bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
Condition: Carcinoma, Non Small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel; Suramin; Docetaxel
Intervention description: IV over 60 minutes, 75 mg/m2; IV over 30 minutes; IV over 60 minutes. 56 mg/m2
Intervention MeSH terms: Suramin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carcinoma, non small cell lung; Second line; Third line

Summary:

      The overall purpose of the study is to determine whether or not the inclusion of suramin to
      standard treatment with docetaxel improves progression-free survival for patients with
      advanced non-small cell lung cancer in the second and third line settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven diagnosis of non-small cell lung cancer

          -  Documented disease progression after first-line chemotherapy for non-small cell lung
             cancer

          -  Stable and treated CNS metastasis is allowed

          -  Radiation must be completed at least 2 weeks prior to starting protocol treatment

          -  Major surgery must be completed at least 4 weeks prior to starting protocol treatment

          -  ECOG performance status 0-2

          -  Sexually active patients must use adequate contraception

          -  Adequate bone marrow function

          -  Adequate renal function

          -  Adequate liver function

        Exclusion Criteria:

          -  Severe hypersensitivity reaction to docetaxel

          -  Pre-existing grade 3 or 4 neuropathy

          -  Women who are pregnant or breastfeeding

          -  Uncontrolled intercurrent illness

          -  Receipt of 3 or more prior chemotherapy regimens
Dexamethasone Solution and Dexamethasone in Mucolox™
Condition: Oral Lichen Planus; Mucous Membrane Pemphigoid; Pemphigus Vulgaris; Chronic Graft-versus-host-disease
MeSH terms: Lichen Planus, Oral; Bronchiolitis Obliterans Syndrome; Pemphigoid, Benign Mucous Membrane; Lichen Planus; Pemphigoid, Bullous; Pemphigus; Graft vs Host Disease
Intervention: dexamethasone 0.5mg/5ml solution; dexamethasone 0.5mg/5ml solution in Mucolox™
Intervention description: Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate; Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Pharmaceutical Solutions; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Topical steroid therapy is considered the first line of treatment for Oral Inflammatory
      Ulcerative Diseases with current treatment regimens requiring multiple application or rinses
      daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has
      the potential to effectively prolong contact time between the medication. The primary
      objective of this study is to determine the clinical efficacy and tolerability of compound
      dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative
      Diseases as measured by a reduction in oral symptoms between patients treated with compounded
      dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical
      commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved
      clinical outcomes due to the need for less frequent application.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older.

          -  Patients with symptomatic biopsy proven Oral Inflammatory Ulcerative Diseases (worst
             VAS sensitivity score ≥ 7 over the last week).

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients already on topical or systemic steroids.

          -  Inability to comply with study instructions.

          -  Uncontrolled intercurrent illness or psychiatric illness/social situations that would
             limit compliance with study requirements.

          -  VAS sensitivity score < 7.

          -  Pregnant women. A urine pregnancy test will be performed for women of child bearing
             potential.

          -  Allergy to fluconazole.
Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
Condition: Inflammation; Pain; Cataract
MeSH terms: Cataract; Inflammation
Intervention: RX-10045
Intervention description: topical therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the efficacy and safety of 2 concentrations
      of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of
      ocular inflammation and pain in subjects undergoing cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with
             posterior chamber intraocular lens implantation in the capsular bag.

        Exclusion Criteria:

          -  Any additional surgical procedures at the time of the cataract surgery

          -  Refractive surgery in the study eye within the past 2 years

          -  History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis,
             scleritis, uveitis) in either eye

          -  Intraocular pressure of > 21 mm Hg in either eye

          -  Proliferative or severe nonproliferative diabetic retinopathy in either eye

          -  Neovascular/wet age-related macular degeneration in either eye
A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia
Condition: Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: KRX-0502
Intervention description: 1g tablets of KRX-0502
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered
      without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis
      dependent chronic kidney disease (NDD-CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-lactating females with negative serum pregnancy test (for females of
             child-bearing potential) at Screening

          -  Age ≥ 18 years

          -  Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening

          -  Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening

          -  eGFR <60 mL/min at Screening using the 4-variable Modification of Diet in Renal
             Disease (MDRD) equation

        Exclusion Criteria:

          -  Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to,
             screening

