bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
Condition: Ileus
MeSH terms: Ileus; Hernia; Hernia, Ventral
Intervention: MOA-728; Placebo
Intervention description: MOA-728 will be administered per the dose and schedule specified in the arm.; Placebo matching to MOA-728 will be administered per the schedule specified in the arm.
Intervention MeSH terms: Methylnaltrexone
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: POI; Hernia; Ventral Wall Hernia Repair; Post Operative Ileus

Summary:

      This study will evaluate the safety and efficacy of two different dose regimens (12
      milligrams [mg] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of
      bowel function in participants receiving opioid analgesia administered via patient-controlled
      anesthesia (PCA), and who had undergone repair of large (greater than or equal to [≥]10
      centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, ages 18 and older.

          -  Scheduled for ventral wall hernia repair with general anesthesia.

          -  Meets the American Society of Anesthesiologists physical status I, II, or III.

        Exclusion Criteria:

          -  Received investigational drug or procedure within 30 days of randomization.

          -  Women who are pregnant or lactating.

          -  Calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate [GFR]
             formula) less than or equal to (</=) 50 milliliters/minute (mL/min).
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
Condition: Cervical Ripening; Induction of Labor; Multiparity
Intervention: Oxytocin
Intervention MeSH terms: Oxytocin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study Purpose: The purpose of this study is to determine the optimal method for induction of
      labor in multiparous women who present with an unfavorable cervix.

      Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in
      place will result in more rapid labor courses, without increasing morbidity or increasing the
      need for operative delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Gestational age > 34 + 0/7 weeks

          -  Prior spontaneous vaginal delivery

          -  Clinical or U/S EFW of <4500 grams

          -  Singleton gestation

          -  Cervical dilation <2 cm

        Exclusion Criteria:

          -  Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery

          -  Placenta within 2 cm of cervical os

          -  Placental abruption, chorioamninoitis, or systemic infection prior to induction

          -  Rupture of membranes prior to induction ->1 prior C/S
Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
Condition: Typical Atrial Flutter
MeSH terms: Atrial Flutter
Intervention: Treatment Arm
Intervention description: The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction
      with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter

        -  Does not result into unacceptable risk of intra-procedural composite serious adverse
           events and,

        -  Does not affect efficacy of the ablation procedure The study will also evaluate the
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed written Informed Consent

          -  Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)

          -  If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD) for
             an arrhythmia other than typical atrial flutter, then they need to be controlled on
             their medication for at least 3 months. If a subject had typical atrial flutter before
             starting the AAD(s) (Class I or Class III) and then subsequently had another
             arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.

          -  One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry
             strip, or transtelephonic monitor within the past 6 months

          -  In good physical health

          -  18 years of age or older

          -  Agree to comply with follow-up visits and evaluation

        Exclusion Criteria:

          -  Prior typical atrial flutter ablation treatment

          -  Pregnancy

          -  Atypical flutter or scar flutter (non isthmus dependent)

          -  Significant coronary heart disease or heart failure; that is unstable angina pectoris
             and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of
             enrollment

          -  A recent myocardial infarction within 3 months of the intended procedure date

          -  Permanent coronary sinus pacing lead

          -  Clinically significant tricuspid valvular disease requiring surgery and/or a
             prosthetic tricuspid heart valve.

          -  Evidence of intracardiac thrombus or a history of clotting disorders

          -  Participation in another investigational study

          -  Cardiac surgery within 1 month prior to the intended procedure date

          -  Allergy or contraindication to Heparin
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Atorvastatin; Placebo to Atorvastatin; Placebo to Ezetimibe; Ezetimibe; Placebo to Evolocumab; Evolocumab
Intervention description: Atorvastatin was supplied as over-encapsulated 20 mg tablets; Placebo matching to atorvastatin supplied as over-encapsulated tablets; Placebo matching to Ezetimibe supplied as over-encapsulated tablets.; Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding.; Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s); Evolocumab supplied as single-use prefilled autoinjector/pen(s)
Intervention MeSH terms: Atorvastatin; Ezetimibe; Evolocumab; 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: 511.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

