bioihbjkbjnl/mcl2 huggingface dataset:
RN624 In Adult Patients With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Naproxen; Placebo; PF-04383119 (RN624)
Intervention description: Oral naproxen 500 mg twice daily for Weeks 1-12.; Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.; Single IV infusion of 200 micrograms/kg RN624 on Day 1
Intervention MeSH terms: Naproxen; Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared
      with placebo and compared with naproxen in the treatment of adult patients with chronic low
      back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of any race, >18 years of age and have BMI ≤39 kg/m2

          -  Present with duration of chronic low back pain of ≥3 months requiring regular use of
             analgesic medication (>4 days per week for the past month)

          -  Primary location of low back pain is between the 12th thoracic vertebra and the lower
             gluteal folds, with or without radiation into the posterior thigh, classified as
             Category 1 or 2 according to the classification of the Quebec Task Force in Spinal
             Disorders

          -  Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment
             at Screening, and completes at least 4 daily pain diaries during the 5 days prior to
             Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4

        Exclusion Criteria:

          -  Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent
             major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)

          -  History of lumbosacral radiculopathy, spinal stenosis associated with neurological
             impairment, or neurogenic claudication

          -  Osteoporotic compression fracture within the last 6 months

          -  Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e.,
             ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel
             disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia;
             Tumors or infections of the spinal cord

          -  Patients receiving acetaminophen only to manage their chronic low back pain

          -  Any uncontrolled or untreated chronic disease
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
Condition: Infections, Papillomavirus
Intervention: Cervarix vaccine; Engerix-B vaccine
Intervention description: All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.; All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 270.0
Sex: Male
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main aim of this vaccine is to prevent cervical cancer in women. However, it could also
      be relevant to vaccinate selected groups of males. Therefore, this study is designed to
      evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male
      subjects aged 10-18 years.
    

Eligibility criteria:

        Inclusion criteria:

          -  A male between, and including, 10 and 18 years of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject prior to enrolment

          -  For subjects below the legal age of consent, a written informed consent must be
             obtained from the subject's parent/guardian. In addition, a written informed assent
             must be obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        Exclusion criteria:

          -  Previous vaccination against Human Papillomavirus (HPV).

          -  Previous vaccination against Hepatitis B, known clinical history of Hepatitis B
             infection.

          -  Cancer or autoimmune disease under treatment.
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
Condition: Erythematotelangiectatic Rosacea
MeSH terms: Rosacea
Intervention: CD07805/47; CD07805/47; CD07805/47; CD07805/47 placebo
Intervention description: 0.5% Topical Gel; 0.18% Topical Gel; 0.07% Topical Gel; Vehicle Topical Gel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erythematotelangiectatic; Rosacea

Summary:

      This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to
      investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel
      (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis
      of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in
      a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%,
      0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once
      daily dosing for one day) of study medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female who is at least 18 years of age.

          -  Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.

          -  CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening
             and on Treatment visit at baseline.

          -  PSA (patient self assessment) score of greater than or equal to 3 at Screening and on
             Treatment visit at baseline.

          -  Presence of 2 or fewer inflammatory facial lesions.

        Exclusion Criteria:

          -  History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis
             obliterans, cerebral or coronary insufficiency, or depression.

          -  History of refractive surgery such as photorefractive keratectomy.

          -  The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants,
             barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers,
             antihypertensive agents, cardiac glycosides, or systemic anticoagulants.

          -  The subject is currently enrolled in an investigational drug or device study or
             participated in such a study in the past 3 months prior to enrollment and is still in
             the exclusion period on the day of the Treatment visit.
18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: 18-F FTC 146
Intervention description: Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to evaluate the study drug, 18F FTC-146, as a positron
      emission tomography (PET) / computed tomography (CT) radiotracer imaging agent to evaluate
      tumor status in patients newly diagnosed with osteosarcoma ("bone cancer").
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with biopsy proven osteosarcoma requiring local surgical intervention.

          -  ECOG ≤ 2

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Chemotherapy in the past 2 months.

          -  Prior history of allergic reaction to 18F FTC 146.

          -  Pregnant or nursing
Therapeutic Substance Abuse Treatment in Pregnancy - 1
Condition: Alcohol Abuse; Cocaine Abuse; Marijuana Abuse
MeSH terms: Marijuana Abuse; Alcoholism; Cocaine-Related Disorders
Intervention: MI-CBT; Brief Advice
Intervention description: Motivationally-enhanced cognitive behavioral skills counseling; Advice and education
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is... To assess whether a behavioral treatment that combines
      motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective
      than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g.
      marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using
      and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer
      gestations and greater birth weight).
    

Eligibility criteria:

        Inclusion Criteria:

        Pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -

        Exclusion Criteria:

        Nonfluent in English or Spanish, pending incarceration, psychotic, cognitively unable to
        give informed consent, actively suicidal or homicidal, already engaged in addictions
        treatment, primarily addicted to nicotine or heroin.

