bioihbjkbjnl/mcl2 huggingface dataset:
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Condition: Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: NRX 194204
Intervention description: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HRPC (Hormone refractory prostate cancer); Androgen independent prostate cancer; CRPC (Castration and Taxane Resistant Prostate Cancer)

Summary:

      This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing
      down/stopping/reversing progression of the castration resistant and taxane resistant prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed prostate cancer

          -  Documented progression on at least one prior hormone treatment, AND at least one
             taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment

          -  Male, Age > 18 years

          -  ECOG (Eastern Cooperative Oncology Group) performance score of 0-2

          -  Adequate bone marrow, renal and hepatic function

          -  Men of childbearing potential must consent to use barrier contraception while on
             treatment and for 90 days thereafter

        Exclusion Criteria:

          -  Prior treatment with NRX 194204 or bexarotene (Targretin)

          -  Presence of parenchymal brain metastases

          -  History of prior malignancy within the past 5 years with the exception of curatively
             treated basal cell or squamous cell carcinoma of the skin or superficial bladder or
             other stage I or stage II cancer in complete remission for at least 12 months

          -  Patients with a history of unstable or newly diagnosed angina pectoris, documented
             history of current serious arrhythmia or congestive heart failure or myocardial
             infarction within 6 months of enrollment

          -  Known HIV or hepatitis B or C infection

          -  Life expectancy < 3 months

          -  Patients with any history of thyroid disease, pituitary disease or treatment with
             thyroid replacement hormone

          -  Patients with a history of pancreatitis or at significant risk of developing
             pancreatitis
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: IFX-1; Placebo
Intervention description: Single IV infusions of IFX-1 diluted in sodium chloride.; Placebo
Intervention MeSH terms: Vilobelimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hidradenitis suppurativa; monoclonal antibody; complement factor C5a; IFX-1; hidradenitis Suppurativa Clinical Response; Inflammation; skin diseases

Summary:

      The purpose of this study is to determine whether IFX-1 is safe and effective in the
      treatment of moderate to severe hidradenitis suppurativa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ≥ 18 years of age

          -  Written informed consent obtained from subject

          -  Diagnosis of HS for at least 1 year

          -  Moderate or severe HS, as indicated by HS lesions in at least 2 distinct areas, 1 of
             which must be at least Hurley Stage II or Stage III

          -  Inadequate response to at least 3 months of oral antibiotics, or intolerance to
             antibiotics

          -  Total abscess and inflammatory nodule (AN) count of ≥ 3

        Exclusion Criteria:

          -  Prior treatment with adalimumab or another biologic product during the 24 weeks before
             Screening

          -  Subjects on permitted oral antibiotic treatment for HS (doxycycline or minocycline
             only) who have not been on a stable dose during the 28 days before Screening

          -  Subject received systemic non-biologic therapy for HS with potential therapeutic
             impact for HS during the 28 days before Screening (other than permitted oral
             antibiotics)

          -  Prior treatment with any of the following medications during the 28 days before
             Screening:

               -  Any other systemic therapy for HS

               -  Any iv anti-infective therapy

               -  Phototherapy (ultraviolet B or psoralen and ultraviolet A)

          -  History of heart disease or malignancy
CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Cyclosporine A; Placebo
Intervention description: topical ocular, eye drops; topical ocular, eye drops
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The objective of this study was to compare the safety, efficacy, and tolerability of two
      different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for
      the treatment of the signs and symptoms of Dry Eye Disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form and HIPAA (Health Insurance Portability and
             Accountability Act ) document

          -  Patient-reported history of dry eye in both eyes

          -  Current use of over-the-counter and/or prescription eye drops for dry eye symptoms

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Women who are pregnant, nursing or planning a pregnancy

          -  Unwillingness to submit a blood pregnancy test at screening and at the last visit (or
             early termination visit) if of childbearing potential, or unwillingness to use
             acceptable means of birth control

          -  Clinically significant slit-lamp findings or abnormal lid anatomy at screening

          -  DED secondary to scarring or ocular or periocular malignancy

          -  History of herpetic keratitis

          -  Active ocular allergies or ocular allergies that are expected to be active during the
             study period

          -  Ongoing ocular or systemic infection at screening or baseline

          -  Wear of contact lenses within 3 months prior to screening or anticipated use of
             contact lenses during the study

          -  History of no response to previous topical Cyclosporine A and/or use of topical
             Cyclosporine A within 6 months prior to screening

          -  Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any
             planned ocular and/or lid surgeries over the study period

          -  Presence of an uncontrolled systemic disease

          -  Presence of a known allergy and/or sensitivity to the study drug or its components
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Condition: Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Metastatic; Prostate Cancer Recurrent
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: 68Ga-PSMA
Intervention description: PET/CT imaging with 68Ga-PSMA:
68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1435.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of
      prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate
      cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined
      in the body.