          -  Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel
             syndrome and/or Crohn's Disease within 24 weeks prior to \ Screening

          -  Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to
             Screening

          -  Kidney transplant anticipated or start of dialysis expected within 16 weeks of
             Screening

          -  History of hemochromatosis

          -  IV iron administered within 4 weeks prior to Screening

          -  Erythropoiesis-Stimulating Agent (ESA) administered within 4 weeks prior to Screening

          -  Blood transfusion within 4 weeks prior to Screening

          -  Receipt of any investigational drug within 4 weeks prior to Screening

          -  Cause of anemia other than iron deficiency or chronic kidney disease

          -  History of malignancy in the last five years

          -  Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12
             months prior to Screening

          -  Any known allergies to iron products

          -  Previous intolerance to oral ferric citrate

          -  Psychiatric disorder that interferes with the subject's ability to comply with the
             study protocol

          -  Planned surgery or hospitalization during the trial

          -  Any other medical condition that, in the opinion of the PI, renders the subject unable
             to or unlikely to complete the trial or that would interfere with optimal
             participation in the trial or produce significant risk to the subject
A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: PRA023 IV; Companion diagnostic (CDx)
Intervention description: PRA023 administered at timepoints as directed by the protocol; CDx+ or CDx-
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: APOLLO-CD; APOLLO; Crohn's Disease

Summary:

      The purpose of this study is to assess the safety and efficacy of PRA023 in participants with
      moderately to severely active Crohn's Disease.

      After the completion of the 12-week induction period, all participants have the option to
      continue in the open-label extension for another 38 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Crohn's disease

          -  Moderately to severely active CD as defined by Crohn's disease activity index (CDAI)
             score and centrally read endoscopy

          -  Must have corticosteroid dependence or have had no response, insufficient response,
             loss of response and/or intolerance to at least one of the following therapies:
             corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF),
             anti-integrin, or anti-interleukin (IL)12/23

          -  Able to provide written informed consent and understand and comply with the
             requirements of the study

        Exclusion Criteria:

          -  Women of child bearing potential (WOCBP) and men with female partner of childbearing
             potential who are unwilling to use two highly effective methods of contraception to
             avoid pregnancy for the entire study period and up to 12 weeks after the last dose of
             study drug

          -  Diagnosis of ulcerative colitis (UC) or indeterminate colitis

          -  CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic
             and/or illeal involvement

          -  Suspected or diagnosed intra-abdominal or perianal abscess at screening

          -  Current stoma or need for colostomy or ileostomy

          -  Previous small bowel resection with a combined resected length of >100 cm or previous
             colonic resection of > 2 segments

          -  Surgical bowel resection within 3 months before screening

          -  Past or current evidence of definite low-grade or high-grade colonic dysplasia not
             completely removed

          -  Subjects in the opinion of the investigator are at an unacceptable risk for
             participation in the study

          -  Subjects who meet the protocol criteria for important laboratory exclusion criteria
Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana
Condition: Smoking, Marijuana
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: CBD
Intervention description: Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: reinforcement, good drug effect, high, mood, cannabidiol

Summary:

      The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400,
      800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and
      cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when
      combined with placebo marijuana, as well as its ability to modulate the behavioral effects of
      active marijuana.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults between the ages of 18 and 50.

          -  Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during
             the preceding 4 weeks.

          -  Able to perform study procedures

          -  Women practicing an effective form of birth control

        Exclusion Criteria:

          -  Female subjects who are currently pregnant or breastfeeding.

          -  Current, repeated illicit drug use other than marijuana

          -  Presence of significant medical illness

          -  History of heart disease

          -  Request for drug treatment

          -  Current parole or probation

          -  Recent history of significant violent behavior

          -  Major psychiatric disorder
Pharmacokinetic Response to BPI in Burns
Condition: Burns
MeSH terms: Burns
Intervention: BPI
Intervention description: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 13 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of a protein called BPI that is naturally
      made by the body's white blood cells to fight infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 13 years to 60 years old

          -  Sustained partial-thickness or full-thickness burn greater than 20% and less than 41%
             TBSA

          -  Parental consent (if subject is less than 18 years old) or individual (if subject is
             equal to or older than 18) signed, informed consent.

          -  Able to start BPI in infusion within 8 hours of burn injury.

        Exclusion Criteria:

          -  Age > 61.

