bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas
Condition: Basal Cell Carcinoma (BCC); Skin Cancer
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: Itraconazole
Intervention description: Cohort A: oral itraconazole 400 mg as 200 mg twice daily; for 1 month
Cohort B: oral itraconazole 200 mg as 100 mg twice daily; for up to 3 months
Intervention MeSH terms: Itraconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1
      million people. There is no effective drug to prevent basal cell carcinomas of the skin.

      We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of
      proliferation and a biomarker (tumor signaling pathway) of BCC development.

      Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and
      has been used for the past 25 years with relatively few side effects. It has been shown in
      mice to reduce a BCC biomarker and to reduce growth of BCCs.

      Thus, it may reduce BCC growth in humans.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  At least one BCC tumor (greater than 4 mm in diameter) at any skin location, to be
             biopsied and surgically removed.

          -  Had at least one liver function test [eg, aspartate aminotransferase (AST), alanine
             aminotransferase (ALT)] with normal results in the last year.

          -  Consent to research use of their BCC tissue.

          -  Cohort A or B: Willing to take itraconazole during the 2 to 3 weeks between biopsy and
             surgical removal of BCC

        EXCLUSION CRITERIA

          -  History or current hepatitis or other liver disease.

          -  Currently taking systemic medications that would affect BCC tumors (oral retinoids) or
             metabolism of itraconazole (anti-convulsants, corticosteroids)

          -  History or current evidence of malabsorption or liver disease within the one year
             prior to enrollment.

          -  History or current evidence of hyperthyroidism increasing metabolism of itraconazole

          -  Unable to attend to 2nd study visit at Stanford for Mohs surgical excision

          -  Current immunosuppression disease (cancer, autoimmune disease)

          -  Receiving immunosuppressive drugs

          -  Pregnant

          -  Lactating

          -  Any female actively trying to become pregnant
Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ketorolac; Pregabalin; Placebo oral capsule; Saline
Intervention description: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.; Pregabalin was administered orally: 75 mg 30 minutes prior to operation.; Placebo oral capsule was administered orally 30 minutes prior to operation.; Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Intervention MeSH terms: Ketorolac; Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: live kidney donor; donor nephrectomy

Summary:

      The investigators will assess how the use of toradol and pregabalin affects return to bowel
      function and see if there is a difference in length of hospital stay. Narcotic use can affect
      bowel function so the investigators hypothesize that use of Toradol will decrease delayed
      bowel function and aid in a patients discharge and reduction of hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients anticipating donating a kidney in a live kidney donor transplant.

        Exclusion Criteria:

          -  Patients not receiving a donor nephrectomy

          -  Pregnant, lactating, or nursing mothers

          -  Medical allergies or history that would otherwise be contraindicated for of a
             non-steroidal anti-inflammatory drug.
Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: IMRT; DWI MRI; Doxorubicin; Modified Barium Swallow Impairment Profile (MBSImP)
Intervention description: Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC; The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.; Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.; The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Intervention MeSH terms: Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-anaplastic; non-medullary; radiation; IMRT; Doxorubicin; 13-070

Summary:

      The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam
      radiation therapy, has on the patient and their thyroid cancer where surgery is not an option
      or where despite surgery, the disease is still present.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that
             is either grossly recurrent after surgery or unresectable with or without metastatic
             disease.

          -  Age ≥18 years

          -  Karnofsky performance status ≥70%

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months after treatment.

          -  Patients must have ability to understand and the willingness to sign a written
             informed consent document.