      To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and
      then have a PET/CT scan. The scan results will be made available to study participants and
      treating physicians.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histopathological proven prostate adenocarcinoma.

          2. Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or
             radiation therapy (external beam or brachytherapy).

               1. Post radical prostatectomy (RP) - according to American Urological Association
                  (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6
                  weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.

               2. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir +
                  greater than or equal to 2 ng/mL rise in PSA.

          3. Karnofsky performance status of ≥ 50.

          4. Age ≥ 18.

          5. Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria:

          1. Current investigational therapy for prostate cancer.

          2. Unable to lie flat, still or tolerate a PET/CT scan.

          3. Prior history of a malignancy within the last 2 years, except skin basal cell or
             cutaneous superficial squamous cell carcinoma that has not metastasized, and except
             superficial bladder cancer.

          4. Prisoner.
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration
Condition: Other Abortion; Spontaneous Abortion
MeSH terms: Abortion, Spontaneous
Intervention: Gabapentin; Placebo
Intervention description: 600mg Gabapentin administered orally 1-2 hours prior to procedure; Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: uterine aspiration

Summary:

      This is a randomized controlled double-blind placebo-controlled trial evaluating the impact
      of gabapentin given preoperatively on perioperative pain scores for women receiving uterine
      aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a
      prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the
      abortion setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women >=18 years-old

          -  Presenting for a surgical abortion

          -  No contraindication to outpatient abortion

          -  No contraindication to gabapentin

          -  Fluency in English and able to provide informed consent

        Exclusion Criteria:

          -  Allergy, sensitivity or contraindication to gabapentin

          -  Severe renal disease

          -  Currently using gabapentin or pregalabin
A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
Condition: Candidiasis, Esophageal; Candidiasis, Invasive; Aspergillosis
MeSH terms: Candidiasis; Aspergillosis; Candidiasis, Invasive
Intervention: Caspofungin
Intervention MeSH terms: Caspofungin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 3 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in
      Japanese children and adolescents with documented Candida or Aspergillus infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients in whom a causative fungus is detected before treatment with the
             study drug or patients with strongly suspected deep-seated fungal infection due to
             Candida species (spp.) or Aspergillus spp.

        Exclusion Criteria:

          -  Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.

          -  Patients who will receive other systemic antifungal agents for the first time in
             screening period
Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer
Condition: Carcinoma, Non Small Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: vorinostat; bortezomib
Intervention description: 400 mg by mouth once daily for days 1-14 of each 21 day cycle; 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle
Intervention MeSH terms: Bortezomib; Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non small cell lung cancer; HDAC; proteasome inhibitor

Summary:

      The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the
      third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy)
      and tolerability of this regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically/histologically confirmed NSCLC

          -  Advance NSCLC (stage IIIB w/ effusion, stage IV, or recurrent disease)

          -  Measurable disease

          -  Two prior systemic anti-cancer (cytotoxic or biologic) regimens for
             advanced/metastatic disease, including one (1) platinum-based chemotherapy

          -  Prior treatment allowed if side effects have resolved and 3 weeks has passed since
             last dose of treatment (1 week for palliative radiation therapy)

          -  ECOG performance status 0, 1, or 2

          -  Patients with brain metastases are allowed, if clinically stable after treatment

          -  Normal liver, kidney, and marrow function

          -  18 years of age or older

          -  Negative pregnancy test for women of child-bearing potential.

          -  Life expectancy 3 months or more

          -  No concurrent use of other antitumor agents

        Exclusion Criteria:

          -  Prior therapy with vorinostat, HDAC inhibitors, or bortezomib

          -  Pre-existing neuropathy grade >/= 2

          -  Myocardial infarction within 6 months prior to enrollment or have NY Heart Association
             Class III or Class IV heart failure

          -  Have taken valproic acid </= 4 weeks prior to enrollment

          -  Previous or current malignancies of other histologies within the past 5 years, except
             cervical carcinoma in situ and adequately treated basal cell or squamous cell
             carcinoma of the skin

          -  Hypersensitivity to bortezomib, boron, or mannitol

          -  Serious medical or psychiatric illness likely to interfere with participation in the
             clinical study

