bioihbjkbjnl/mcl2 huggingface dataset:
A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)
Intervention description: Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Chronic Pain; Acetaminophen; Tramadol; JNS013

Summary:

      The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride
      plus acetaminophen (JNS013) with long term administration in participants with chronic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants whose pain cannot be controlled sufficiently with at least 14-day
             continuous treatment with identical oral non steroid anti inflammatory drugs (NSAIDs)
             at a usual maximum dose during 3 months prior to this study

          -  Ambulatory participants without need for any supportive device or assistance during
             daily life

          -  Outpatients

          -  Participants who do not plan to change the therapeutic policy and content of the
             medications for underlying disease during screening period to the end of Treatment
             Period I

          -  Sustention of chronic pain due to Osteo Arthritis (OA), Low Back Pain (LBP),
             Rheumatoid Arthritis (RA), Neck Shoulder Arm Syndrome (NSAS), Diabetic Neuropathy
             (DN), Post herpetic Neuralgia (PHN) or other for at least 3 months

        Exclusion Criteria:

          -  Participants with conditions for which opioids are contraindicated

          -  Participants with conditions for which APAP are contraindicated

          -  Participants with history of convulsion or the possibility of convulsive seizure

          -  Participants with concurrent, previous, or possible alcohol dependence, drug
             dependence, or narcotic addiction

          -  Pregnant Participants or those who may be pregnant, lactating mothers, and
             Participants who wish pregnancy during the study period.
Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
Condition: Pregnancy, Unwanted
Intervention: vaginal 2% Xylocaine; standard lidocaine paracervical block
Intervention description: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block; 1% lidocaine paracervical injection
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: abortion; pain management

Summary:

      Despite global efforts to decrease discomfort during surgical abortion, pain remains a
      limiting factor in where and how procedures are performed. Several studies have investigated
      different methods of delivering cervical anesthesia prior to abortion, however to the best of
      the investigators' knowledge, there is no published data that 1) rigorously examines the
      effect of a time interval between local anesthetic administration and procedure initiation,
      or 2) explores whether adequate pain relief is possible through self-administered,
      non-invasive means alone. Research in this area has a significant public health impact, given
      the large number of women worldwide who seek abortions.

      The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in
      place of the traditional paracervical block prior to first trimester surgical abortion. They
      hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion
      related pain at a variety of time points throughout the procedure. This is a non-inferiority,
      open label, randomized controlled trial.

      If self-administered vaginal gel is acceptable and effective, it would increase options for
      pain control during abortion and other gynecologic procedures.
    

Eligibility criteria:

        Inclusion criteria:

          -  Women ages 18 and older undergoing elective surgical abortion at 5 and 0/7 to 11 and
             6/7 weeks gestational age

          -  Use of IV sedation for pain management

          -  English or Spanish speaking

          -  Ability to give informed consent

        Exclusion criteria:

          -  Any pre-operative use of misoprostol (typically given at 12 weeks and above in this
             clinic)

          -  Allergy to study medications: lidocaine, midazolam, fentanyl

          -  Known uterine anomaly

          -  Prior cervical surgery.
Atorvastatin for HAART Suboptimal Responders
Condition: Acquired Immune Deficiency Syndrome Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: atorvastatin, Lipitor®; Placebo
Intervention description: PBMC collected for immune activation assays using flowcytometry; PBMC collected for immune activation assays using flowcytometry
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: immune activation; antiretroviral therapy; atorvastatin; immune exhaustion; adults; Africa

Summary:

      We hypothesise that atorvastatin changes immune activation among HAART-treated adults with
      suboptimal cluster cell differentiation 4 (CD4) recovery by 25%
    

Eligibility criteria:

        List of inclusion Criteria: HIV-infected adults on antiretroviral therapy for at least 6
        years with sustained viral suppression (viral load<400 copies), and CD4 increase below 300
        cells (difference between current and baseline CD4 count).