        -
Study of Cyclosporine in Post-LASIK Patients
Condition: Laser In Situ Keratomileusis
Intervention: Cyclosporine 0.010% eye drops; Cyclosporine 0.005% eye drops; Placebo (Vehicle for Cyclosporine)
Intervention description: Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.; Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.; Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Intervention MeSH terms: Cyclosporine; Ophthalmic Solutions; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 621.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops
      administered twice daily before and following LASIK surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is scheduled for bilateral LASIK surgery

          -  Patient is in good general health

          -  Eye glasses prescription of -1 to -8

        Exclusion Criteria:

          -  Significant Dry Eye

          -  Presence of eye disease

          -  Uncontrolled systemic disease

          -  Previous use of RESTASIS®
Treatment of Depression in Parkinson's Disease Trial
Condition: Parkinson Disease; Depression
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Intervention: paroxetine; Nortriptyline; placebo
Intervention description: Paroxetine CR 12.5 - 25 mg q hs; nortriptyline 25 - 75 mg q hs; matching placebo
Intervention MeSH terms: Paroxetine; Nortriptyline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's disease; Parkinson disease; depression; antidepressants; nortriptyline; paroxetine

Summary:

      The goal of this study is to evaluate the effectiveness and safety of two
      antidepressants--nortriptyline and paroxetine, compared to placebo in patients with
      Parkinson's disease and depression.
    

Eligibility criteria:

        inclusion criteria:

          -  Parkinson's disease without dementia.

          -  Depression.

          -  Males or females.

        exclusion criteria:

          -  Psychosis

          -  Heart block
A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
Condition: Thrombosis; Hip Replacement
MeSH terms: Thrombosis
Intervention: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
Intervention MeSH terms: Edoxaban; Factor Xa Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 903.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-coagulant; hip replacement; hip replacement surgery; unilateral hip replacement surgery; DeepVein Thrombosis; Venous Thromboembolism; pulmonary embolism; Prevention of Blood Clots

Summary:

      This study is to assess if DU176b is effective in prevention of blood clots following hip
      replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up
      visits.
    

Eligibility criteria:

        1. 18 years of age or older; male or female.

          2. Able to provide written informed consent.

          3. Must be scheduled for elective unilateral total hip replacement surgery. Only primary
             surgeries accepted.

          4. If female, must be either one year post-menopausal, surgically sterile, or using
             medically accepted contraceptive measures as judged by the Investigator and in
             accordance with local regulatory requirements.
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: CSL425; CSL425; Placebo
Intervention description: CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.; CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).; Vaccine diluent, thimerosal 0.01% (weight/volume).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1313.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for
      eliciting an immune response to H1N1 influenza in healthy adults
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 and older, inclusive, at the time of providing informed
             consent.

          -  Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically
             sterile) must be abstinent or be willing to use a medically accepted contraceptive
             regimen for the duration of the study. Females of child bearing potential must return
             a negative urine pregnancy test result at enrolment and prior to each study
             vaccination.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to
             eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study
             Vaccine.
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
Condition: Relapsed/Refractory Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: brexucabtagene autoleucel; Cyclophosphamide; Fludarabine; Axicabtagene Ciloleucel
Intervention description: A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells; Administered intravenously; Administered intravenously; A single infusion of axicabtagene ciloleucel anti-CD 19 CAR T cells
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Axicabtagene ciloleucel; Brexucabtagene autoleucel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel
      (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
    

Eligibility criteria:

        Key Inclusion Criteria:

        Up to 5 prior regimens for MCL. Prior therapy must have included:

          -  Anthracycline or bendamustine-containing chemotherapy and

          -  Anti-CD20 monoclonal antibody therapy and

          -  Ibrutinib or acalabrutinib

        At least 1 measurable lesion

        Platelet count ≥ 75,000/uL

        Creatinine clearance (as estimated by Cockcroft Gault) > or = to 60 mL/min

        Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an
        echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings

        Baseline oxygen saturation >92% on room air.

        Key Exclusion Criteria:

          -  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B
             (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or
             hepatitis C is permitted if the viral load is undetectable per standard serological
             and genetic testing

          -  History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,
             cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or
             any autoimmune disease with central nervous system (CNS) involvement

          -  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
             requiring IV antimicrobials for management.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
Condition: Lower Urinary Tract Symptoms; Bladder Outlet Obstruction
MeSH terms: Urinary Bladder Neck Obstruction; Lower Urinary Tract Symptoms
Intervention: solifenacin succinate; tamsulosin hydrochloride; Placebo to solifenacin; Placebo to tamsulosin
Intervention description: Solifenacin succinate tablets; Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 222.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Lower Urinary Tract Symptoms; Bladder Outlet Obstruction; Treatment; Solifenacin Succinate; Tamsulosin hydrochloride

Summary:

      A study to evaluate the safety of the co-administration of solifenacin succinate with
      tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet
      obstruction (BOO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction
             (BOO)

          -  BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20

          -  Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8
             (Inclusion criteria for Baseline also)

          -  Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120
             mL during free flow in a representative assessment of uroflowmetry.

        Exclusion Criteria:

          -  History of urinary retention in preceding 12 months

          -  Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes
             within 12 months.

          -  Known clinical history or diagnosis of chronic inflammation, stone in bladder or
             ureter, or other causes of outflow tract obstruction

          -  Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except
             non-metastatic basal or squamous cell carcinoma of the skin that had been treated
             successfully

          -  Clinically significant cardiovascular or cerebrovascular diseases within 6 months
             prior to Visit 1
Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Intervention: Cantharidin; Placebo; Gauze occlusion bandage
Intervention description: cantharidin 0.7% topical liquid; Placebo topical liquid; Gauze occlusion bandage with adhesive tape
Intervention MeSH terms: Cantharidin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if cantharidin is a safe and effective treatment
      for molluscum contagiosum in kids
    

Eligibility criteria:

        Inclusion Criteria:

          -  2-17years

          -  Healthy

          -  <50 molluscum contagiosum lesions

        Exclusion Criteria:

          -  Immunosuppressed

          -  Oral corticosteroids

          -  Sexually active/pregnant