Summary:

      The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab
      administered subcutaneously (SC) every month, compared with ezetimibe, on low-density
      lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to
      tolerate an effective dose of a statin due to muscle-related side effects (MRSE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 80 years of age

          -  Subject not at LDL-C goal

          -  History of statin intolerance

          -  Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks

          -  Fasting triglycerides ≤ 400 mg/dL

        Exclusion Criteria:

          -  New York Heart Association (NYHA) III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes

          -  Poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism
Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
Condition: Blood Coagulation Disorders; Hemorrhage
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
Intervention: Fresh frozen plasma transfusion
Intervention description: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Fresh frozen plasma; Bleeding

Summary:

      The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in
      patients with moderately elevated international normalized ratios (INR) prior to undergoing
      an invasive procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. INR level between 1.50 and 2.50 inclusive

          2. undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology

        Exclusion Criteria:

          1. undergoing a surgical procedure in the operating room;

          2. active bleeding;

          3. undergoing a procedure involving or proximal to the central nervous system or spinal
             cord;

          4. cardiac catheterization,

          5. using 4 factor plasma concentrates

          6. using systemic heparin/heparinoid therapy, direct factor X inhibitors and other
             anticoagulants for which plasma will not correct prolonged INR;

          7. platelet count less than 50,000/ul,

          8. congenital coagulation disorders;

          9. acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the
             disorder;

         10. women who are pregnant and;

         11. unwillingness to consider blood transfusion.
Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
Condition: Articular Cartilage Defect
MeSH terms: Cartilage Diseases; Fractures, Stress
Intervention: autologous cultured chondrocytes on porcine collagen membrane; Microfracture
Intervention description: Implantation via mini-arthrotomy; Microfracture performed by arthroscopic surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Cartilage legions; symptomatic focal cartilage defects; microfracture; MACI; autologous chondrocyte

Summary:

      The objective of this trial is to demonstrate superior efficacy and safety of MACI compared
      with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with
      symptomatic articular cartilage defects of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic, single or multiple full-thickness cartilage defects of the knee with or
             without bone involvement

        Exclusion Criteria:

          -  Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of
             porcine or bovine origin

          -  Severe osteoarthritis of the knee

          -  Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood
             coagulation disorders

          -  Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a
             concomitant procedure to prepare the knee for a MACI implant.
A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
Condition: Pain
MeSH terms: Toothache
Intervention: Ibuprofen/Caffeine; Ibuprofen; Placebo
Intervention description: Ibuprofen/Caffeine fixed-dose combination; Ibuprofen capsule; Placebo treatment
Intervention MeSH terms: Ibuprofen; Caffeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 374.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: third molar extraction; ibuprofen; ibuprofen/caffeine; post-surgical dental pain

Summary:

      An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental
      pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 16 years to 40 years of age (inclusive).

          -  Subjects who have undergone outpatient surgical extraction of 3 or more third molars,
             of which at least 2 must be a partial or complete bony mandibular impaction within 30
             days of Screening and have met baseline pain criteria as described in this protocol

          -  Examined by the attending dentist or physician and medically cleared to participate in
             the study.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
             metabolic or allergic disease (including drug allergies, but excluding untreated,
             asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator
             to place the subject at increased risk including the presence or history within 2
             years of screening of the following medical conditions/disorders:

               -  Bleeding disorder;

               -  Gastrointestinal ulcer or gastrointestinal bleeding;

               -  Paralytic ileus or other gastrointestinal obstructive disorders.

