bioihbjkbjnl/mcl2 huggingface dataset:
An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
Condition: Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Nilotinib
Intervention description: Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CML; Leukemia; Tasigna; nilotinib; AMN107; CML-CP; Chronic Phase

Summary:

      The purpose of this exploratory study will be to examine changes in chronic low grade chronic
      adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading,
      when patients are switched from imatinib to nilotinib therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients ≥ 18 years of age

          2. Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2

          3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)

          4. Patients must be an imatinib responder and achieved the following efficacy milestones
             as appropriate for the length of time on imatinib therapy as per protocol

          5. CML-CP patients initiated on any dose of imatinib

          6. Ability to provide written informed consent prior to any study related screening
             procedures being done

        Exclusion Criteria:

          1. Loss of CHR or cytogenetic response

          2. Prior accelerated phase or blast phase CML

          3. Previously documented T315I mutation

          4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than
             Ph+.

          5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.

          6. Treatment with other investigational agents within 30 days of Day 1.

          7. History of non-compliance to medical regimens or inability to grant consent.

          8. Women who are pregnant, breast feeding, or of childbearing potential without a
             negative serum test at baseline. Male or female patients of childbearing potential
             unwilling to use contraceptive precautions throughout the trial and 3 months following
             discontinuation of study drug. Post-menopausal women must be amenorrheic for at least
             12 months to be considered of non-childbearing potential. Women of childbearing
             potential must have a negative serum pregnancy test prior to the first dose of
             nilotinib.

        Other protocol-defined inclusion/exclusion criteria may apply
Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users
Condition: Menstruation Disturbances
MeSH terms: Hemorrhage; Menstruation Disturbances
Intervention: Tamoxifen; Placebo
Intervention description: 7 day course of tamoxifen during an episode of irregular vaginal bleeding; 7 day course of placebo during an episode of irregular vaginal bleeding
Intervention MeSH terms: Tamoxifen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: Female
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Contraceptive implant; Irregular vaginal bleeding; Etonogestrel implant

Summary:

      The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal
      bleeding in women who are using the Etonogestrel contraceptive implant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current user of the etonogestrel implant (Nexplanon, Implanon) for at least one month

          -  Experiencing bleeding episodes more frequently than every 24 days, or a single episode
             of bleeding lasting longer than 14 days

          -  English or Spanish speaking

          -  Planning to continue implant use for six months

          -  Access to a cell phone that can accept and send text messages

        Exclusion Criteria:

          -  Postpartum within six months

          -  Post-abortion within six weeks

          -  Pregnant

          -  Breast-feeding

          -  Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant

          -  Bleeding dyscrasia

          -  Anticoagulation use

          -  Active cervicitis

          -  Allergy to tamoxifen

          -  History of venous thromboembolism

          -  Current or past breast or uterine malignancy

          -  Use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine,
             rifampicin, aminoglutethimide, phenobarbital)
Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
Condition: Essential Hypertension ( Mild to Moderate)
MeSH terms: Hypertension; Essential Hypertension
Intervention: Aliskiren; Hydrochlorothiazide; Amlodipine
Intervention description: Aliskiren 150 or 300 mg; Hydrochlorothiazide 12.5 or 25 mg; Amlodipine 5 or 10 mg
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential Hypertension ( mild to moderate)

Summary:

      This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood
      pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting
      Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood
      Pressure [msDBP] ≥ 90 and <110 mmHg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients ≥ 18 years of age

          -  Patients with a diagnosis of mild to moderate hypertension at Visit 1

          -  All patients must have a msSBP ≥ 140 mmHg and < 180 mmHg and/or msDBP ≥ 90 mmHg and <
             110 mmHg mmHg at Visit 3

        Exclusion Criteria:

          -  Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg

          -  Secondary form of hypertension

          -  Current diagnosis of heart failure (NYHA Class II-IV)

          -  Current angina pectoris requiring pharmacological therapy (other than stable doses of
             oral or topical nitrates)

