bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Upadacitinib
Intervention description: Tablet; Oral; Tablet; Oral
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 661.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Musculoskeletal Disease; Arthritis; Joint Disease; Anti-inflammatory agents; Antirheumatic agents; Upadacitinib; ABT-494

Summary:

      The primary objectives of this study are to compare the efficacy, safety, and tolerability of
      upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and
      symptoms of adults with moderately to severely active rheumatoid arthritis who were on a
      stable dose of csDMARDs and had an inadequate response to csDMARDs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female, at least 18 years old.

          -  Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.

          -  Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for
             greater than or equal to 3 months and on a stable dose for greater than or equal to 4
             weeks prior to the first dose of study drug. The following csDMARDs are allowed:
             methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.

          -  Meets the following minimum disease activity criteria: greater than or equal to 6
             swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints
             (based on 68 joint counts) at Screening and Baseline Visits.

          -  Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled
             (up to 20% of study population) if they have documented evidence of intolerance to
             bDMARDs or limited exposure (less than 3 months) and have satisfied required washout
             periods.

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
             tofacitinib, baricitinib, and filgotinib).

          -  History of inflammatory joint disease other than RA. History of secondary Sjogren's
             Syndrome is permitted.

          -  Subjects who are considered inadequate responders to bDMARD therapy as determined by
             the Investigator.
Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13-valent Pneumococcal Conjugate Vaccine; 7 valent pneumococcal conjugate vaccine
Intervention description: 1 dose at 2, 4, 6 and 12 months of age; 1 dose at 2, 4, 6 and 12 months of age
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1866.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nasopharyngeal Colonization; Streptococcus pneumoniae; Healthy Infants; Vaccines; Pneumococcal Conjugate Vaccine

Summary:

      This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine
      (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants aged 2 months (42-98 days) at time of enrolment.

          -  Available for the entire study period and whose parent/legal guardian can be reached
             by telephone.

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal vaccine.

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Contraindication to vaccination with a pneumococcal conjugate vaccine.
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Condition: Endotracheal Intubation; Continuous IV Sedation; ICP Monitoring
Intervention: Standard-of-Care plus Dexmedetomidine; Standard-of-Care
Intervention description: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment; Subjects who are treated with the standard of care sedation regiment only.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in
      addition to the current standard-of-care for sedation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to Duke University Neuro Critical Care Unit (NCCU)

          -  Adult (18 years of age or older)

          -  Expected Mechanical Ventilation for >48 hours with sedation

          -  Intraventricular catheter in situ

        Exclusion Criteria:

          -  Hypersensitivity to study drugs

          -  Prisoners

          -  Moribund state or death expected within 24 hours

          -  Surgery planned within 24 hours of subject enrollment

          -  Receiving study drug, Precedex, prior to entering study
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections
Intervention: Ciprofloxacin; Non-quinolone antibiotic
Intervention description: Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label; Common used dose and route
Intervention MeSH terms: Anti-Bacterial Agents; Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1029.0
Sex: All
Minimum age: 2 Months
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Pediatrics; Safety; Musculoskeletal System; Neurologic Manifestations; Joint Diseases; Joint Deformities, Acquired

Summary:

      Objective and subjective musculoskeletal evaluations will be performed to determine
      differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we
      can tell what the natural occurrence of such musculoskeletal conditions is in the general
      pediatric population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is >/= 2 months of age through 16 years of age

          -  A parent/caregiver must sign an informed consent

          -  Patient must provide assent, as appropriate based on local institutional review board
             guidelines

        Exclusion Criteria:

          -  Patients presenting with the following conditions:

               -  exacerbations of cystic fibrosis (CF)

               -  meningitis

               -  Brain abscess

               -  bacterial endocarditis,

               -  Bone and joint infections

          -  having any of the following conditions but lacking a personal history may be admitted
             to the trial:

               -  Arthritis

               -  Juvenile rheumatoid arthritis (JRA)

               -  Rheumatoid arthritis (RA)

               -  Systemic lupus erythematosis (SLE)

               -  History of rheumatic fever

               -  Psoriasis

               -  Inflammatory bowel disease

               -  Osteoarthritis (OA)

          -  Known underlying rheumatological disease, joint problems known to be associated with
             arthropathy.