          -  Pregnant female subjects; breastfeeding female subjects; fertile male subjects and
             female subjects of childbearing potential who are unwilling or unable to use a highly
             effective method of contraception

          -  Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or
             other component of the product.
Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Abicipar Pegol; Ranibizumab; Sham Procedure
Intervention description: Abicipar pegol intravitreal injection.; Ranibizumab intravitreal injection.; Sham injection.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 949.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of abicipar pegol in participants with neovascular
      age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of age-related macular degeneration in at least 1 eye

          -  Best corrected visual acuity of 20/40 to 20/320 in the study eye

          -  Best corrected visual acuity of 20/200 or better in the non-study eye

        Exclusion Criteria:

          -  History of vitrectomy, macular surgery, or glaucoma surgery in the study eye

          -  Cataract or refractive surgery in the study eye within the last 3 months
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: MEDI4736; Tremelimumab; MEDI4736+Tremelimumab; Cetuximab; 5-fluorouracil (5FU); Cisplatin; Carboplatin
Intervention description: Anti-PD-L1 antibody; Anti-CTLA-4 Antibody; Monoclonal Antibody; Chemotherapy Agent; Chemotherapy agent; Chemotherapy Agent
Intervention MeSH terms: Carboplatin; Fluorouracil; Cetuximab; Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 823.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN

Summary:

      This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine
      the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus
      SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior
      systemic chemotherapy for recurrent or metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥18 years at the time of screening

          2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx,
             hypopharynx, or larynx).

          3. A fresh tumor biopsy for the purpose of screening or an available archival tumor
             sample. Tumor lesions used for fresh biopsies should not be the same lesions used as
             RECIST target lesions, unless there are no other lesions suitable for biopsy.

          4. No prior systemic chemotherapy for recurrent or metastatic disease

          5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance
             status of 0 or 1 at enrollment

          6. No prior exposure to immune-mediated therapy,

        Exclusion Criteria:

          1. Histologically or cytologically confirmed head and neck cancer of any other primary
             anatomic location in the head and neck not specified in the inclusion criteria
             including patients with SCCHN of unknown primary or non-squamous histologies (eg,
             nasopharynx or salivary gland)

          2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in
             the primary treatment setting

          3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days
             prior to first dose of study treatment

          4. Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis
Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ipragliflozin; Placebo; Sitagliptin
Intervention description: 50 mg tablet administered orally; Placebo to ipragliflozin tablet administered orally; Background medication; 50 mg tablet administered orally
Intervention MeSH terms: Sitagliptin Phosphate; Ipragliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 143.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily
      in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic
      control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is
      that the addition of ipragliflozin compared with placebo provides greater reduction in
      hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy

          -  HbA1c ≥7.0% and ≤10.0% before study start

        Exclusion Criteria:

          -  History of Type 1 diabetes mellitus or a history of ketoacidosis

          -  History of any of the following medications: thiazolidinediones (TZD) and/or insulin
             within 12 weeks prior to study participation and sodium glucose cotransporter 2
             (SGLT2) inhibitors anytime

          -  Currently has a urinary tract infection or genital infection with subjective symptom
A Study for Patients With Head and Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: pemetrexed; cisplatin; placebo
Intervention description: 500 mg/m^2, IV, every 21 days, six 21 day cycles; 75 mg/m^2, administered IV, every 21 days, six 21 day cycles; Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 795.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in
      head and neck cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  You must have head and neck cancer that has returned and cannot be treated with
             surgery or other types of treatment. OR You must have head and neck cancer that was
             just found and has spread to other parts of your body.

          -  You must have a performance status of 0,1 or 2. This means that you must at least be
             able to get around, be able to take care of yourself and must be up and about most of
             the day.

          -  Your test results must show that your liver, kidneys and blood cells are working
             normally.

          -  You must understand and sign the form that gives your agreement to willingly be part
             of the study.

          -  You must be at least 18 years of age.

        Exclusion Criteria:

          -  You cannot have previously been given other treatment for cancer that has spread to
             other parts of your body.

          -  You cannot have a serious sickness that might keep you from finishing the study (for
             example a bad infection).

          -  You cannot have any extra fluid in your chest or bowel area unless your doctor tells
             you it can be drained before you join the study.

          -  You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip
             cancer, or salivary gland cancer.

          -  If you are taking high dose aspirin or other medicines called non-steroidal
             anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot be
             in the study. Your doctor or a member of the study team can explain which drugs are
             non-steroidal anti-inflammatory drugs.