bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Carcinoma, Neuroendocrine; Carcinoma, Medullary; Multiple Endocrine Neoplasia Type 2a; Thyroid Diseases
Intervention: ZD6474 (vandetanib)
Intervention description: 100 mg once daily oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: medullary thyroid cancer; MTC; hereditary medullary thyroid cancer; thyroid cancer

Summary:

      This will be a Phase II, open label study to establish the effect of once-daily oral doses of
      ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid
      cancer in whom no standard therapeutic option is available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent

          -  Previously confirmed histological diagnosis of locally advanced or metastatic
             hereditary medullary thyroid carcinoma without standard therapeutic options

          -  Aged 18 or over and a life expectancy of more than 12 weeks

        Exclusion Criteria:

          -  The last dose of prior chemo/radiation received less than 4 weeks before the start of
             study therapy

          -  Congenital long QT syndrome or 1st degree relative with unexplained sudden death under
             40 years of age, history of arrhythmia
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
Condition: Diffuse Cutaneous Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: JBT-101; Placebo; Part B Open-Label Extension
Intervention description: JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84.; Placebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84.; JBT-101 20mg bid on Days 1-364
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: JBT-101, Lenabasum, Systemic Sclerosis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Part A

          -  Diffuse cutaneous systemic sclerosis

          -  Have skin thickening from SSc in a body area suitable for repeat biopsy

          -  Disease duration ≤ 3 years from the first non-Raynaud's phenomenon or >3 years and ≤ 6
             years from the first non-Raynaud's phenomenon and high sensitivity C-reactive protein
             > 3 mg/L, high sensitivity interleukin-6 > 5 pg/mL, or increase in mRSS ≥ 5 points
             over the last 6 months with total RSS ≥ 12.

          -  Stable treatment for SSc for at least 28 days before Visit 1

        Part B

        •Completion of dosing in Part A without permanent discontinuation of study product because
        of safety or tolerability reasons.

        Exclusion Criteria (Part A and B):

          -  Severe or unstable systemic sclerosis

          -  Significant diseases or conditions other than systemic sclerosis that may influence
             response to the study product or safety;

          -  Any one of the following values for laboratory tests at Screening:

               1. A positive pregnancy test (or at Visit 1);

               2. Hemoglobin < 10 g/dL

               3. Neutrophils < 1.0 x 10^9/L

               4. Platelets < 75 x 10^9/L

               5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation

               6. Serum transaminases > 2.0 x upper normal limit

               7. Total bilirubin ≥ 1.5 x upper limit of normal

          -  Any other condition that, in the opinion of the Principal Investigator, is clinically
             significant and may put the subject at greater safety risk, influence response to
             study product, or interfere with study assessments.
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment
Condition: Hazardous Drinking; Cigarette Smoking
Intervention: Naltrexone; Placebo
Intervention description: Daily 50 mg naltrexone; Matched naltrexone placebo
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking
      cessation outcomes in heavy drinkers seeking smoking cessation treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1.) be at least 18 years of age, 2.) drink heavily at least once per month on average
             (≥4 drinks per occasion for women; ≥5 drinks for men), 3.) have smoked cigarettes
             regularly for at least one year, 4.) currently smoke at least 5 cigarettes a day, 5.)
             currently be using no other tobacco products or nicotine replacement therapy

        Exclusion Criteria:

          -  1.) meet criteria for current substance dependence (excluding nicotine and alcohol);
             2.) report opiate use in the past month, have a drug screen positive for opiates, or
             require opiate containing medications for pain management; 3.) meet criteria for a
             current major depressive or manic episode; 4.) are currently psychotic or suicidal;
             5.) have an unstable or serious medical condition that would preclude use of the
             nicotine patch or naltrexone (e.g., unstable angina pectoris, severe arrhythmia,
             recent congestive heart failure); 6.) have aspartate aminotransferase or alanine
             aminotransferase levels of more than 3 times the reference range or elevated bilirubin
             levels; or 7.) are currently pregnant or lactating, intend to become pregnant, or are
             not using a reliable means of birth control.
Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Genistein; Placebo
Intervention description: Genistein is a natural supplement that comes from soy. Genistein will be taken orally (30 mg twice daily) for 12 weeks.; A placebo pill will be taken orally for 12 weeks.
Intervention MeSH terms: Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Genistein is a natural supplement that comes from soy. The purpose of this study is to see if
      genistein has any effect on preventing or reducing heart disease and diabetes risk in men
      receiving Androgen Deprivation Therapy for prostate cancer. A combination of nutritional
      measures, blood markers and imaging tools will assess body composition, lipid levels and
      insulin resistance. Information from this pilot study will increase understanding of
      interventions which may prevent or reduce health risks during prostate cancer treatment. This
      project involves 24 men who will receive androgen deprivation therapy for prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical indication for androgen deprivation therapy (ADT) via luteinizing
             hormone-releasing hormone (LHRH) analog ± oral anti-androgen

