bioihbjkbjnl/mcl2 huggingface dataset:
Dose-ranging Study of Nemolizumab in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Nemolizumab; Placebo
Intervention description: Injection every 4 weeks during 24 weeks (last injection at week 20); Injection every 4 weeks during 24 weeks (last injection at week 20)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic
      dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately
      controlled with topical treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects ≥ 18 years (or legal age when higher)

          -  Chronic AD, that has been present for at least 2 years before the visit

          -  Eczema Area and Severity Index (EASI) score ≥12

          -  Investigator Global Assessment (IGA) score ≥ 3

          -  AD involvement ≥ 10% of Body Surface Area (BSA)

          -  Severe pruritus on at least 3 of the last 7 days before the visit

          -  Documented recent history (within 6 months before the visit) of inadequate response to
             topical medications

          -  Female subjects must fulfill one of the criteria below:

               -  Female subjects of non-childbearing potential

               -  Female subjects of childbearing potential who agree to a true abstinence or to
                  use an effective or highly effective method of contraception throughout the
                  clinical trial and for 120 days after the last study drug administration

        Exclusion Criteria:

          -  Body weight < 45 kg

          -  subjects with a medical history of asthma requiring hospitalization in the last 12
             months before screening visit and/or whose asthma has not been well-controlled during
             the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of
             the predicted value

          -  Cutaneous bacterial or viral infection within 1 week before the screening visit or
             during the run-in period

          -  Infection requiring treatment with oral or parenteral antibiotics, antivirals,
             antiparasitics or antifungals within 1 week before the screening visit or during the
             run-in period

          -  History of intolerance to low or mid potency TCS or for whom TCS is not advisable
Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: pTVG-HP; rhGM-CSF
Intervention description: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period; rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
Intervention MeSH terms: Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are trying to find new methods to treat prostate cancer. The approach the
      investigators are taking is to try to enhance patients' own immune response against the
      cancer. In this study the investigators will be testing the effectiveness of a vaccine that
      may be able to help the body fight prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of adenocarcinoma of the prostate

          -  Completion of local therapy by surgery and/or ablative radiation therapy at least 3
             months prior to entry, with removal or ablation of all visible disease, including
             seminal vesical and/or local lymph node involvement

          -  Rising prostate specific antigen (PSA) levels without scan evidence of metastatic
             disease

          -  Asymptomatic or mildly symptomatic and life expectancy of at least 4 months

        Exclusion Criteria:

          -  Small cell or other variant prostate cancer histology

          -  Evidence of immunosuppression

          -  Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly
             with radiation therapy or at time of prostatectomy. In this situation, no more than 24
             months of androgen deprivation must have been given and treatment must not have been
             within 12 months prior to screening for this study.

          -  Serum testosterone at screening < 50 ng/dL

          -  Known bone metastases or lymph node involvement as determined by bone scan or computed
             tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry

          -  Prior vaccine therapy for prostate cancer

          -  Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)

          -  Severe intercurrent medical conditions or laboratory abnormalities that would impart,
             in the judgment of the Medical Monitor, excess risk associated with study
             participation or study agent administration
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
Condition: Patients at Risk for Melanoma
MeSH terms: Melanoma
Intervention: N-acetylcysteine; Placebo arm
Intervention description: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses; Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase II intervention to propose a new melanoma chemoprevention agent. The
      investigators believe oxidative stress/damage in nevi is a probable indication for melanoma
      risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi
      from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate
      whether administration of NAC around the time of UV exposure will reduce melanoma risk in
      high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and
      2) examine key genetic variants that will identify which individuals are most likely to
      benefit from chemoprotection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have at least 2 nevi (each >6 mm diameter) not clinically suspicious for melanoma
             that can be biopsied.

          -  Must be able to receive informed consent and sign an approved consent form that
             conforms to federal and institutional guidelines.

        Exclusion Criteria:

          -  The patient is a minor (< 18 years old).

          -  The patient cannot speak/understand English or Spanish. (NOTE: A Spanish consent form
             and certified interpreter can be made available if needed)

          -  The patient is pregnant. (NOTE: All female patients who have not had a hysterectomy
             and are not post-menopausal (i.e. post-menopausal for 1 year and not of child-bearing
             potential) will have a urine pregnancy test.)

          -  The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or
             considered vulnerable.

          -  The patient has history of allergic reaction to NAC.

          -  The patient has history of severe asthma.

          -  The patient has been taking NAC or any other oral antioxidant.

