bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
Condition: Chronic Kidney Disease Requiring Chronic Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: PA21 (2.5 g tablet containing 500 mg iron); Sevelamer carbonate
Intervention description: Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).; Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 659.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PA21; Phosphate Binder

Summary:

      This is a Phase 3, randomised, active controlled, multicentre extension study to investigate
      the long-term safety and efficacy of PA21, a phosphate binder, for control of
      hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A
      (NCT01324128), subjects have already been enrolled and have been treated with study
      medication for at least 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed treatment in Protocol PA-CL-05A

          -  Written Informed Consent

        Exclusion Criteria:

          -  Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)

          -  Other significant medical conditions

          -  Pregnancy
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Edema
Intervention: Brolucizumab; Aflibercept
Intervention description: Intravitreal injection; Intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 566.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema; intravitreal injection; brolucizumab; aflibercept; double-masked; Diabetic Macular Edema (DME); macular edema; diabetic retinopathy

Summary:

      The purpose of this study was to evaluate the efficacy and safety of brolucizumab in
      treatment of patients with visual impairment due to diabetic macular edema (DME).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent before any assessment

          -  Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening

          -  Medication for the management of diabetes stable within 3 months prior to
             randomization and is expected to remain stable during the course of the study

        Exclusion Criteria:

          -  Active proliferative diabetic retinopathy in the study eye

          -  Active intraocular or periocular infection or active intraocular inflammation in study
             eye

          -  Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25
             millimeters mercury (mmHg)

          -  Previous treatment with anti-VEGF drugs or investigational drugs in the study eye

          -  Stroke or myocardial infarction during the 6-month period prior to baseline

          -  Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value
             ≥100 mmHg

        Other protocol-specified inclusion/exclusion criteria may apply
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
Condition: Metastatic Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Ibrutinib; Gemcitabine; Nab-paclitaxel
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 430.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with
      nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic
      pancreatic adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.

          2. Stage IV disease diagnosed within 6 weeks of randomization

          3. Adequate hematologic function:

               -  Absolute neutrophil count (ANC) ≥1.5 x 109/L

               -  Platelet count ≥100 x 109/L

               -  Hemoglobin ≥9 g/dL

          4. Adequate hepatic and renal function defined as:

               -  AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x
                  ULN without liver metastases

               -  Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present

               -  Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of
                  non-hepatic origin, such as hemolysis)

               -  Estimated Creatinine Clearance ≥30 mL/min

          5. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN

          6. KPS ≥70.

          7. Eastern Cooperative Oncology Group (ECOG) 0-1

        Exclusion Criteria:

          1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or
             cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.

          2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma

          3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in
             case of clinical suspicion of central nervous system involvement).

          4. Major surgery within 4 weeks of first dose of study drug.

          5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

          6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: HD Mesh Ablation System; Anti-arrhythmic drugs
Intervention description: Ablation using the HD Mesh Ablation System; 5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation
Intervention MeSH terms: Anti-Arrhythmia Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomized controlled study of the Bard High Density Mesh Ablation System for
      treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh
      Ablation System is as safe as and more effective than anti-arrhythmic drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one
             class I or III anti-arrhythmic drug

          -  Other inclusion criteria

        Exclusion Criteria:

          -  Previous surgical or catheter ablation to treat AF

          -  Permanent AF

          -  Uncontrolled or unstable medical conditions

          -  Other exclusion criteria
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Placebo; Sotagliflozin
Intervention description: Placebo once daily, before first meal of the day.; Sotagliflozin once daily, before first meal of the day.
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 793.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose
      or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when
      used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have
      inadequate glycemic control with insulin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants had given written informed consent to participate in the study in
             accordance with local regulations.

          -  Adult participants 18 years and older with a diagnosis of T1D made at least 1 year
             prior to informed consent.

          -  Participants were being treated with insulin or insulin analog delivered. via
             continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).

          -  Willing and able to perform self-monitored blood glucose (SMBG) and complete the study
             diary as required per protocol.

          -  At the Screening Visit, A1C must be between 7.0% to 11.0%.

          -  Females of childbearing potential must use an adequate method of contraception and
             have a negative pregnancy test .

        Exclusion Criteria:

          -  Use of antidiabetic agent other than insulin or insulin analog at the time of
             screening.

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to
             randomization.

          -  Chronic systemic corticosteroid use.

          -  Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the
             Investigator.
A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab Pegol (CDP870)
Intervention description: Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 596.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia; CDP870; CZP

Summary:

      An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with
      Crohn's Disease who have completed a 26-week blinded study (CDP870-031 [NCT00152490] or
      CDP870-032 [NCT00152425]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
             clinical studies in which the subject completed the trial at Week 26. Subjects may
             have received active or placebo or both treatments in the prior study

          -  Subjects must be able to understand the information provided to them and give written
             informed consent

        Exclusion Criteria:

          -  Any exclusion criterion that would have prevented the subject's participation in the
             qualifying pivotal study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425],
             although the criterion that excludes previous participation in a clinical trial of
             Certolizumab Pegol does not apply. In addition there are no limits on the Clinical
             Disease Activity Index (CDAI) score at entry
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose); Secukinumab placebo provided in 1 mL autoinjector
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 414.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic arthritis; AIN457; PsA; ACR; CASPAR; PASDAS; secukinumab; autoinjector

Summary:

      The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,
      and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic
      Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),
      disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis
      factor alpha (TNFα) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for
             Psoriatic ARthritis (CASPAR) criteria.