        List of exclusion Criteria: History of an opportunistic infection within the previous six
        months, Pregnancy, History of myositis, History of ingestion of lipid-lowering agents at
        the baseline visit, Use of therapeutic agents known to have substantial drug-drug
        interactions with statins, and individuals on PI-containing HAART
Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; Placebo
Intervention description: Fulvestrant was supplied as a castor oil based solution in clear neutral glass pre-filled syringes. Each syringe will contain 250 mg of fulvestrant in 5 ml.; Matching placebo was supplied as a castor oil based solution in clear neutral glass prefilled syringes. Each syringe will contain 5 ml.
Intervention MeSH terms: Fulvestrant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced breast cancer; metastatic breast cancer

Summary:

      The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with
      the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive
      advanced breast cancer who have failed a prior endocrine treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women defined as a woman who has stopped having menstrual periods

          -  Breast Cancer has continued to grow after having received treatment with an
             anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor

          -  Requiring hormonal treatment

          -  Oestrogen-receptor positive tumour

          -  Written informed consent to participate in the trial

        Exclusion Criteria:

          -  Treatment with an investigational or non-approved drug within one month

          -  An existing serious disease, illness, or condition that will prevent participation or
             compliance with study procedures

          -  A history of allergies to any active or inactive ingredients of fulvestrant (i.e.
             castor oil)

          -  Treatment with more than one regimen of chemotherapy for advanced breast cancer

          -  Treatment with more than one regimen of hormonal treatment for advanced breast cancer
Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Condition: Chronic Post Traumatic Headache
MeSH terms: Post-Traumatic Headache; Tension-Type Headache; Headache
Intervention: OnabotulinumtoxinA
Intervention description: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Mild Traumatic Brain Injury; Concussion; Post Concussive Headache

Summary:

      This study will provide evidence on whether the use of an FDA-approved drug therapy for the
      treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of
      chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the
      head, or a fall, or a motor vehicle accident, or some other traumatic event.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months

          -  Suffer at least fifteen total headache days per month

          -  Ability to speak and read English

        Exclusion Criteria:

          -  Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA

          -  Previous use of OnabotulinumtoxinA for treatment of headache

          -  Any medications commonly used as headache preventives started less than 3 months prior
             to enrollment

          -  Prior or current diagnosis of major psychiatric disorder or other central nervous
             system disorder

          -  Less than 80% compliance (recorded for less than 24 days) in the 30 day screening
             headache diary

          -  Subjects who are pregnant or trying to become pregnant within the timeframe of the
             study
Low Dose Aspirin for Venous Leg Ulcers
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: Aspirin; Placebo
Intervention description: 150 mg aspirin in capsule form once daily for up to 24 weeks; Matching placebo capsule containing inert bulking agent
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Identical placebo with only difference being unique code on bottle containing product.
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Venous ulcer, varicose ulcer, gravitational ulcer, aspirin

Summary:

      Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work,
      lifestyles and activity, especially in older patients. There are few effective treatments -
      compression therapy (tight bandaging or stockings) helps healing, but about half the people
      with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin
      as well as using compression may speed up healing for VLU, but the current evidence is not
      enough to change clinical practice. We will conduct a randomised controlled trial to test
      whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older

          -  Determined to have a venous leg ulcer (clinical indications of venous ulceration,
             Ankle Brachial Index ≥ 0.8, and other causative aetiologies ruled out)

          -  Able to tolerate compression therapy

          -  Able to provide written informed consent

          -  Confirmation with participant's general practitioner that the participant can take low
             dose aspirin or placebo.

        Exclusion Criteria:

          -  Pregnant or breast-feeding women

          -  History of myocardial infarction, stroke, transient ischaemic attack, angina or
             significant peripheral arterial disease

          -  History of adverse effects related to aspirin use

          -  Currently using aspirin, or other anti-platelet or anticoagulant therapy

          -  Opinion of screening medical practitioner at National Institute of Health Innovation
             that participant has an existing condition or treatment that is a contraindication to
             use of aspirin or to participation in the trial.
A Long-term Safety Study of Once-daily Travatan
Condition: Glaucoma, Open-angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle
Intervention: Travatan
Intervention description: Travoprost (0.004%) 1 drop each eye once daily
Intervention MeSH terms: Travoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 502.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; POAG; OAG; OHT

Summary:

      Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular
      hypertension.
    