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Inability to comply with study and/or follow-up procedures
Open Label Study of Long Term Evaluation Against LDL-C Trial
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab; Standard of care
Intervention description: Administered by subcutaneous injection; Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Intervention MeSH terms: Evolocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1324.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: High cholesterol; Raised cholesterol; Cholesterol; Elevated Cholesterol

Summary:

      The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be
      safe and well tolerated in adults with hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154
             (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764),
             and 20110231 (NCT01652703)

        Exclusion Criteria:

          -  Experienced a treatment-related serious adverse event that led to investigational
             product (IP) discontinuation in the parent study

          -  Have an unstable medical condition, in the judgment of the investigator

          -  Known sensitivity to any of the products to be administered during dosing

          -  Currently enrolled in another investigational device or drug study (excluding
             evolocumab (AMG 145) parent study), or less than 30 days since ending another
             investigational device or drug study(s),or receiving other investigational agent(s)
Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)
Condition: Atherosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Intervention: Clopidogrel 75 mg daily; water pill daily
Intervention description: Daily dose of 75 mg Clopidogrel; Daily dose of water pill (placebo)
Intervention MeSH terms: Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Saphenous vein; Intimal hyperplasia; Coronary artery bypass graft surgery; Antiplatelet therapy; Clopidogrel; Saphenous vein graft disease

Summary:

      The purpose of this study is to determine whether the combination of clopidogrel with aspirin
      prevents the development of blockages (atherosclerosis) in vein grafts one year after
      coronary artery bypass surgery (CABG) compared to aspirin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts,
             with or without the use of cardiopulmonary bypass.

        Exclusion Criteria:

          -  Emergency surgery

          -  Valve surgery

          -  Redo CABG

          -  Left ventricle ejection fraction < 25%

          -  Serum creatinine > 130 µmol/L

          -  Preoperative use of clopidogrel (with the exception of the current admission)

          -  Preoperative use of warfarin; allergy to aspirin or clopidogrel.

          -  History of cerebrovascular accident

          -  History of severe liver disease

          -  Morbid obesity

          -  Current malignancy
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome; Cognitive Dysfunction
Intervention: Donepezil hydrochloride (Aricept)
Intervention description: Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in
      children with Down syndrome who have finished the preceding 10-week, double-blind study of
      donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic
      visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Down syndrome (established during study E2020-A001-220).

          -  Completion of study E2020-A001-219 (NCT00570128 [also known as A2501059]) with no
             ongoing seroius adverse events and no severe drug reactions.

        Exclusion Criteria:

          -  Weight less than 20 kg.

          -  Clinically significant conditions affecting absorption, distribution or metabolism of
             the study medication.

          -  No reliable parent or caregiver, or unwillingness or inability of parent or caregiver
             to fulfill the requirements of the study.

          -  Females of childbearing potential who are not practicing an effective means of birth
             control.
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: ECF843; ECF843 vehicle
Intervention description: Topical ocular eye drop; Topical ocular eye drop
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-masked
Enrollment: 558.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Sjogrens; dry eye syndrome (DES); Keratoconjunctivitis sicca (KCS); keratitis; Xerophthalmia; Sjögren's Syndrome; Sjogren's Syndrome

Summary:

      The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety
      of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs
      Vehicle. Both parts of the study included a double-masked study design, with randomization
      stratified for subjects with Sjogren's Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment

          -  Adult male or female subjects 18 years of age or older

          -  At least 6 months history of dry eye disease in both eyes

          -  Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis

          -  Composite corneal fluorescein staining score >= 4 (modified National Eye Institute
             (NEI) scale) in at least one eye

          -  Schirmer score >= 1 and =< 10 mm after 5 minutes in at least one eye

          -  Patients with Sjögren's Syndrome must have dry eye

        Exclusion Criteria:

          -  Ocular infection in either eye within 30 days prior to Screening

          -  Use of artificial tears, gels, lubricants within 4 hours of the Screening Visit

          -  Use of contact lenses in either eye within 14 days of Screening

          -  Uncontrolled ocular rosacea

          -  Clinically significant conjunctivochalasis in either eye

          -  Other Corneal conditions affecting the corneal structure

          -  Severe ocular conditions such as herpes, graft versus host disease, Stephen's Johnson
             Syndrome, sarcoidosis

          -  Currently active, or history of ocular allergies during the time of year the patient
             will be participating in the study

          -  Patients with current punctal plugs or punctal cauterization or occlusion

          -  Chronic medications (both over the counter and prescription) that have not been stable
             for at least 30 days prior to Screening.

