bioihbjkbjnl/mcl2 huggingface dataset:
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
Condition: Mucositis; Solid Tumors; Stomatitis; Head and Neck Cancer; Squamous Cell Carcinoma
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Intervention: Placebo; palifermin; cisplatin chemotherapy; Radiotherapy
Intervention description: Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m^2 on Days 1, 22, and 43.; Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.
Intervention MeSH terms: Cisplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SCCHN; Palifermin; Mucositis; Oral Cavity; Oropharynx; Nasopharynx; Hypopharynx; Larynx; Mouth Pain; Mouth Sores; Radiation Therapy; Radiotherapy; Radiochemotherapy; Concurrent Chemotherapy; Xerostomia; Stomatitis; Mucosa; KGF; rHuKGF; Keratinocyte Growth Factor; HNC; Head and Neck Cancer; Oral Mucositis

Summary:

      The purpose of this research study is to test the safety and effectiveness of palifermin to
      determine if weekly doses can be safely administered to reduce the incidence (occurrence of),
      duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in
      the mouth). Mucositis is a common side effect for patients receiving chemotherapy
      (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and
      neck cancer (HNC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically documented squamous cell carcinoma involving either the oral cavity,
             oropharynx, nasopharynx, hypopharynx, or larynx

          -  Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected
             disease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to
             radiotherapy with concurrent chemotherapy as the definitive treatment modality

          -  At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa
             that can be visualized

          -  Concurrent chemotherapy regimen of Cisplatin 100mg/m^2 on days 1, 22, and 43

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal
             to 2

          -  Adequate hematologic, renal and hepatic function

          -  Negative pregnancy test by serum or urine

          -  Signed informed consent

        Key Exclusion Criteria:

        - Presence or history of any other primary malignancy (other than curatively treated in
        situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for
        greater than 3 years)
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
Condition: Severe Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene BPO Gel associated with Doxycyline Hyclate; Vehicle Gel associated with Doxycycline Hyclate
Intervention description: Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.; Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Intervention MeSH terms: Doxycycline; Adapalene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 459.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Acne

Summary:

      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide
      (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to
      Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg
      Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens
      will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Subjects of any race, aged 12 to 35 years inclusive

          -  Subjects with severe facial acne (global severity score of 4)

          -  Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
             excluding the nose

          -  Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open
             comedones and closed comedones) on the face, excluding the nose

        Exclusion Criteria:

          -  Subjects with more than 3 nodules or cysts on the face,

          -  Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced
             acne, etc.)
Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)
Condition: Breast Cancer
Intervention: Paravertebral Block; Pectoral Nerve Block
Intervention description: 20-30 mL 0.5% Ropivacaine; 20-30 mL 0.5% Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).
Masking: None (Open Label)
Enrollment: 89.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Surgery; Breast; Pectoral Nerve Block; Paravertebral Block; Analgesia; Mastectomy

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients ≥ 18 years of age

          -  Total mastectomy or partial mastectomy with or without reconstruction OR planned
             lumpectomy.

          -  Patient determined by their surgeon as medically able to receive a regional block for
             post-operative analgesia

          -  Patient agrees to participate in the study and signs informed consent

        Exclusion Criteria:

          -  Neoadjuvant radiation therapy

          -  Stage IV cancer

          -  Previous breast surgery (excluding percutaneous biopsies of all types)

          -  History of either PVB or PEC procedures

          -  Planned general anesthesia use during surgery

          -  Allergies to ropivacaine, midazolam, fentanyl, or propofol

          -  Pregnant women

          -  Prisoners

          -  Adults unable to consent

          -  Non-English-speaking patients
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Flublok; Afluria
Intervention description: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.; Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2640.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      The hypothesis for this trial is that the incidence of a pre-defined composite of common
      systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that
      reported for licensed IIV recipients. Another hypothesis is that the safety and
      reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety
      profiles previously observed with Flublok and with the licensed comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ambulatory adults aged 50 years and older

          2. Medically stable, as determined by medical history and targeted physical examination
             based on medical history, if appropriate

          3. Able to understand and comply with planned study procedures

          4. Provides written informed consent prior to initiation of any study procedure.

        Exclusion Criteria:

          1. Known contraindication to either study vaccine (see product package inserts)

          2. Receipt of any other influenza or other vaccine within 30 days prior to enrollment in
             this study.

          3. Receipt of any new medication within 30 days prior to enrollment in this study

          4. Plans to participate in any investigation involving an investigational product during
             this study.

          5. Pre-existence of atopic dermatitis or any other cutaneous disorder that could
             complicate the evaluation of potential primary endpoints.

          6. Any clinical or social circumstance that in the opinion of the investigator could
             interfere with compliance with study procedures or interfere with the interpretation
             of clinical data.
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
Condition: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Fibrosis
Intervention: ombitasvir/paritaprevir/ritonavir; dasabuvir; Ribavirin
Intervention description: tablet; tablet; tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Hepatitis C; End-stage renal disease; Hepatitis C Genotype 1; Severe Renal Impairment; renal disease; Compensated Cirrhosis; Renal impairment; dialysis; Hepatitis C Virus; cirrhosis

Summary:

      This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week
      regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in
      HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30,
      including those on hemodialysis or peritoneal dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.