          -  Pregnant women

          -  HIV positive patients

          -  Hepatitis infection (HCV or HBV) patients
Intravenous L-Citrulline Influence on the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19
Condition: Acute Hypoxemic Respiratory Failure
MeSH terms: Respiratory Insufficiency
Intervention: L-Citrulline; Placebo
Intervention description: L-Citrulline (Turnobi) for Injection. Patients will receive an initial bolus of 20 mg/kg (maximum 1500 mg), followed by study infusion of 9 mg/kg per hour (maximum 700mg) for up to 10 days.; Patients randomized to placebo will receive equal volume bolus and study infusion of 5% dextrose water for a maximum of 10 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo controlled and Active Drug
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double Blind Clinical Trial
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous
      L-Citrulline (Turnobi) to Delay and Potentially Prevent the Need for Invasive Mechanical
      Ventilation for Acute Hypoxemic Respiratory Failure in Patients with COVID-19 (SARS-CoV2)
      Illness. To evaluate safety and efficacy of a bolus loading dose and continuous intravenous
      infusion of L-Citrulline compared to placebo in patients hospitalized with COVID-19 infection
      (SARS-CoV-2).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65 years.

          2. Clinical evidence of COVID-19 (SARS-CoV2) infection, defined as a positive COVID-19
             laboratory test plus evidence of an acute hypoxemic respiratory illness requiring
             oxygen.

          3. Admitted and transferred to floor without intubation.

        Exclusion Criteria:

          1. No consent/inability to obtain consent

          2. Patient, surrogate, or physician not committed to full support

          3. Malignant or other irreversible condition and estimated 28-day mortality ≥ 50%

          4. Moribund patient not expected to survive 48 hours (as defined by primary medical team)
             from start of study infusion

          5. End-stage Liver Disease as defined by Child-Pugh Score > 9

          6. Currently enrolled in, or participated in another study of an investigational compound
             within the last 30 days

          7. Pregnant female, or female who is breast feeding

          8. Allergy to L-citrulline or arginine or any citrulline- or arginine-containing product

          9. Patient not otherwise suitable for the study in the opinion of any of the
             investigators

         10. Requirement for intubation and invasive mechanical ventilation before study enrollment
A Double-blind Randomized Placebo Controlled Clinical Trial Evaluating Effect of Chlorhexidine Gluconate 2% Cloth vs Placebo Cloth Baths on the Incidence of Central Line-Associated Blood Stream Infections in Outpatient Hematopoietic Stem Cell Transplant Patients
Condition: Stem Cell Transplant Complications
MeSH terms: Sepsis
Intervention: Chlorhexidine Gluconate 2% Wipe; Placebo Wipe
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after
      hematopoietic stem cell transplant in prevention of central line associated blood stream
      infections. Half of the participants will use 2% CHG washcloths and other half will use
      placebo washcloths.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for
             transplant

          -  Age 18 and up

        Exclusion Criteria:

          -  Experienced an allergy or rash related to use of chlorhexidine washcloths or other
             chlorhexidine products

          -  Extensive open wounds
Aspirin and Antiretroviral Therapy in HIV Infected Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Aspirin 325mg; Antiretroviral therapy (ART)
Intervention description: Patients randomized to Aspirin 325mg po daily versus placebo pill daily; Patients randomized to start ART immediately or defer use for 1 month
Intervention MeSH terms: Aspirin; Anti-Retroviral Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: HIV; Cardiovascular Disease; Endothelial Dysfunction

Summary:

      The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy)
      and aspirin use on risk for cardiovascular disease among HIV infected persons.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV-infected (by positive HIV Ab or detectable HIV RNA level)

          2. No ART for at least previous 3 months

          3. Ready to start or re-start ART (regimen pre-chosen by patient and provider)

        Exclusion Criteria:

          1. Age < 18 years, or >60 years

          2. Pregnancy

          3. Current aspirin use

          4. Presence of known atherosclerotic CVD determined by:

               1. Previous myocardial infarction

               2. Significant coronary atherosclerosis by angiography

               3. Coronary revascularization procedure (coronary stent or surgical bypass)

               4. Previous cerebral vascular accident (stroke)

               5. Ischemic cardiomyopathy

               6. Carotid stenosis (>25% narrowing by carotid ultrasound)

               7. Aortic aneurysm

               8. Symptomatic peripheral vascular disease (claudication)

               9. Surgical revascularization procedure of peripheral vessels

          5. Hospitalization (within prior 2 weeks of study entry)

          6. Concurrent self-limited bacterial infections (does not include chronic viral
             infections)

          7. Clinical or pathologic diagnosis of systemic vasculitis

          8. Active drug or alcohol use