          -  Second or third degree heart block without a pacemaker

          -  Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial
             fibrillation or atrial flutter, during the 12 months prior to Visit 1

        Other protocol-defined inclusion/exclusion criteria may apply.
Antibiotic Elution in Total Knee Arthroplasty
Condition: Total Knee Replacement
Intervention: hand mixed vancomycin; hand mixed tobramycin; pre-mixed tobramycin
Intervention description: hand mixed vancomycin powder into cement; hand mixed tobramycin into cement; this cement is already pre-mixed with tobramycin
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin; Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: patient will not know which antibiotic cement group they are in
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to characterize and quantify the level of antibiotics eluted from
      antibiotic laden cement after primary cemented total knee arthroplasty.

      Patients will be identified by medical record review to make sure they meet inclusion and
      exclusion criteria.

      Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups
      which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed
      tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group.
      Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the
      knee postoperatively will be collected as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age over 18

          -  Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.

          -  Primary diagnosis of knee osteoarthritis

               -  Exclusion Criteria:

          -  Diminished mental capacity

          -  Vancomycin allergy

          -  Tobramycin allergy

          -  Patient history requiring IV administration of vancomycin or tobramycin
             perioperatively

          -  Chronic kidney disease stage III and stage IV
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
Condition: Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
MeSH terms: Tetanus; Diphtheria; Poliomyelitis; Tetany
Intervention: GSK Biologicals' combined DTPa-IPV/Hib vaccine
Intervention description: 4 intramuscular injections
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2590.0
Sex: All
Minimum age: 11 Weeks
Maximum age: 17 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster
      vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with
      GSK Biologicals' rotavirus vaccine or Placebo.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion criteria

          -  Subjects must have been enrolled in the Rota-028 study.

          -  A male or female between, and including, 11 and 17 weeks of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol

        Exclusion criteria

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs during the study period.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before each dose of the vaccine and ending 30
             days after.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.
Haloperidol vs Conventional Therapy for Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Haloperidol; Conventional Therapy
Intervention description: Intravenous dose of haloperidol 5 mg.; Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Randomized controlled trial comparing haloperidol combined with conventional therapy and
      conventional therapy alone in patients with symptomatic gastroparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous diagnosis of GP including those without formal gastric emptying studies.

          -  Patients presenting with unresolving nausea, vomiting, and abdominal pain that is
             attributable to their GP.

        Exclusion Criteria:

          -  History of QT prolongation or presence on a 12 leads electrocardiogram.

          -  Presence of concomitant acute abdominal pathology including but not limited to
             hepatobiliary disease, ischemia, and abdominal aneurysm.

          -  Prisoners

          -  Hypotension (systolic blood pressure below 90 mm Hg)

          -  Pregnant women

          -  Patients who are cognitively impaired and/or unable to consent for the study

          -  Age <18

          -  Allergy to haloperidol
An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Oxycodone/naloxone
Intervention description: Oxycodone/naloxone titration
Intervention MeSH terms: Oxycodone; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: moderate to severe non-malignant chronic pain

Summary:

      Objectives:

        1. Objective of main interest

           - To assess the drop-out rate caused by adverse event* after 6 weeks treatment

        2. Further objectives

             -  To assess the drop-out rate caused by adverse event* after 1 week treatment

             -  To assess the pain reduction rate after 6 weeks treatment from baseline

             -  To assess the Euroquol (EQ-5D) quality of life

             -  To assess physician's overall satisfaction

             -  To assess subject's overall satisfaction

             -  To assess safety
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 20 and <80 years of age

          -  Patients who have non-malignant chronic pain(≥90 days)

          -  Patients who have moderate to severe pain intensity which is not controlled with
             non-strong opioid

          -  Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated
             for 90 days)

          -  Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90
             days)

          -  Patients who signed a written informed consent form

        Exclusion Criteria:

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive urine pregnancy test

          -  Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients

          -  Patient who needs acute dose titration or whose pain intensity fluctuate significantly
             in a short period according to investigator's judgment

          -  Having used other investigational drugs at the time of enrollment, or within 30 days
             of enrollment
UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD)
Condition: Neovacular Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Neovascular Age-related Macular Degeneration
Intervention description: Blood measurement
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 205.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: nAMD, VEGF, VEGF agent, BCVA, CRT, Ranibizumab, Lucentis, Aflibercept, Eylea

Summary:

      This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with
      neovascular Age-related Macular Degeneration following treatment with Ranibizumab or
      Aflibercept.