          -  Patients with any pre-treatment baseline musculoskeletal exam abnormalities

          -  Known risk of experiencing seizures, a history of any convulsive disorders

          -  Requiring any concomitant therapeutic course of systemic antibacterial agent

          -  Participation in any industry-sponsored clinical drug development study within one
             month prior to this study

          -  Known significant liver impairment (ALAT/ASAT and/or baseline bilirubin > 3 times
             upper limit of normal)

          -  Known significant renal insufficiency (calculated creatinine clearance of < 30
             ml/min/1.73 m²)

          -  Are pregnant or lactating, or are sexually active and using unreliable contraception.
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
Condition: Lung Transplantation
Intervention: standard therapy; Everolimus
Intervention description: centre specific CNI-based triple drug immunosuppression; quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids
Intervention MeSH terms: Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung transplantation; everolimus; kidney function; renal function

Summary:

      This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive
      regimen versus a standard immunosuppressive regimen concerning kidney function in lung
      transplant recipients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment

        Exclusion criteria:

          -  Patients with thrombocytopenia (platelets <100,000/mm³), with an absolute neutrophil
             count of <1,500/mm³ or leucopenia (leucocytes <3000/mm³), with anemia with Hb < 8g/dl
             at time of screening

          -  Patients with uncontrolled hypercholesterolemia (> 350 mg/dL; > 9.1 mmol/L) or
             hypertriglyceridemia (> 750 mg/dL; > 8.5 mmol/L) at time of screening

          -  Patients with a history of malignancy of any organ system, treated or untreated,
             during the last five years, whether or not there is evidence of local recurrence or
             metastases, except squamous or basal cell carcinoma of the skin Other protocol-defined
             inclusion/exclusion criteria may apply
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab; Placebo; Atorvastatin; Ezetimibe; Diet Only
Intervention description: Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month; Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.; Background lipid lowering therapy: ezetimibe 10 mg orally once a day; Diet only, no lipid lowering background drug given
Intervention MeSH terms: Atorvastatin; Ezetimibe; 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: 905.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cholesterol; High Cholesterol; Elevated Cholesterol; Raised Cholesterol

Summary:

      To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC)
      evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent.

          -  Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background
             lipid-lowering therapy:

               -  < 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk
                  equivalent

               -  < 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent

               -  OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO
                  QD and ezetimibe 10 mg PO QD

          -  Fasting triglycerides ≤ 400 mg/dL

        Exclusion Criteria:

          -  New York Heart Association (NYHA) II-IV heart failure, or last known left ventricular
             ejection fraction < 30%

          -  Uncontrolled cardiac arrhythmia

          -  Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
             coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization,
             type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes

          -  Uncontrolled hypertension
Study of rhASB in Patients With Mucopolysaccharidosis VI
Condition: Mucopolysaccharidosis VI
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis VI
Intervention: N-acetylgalactosamine 4-sulfatase; Placebo/rhASB
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment
      in patients with Mucopolysaccharidosis VI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient consent

          -  Patient must have successfully completed study ASB-03-05, including having received at
             least 20 of 24 scheduled weekly infusions and having missed no more then two
             consecutive infusions

          -  If female of childbearing potential, patient must have a negative pregnancy test

        Exclusion Criteria:

          -  Pregnant or lactating patient

          -  Patient has received an investigational drug within 30 days prior to study enrollment

          -  Patient is unwilling or unable to travel to the primary site for periodic assessments
Video Double-Lumen Tube Prospective Randomized Study
Condition: Other Surgical Procedures
Intervention: Non-Video Double Lumen Tube (DLT); Fiberoptic Bronchoscopy (FOB); Video Double Lumen Tube (VDLT)
Intervention description: Participant receives non-video double lumen tube (DLT) placement before surgery.; Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.; Participant receives video double lumen tube (VDLT) placement before surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Surgical Procedure; Fiberoptic bronchoscopy; FOB; Non-Video Double Lumen Tube; DLT; Video Double Lumen Tube; VDLT

Summary:

      The goal of this clinical research study is to learn how often a fiberoptic bronchoscopy (FOB
      -- also known as a fiberoptic scope procedure) needs to be used with a video double lumen
      tube (VDLT) during surgeries that require lung isolation. On this study, you will have one of
      2 types of commonly-used breathing tubes used, either a VDLT or a non-video double lumen tube
      (called a non-video DLT). An FOB may or may not be performed, as described below.