          -  The patient has recent history (i.e., 3 months) of sunless tanning (tanning bed) or
             extensive sunburn.
Supported Employment: Motivational Enhancement for Entry and Outcome
Condition: Psychotic Disorders; Bipolar Disorder; Unemployment
MeSH terms: Bipolar Disorder; Psychotic Disorders
Intervention: Adapted Motivational Interviewing (AMI); Support and Education for Recovery (SER)
Intervention description: Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.; Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Veterans; Vocational Rehabilitation

Summary:

      The purpose of this study is to compare 6 monthly counseling sessions to 6 monthly
      information sessions on Veterans' decisions to (a) participate in vocational rehabilitation
      services and (b) become employed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible to receive VA services

          -  Diagnosis of serious mental illness: schizophrenia, schizoaffective, psychosis NOS,
             bipolar disorder, or depression with psychotic features

          -  Currently unemployed

          -  Not currently enrolled in Supported Employment services

          -  Expects to stay within 100 miles of Bedford, MA for the next 18 months

          -  Has a significant other (friend or family member) who is also willing to participate
             (a criterion required only from March 2011 to March 2012 of the recruitment period)

        Exclusion Criteria:

          -  Currently in prison

          -  Not able to provide informed consent

          -  Not able to speak and understand English
Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron Overload
Condition: Cardiac Iron Overload
MeSH terms: Iron Overload
Intervention: Deferasirox and Deferoxamine
Intervention MeSH terms: Deferasirox; Deferoxamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Cardiac iron overload,; deferasirox,; deferoxamine

Summary:

      This study will evaluate the efficacy and safety of deferasirox in combination with
      deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due to
      chronic blood transfusions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with β-thalassemia major or Diamond-Blackfan anemia (DBA) or congenital
             sideroblastic anemia on chronic transfusion therapy

          -  Myocardial T2* value that is ≥ 5 and < 10 ms

          -  Left ventricular ejection fraction (LVEF) ≥ 56% as determined by Magnetic resonance
             imaging (MRI)

          -  Liver Iron Concentration (LIC) ≥ 7 mg Fe /g dw as determined by R2 MRI.

          -  Lifetime history of at least 50 units of red blood cell transfusions, and must be
             receiving at least ≥ 8 units/yr of red blood cell transfusions

          -  Serum ferritin ≥ 1000 ng/mL

        Exclusion Criteria:

          -  Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or
             exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)

          -  Patients unable to undergo study assessments including MRI

          -  Patients with serum creatinine greater than Upper limit of normal ULN)range or with
             significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥1.0
             mg/mg in a non-first void urine sample at baseline.

        Other protocol-defined inclusion/exclusion criteria may apply
Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)
Condition: Hemorrhagic Shock
MeSH terms: Shock; Shock, Hemorrhagic
Intervention: Premarin IV; Placebo
Intervention description: One time dose of Premarin IV; One time dose of placebo.
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      Based on encouraging results from animal studies, the investigators hypothesize that early
      administration of IV Premarin® in patients with hemorrhagic shock will safely reduce
      secondary injury, and improve survival.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age≥ 18 yrs or < 50 yrs

          2. Blunt or penetrating trauma leading to presumed hemorrhagic shock

          3. Pre-hospital or ED systolic blood pressure < 90

          4. Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital or
             Baylor University Medical Center Emergency Department, Level I Trauma Centers in
             Dallas, Texas

        Exclusion Criteria:

          1. Those who would receive the study drug > 120 minutes after the traumatic event

          2. Time of injury is unknown

          3. Known indication for IV estrogen

          4. Known contraindication for estrogen

          5. Estimated age <18 or > 50 years

          6. Cardiopulmonary Resuscitation (CPR) prior to randomization

          7. Known incarceration

          8. Severe hypothermia (suspected T < 28° C)

          9. Drowning or asphyxia due to hanging

         10. Burns total body surface area (TBSA) > 20%

         11. Isolated penetrating injury to the head

         12. Known inclusion in another interventional trial related to this traumatic event prior
             to randomization

         13. Known legal do not resuscitate (DNR) orders in place prior to randomization

         14. Recognized spinal cord injury prior to study drug administration
A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
Condition: Vincristine Induced Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Intervention: Acetylcarnitine; Placebo
Intervention description: Acetylcarnitine is taken 2 times a day for days 1 through 21.; Placebo is taken 2 times a day for days 1 through 21.
Intervention MeSH terms: Acetylcarnitine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent
      painful nerve damage and nerve pain which is caused by vincristine, a drug used in
      chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug
      available for purchase as a nutritional supplement but for the purpose of this study is
      experimental.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must meet the following inclusion criteria.