Eligibility criteria:

        Adult patients of any race and either sex with chronic angle-closure glaucoma.
Telemedicine Interventions for Obstructive Sleep Apnea (OSA)
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes
Intervention: Physical activity; Diet; Health education
Intervention description: Moderate-intensity physical activity; Dietary weight loss; Attention control intervention
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sleep apnea; Sleep symptoms; Quality of Life

Summary:

      This project is investigating whether both moderate-intensity physical activity and dietary
      weight loss will independently reduce sleep apnea symptoms and improve quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician diagnosis of sleep apnea

          -  Apnea-hypopnea index >10/hr

          -  BMI over 24 kg/m2

        Exclusion Criteria:

          -  Angina pectoris

          -  History of myocardial infarction within 6 months
A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 316.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor
      necrosis factor (TNF) inhibitor-experienced participants with radiographic axial
      spondyloarthritis (rad-axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are ambulatory.

          -  Have an established diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with
             sacroiliitis defined radiographically according to the modified New York criteria.

          -  Participants have a history of back pain ≥3 months with age at onset <45 years.

          -  Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.

          -  Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range
             for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.

          -  Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

        Exclusion Criteria:

          -  Have total ankylosis of the spine.

          -  Have never taken a TNF inhibitor medication or have taken more than 2.

          -  Have recently received a live vaccine within 12 weeks or have had a vaccination with
             Bacillus Calmette-Guerin (BCG) within the past year.

          -  Have an ongoing or serious infection within the last 12 weeks or evidence of active
             tuberculosis.

          -  Have a compromised immune system.

          -  Have any other serious and/or uncontrolled diseases.

          -  Have either a current diagnosis or a recent history of malignant disease.

          -  Have had major surgery within 8 weeks of baseline, or will require surgery during the
             study.

          -  Are pregnant or breastfeeding.
Safety and Efficacy of KPI-121 in Subjects With DED
Condition: Kerato Conjunctivitis Sicca
MeSH terms: Conjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Keratoconjunctivitis
Intervention: KPI-121 Ophthalmic Suspension; Vehicle
Intervention description: KPI-121 Ophthalmic Suspension; Vehicle for KPI-121 0.25% ophthalmic suspension
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 901.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%
      ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented
      clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2
      drops instilled in each eye four times daily (QID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a documented clinical diagnosis of dry eye disease in both eyes

        Exclusion Criteria:

          -  Known hypersensitivity or contraindication to the investigational product(s) or
             components

          -  History of glaucoma, IOP>21 mmHg at the screening or randomization visits, or being
             treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance; or have
             been exposed to an investigational drug within 30 days prior to screening.

          -  In the opinion of the Investigator or study coordinator, be unwilling or unable to
             comply with study protocol or unable to successfully instill eye drops.
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vilazodone; Placebo; Fluoxetine
Intervention MeSH terms: Fluoxetine; Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 473.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      compared with placebo in pediatric outpatients (7-17 years of age) with major depressive
      disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female outpatients between 7-17 years of age

          -  Primary diagnosis of Major Depressive Disorder (MDD)

          -  Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

          -  Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

        Exclusion Criteria:

          -  Current (past 3 months) principal Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder
             other than major depressive disorder (MDD) that is the primary focus of treatment.

          -  History of suicidal behavior, or requires precaution against suicide

          -  Not generally healthy medical condition

          -  Seizure disorder
Nutrition and Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Fermented Soy; Placebo
Intervention description: Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.; A placebo compliment to the active intervention with identical packaging and labeling will be used.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fermented Soy

Summary:

      The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults
      with localized prostate cancer prior to radical prostatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically verified Prostate Cancer (at any stage)

          -  Scheduled to be treated by radical prostatectomy within the next 4-10 weeks

          -  Understanding and willingness to provide consent

        Exclusion Criteria:

          -  Previous (within 6 months of enrollment) or concurrent hormonal therapy or
             chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride
             and dutasteride)

          -  History of hormone dependent malignancies

          -  Concomitant thyroid disease or currently taking thyroid hormone replacement medication

          -  Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or
             vegetarian nutrition, or any other extreme dietary habits

          -  Current or past history of any liver or pancreas disease

          -  History of allergy or hypersensitivity to soy-containing products

          -  Malabsorption conditions that might interfere with absorption of the investigational
             product