          -  Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

          -  Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

          -  Inadequate control of symptoms with NSAID.

        Exclusion Criteria:

          -  Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
             infectious or malignant process.

          -  Subjects taking high potency opioid analgesics.

          -  Previous exposure to secukinumab or other biologic drug directly targeting
             interleukin-17 (IL-17) or IL-17 receptor.

          -  Ongoing use of prohibited psoriasis treatments / medications.

          -  Subjects who have ever received biologic immunomodulating agents except for those
             targeting TNFα.

          -  Previous treatment with any cell-depleting therapies.
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Adalimumab; Placebo
Intervention description: Subcutaneous (SC) injection; Subcutaneous (SC) injection
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: 101.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; adalimumab

Summary:

      The purpose of the study is to demonstrate the efficacy and safety, and to assess the
      pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with
      moderate to severe ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with
             biopsy.

          -  Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of
             2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or
             both.

        Exclusion Criteria:

          -  Subject with Crohn's disease (CD) or indeterminate colitis (IC).

          -  Current diagnosis of fulminant colitis and/or toxic megacolon.

          -  Subjects with disease limited to the rectum (ulcerative proctitis) during the
             screening endoscopy.

          -  Chronic recurring infections or active tuberculosis (TB).
Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Placebo; Aliskiren 75 mg; Aliskiren 150 mg; Aliskiren 300 mg
Intervention description: Placebo tablet taken once daily in the morning with a light meal.; Aliskiren 75 mg tablet taken once daily in the morning with a light meal.; Aliskiren 150 mg tablet taken once daily in the morning with a light meal.; Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 756.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Hypertension; ≥ 65 years; aliskiren; placebo; light meal

Summary:

      This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in
      elderly patients with essential hypertension when given with a light meal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients 65 years of age and older.

          -  Patients who are eligible and able to participate in the study, and who consent to do
             so after the purpose and nature of the investigation has been clearly explained to
             them (written informed consent).

          -  At the randomization visit patients must have an office msSBP greater than or equal to
             150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg
             difference during the last two visits of the single blind run-in period.

        Exclusion Criteria:

          -  Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood
             pressure (msSBP) ≥ 180 mmHg].

          -  History or evidence of a secondary form of hypertension.

          -  Known Keith-Wagener grade III or IV hypertensive retinopathy.

          -  History of hypertensive encephalopathy or cerebrovascular accident, including a
             history of transient ischemic cerebral attack (TIA).

          -  Current diagnosis of heart failure (NYHA Class II-IV).

          -  History of myocardial infarction, coronary bypass surgery, or any percutaneous
             coronary intervention (PCI).

          -  Current angina pectoris requiring pharmacological therapy other than nitrates.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
Condition: HIV Associated Diarrhea
MeSH terms: Diarrhea
Intervention: Crofelemer 125 mg; Crofelemer 250 mg; Crofelemer 500 mg; Placebo
Intervention description: Crofelemer 125 mg; Crofelemer 250 mg; Crofelemer 500 mg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 374.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; AIDS; Diarrhea; HIV Associated Diarrhea

Summary:

      This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study.
      This study will compare an investigational new drug (crofelemer) to placebo for the control
      of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of
      study drug based on safety and response to therapy and the second stage will evaluate further
      the effectiveness of the optimal dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of HIV-1 infection confirmed by standard serological tests

          -  Stable medical regimen for treatment of HIV disease and associated conditions for at
             least 4 weeks prior to screening

          -  Patient-reported history of diarrhea, defined as either persistently loose stools
             despite regular ADM use, or one or more watery bowel movements per day without regular
             ADM use, of at least 1 month duration

          -  Colonoscopy within the past 5 years if ≥ 50 years of age.

        Exclusion Criteria:

          -  Pregnancy or breast-feeding

          -  Current or past gastrointestinal (GI) medical or surgical conditions

          -  Use of certain opiate pain medication within 2 weeks of screening

          -  Use of an antibiotic within 2 weeks prior to screening, with the exception of stable
             antibiotic therapy for prophylactic treatment of infection or an HIV-associated
             condition

          -  CD4 counts < 100 cells/mm3

          -  Previous randomization into this study, or into any other crofelemer study
Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
Condition: Non-segmental Vitiligo
MeSH terms: Vitiligo
Intervention: Ruxolitinib cream; Vehicle
Intervention description: Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Vehicle cream is a topical formulation applied as a thin film to affected areas.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vitiligo; non-segmental; JAK inhibitor

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in
      adolescent and adult participants with non-segmental vitiligo for whom total body involved
      vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5%
             BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body
             vitiligo area (facial and nonfacial) not exceeding 10% BSA.

          -  Agree to discontinue all agents used to treat vitiligo from screening through the
             final safety follow-up visit. Over-the-counter preparations deemed acceptable by the
             investigator and camouflage makeups are permitted.

          -  Must be willing to take appropriate contraceptive measures to avoid pregnancy or
             fathering a child for the duration of study participation.

        Key Exclusion Criteria:

          -  No pigmented hair within any of the vitiligo areas on the face.

          -  Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or
             other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy,
             postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus,
             chemical leukoderma, and tinea versicolor).

          -  Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo
             or other pigmented areas.

          -  Use of protocol-defined treatments within the indicated washout period before
             baseline.