               -  The subject must have a confirmed diagnosis of acute lymphoblastic leukemia
                  within 1 week of starting therapy

               -  Currently being treated on a standard ALL induction regimen

               -  Subjects must be greater than or equal to 5 and less than 18 years old

               -  Signed informed consent

        Exclusion Criteria:

          -  Subjects will be excluded for the following:

               -  Preexisting neurologic disease, including grade II, III, or IV neurological
                  status by NCI Common Toxicity Criteria v3.0 on clinical exam

               -  History of hypersensitivity to vincristine

               -  History of hypersensitivity to Acetyl-L-carnitine

               -  Previous use of Acetyl-L-carnitine

               -  Concurrent anti-convulsant use

               -  Concurrent Gabapentin use

               -  Concurrent Glutamine use

               -  Liver Function: Total bilirubin greater than 1.3 mg/dL and serum glutamic-pyruvic
                  transaminase (SGPT) (ALT) greater than 5 x upper limit of normal for age and
                  serum albumin less than 2 g/dL

               -  Patients who are pregnant
Anti-Inflammatory Agent in Sinusitis
Condition: Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps
Intervention: AZ compound; Collection of Biological Specimens; Intranasal corticosteroid; Placebo
Intervention description: 40 mg three times daily po for 12 weeks; collection of biomarkers for analysis of nasal disease; QD Nasal Spray; looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks
Intervention MeSH terms: Mometasone Furoate; Fluticasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving
      signs and symptoms of disease in patients with sinusitis.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Females must have a negative urine pregnancy test at screening unless documented to have
        a hysterectomy or be postmenopausal.

        Exclusion Criteria:

          1. Inability or unwillingness of a participant to give written informed consent or comply
             with study protocol

          2. Use of any investigational drugs within 30 days of screening.

          3. Acute infection needing antibiotic treatment at screening.
Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country
Condition: Breast Cancer; Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Tamoxifen
Intervention description: Tamoxifen 20mg by mouth daily
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast neoplasms; Breast cancer; Locally advanced breast cancer; Neoadjuvant endocrine therapy; Tamoxifen; Low and middle income country

Summary:

      This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with
      locally advanced hormone receptor positive breast cancer in a low/middle income country.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient evaluated and treated at INCAN

          -  Patients must provide informed consent

          -  Patient must be ≥ 18 years of age.

          -  Life expectancy ≥ 6 months

          -  Clinical locally advance breast cancer (Stage IIB or III)

          -  Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone
             receptor (PR)-positive breast cancer with ER or PR Allred Score > 4

          -  Patient must have an ECOG Performance Status of 0-2

          -  Patients must be able to swallow and retain oral medication

        Exclusion Criteria:

          -  Patient must not have received any prior chemotherapy, radiation therapy, or biologic
             therapy for invasive breast cancer within the past five years

          -  Patient must not be pregnant or nursing

          -  Patient must not have had any prior malignancy except for adequately treated basal
             cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which
             the patient has been disease-free for five years.

          -  Women of childbearing age unable or unwilling to use contraception
Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
Condition: Kidney Failure, Acute; Renal Replacement Therapy
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Intervention: Sodium bicarbonate; Normal saline; Bicarbonate; Placebo
Intervention description: IV bicarbonate given with amount based on patient weight; IV Normal saline with volume given determined by patient weight; IV bicarbonate, dosed by weight; Normal saline, with volume given based on patient weight
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Renal Failure; Cardiac Surgery; Sodium Bicarbonate; Length of Stay; Mortality

Summary:

      The purpose of this study is to determine if the incidence of acute renal failure (ARF) in
      high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating
      patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will
      be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal
      saline. The volume of fluid given in each arm of the study is equal. All other interventions
      in those patients will be according to standard cardiothoracic anesthesia protocol at our
      institution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Calculated GFR ≤ 60 ml/min/m2 (MDRD)

        OR

          -  Any combination of two (2) of the following:

          -  Age ≥ 70

          -  Complex surgery (any of the following):

               -  CABG/Valve

               -  Redo operation

               -  Deep hypothermic arrest

          -  ≥ 2 valves

          -  History of PVD surgery

          -  EF < 35%

          -  Presence of diabetes mellitus

          -  Prior kidney transplant

        Exclusion Criteria:

          -  Age < 18

          -  Pre-existing ESRD (dialysis patients)

          -  Pre-op GFR ≤ 15 ml/min/m2

          -  Pre-op bicarbonate level ≥ 30 mEq/L

          -  Emergency surgery (unable to effectively consent)

          -  Pregnancy

          -  Heart transplant (OHT)

          -  Aortic surgery (proximal or distal)