          -  Use of Restasis®, Cequa®, or Xiidra® within 30 days prior to Screening

          -  Use of ocular, nasal, inhaled, or systemic corticosteroids within 30 days of Screening

          -  History of malignancy of any organ system within the past five years

          -  Pregnant or nursing women
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
Condition: Dyslipidemia
MeSH terms: Dyslipidemias; Hypertriglyceridemia
Intervention: ETC-1002; Placebo
Intervention description: ETC-1002 daily for 12 weeks; Placebo daily for 12 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of
      ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Provision of written informed consent prior to any study-specific procedure

          -  Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating
             medications and supplements

          -  Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications
             and supplements

          -  BMI between 18 and 35 mg/kg2

        Major Exclusion Criteria:

          -  Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension

          -  Females of child bearing potential (i.e., females who are not surgically sterile or
             post-menopausal)
Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: PD 0332991; letrozole; letrozole
Intervention description: 125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles; 2.5 mg/d tablets orally on a continuous regimen; 2.5 mg/d tablets orally on a continuous regimen
Intervention MeSH terms: Letrozole; Palbociclib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 177.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hormone-receptor positive advanced breast cancer

Summary:

      The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess
      the effect of the combination on advanced breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inoperable estrogen receptor positive and HER2 negative breast cancer.

          -  Postmenopausal status.

          -  Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2
             - CCND1 amplification and/or loss of p16 as determined by the central laboratory.

          -  Acceptable bone marrow, liver and kidney function.

        Exclusion Criteria:

          -  Prior or concomitant treatment for advanced breast cancer.

          -  Other major cancer in the past 3 years.

          -  Important cardiovascular events in the past 6 months.
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
Condition: Pain, Postoperative; Mammaplasty
MeSH terms: Pain, Postoperative
Intervention: Dexamethasone 4mg; Saline
Intervention description: The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.; The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The surgeon (investigator), patient, and anesthesiologists were not aware of which arm each participant was assigned to. Furthermore, each injected analgesic was premixed and uniformly labeled to maintain blinding.
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been
      shown to enhance pain control and prolong the time until first request for postoperative
      narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been
      investigated in any types of breast surgery. The investigators assessed if the combination of
      dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast
      reduction surgery resulted in improved pain control relative to bupivacaine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Age 18-80

          -  Bilateral reduction mammaplasty

          -  American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3

          -  Must choose to receive preoperative nerve block as part of pain management strategy

        Exclusion Criteria:

          -  Allergy to dexamethasone or bupivacaine

          -  History of postoperative nausea and vomiting following anesthesia

          -  History of chronic pain conditions

          -  History of narcotic abuse or dependency

          -  History of chronic renal disease

          -  History of chronic liver disease
ET-01 in Subjects With Lateral Canthal Lines, LCL-209
Condition: Lateral Canthal Lines, LCL; Crow's Feet
Intervention: botulinum toxin, Type A; Vehicle
Intervention description: topical liniment; Vehicle Formulation
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: vehicle controlled, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: Female
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  females 25 - 65 years of age

          -  minimal to moderate Crow's Feet wrinkles at rest

          -  moderate to severe Crow's Feet on contraction

          -  adequate vision to assess facial wrinkles in a mirror

          -  willingness to refrain from products affecting skin remodeling

          -  female subjects must be not pregnant and non-lactating

          -  subjects should be in good general health

        Exclusion Criteria:

          -  history of adverse reactions to any prior botulinum toxin treatments

          -  history of vaccination or non-response to any prior botulinum toxin treatments

          -  botulinum toxin treatment in the prior 6 months

          -  present or history of neuromuscular disease, eyelid ptosis, muscle weakness,
             paralysis, or "dry eye"

          -  history of peri-ocular surgery, brow lift or related procedures

          -  procedures affecting the lateral canthal region in the prior 12 months

          -  application of topical prescription medication to the treatment area

          -  female subjects who are pregnant or are nursing a child