          -  Diagnosis of prostate cancer

          -  ECOG performance status ≤ 2

          -  Life expectancy > 6 months

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Transmural myocardial infarction, unstable angina, or congestive heart failure
             requiring hospitalization within the last 6 months

          -  Acute coronary event within the past month

          -  Use of intravenous antibiotics within the last 6 months

          -  Chronic liver disease

          -  Current use of cytotoxic or immunosuppressive drugs

          -  Chronic glucocorticoid or acute glucocorticoid or other synthetic steroid intake
             within the last month

          -  Chronic diarrhea or malabsorptive diseases (e.g., Crohn's disease)

          -  Stage 5 chronic kidney disease or need for hemodialysis

          -  Supplemental oxygen dependency

          -  Brain metastasis

          -  Severe cognitive dysfunction impairing ability to provide informed consent or consume
             study drug

          -  Dysphagia or requirement for artificial feeding

          -  Surgery or hospitalization within the last month

          -  Chemotherapy or radiation therapy within the last 60 days

          -  Insulin dependent diabetes

          -  HIV/AIDS

          -  History of organ transplant

          -  ECOG performance status > 2
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Placebo
Intervention description: 5 mg orally once daily for 20 weeks; 10 mg orally once daily for 20 weeks; 20 mg orally once daily for 20 weeks; 30 mg orally once daily for 20 weeks; 40 mg orally once daily for 20 weeks; Orally once daily for 20 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure; Heart Failure with Preserved Ejection Fraction

Summary:

      The objective of the study is to find the optimal dose of once daily oral neladenoson
      bialanate (BAY1067197) when given in addition to appropriate therapy for specific
      comorbidities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 45 years and older

          -  Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV,
             LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP

        Exclusion Criteria:

          -  Acute decompensated heart failure within the past 4 weeks

          -  Inability to exercise

          -  Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF <
             40%)
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Condition: Moderate or Severe Submental Fullness
Intervention: Deoxycholic Acid Injection; Placebo
Intervention description: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Phase 2 trial to evaluate the safety and potential efficacy of one concentration of
      deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the
      reduction of submental fat (fat beneath the chin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Submental fat that was considered undesirable by the subject and graded by the
             investigator as 2 or 3 using the submental fat (SMF) rating scale

          -  Good general health

          -  Signed informed consent

        Exclusion Criteria:

          -  History of any treatment in the neck or chin area

          -  Loose skin or prominent platysmal bands in the neck or chin area

          -  Recent treatment with anticoagulants

          -  Presence of clinically significant health problems
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
Condition: Alzheimer's Disease; Dementia With Lewy Bodies; Parkinson's Disease Dementia
MeSH terms: Parkinson Disease; Alzheimer Disease; Dementia; Lewy Body Disease
Intervention: RVT-101 35 mg; Placebo
Intervention description: RVT-101 once daily, oral, 35-mg tablets; Placebo once daily, oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: RVT-101; intepirdine; Alzheimer's disease; Dementia with Lewy bodies; Lewy body dementia; Parkinson's Disease Dementia

Summary:

      This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in
      patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Male or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia with
        Lewy bodies (DLB), or Parkinson's disease dementia (PDD).

        Mini Mental State Examination score 14 to 26 Gait impairment, as assessed by history
        gathered by the clinical investigator and quantitative measurements Subjects must be on
        stable background acetylcholinesterase inhibitor therapy

        Key Exclusion Criteria:

        History and/or evidence of any other CNS disorder that could be interpreted as a cause of
        dementia (in the opinion of the investigator) Any clinically relevant concomitant disease
        which, in the opinion of the investigator, makes the subject unsuitable for inclusion in
        the study.
Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor
Condition: Cancer
MeSH terms: Melanoma
Intervention: GSK1120212
Intervention description: Daily oral dosing
Intervention MeSH terms: Trametinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GSK1120212; BRAF Inhibitor; melanoma; MEK Inhibitor

Summary:

      MEK113583 is a Phase II open-label, multi-site study to investigate the objective response
      rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive
      melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent
      and highly selective inhibitor of MEK activation and kinase activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF
             inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior
             chemotherapy or immunotherapy, without treatment with a BRAF inhibitor.

