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
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
Condition: Cystic Fibrosis; Pancreatic Exocrine Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Pancrelipase Delayed Release; Placebo Comparator
Intervention description: 12,000 unit Capsules, dosed individually based on fat intake.; Placebo
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Pancreatic Exocrine Insufficiency

Summary:

      This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat
      and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to
      Cystic Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis

          -  Confirmed PEI by historical Coefficient of fat Absorption < 70% without
             supplementation or current or historical fecal elastase < 50µg/stool (within the last
             12 months)

          -  Currently receiving treatment with a commercially available pancreatic enzyme product
             on a stable dose for more than 3 months

          -  Clinically stable condition without evidence of acute respiratory disease or any other
             acute condition

          -  Stable body weight and agrees to abstain from sexual activity

        Exclusion Criteria:

          -  Ileus or acute abdomen

          -  History of fibrosing colonopathy, celiac disease, gastrectomy, Crohn´s disease and
             small bowel surgery other than minor resection due to meconium ileus without resulting
             in malabsorption syndrome

          -  History of distal ileal obstruction syndrome within 6 months of enrollment

          -  Use of an immunosuppressive drug

          -  Any type of malignancy involving the digestive tract in the last 5 years

          -  Known infection with HIV
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: Inhaled Iloprost (5 μg); Inhaled Placebo; Sildenafil; Bosentan
Intervention description: iloprost inhalation solution (Ventavis) (5 μg); inhaled placebo; oral sildenafil (dosage between 60 and 300 mg/day); oral bosentan (dosage between 62.5 and 125 mg BID)
Intervention MeSH terms: Bosentan; Sildenafil Citrate; Iloprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 12 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: PAH; Pulmonary Arterial Hypertension

Summary:

      The purpose of this multi-center international trial is to evaluate the safety and
      effectiveness of adding iloprost or placebo (an inactive substance that contains no active
      study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will
      also examine whether patients on sildenafil can reduce the number of iloprost inhalations
      from the approved 6 doses per day to 4 doses per day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 12-85 years; of either gender.

          -  Confirmed PAH due to idiopathic pulmonary arterial hypertension (IPAH) or familial
             pulmonary arterial hypertension (FPAH).

          -  6-minute walk distance (6-MWD) between 100-450 meters at screening.

          -  On a stable dose of sildenafil, with or without bosentan.

        Exclusion Criteria:

          -  Any treatment for PAH with prostacyclins, prostacyclin analogues, endothelin-1
             antagonists, or phosphodiesterase-5 (PDE-5) inhibitors other than sildenafil within
             the past 12 weeks.

          -  Pulmonary hypertension due to conditions other than those stated in inclusion
             criteria.

          -  Additional PAH medications added within the past 12 weeks.
Midodrine for the Treatment of Refractory Hypotension
Condition: Hypotension; Critical Illness
MeSH terms: Hypotension; Critical Illness
Intervention: Midodrine; Placebo
Intervention description: Patients will be randomized to blinded to 20 mg of midodrine; Patients will be randomized to blinded placebo control
Intervention MeSH terms: Midodrine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Midodrine; Hypotension; Intensive care unit; IV vasopressors; ICU discharge

Summary:

      We hypothesize that midodrine treatment of refractory hypotension in patients otherwise ready
      for discharge from the ICU shortens duration of receiving IV vasopressors and SICU length of
      stay without increasing MGH length of stay or putting the patient at risk of being readmitted
      to an ICU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Admitted to the SICU

          -  Requiring IV vasopressors at a rate of less than 100 mcg/min of phenylephrine, or 8
             mcg/min of norepinephrine, or 60 mcg/min of metaraminol; and unable to wean for more
             than 24 hours while still maintaining desired blood pressure goal

        Exclusion Criteria:

          -  Inadequate tissue oxygenation

          -  Liver failure

          -  Renal failure

          -  Hypovolemic shock or hypotension due to adrenal insufficiency

          -  Pregnancy

          -  Severe organic heart disease

          -  Urinary retention

          -  Pheochromocytoma

          -  Thyrotoxicosis

          -  Midodrine as pre-admission medication

          -  Any known allergies to midodrine

          -  Enrollment in another clinical trial
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Telaprevir; pegylated interferon (Peg-IFN) alfa-2a; ribavirin (RBV)
Intervention description: 750 mg orally every 8 hours (q8h) for 12 weeks; 180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.; 1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Telaprevir; Roll-over study

Summary:

      The purpose of this study is to provide access to telaprevir for patients from the control
      group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and
      tolerability of telaprevir in combination with standard treatment will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient from the control group of the C216 study who failed therapy for virologic
             reasons

          -  Patient must have completed all assessments in the C216 trial

          -  Patient must be willing to use 2 effective methods of birth control for up to 7 months
             after last dose of study medication

        Exclusion Criteria:

          -  Patient received any direct acting anti-viral HCV therapy after discontinuation of the
             C216 trial

          -  Patient has history of decompensated liver disease

          -  Patient has history of acute or chronic pancreatitis

          -  Patient has condition that requires use of systemic corticosteroids

          -  Patient who prematurely stopped medication for non-compliance or for whom it would be
             unsafe to repeat treatment

          -  Patient has history of decompensated liver disease or history of cirrhosis with
             hepatocellular carcinoma
A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Tislelizumab; Paclitaxel; Nab-paclitaxel; Carboplatin
Intervention description: Administered intravenously as described; Administered intravenously as described; Administered intravenously as described; Administered intravenously as described
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Tislelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and
      safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line
      treatment in advanced squamous non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age 18-75 years old, male or female, and signed informed consent form (ICF)

          2. Advanced NSCLC diagnosed by pathological or clinical physicians

          3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

          4. Participants must have ≥ 1 measurable lesion as defined per Response Evaluation
             Criteria in Solid Tumors (RECIST) v1.1