          -  Inhalational injury requiring mechanical ventilation.

          -  Partial and full thickness burns totaling > 41% total body surface area

          -  Cardiac dysfunction, defined as the presence of any of the following:

               1. New York Heart Class 3 or 4 heart failure.

               2. Unstable angina or acute myocardial infarction.

               3. Left ventricular ejection fraction known to be < 35%.

          -  Electrical or lightening induced burn injury or any injury that required
             cardio-pulmonary resuscitation.

          -  Concomitant non-burn trauma with an ISS > 9.

          -  Non-survivable injury secondary to burn size - patients made DNR or comfort care due
             to burn size.

          -  Patients with known causes of immunosuppression:

               1. Known history of HIV/AIDS

               2. Chronic steroid use for underlying medical conditions (equivalent to 15 mg
                  prednisone/day).

               3. Active oncolytic therapy for known malignancy

          -  Known or suspected pregnancy

          -  Known allergy to rBPI21
Study of OPA-15406 Ointment in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: OPA-15406; Placebo
Intervention description: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.; Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 15 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in
      patients with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

        Exclusion Criteria:

          -  Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a
             sudden intensification of atopic dermatitis.

          -  Subjects who have an active viral skin infection.

          -  Subjects with a current or history of malignancy.
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
Condition: IgA Nephropathy (IgAN); Berger Disease; Glomerulonephritis, IgA
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA; Glomerulonephritis
Intervention: Placebo; Cemdisiran
Intervention description: Normal saline (0.9% NaCl) matching volume of cemdisiran doses were administered SC.; Cemdisiran was administered by SC injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults
      with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite
      standard of care, which includes treatment with angiotensin-converting enzyme (ACE)
      inhibitors or angiotensin receptor blockers (ARB). These participants are at high risk for
      progression of kidney disease, which can result in end-stage renal failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with primary IgAN

          -  Currently being treated for IgAN with stable, optimal therapy, including an ACE
             inhibitor or ARB.

          -  Has urine protein greater than or equal to 1 gram/24-hour

          -  Has hematuria (blood cells present in urine)

        Exclusion Criteria:

          -  Has renal disease other than IgAN

          -  Has a diagnosis of rapidly progressive glomerulonephritis

          -  Has a diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis)

          -  Has poor kidney function with estimated glomerular filtration rate (eGFR) <30
             milliliters per minute per 1.73 meters square (mL/min/1.73 m^2)

          -  Has known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV)
             infection or hepatitis B virus (HBV) infection

          -  Has on-going high blood pressure

          -  Treated with systemic corticosteroids for more than 7 days, or other immunosuppressant
             agents in the past 6 months

          -  Received an organ transplant
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Lixivaptan
Intervention description: Oral vasopressin V2 receptor antagonist
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the
      pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan
      in Autosomal Dominant Polycystic Kidney Disease subjects with chronic kidney disease (CKD) in
      stages CKD1, CKD2 or CKD3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, between 18 and 65 years of age at the time of screening

          -  Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 with eGFR calculated
             by the CKD EPI equation

          -  Diagnosed with ADPKD by modified Ravine criteria

          -  Considered by Investigator to be in good health relative to underlying CKD status and
             clinically stable with respect to underlying CKD

        Exclusion Criteria:

          -  Known sensitivity or idiosyncratic reaction to lixivaptan, its related compounds such
             as benzazepines (e.g., tolvaptan, conivaptan, benazepril, fenoldopam, or mirtazapine),
             or any compound listed as being present in the study formulation

          -  Women who are pregnant or breast feeding

          -  Subjects have taken tolvaptan, oral or intravenous antibiotics, or any investigational
             drug or used an investigational device within 30 days or 5 half-lives, whichever is
             longer, prior to first study dose

          -  Subject has a transplanted kidney, or absence of a kidney

          -  Subjects with clinically significant incontinence, overactive bladder, or urinary
             retention (e.g., benign prostatic hyperplasia)

          -  Subjects with clinically significant liver disease, or clinically significant liver
             function abnormalities or serology other than that expected for ADPKD with cystic
             liver disease at baseline

          -  Subjects with any clinically significant concomitant disease or condition other than
             ADPKD (including treatment for such conditions) that, in the opinion of the
             Investigator, could either interfere with the study drug or pose an unacceptable risk
             to the subject