:

          -  Patients with imminent risk of suicide or injury to self, others, or property.

          -  Patients who are otherwise considered ineligible for the study by the investigator.