bioihbjkbjnl/mcl2 huggingface dataset:
Mitigation of Radiation Pneumonitis and Fibrosis
Condition: Lung Cancer; Radiation Pneumonitis
MeSH terms: Pneumonia; Radiation Pneumonitis
Intervention: Enalapril; placebo
Intervention description: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer; Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
Intervention MeSH terms: Enalapril
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 50.0
Sex: All
Minimum age: 35 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: lung cancer; radiation pneumonitis; mitigation; enalapril; placebo

Summary:

      This project will test the effect of enalapril to mitigate the lung damage that can occur as
      a side effect of radiation therapy for lung cancer or other intrathoracic cancers. Thousands
      of Veterans develop lung cancer every year, and are treated by radiation therapy. Studies of
      lung radiation injury in laboratory animals show that with enalapril, investigators can
      significantly reduce the severity of radiation injury to the lung. Enalapril is FDA approved
      and in common use for treatment of hypertension, kidney disease, and heart failure. These
      studies will advance that work to human use. Successful mitigation of lung radiation damage
      will improve the quality of life in Veterans and non-Veterans who are treated for lung cancer
      by radiation, and may also improve cure rates of radiation therapy for lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women undergoing radiation therapy to the chest for cancer at the Baltimore,
             the Milwaukee, and Ann Arbor Veterans Affairs Hospital are eligible.

          -  Subjects who require radiation therapy to attempt to cure or to palliate their disease
             will be eligible for this study.

        Exclusion Criteria:

          -  Subjects eligible for surgical resection and who do not need radiation therapy will
             not be eligible for this study.

          -  Subjects who must remain on ACE inhibitors, angiotensin blockers, or renin antagonists
             will be excluded.
A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Ixabepilone; Cetuximab
Intervention description: Intravenous Infusion (IV), 32 mg/m^2 every 21 days.; Initial dose of 400 mg/m^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m^2 IV over 1 hour.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if ixabepilone plus cetuximab
      improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic
      cancer compared to historical data. The safety of this combination treatment will also be
      studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced
             disease that is not surgically resectable, or distant metastatic disease)

          -  Participants must have measurable disease as per Response Evaluation Criteria In Solid
             Tumors (RECIST) guidelines

          -  Participants must not have received prior chemotherapy, immunotherapy or
             chemoradiotherapy for advanced pancreas cancer

          -  Karnofsky performance status (KPS) of 70-100

          -  Adequate hematologic, hepatic and renal function
DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Intervention: Laser Photocoagulation; Intravitreal Aflibercept Injection
Intervention description: laser every 16 weeks as needed
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of
      Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular
      edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and
      EU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with clinically significant DME with central involvement

          -  Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular
             edema

          -  ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye

        Exclusion Criteria:

          -  History of vitreoretinal surgery in the study eye

          -  Panretinal laser photocoagulation or macular laser photocoagulation in the study eye
             within 3 months of screening

          -  Previous use of intraocular or periocular corticosteroids in the study eye within 3
             months of screening

          -  Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium,
             anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening

          -  Uncontrolled diabetes mellitus

          -  Uncontrolled hypertension defined as systolic > 180mmHg or > 160 mmHg on 2 consecutive
             measurements or diastolic > 100 mmHg on optimal medical regimen

          -  Ocular disorders in the study eye, other than DME, that may confound interpretation of
             study results
A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Abicipar pegol
Intervention description: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate abicipar pegol for safety and treatment effects in
      participants with neovascular age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants, 50 years of age or older at the time of informed consent

          -  Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen
             equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment)
             visits in the study eye

          -  BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to
             treatment) in the non-study eye

        Exclusion Criteria:

          -  Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)

          -  Previous or concurrent macular laser treatment (study eye)

          -  Cataract or refractive surgery within 3 months prior to baseline (study eye)
Investigation of Naltrexone for Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Intervention: Naltrexone; Placebo
Intervention description: Targeted dosage of 50mg PO daily; Sugar pills daily PO
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: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Naltrexone; Pathological Gambling; Opioid Antagonist

Summary:

      The investigators plan to investigate the safety, tolerability, and efficacy of the opioid
      antagonist naltrexone in Pathological Gambling. We hypothesize that naltrexone will be
      superior to placebo in reducing gambling urges and behavior, when combined with adjuvant
      non-pharmacological treatment as usual.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women over age 18

          2. Current DSM-IV PG Diagnosis as determined by a score of ≥ 5A criteria and B criterion
             present on the SCI-PG and a score ≥ 5 on the SOGS