          5. Must be treatment-naive for locally advanced or metastatic squamous NSCLC

          6. Life expectancy ≥ 12 weeks

          7. Participants must have adequate organ function

          8. Male/Female is willing to use a highly effective method of birth control

        Key Exclusion Criteria:

          1. Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing
             mutation or anaplastic lymphoma kinase (ALK) gene translocation

          2. Received any approved systemic anticancer therapy

          3. Received prior treatment with EGFR inhibitors or ALK inhibitors

          4. Received prior therapies targeting programmed death 1 (PD-1) or programmed death
             ligand 1 (PD-L1)

          5. With history of interstitial lung disease

          6. Clinically significant pericardial effusion

          7. Severe infections, active leptomeningeal disease or uncontrolled, untreated brain
             metastasis

          8. Any major surgical procedure before randomization

          9. Human immunodeficiency virus infection

         10. Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)

         11. Active autoimmune diseases or history of autoimmune diseases

         12. History of allergic reactions to chemotherapy

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: fesoterodine fumarate
Intervention description: 12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.
Intervention MeSH terms: Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 516.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB)
      symptom relief in OAB patients who were dissatisfied with their prior therapy with
      tolterodine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per
             24 h documented in the baseline bladder diary)

          -  OAB patients dissatisfied with their prior therapy with tolterodine

        Exclusion Criteria:

          -  Patients with any contraindication to fesoterodine usage, e.g., urinary retention,
             gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to
             the drug or its ingredients.

          -  Patients with significant hepatic and renal disease or other significant unstable
             diseases.

          -  OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
             etc.
Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function
Condition: Renal Function; Endothelial Function; Blood Pressure; Overweight; Obesity
MeSH terms: Overweight
Intervention: Vitamin D ergocalciferol; Probenecid; Allopurinol; Placebo; Placebo
Intervention description: 50,000 unit soft gel capsule once per week for 8 weeks; 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total); 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total); Placebo soft gel once per week for 8 weeks; Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total)
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Allopurinol; Probenecid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: renin angiotensin system; vitamin D; uric acid; allopurinol; probenecid; endothelial function

Summary:

      The investigators hypothesize that, among non-hypertensive overweight and obese individuals,
      treatment of vitamin D deficiency and lowering uric acid concentrations (by either xanthine
      oxidase inhibition or increased renal excretion) will attenuate renin angiotensin system
      (RAS) activation, improve endothelial function, and lower blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25(OH)D < 20 ng/mL OR Uric acid ≥ 5 mg/dL

          -  Age ≥ 18, ≤ 75 years

          -  Body Mass Index (BMI) ≥ 25 kg/m^2

        Exclusion Criteria:

          -  Hypertension, or on BP-lowering medicine

          -  Diabetes

          -  Coronary Heart Disease

          -  estimated glomerular filtration rate (EGFR) <60 mL/min

          -  Kidney stones

          -  Active cancer (except non-melanoma skin cancer)

          -  Pregnant

          -  Taking vitamin D supplements and unwilling to stop

          -  Osteoporosis

          -  Hypo- or hypercalcemia

          -  Hypo- or hyperphosphatemia

          -  Known allergy to angiotensin-converting enzyme (ACE)-inhibitors

          -  Taking medication for hyperuricemia

          -  Gout, anemia, cirrhosis, active/chronic hepatitis, abnormal aspartate aminotransferase
             (AST), alanine aminotransferase (ALT) or total bilirubin levels, or anemia

          -  Known allergy to either allopurinol or probenecid

          -  Current use of didanosine, azothioprine, methotrexate, ketoprofen, ketorolac,
             mycophenolate, or ACE-inhibitors
Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
Condition: Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V; Lipidoses; Hyperlipidemias; Hyperlipoproteinemias
Intervention: MK-0524A; Atorvastatin; Simvastatin
Intervention MeSH terms: Atorvastatin; Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2340.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the
      effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A
      coadministered with simvastatin) will be superior to atorvastatin on decreasing the low
      denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio
      for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg
      MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg
      MK-0524B versus 80 mg atorvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant 18 to 80 years of age with Mixed Hyperlipidemia with LDL-C between 130 and
             190 mg/dL and Triglycerides between 150 and 500 mg/dL

        Exclusion Criteria:

          -  Pregnant or lactating women, or women intending to become pregnant

          -  Diabetes mellitus that is poorly controlled, newly diagnosed, or taking new or
             recently adjusted antidiabetic therapy (with the exception of ± 10 units of insulin)

          -  Human immunodeficiency virus (HIV) positive

          -  Any of the following within the past 3 months: heart attack, stoke, heart bypass
             surgery, unstable angina, angioplasty

          -  Active or chronic liver disease
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablets administered orally in a divided daily dose according to weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus (HCV); Ledipasvir/Sofosbuvir; Ribavirin

Summary:

      The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
      ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without
      ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or
      LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV RNA > 15 IU/mL at screening

          -  HCV genotype 1 or 4

          -  Chronic HCV infection (≥ 6 months)

          -  Prior virologic failure after treatment with SOF in combination with simeprevir (SMV)
             ± RBV or with RBV ± pegylated interferon (PEG)

          -  Cirrhotic and non-cirrhotic as determined by standard methods

          -  Male and female individuals of childbearing potential who engage in heterosexual
             intercourse must agree to use protocol specified method(s) of contraception

        Key Exclusion Criteria:

          -  Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors

          -  Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF

          -  Pregnant or nursing female or male with pregnant female partner

          -  Coinfection with HIV or hepatitis B virus

          -  Current or prior history of clinical hepatic decompensation

          -  Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin
             cancers)

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment, assessment or compliance with the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.