bioihbjkbjnl/mcl2 huggingface dataset:
Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy
Condition: Breast Cancer; Skin Reactions Secondary to Radiation Therapy
MeSH terms: Breast Neoplasms; Dermatitis; Radiodermatitis
Intervention: Dakin's solution; radiation therapy; questionnaire administration; laboratory biomarker analysis
Intervention description: Applied topically; Undergo radiation therapy; Ancillary studies; Optional correlative studies
Intervention MeSH terms: Sodium Hypochlorite; Eusol; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in
      patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin
      condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's
      solution may help reduce dermatitis caused by radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with breast cancer who plan to undergo radiation therapy to the breast or chest
             wall

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Women with scleroderma or discoid lupus

          -  Women with inflammatory breast cancer as evidenced by clinical assessment

          -  Women with breast cancer involving the skin

          -  Women who have undergone prior radiotherapy to the chest wall and/or breast
Almond Butter and Fasting Glucose
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Almond Butter
Intervention description: Natural almond butter
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A two-period randomized crossover study will be conducted to determine the effect of almond
      butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not
      taking insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals with diagnosed type 2 diabetes

          -  Not on insulin therapy

          -  On stable does of oral antihyperglycemic agent (no dose change for 6 months)

          -  Currently monitoring blood glucose at home via glucometer

          -  Willing and able to adhere to study protocol

        Exclusion Criteria:

          -  Individuals with type 1 diabetes, cardiovascular disease, kidney disease, liver
             disease, cancer or inflammatory conditions (e.g. GI disorders, rheumatoid arthritis)

          -  Women who are pregnant, breastfeeding, or have been pregnant within the last 6 months
             or breastfeeding within the last 6 weeks

          -  Individuals who smoke or use tobacco products

          -  Use of insulin therapy or sulfonylurea medications

          -  Allergy to any tree nut

          -  Liver or kidney disease

          -  Allergy to Dexcom CGM adhesive
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: PG-760564; Placebo dose; PG-760564
Intervention description: 100 mg BID, of oral PG-760564; placebo, BID, oral for 12 weeks; 25 mg BID, of oral PG-760564
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group,
      multicenter study to evaluate the safety, efficacy, and PK of oral administration of
      PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of
      PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening
      visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and
      anti-cytokine therapies except MTX. After the washout period, patients determined to be
      eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or
      placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after
      the last treatment visit. The primary efficacy endpoint will be the proportion of patients
      meeting the ACR 20 response criteria after 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis

          -  Disease duration of at least 6 months

          -  Must be treated with Methotrexate for at least 24 weeks

          -  At least 6 swollen joints and 6 tender joints

          -  Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)

          -  Women of childbearing age and all males must use acceptable method of birth control

        Exclusion Criteria:

          -  Tuberculosis

          -  Malignancies

          -  Abnormal electrocardiograms as described in the protocol

          -  Current infection or recurrent infections or immunodeficiency

          -  Liver diseases and abnormalities in liver function tests as described in the protocol

          -  Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA;

          -  History of demyelization diseases

          -  Any condition that in the opinion of the investigator could be detrimental to patients
             enrolling in the study including clinically important changes in laboratory values and
             other diseases described in the protocol
Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
Condition: Cerebral Vasospasm
MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage
Intervention: Milrinone; Placebo
Intervention MeSH terms: Milrinone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subarachnoid Hemorrhage; Cerebral Vasospasm; Milrinone; Hyperdynamic Therapy

Summary:

      The purpose of this study is to evaluate the usefulness of adding Milrinone to the current
      standard treatment for cerebral vasospasm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 18 years of age

          -  Aneurysmal subarachnoid hemorrhage, proven on CT angiogram or digital subtraction
             angiography

          -  Aneurysm treated, either by endovascular embolization or surgical clip ligation

          -  Evidence of increased velocities on transcranial dopplers (TCDs) and/or radiographic
             evidence of vasospasm as seen on angiogram

          -  Cerebral vasospasm as demonstrated by patient's clinical exam (new focal deficit or
             change in mental status not attributable to any other cause)

        Exclusion Criteria:

          -  Recurrent subarachnoid hemorrhage

          -  Untreated ruptured aneurysm, for any reason

          -  Patients who die prior to treatment for aneurysm

          -  Patients who are not able to complete at least 6 months of follow-up

          -  Patients who are admitted already in vasospasm (i.e. a delayed admission)

          -  Creatinine clearance less than 20 ml/min

          -  Women with a positive pregnancy test or who are lactating

          -  Other comorbidity which may adversely affect patient outcome, at the discretion of the
             principal investigator
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Liposomal Doxorubicin; Cyclophosphamide; Trastuzumab
Intervention MeSH terms: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HER2 positive breast cancer; Metastatic breast cancer

Summary:

      Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that
      will be administered every 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must sign an informed consent before of specific procedures of clinical
             trial.

          -  Patients with histologically confirmed breast cancer and overexpression of Her2neu.

          -  Age> 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) equal or < 2.

          -  Patients have not been treated previously with chemotherapy for metastatic disease.

          -  Patients must have at least one measurable lesion according to RECIST criteria.

          -  Patients should have an adequate organ function to tolerate chemotherapy.

        Exclusion Criteria:

          -  Patients with hypersensitivity reactions to any of the medications of the clinical
             trial.

          -  Patients who are pregnant or lactating are not eligible.

          -  Hepatic disease.

          -  Not controlled active infection

          -  Symptomatic metastatic brain cancer

          -  Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300
             mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Condition: SARS-CoV 2
Intervention: SARS-CoV-2 convalescent plasma; Plasma from a volunteer donor
Intervention description: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.; Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19

Summary:

      To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the
      risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or
      oropharyngeal viral shedding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years of age

          -  Competent and capable to provide informed consent

          -  • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for
             antigen, oropharyngeal or nasopharyngeal swab

          -  Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F),
             cough, or other COVID associated symptoms like anosmia

          -  ≤ 8 days since the first symptoms of COVID-19

          -  ≤ 8 days since first positive SARS-CoV-2 RNA test

          -  Able and willing to comply with protocol requirements listed in the informed consent

        Exclusion Criteria:

          -  Hospitalized or expected to be hospitalized within 24 hours of enrollment

          -  Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion
             of the principal investigator, would affect subject safety and/or compliance

          -  History of prior reactions to transfusion blood products

          -  Inability to complete therapy with the study product within 24 hours after enrollment

          -  Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation
             (monoclonal antibodies, compassionate use or study trial related). Steroid treatment
             at any time does not affect study eligibility
A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Intervention: Thymosin Beta 4; Placebo
Intervention description: Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days; Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Epidermolysis Bullosa; cutaneous wound-healing; chronic wound-healing; Thymosin Beta 4; laminin-5

Summary:

      The purpose of this study is to investigate a treatment to enhance the healing of acute and
      chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with
      Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source -
      FDA Office of Orphan Product Development (OOPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent form signed by the patient or patient's legal representative; also,
             if the patient is under the age of majority but capable of providing assent, signed
             assent from the patient

          -  Diagnosis of junctional or dystrophic EB.

          -  Patients who present with Hallopeau-Siemens subtype may be enrolled.

          -  At least one active, unroofed EB erosion on the limb or on the trunk.

          -  Lesion size 5 to 50 cm2, inclusive.

          -  Stable lesion present for 14-60 days before enrollment.

          -  More that one member in a family can be enrolled as long as that member is treated to
             a different cohort with an assurance that the study medication will not be shared.

          -  No clinically significant abnormalities (Grade 2 or higher on the National Cancer
             Institute [NCI] toxicity scale) on Screening laboratory tests, except for the
             following specific laboratory threshold result: albumin must be 2 g/dL or higher;
             hemoglobin must be 8 g/dL or higher.

        Exclusion Criteria:

          -  Clinical evidence of local infection of the index (targeted) lesion.

          -  Use of any investigational drug within the 30 days before enrollment.

          -  Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.

          -  Use of systemic or topical steroidal therapy within the 30 days before
             enrollment.Inhaled steroids are allowed.

          -  Use of systemic antibiotics within the 7 days before enrollment.