          2. Screening laboratory result indicating HCV genotype 1 infection.

          3. Subject has never received antiviral treatment for hepatitis C infection
             (treatment-naive subject) or subject has received previous treatment with
             peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of
             treatment or relapsed after end of treatment).

          4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the
             Modification of Diet in Renal Disease (MDRD) method.

        Exclusion Criteria:

          1. Women who are pregnant or breastfeeding.

          2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
             Immunodeficiency Virus (HIV Ab).

          3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical
             history of liver decompensation such as ascites (noted on physical exam), variceal
             bleeding, or hepatic encephalopathy.
Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Condition: Neural Tube Defects; Contraception; Oral Contraceptives (OC)
MeSH terms: Neural Tube Defects; Spinal Dysraphism
Intervention: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate; Drospirenone/Ethinylestradiol (Yaz)
Intervention description: 0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF); 0.020 mg ethinylestradiol with 3.0 mg drospirenone
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 385.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy women requesting contraception; Folic Acid

Summary:

      The purpose of this study is to determine whether the study drug is safe and effective
    

Eligibility criteria:

        Inclusion Criteria:

        - Healthy women between 18 and 40 requesting oral contraception

        Exclusion Criteria:

        - The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception
        metabolism will be prohibited during the study
A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: adalimumab
Intervention description: 40 mg or 80 mg every other week, subcutaneous
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis

Summary:

      To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with
      active ankylosing spondylitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who meets the definition of Ankylosing Spondylitis based on the Modified New
             York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an
             inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory
             drugs

        Exclusion Criteria:

          -  History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV

          -  Previously received anti-TNF therapy

          -  Spinal surgery or joint surgery involving joints to be assessed within 2 months prior
             to the Screening
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
Condition: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypertriglyceridemia
Intervention: Epanova® (omega-3 carboxylic acids); corn oil control
Intervention description: Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE); corn oil control arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13078.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: omega-3 carboxylic acid

Summary:

      The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design
      that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high
      risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once
      daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women, ≥18 years of age.

          2. Patient must be on a stable diet and statin* therapy at least 4 weeks prior to
             randomization (Visit 2) and meet the following criteria:

               1. LDL-C <100 mg/dL

               2. TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for
                  women

          3. Patient is at high risk for a future cardiovascular event if at least one of the
             following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or
             medical records at the time of screening:

               1. Any atherosclerotic CVD as defined in protocol.

               2. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50
                  years of age for women, plus one of the risk factors defined in protocol.

               3. Male patients >50 years of age or females >60 years of age, with at least one of
                  the risk factors defined in protocol.

        Key Exclusion Criteria:

        1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid
        ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its
        analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.
A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis
Condition: Pharyngitis
MeSH terms: Pharyngitis
Intervention: Placebo; Flurbiprofen
Intervention description: Participants were instructed to suck one placebo lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.; Participants were instructed to suck one flurbiprofen 8.75 mg lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.
Intervention MeSH terms: Flurbiprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg
      lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen
      lozenge throughout the course of treating sore throat due to acute pharyngitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient has a complaint of sore throat.

          2. If the patient is a female of childbearing potential, she has been using effective
             contraception since the last date of menses and is not breast-feeding or lactating.

          3. If the patient is a female of childbearing potential, the patient must have a negative
             urine pregnancy.

          4. The patient has provided written informed consent prior to any study-related
             procedures.

        Exclusion Criteria:

          1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days,
             is currently experiencing clinically significant upper gastrointestinal complaints, or
             is currently taking medication regularly (≥ three times in the previous week).

          2. The patient has a history of any hepatic disease or renal dysfunction.

          3. The patient has a history of chronic analgesic use (≥ three times per week over the
             prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study
             per investigator's clinical decision.)
Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Memantine; Placebo
Intervention description: 20 mg Oral Tablets Once Daily; Oral Tablets Once Daily
Intervention MeSH terms: Memantine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 369.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease

Summary:

      The primary objective of this study is to examine the efficacy of memantine on cognition and
      behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.
    

Eligibility criteria:

        Inclusion Criteria:

        Outpatients who:

          -  had a primary diagnosis of probable Alzheimer's Disease (AD) according to National
             Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's
             Disease and Related Disorders Association (NINDS-ADRDA) criteria, and with Diagnostic
             and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM IV TR)
             criteria for dementia of the Alzheimer's type

          -  had moderate to severe dementia, defined as a Mini Mental State Examination (MMSE)
             total score >=5 and <=15 at screening. Before substantial protocol amendment SA04
             (dated 7 October 2004) was implemented, the MMSE total score range at screening was
             >=8 and <=18. Substantial protocol amendment SA07 (dated 4 September 2009) allowed
             patients who had previously had an MMSE score of 16 or 17 to be re-screened >6 months
             after their initial screening and, if there was documented evidence of cognitive
             decline, to be enrolled in the study

          -  had a Neuropsychiatric Inventory (NPI) total score >=13 and an NPI
             agitation/aggression subitem score >=1 at screening and baseline

          -  did not have vascular dementia or a modified Hachinski Ischaemia Scale score >4 at
             screening

        Exclusion Criteria:

          -  Evidence of clinically significant active disease, evidence of other neurological
             disorders, and previous treatment with memantine