          3. Gambling behavior within 2 weeks prior to enrollment

          4. For women, stable use of a medically accepted form of contraception and negative
             results on urine pregnancy test at study onset

          5. Currently entering, enrolled, or interested in treatment for PG

        Exclusion Criteria:

          1. Gambling that does not meet DSM-IV criteria for PG

          2. Unstable medical illness or clinically significant abnormalities on laboratory tests,
             EKG, or physical examination at screen

          3. Past or current acute hepatitis or liver failure

          4. History of renal impairment

          5. Current or recent (within one week) treatment with an opioid agonist/opioid analgesic
             or current opioid withdrawal

          6. Opiate agonist maintenance therapy (e.g. methadone)

          7. Known sensitivity to opioid antagonists

          8. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          9. A need for medication with unfavorable interactions with naltrexone

         10. Clinically significant suicidality

         11. Lifetime history of dementia, schizophrenia, or any psychotic disorder determined by
             SCID

         12. Clinically significant cognitive impairment

         13. Previous treatment with naltrexone or nalmefene

         14. Treatment with investigational medication or depot neuroleptics within 3 months

         15. Lack of proficiency in written and spoken English

         16. Unable to travel to study sites for appointments
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: nemolizumab (CIM331); Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic
      dermatitis patients who are inadequately controlled by or intolerant to topical therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 and ≤65 years of age at the time of consent.

          -  Patients with Atopic Dermatitis

          -  Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit

          -  Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit

          -  static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

        Exclusion Criteria:

          -  Serological evidence of hepatitis B virus or hepatitis C virus infection

          -  Known human immunodeficiency virus infection

          -  Ongoing treatment with specific or non-specific hyposensitization therapy for AD

          -  Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week
             prior to randomization

          -  History of infection including skin infection requiring treatment with oral or
             intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to
             randomization.

          -  Evidence of tuberculosis (TB) infection as defined by a positive purified protein
             derivative (PPD) and/or positive interferon-gamma release assay.

          -  Pregnant or lactating women.
Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients
Condition: Thrombotic Microangiopathies; Atypical Hemolytic Uremic Syndrome; Multiple Organ Dysfunction Syndrome
MeSH terms: Azotemia; Hemolytic-Uremic Syndrome; Atypical Hemolytic Uremic Syndrome; Vascular Diseases; Thrombotic Microangiopathies; Syndrome; Hemolysis; Multiple Organ Failure
Intervention: Eculizumab
Intervention description: Eculizumab will be administered as intravenous infusion (IV) over 60 minutes. The dosage form will be 300 mg single-use vials each containing 30 mL of 10 mg/mL sterile, preservative-free solution.
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Healthy volunteers: No
Keywords: Hematopoietic Stem Cell Transplant

Summary:

      Hematopoietic stem cell transplantation (HCT)-associated thrombotic microangiopathy (TMA) is
      an understudied complication of HCT that significantly affects transplant related morbidity
      and mortality. The investigators hypothesize that early intervention with complement blocker
      eculizumab will double survival in HCT recipients with high risk TMA, as compared to
      historical untreated controls. An optimal eculizumab dosing schedule can be determined for
      this population through eculizumab pharmacokinetic/pharmacodynamic (PK/PD) testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of any age undergoing allogeneic or autologous HCT

          -  Histologic TMA diagnosis OR clinical TMA diagnosis and presenting with high risk
             disease features including elevated plasma sC5b-9 above laboratory normal value
             (≥244ng/ml) and proteinuria measured as ≥30mg/dL of protein on random urinalysis x2 or
             protein/creatinine ratio ≥1mg/mg or patient receiving renal replacement therapy.

          -  Minimum weight of ≥ 5kg.

        Exclusion Criteria:

          -  Known hypersensitivity to any constituent of the study medication.

          -  Subjects with unresolved serious Neisseria meningitides infection or progressive
             severe infection.

          -  Patients with diagnosis of TTP as defined by ADAMST13 activity test <10%.

          -  Patients previously treated with eculizumab or other complement blocker for TMA within
             the 60 days prior to first dose of study treatment.
Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Intervention: Modafinil; Placebo
Intervention description: 200 mg or 400 mg /daily; Placebo / daily
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methamphetamine Dependence

Summary:

      The purpose of this study will be to examine the safety and efficacy of modafinil in
      increasing number of methamphetamine non-use weeks in subjects with methamphetamine
      dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between the ages of 18 and 65

          -  Methamphetamine dependent as defined by DSM-IV criteria

          -  Must be in good general heath with a history of methamphetamine use at screening

          -  Must be able to provide written informed consent

          -  If female and of child bearing potential, must agree to use birth control.