          -  Current or former malignancy.

          -  Arterial or venous disorder resulting in ulcerated wounds.

          -  Diabetes mellitus.

          -  Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed
             at Screening for female patients of childbearing potential.)
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: leuprolide acetate FluidCrystal® injection depot; leuprolide acetate
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: Male
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: prostate cancer; leuprolide

Summary:

      The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and
      safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive
      leuprolide acetate administered subcutaneously once monthly during 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men ≥40 and ≤85 years of age

          -  Histological or cytological proven adenocarcinoma of the prostate requiring hormone
             therapy

          -  Life expectancy over 12 months

          -  World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG)
             performance status of 0, 1 or 2

          -  Adequate and stable renal function

          -  Adequate and stable hepatic function

        Exclusion Criteria:

          -  Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction

          -  Serum Testosterone levels below 150 ng/dL at Screening visit

          -  Medical or radiological prostate cancer treatments within 2 months prior to the
             Screening visit

          -  Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit

          -  Prior orchiectomy, hypophysectomy, or adrenalectomy

          -  Prior use of LHRH agonists within 12 months prior to the Screening visit and during
             the study
Does Guanfacine Attenuate Stress-Induced Drinking?
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: Guanfacine 3mg/day; Guanfacine 1.5mg/day; Placebo
Intervention description: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.; 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alcohol; Drinkers; Guanfacine

Summary:

      Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize
      that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed)
      during the 2-hour self-administration period across two laboratory sessions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21-65

          -  Able to read and write English

          -  Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for
             current (past 6 months) alcohol abuse or alcohol dependence

        Exclusion Criteria:

          -  Participants with any significant current medical conditions, seizures, delirium or
             hallucinations, or other unstable medical conditions including HIV

          -  Current DSM-IV abuse or dependence on substances, other than alcohol abuse, alcohol
             dependence, or nicotine dependence

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal or evidence of current (past 6-month) mental illness

          -  Meet DSM-IV criteria for current (past-6 month) attention deficit hyperactivity
             disorder (ADHD)

          -  Specific exclusions for administration of guanfacine not already specified include:
             EKG evidence at baseline screening of any clinically significant conduction
             abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker;
             history of fainting, syncopal attacks, heart failure or myocardial infarction, or
             impaired liver as indicated by aspartate aminotransferase (AST), alanine
             aminotransferase (ALT) > 3x normal or renal function (estimated creatinine clearance
             <60 cc/min); treatment with any antihypertensive drug or any alpha-adrenergic blocker;
             use of any central nervous system (CNS) depressant (e.g., phenothiazines,
             barbiturates, benzodiazepines)

          -  Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

          -  Individuals who are seeking treatment for drinking
Does Nesiritide Provide Renal Protection
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: Nesiritide; Placebo
Intervention description: infuses at 0.01MCG/KG/min for 48 hours; infuses at 0.01MCG/KG/min for 48 hours
Intervention MeSH terms: Natriuretic Peptide, Brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: renal failure; cardiopulmonary bypass

Summary:

      This project evaluates whether nesiritide, human recombinant brain natriuretic peptide,
      confers renal protection during cardiovascular surgery by attenuating the inflammatory
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing surgery on their aortic arch, ascending aorta, or having aortic
             valve or mitral valve surgery

          -  Baseline MDRD (modification of diet in renal disease) calculated GFR (Glomerular
             Filtration Rate) 30-90 ml/min.

          -  Signed Informed Consent

        Exclusion Criteria:

          -  Age <18 or >80

          -  Ejection Fraction <30%.

          -  Presence of endocarditis or other infection.

          -  Presence or anticipated use of an intra-aortic balloon pump.

          -  History of an organ transplant.

          -  History of an adverse reaction to nesiritide.

          -  Surgery performed without cardiopulmonary bypass.

          -  Receiving Aprotinin

          -  Dopamine administered in doses <5 mcg /kg min.

          -  Women of child bearing potential or pregnant or breastfeeding.

          -  Participation in any other investigational trial

          -  Jehovah Witness

          -  Bleeding Disorder

          -  Active Endocarditis