      The level of effectiveness of the VDLT and non-video DLT will be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients need lung isolation for purposed surgery

          2. 18 years or older

          3. All patients to give written informed consent to participate

        Exclusion Criteria:

          1. Patient with known tracheobronchial anatomical anomalies

          2. Patient requiring emergency operations

          3. Patients with known difficult airways

          4. Patients where other lung isolation devices may be warranted (tracheostomy, nasal
             intubation)

          5. Patient requiring sizes not available in DLT or VDLT

          6. Patients requiring a right sided VDLT or DLT
Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Condition: Dehydration, Diverting Ileostomy, Loperamide
MeSH terms: Dehydration
Intervention: Loperamide
Intervention description: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
Intervention MeSH terms: Loperamide; Antidiarrheals
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced
      by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and
      familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or
      other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may
      potentially have a delay in the adjuvant therapy when faced with this complication.

      Studies performed in this groups of patients report a readmission rate of 17-21% for
      dehydration.

      Loperamide has been shown to significantly decrease the daily volume of weight of stool in
      these patients.

      The purpose of this study is to establish whether loperamide given at 4mg three times daily
      for 14 days from day of discharge empirically decreases 30 days readmission rate for
      dehydration.

      The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the
      readmission rates, that severity of dehydration will be decreased.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to freely give written informed consent to participate in the study and have
             signed the Informed Consent Form;

          2. Males or females, age 18 and older at the time of study screening;

          3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing
             elective surgery

        Exclusion Criteria:

          1. Mentally incompetent or unable or unwilling to provide informed consent or comply with
             study procedures

          2. American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries

          3. Children <18

          4. Pregnant patients

          5. Patients who have intra-abdominal sepsis or partial or intermittent bowel obstruction
             or enteritis

          6. Patients who are on long term steroids, opioids or antidiarrheals pre operatively

          7. Patients who are administered pro kinetics eg. Metoclopramide

          8. Patients with recurrent disease in their small bowel - Crohn's disease, or previous
             irradiated pelvis resulting in irradiation bowel disease

          9. End ileostomies
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: pirfenidone
Intervention description: Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
Intervention MeSH terms: Pirfenidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1058.0
Sex: All
Minimum age: 40 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: idiopathic; pulmonary; fibrosis

Summary:

      This is an open-label, multi-center, extension study for patients with IPF who complete a
      qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain
      additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a
      qualifying InterMune clinical trial of pirfenidone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completes the qualifying clinical study final visit

          -  In the opinion of the principal investigator (PI), has been generally compliant with
             study requirements during the qualifying study, or must be considered eligible to
             enroll in PIPF-012 by the InterMune medical monitor

          -  Is able to provide informed consent and comply with the requirements of the study

        Exclusion Criteria:

          -  Is pregnant or lactating

          -  Has known hypersensitivity to any of the components of the study drug

          -  Starts participation in another interventional clinical trial between the end of
             participation in the qualifying InterMune clinical trial and entry into PIPF-012

          -  Receives concomitant and/or excluded medications as defined in the protocol

          -  Permanently discontinues study drug during the qualifying study for any reason before
             study completion
Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
Condition: Appendicitis
MeSH terms: Appendicitis
Intervention: Diagnostic CT; Diagnostic CT
Intervention description: 2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose)); 8 mSv in an average patient (Standard-dose CT)
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 891.0
Sex: All
Minimum age: 15 Years
Maximum age: 44 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether low-dose CT is not inferior to
      standard-dose CT in the rate of unnecessary appendectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suspected of having acute appendicitis

          -  Referred for abdomen CT from Emergency Department

        Exclusion Criteria:

          -  Body mass index < 18.5 kg/m2 (ultrasonography is favored)

          -  Intravenous contrast-enhancement is contraindicated