        Exclusion Criteria:

          -  Please contact site for more information
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
Condition: Vitrectomy
Intervention: Ocriplasmin 25µg; Ocriplasmin 75µg; Ocriplasmin 125µg; Placebo
Intervention description: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.; Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.; Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.; Intravitreal injection of placebo
Intervention MeSH terms: Plasminogen; Fibrinolysin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multicenter study to compare multiple doses of intravitreal microplasmin in patients
      undergoing surgical vitrectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients in whom vitrectomy is indicated

        Exclusion Criteria:

          -  Posterior Vitreous Detachment (PVD) present at baseline

          -  Vitreous hemorrhage

          -  Certain vitreoretinal conditions including proliferative disease, rhegmatogenous
             retinal detachment, and proliferative vitreoretinopathy (PVR)

          -  Have had a vitrectomy in the study eye at any time
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: Eslicarbazepine acetate; Placebo
Intervention description: Scored tablets; oral route
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain herpetic neuralgia

Summary:

      The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL)
      as therapy for patients with post-herpetic neuralgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent to participate in the study

          -  Men and women aged 18 years or older

          -  Previous diagnosis of herpes zoster

          -  Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3
             months after healing of the herpes zoster skin rash

          -  Cooperation and willingness to complete all aspects of the study

          -  Completion of at least 4 daily diaries during the week preceding randomisation

          -  A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before
             randomisation.

        Exclusion Criteria:

          -  Pain of other origin that might confound the assessment of neuropathic pain of
             postherpetic origin

          -  Active herpes zoster lesion or dermatitis of any origin at the affected site

          -  Subjects who had neurological ablation by block or neurosurgical intervention for
             control of pain

          -  Significant or unstable medical or psychiatric disorders

          -  Drug or alcohol abuse in the preceding 2 years

          -  Severe renal function impairment, as shown by calculated creatinine clearance values <
             30 mL/min at screening

          -  Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or
             aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood
             cell count (WBC) <2,500 cells/mm3)

          -  Previous participation in any study with eslicarbazepine acetate

          -  Pregnancy or breast feeding

          -  History of hypersensitivity to the investigational products or to drugs with a similar
             chemical structure

          -  History of non-compliance

          -  Likelihood of requiring treatment during the study period with drugs or other
             interventions not permitted by the clinical study protocol

          -  Participation in a clinical study within 3 months prior to screening

          -  Any clinical significant concomitant condition which might influence the assessments
             or conduct of the trial.
Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: Bystander-Based Autologous Tumor Cell Vaccine
Intervention description: The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent melanoma; stage III melanoma; stage IV melanoma

Summary:

      The purpose of this study is to find out what effects (good and/or bad) this new cancer
      vaccine has on the patient and their cancer, whether it is safe and whether it can help get
      rid of their cancer (malignant melanoma). We want to check how the patient's immune system
      reacts, both before and after the vaccine treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed stage IIIC or stage IV melanoma

          -  Measurable disease

          -  Age 18 or older

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  No radiation therapy within 2 weeks prior to first vaccine administration

          -  No chemotherapy within 4 weeks prior to first vaccine administration

          -  No steroid therapy within 4 weeks prior to first vaccine administration

          -  No surgery within 10 days prior to first vaccine administration

          -  Patient's written informed consent

          -  Patient's ability to comply with the visit schedule and assessments required by the
             protocol

          -  Adequate organ function (measured within a week of beginning treatment):

               -  White blood count (WBC) > 3,000/mm^3 and absolute neutrophil count (ANC)
                  >1500/mm^3

               -  Platelets > 100,000/mm^3

               -  Hematocrit > 25% and Hgb > 8 g/dL

               -  Bilirubin < 2.0 mg/dL

               -  Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min

        Exclusion Criteria:

          -  Symptomatic or untreated brain metastasis

          -  Any serious ongoing infection

          -  Current corticosteroid or other immunosuppressive therapy

          -  Any other pre-existing immunodeficiency condition (including known HIV infection)

          -  Pregnant or lactating women -- Patients in reproductive age must agree to use
             contraceptive methods for the duration of the study (*A pregnancy test will be
             obtained before treatment)

          -  ECOG performance status of 2, 3, or 4

          -  Any second active primary cancer