          -  Documented positive BRAF mutation (V600E, V600K, or V600D).

          -  Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to
             enrollment.

          -  The subject must have a radiographically measurable tumor.

          -  The subject is able to carry out daily life activities without significant difficulty
             (ECOG performance status score of 0 or 1).

          -  Able to swallow and retain oral medication.

          -  Sexually active subjects must use acceptable methods of contraception during the
             course of the study.

          -  Adequate organ system function and blood cell counts.

        Exclusion Criteria:

          -  The subject has had major surgery or received certain types of cancer therapy within
             21 days before starting the study.

          -  Previous treatment with a MEK inhibitor.

          -  Current use of a prohibited medication listed in the protocol.

          -  Uncontrolled glaucoma.

          -  Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery,
             and the disease has been stable for at least 2 months prior to enrollment.

          -  Current severe or uncontrolled systemic disease.

          -  History of clinically significant heart, lung, or eye/vision problems.

          -  Significant unresolved side effects from previous anti-cancer therapy.

          -  The subject is pregnant or breastfeeding.
Botulinum Toxin for the Management of Chronic Orchialgia
Condition: Chronic Testicular Pain
Intervention: Botox Injection; Normal saline injection
Intervention description: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.; One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8.0
Sex: Male
Healthy volunteers: No
Keywords: Chronic testicular pain; Orchialgia; Botulinum toxin; Botox; Urology

Summary:

      The purpose of this research study is to determine if Botox injections will provide relief
      from chronic testicular pain. In the study, the spermatic cord of particpants will be
      injected with either Botox or a placebo of saline. Botox is currently used to treat other
      urological conditions like overactive bladder and lower urinary tract problems. For these
      conditions, Botox works by relaxing muscles in the affected areas. The investigators believe
      that Botox will act similarly in the treatment chronic testicular pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of chronic testicular pain (orchialgia)

        Exclusion Criteria:

          -  Active infection of urinary tract (UTI)

          -  Active infection of the scrotal skin of the affected side

          -  Bilateral orchiectomy
Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)
Condition: Choroidal Neovascularization; Age-Related Maculopathy
MeSH terms: Choroidal Neovascularization; Macular Degeneration; Neovascularization, Pathologic
Intervention: dexamethasone; ranibizumab
Intervention description: 700 µg dexamethasone intravitreal injection at Day 1 in the study eye.; Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Intervention MeSH terms: Dexamethasone; Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as
      adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with
      choroidal neovascularization secondary to age-related macular degeneration. Subjects will be
      followed for 26 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  50 years of age or older with active subfoveal choroidal neovascularization (CNV)
             secondary to AMD

          -  Central retinal thickness ≥ 300 µm

          -  Visual acuity between 20/400 and 20/32

          -  Eligible for Anti-VEGF therapy

        Exclusion Criteria:

          -  Previous treatment for CNV due to AMD

          -  High eye pressure

          -  Glaucoma

          -  Uncontrolled systemic disease

          -  Known allergy to the study medications

          -  Recent eye surgery or injections in the eye

          -  Female subjects that are of childbearing potential
Exparel Interscalene vs Indwelling Catheter
Condition: Pain
Intervention: Exparel; Indwelling Interscalene Catheter
Intervention description: A shot of long acting local anesthetic for post operative pain management; ropivacaine, given through a catheter inserted between the shoulders
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 40 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: shoulder surgery, post operative pain

Summary:

      The investigators are comparing an indwelling catheter with intermediate duration local
      anesthetic to a single shot peripheral nerve block with long acting a local anesthetic
      (Exparel).
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesia (ASA) 1, 2, and 3

          -  Ages 40-74

          -  Patients scheduled for total shoulder replacement

        Exclusion Criteria:

          -  ASA 4 and 5

          -  Pre-existing pain disorder

          -  Regular consumption of chronic pain medication

          -  pregnant women

          -  any medical condition such as a clotting disorder

          -  anatomic abnormality that precludes use of an indwelling scalene catheter

          -  Body Mass Index (BMI) >40

          -  Patient refusal

          -  Pre-existing diabetic neuropathy or Hemoglobin A1c >9

          -  Failed block