      Free plasma VEGF-A level was measured in this study .
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Newly diagnosed Age-related Macular Degeneration (AMD)

          -  No previous treatment received for diagnosed AMD

          -  Visual Acuity 6/7.5 to 6/96

        Key Exclusion Criteria:

          -  standard exclusion criteria for anti-VEGF treatment

          -  Visual Acuity <6/96

          -  nAMD in both eyes, or any condition in other eye which may have required anti- VEGF
             treatment during study period

          -  other disease in candidate eye which could have compromised visual acuity or required
             medical/surgical intervention during study period

          -  participation to other clinical study with 'not approved' treatment within a year
             prior to UNRAVEL study participation.
Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Lumason
Intervention description: 2.4 mL per lesion
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out if a different type of imaging study called
      contrast enhanced ultrasound (CEUS) is as good as, or better than CT or MRI in patients
      diagnosed with hepatocellular carcinoma (HCC) after receiving TACE treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥18 years of age) patients with diagnosed HCC (via imaging, biopsy, or
             combination of imaging and biochemical markers), who are treated with their first
             round of TACE.

          -  Sex: male or female

          -  BMI ≤ 40

        Exclusion Criteria:

          -  Children (<18), pregnant patients

          -  Patients who do not speak English

          -  Patients with a history of hypersensitivity reactions to sulfur hexafluoride lipid
             microsphere components or to any of the inactive ingredients in Lumason.

          -  Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute
             coronary artery syndromes, worsening or unstable congestive heart failure, or serious
             ventricular arrhythmias)

          -  Patients who have a prior non-contrast ultrasound, within last 3 months (at time of
             consent), where the tumor could not be seen - most commonly due to severe steatosis or
             obesity.

          -  Pregnant or nursing woman

          -  Patients who do not plan to get their follow-up CT/MRI at Hershey Medical Center.
Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis
Condition: Facial Nerve Injuries; Facial Paresis Associated With Facial Nerve Dysfunction; Facial Asymmetry; Synkinesis
MeSH terms: Facial Nerve Injuries; Facial Paralysis; Paresis; Synkinesis; Facies; Facial Asymmetry
Intervention: OnabotulinumtoxinA Injectable Product; AbobotulinumtoxinA Injectable Product; Incobotulinumtoxin A Injectable Product
Intervention description: Administered to treat facial synkinesis; Administered to treat facial synkinesis; Administered to treat facial synkinesis
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Facial paralysis; Facial synkinesis; Botulinum toxin

Summary:

      The purpose of this study is to compare the effectiveness of three commercially available
      botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported
      outcome measures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Facial synkinesis

        Exclusion Criteria:

          -  Previous complication from botulinum toxin neuromodulator injection

          -  Inability to understand or complete the SAQ survey

          -  Inability to participate in follow-up

          -  Pregnancy
Dosing Flexibility Study in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab pegol; Certolizumab pegol; Placebo
Intervention description: 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks); 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each); placebo (saline) administered as two injections every 2 weeks
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 333.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Joint Disease; Arthritis; Certolizumab pegol; Cimzia

Summary:

      During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and
      4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and
      16. At Wk 18 patients will be grouped as responders or non-responders based on results of the
      ACR20 at Week 16.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with established adult rheumatoid arthritis currently on Methotrexate for at
             least 3 months

        Exclusion Criteria:

          -  All concomitant diseases or pathological conditions that could interfere and impact
             the assessment of the study treatment

          -  Previous clinical trials participation and previous biological therapy that could
             interfere with the results of the present clinical trial