bioihbjkbjnl/mcl2 huggingface dataset:
Combination Chemotherapy for Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Gemcitabine; cisplatin
Intervention description: Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).; Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the objective tumor response of the first-line
      therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  You are female in the age of 18 to 75 years old.

          -  You have been diagnosed with the metastatic breast cancer.

          -  You have desire and an opportunity to visit your doctor in medical site, both during
             realization of the active treatment program, and within 24 months of medical follow
             up.

          -  You must sign this informed consent form

        Exclusion Criteria:

          -  You are pregnant or breastfeeding.

          -  Your laboratory parameters fall outside the limits, admitted by requirements of the
             present clinical study.

          -  You have been diagnosed with serious concomitant or acute infectious disease.

          -  You have used experimental medications within the last month.
A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: PF-05212384; irinotecan; Cetuximab; Irinotecan
Intervention description: 30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability.; 90 minutes IV infusion of irinotecan 180mg/m^2 on days 1 and 15 of each cycle; 120 minute IV infusion of cetuximab 400mg/m^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1; 90 minutes IV infusion of Irinotecan 180mg/m^2 on days 1 and 15 of each cycle
Intervention MeSH terms: Irinotecan; Cetuximab; Gedatolisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic colorectal cancer; colorectal cancer; KRAS; colon cancer; mCRC; CRC; PF-05212384; KRAS wild type colorectal cancer; irinotecan; cetuximab; NRAS

Summary:

      This study will investigate whether the combination of PF-05212384 plus Irinotecan improves
      progression free survival in patients with KRAS and NRAS wild type metastatic colorectal
      cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in
      Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients
      enrolled at Japanese sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  KRAS and NRAS wild type metastatic colorectal cancer

          -  Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and
             fluoropyrimidine therapy in the metastatic setting.

          -  Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2

          -  At least one measurable lesion by Response Evaluation Criterion in Solid Tumors
             [RECIST]

        Exclusion Criteria:

          -  More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.

          -  Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor

          -  Patients who have discontinued treatment with prior irinotecan therapy due to
             toxicity.

          -  Prior radiation to the pelvis or abdomen

          -  Patients with history of interstitial lung disease.
An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Intervention: SPD557; placebo
Intervention description: 0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment; matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GERD; Gastroesophageal reflux disease; SPD557; Proton pump inhibitors

Summary:

      The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters
      of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal
      Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump
      inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability
      will be evaluated.
    

Eligibility criteria:

        Inclusion criteria:

          1. Written ICF signed voluntarily before the first trial related activity.

          2. Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation) during
             the last 6 months

          3. Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.

          4. ≥3 days per week with heartburn and/or regurgitation symptoms of at least moderate
             severity and a minimum of 25 liquid containing reflux events over 24h (pH/MII
             monitoring).

        Exclusion criteria:

          1. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects
             with major GI disorders.

          2. Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease,
             neurologic, cancer or AIDS.

          3. Alarm symptoms suggestive of malignancies or organic disease.
Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
Condition: Persian Gulf Syndrome
MeSH terms: Syndrome; Persian Gulf Syndrome
Intervention: Carnosine; Placebo
Intervention description: 500mg Carnosine x2 daily; Microcrystalline cellulose placebo tablets x2 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: 33.0
Sex: All
Minimum age: 34 Years
Maximum age: 82 Years
Healthy volunteers: No
Keywords: Carnosine; antioxidant; Persian Gulf War; Gulf War Syndrome; GWI; Gulf War Illness; Exercise; Chronic Fatigue; Fibromyalgia; Veterans; Irritable Bowel Syndrome; Migraine headaches; Neuropathy; Multiple Chemical Sensitivity

Summary:

      The purpose of this study is to perform a randomized double-blind, placebo-controlled, 12
      week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle
      strength outcomes in 100 GWI subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of military enlistment between August 1, 1990 and July 31, 1991, and
             deployment for 30 consecutive days to:

               -  Persian Gulf waters and adjacent land areas,

               -  Other global locations, or,

               -  U.S. only. 1990-1991 enlistment status:

               -  Active duty

               -  National Guard

               -  Reserves

        Exclusion Criteria:

          -  HIV/AIDS

          -  Pregnant Women

          -  Active Duty Military Personnel

          -  Children

          -  Incarceration
A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Ravagalimab 600 mg; Ravagalimab 300 mg
Intervention description: Ravagalimab 600 mg was administered intravenously (IV).; Ravagalimab 300 mg was administered subcutaneously (SC).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis (UC); ABBV-323; Ravagalimab

Summary:

      Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab
      (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must voluntarily sign and date an informed consent, approved by an
             independent ethics committee (IEC)/institutional review board (IRB), prior to the
             initiation of any screening or study-specific procedures.

          -  Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of
             biopsy results consistent with the diagnosis of UC in the assessment of the
             Investigator, must be available.

          -  Participant meets the following disease activity criteria: Active UC with an Adapted
             Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central
             review).

          -  History of inadequate response, loss of response, or intolerance to one or more of the
             approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or
             tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have
             received open-label drug).

        Exclusion Criteria:

          -  Participant having an active, chronic, or recurrent infection that based on
             Investigator's clinical assessment makes the participant an unsuitable candidate for
             the study.

          -  Participant having any malignancy except for successfully treated non-metastatic
             cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the
             cervix.

          -  Participant with history of dysplasia of the gastrointestinal tract or evidence of
             dysplasia in any biopsy performed during the screening endoscopy other than completely
             removed low-grade dysplastic lesions.

          -  Laboratory values not meeting the following criteria : Serum aspartate transaminase
             (AST) and alanine transaminase (ALT) <= 2* upper limit of normal (ULN); Total white
             blood cell (WBC) count >= 3.0*10^9/L.
Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Coagulation Factor IX variant; Coagulation Factor IX variant
Intervention description: Single intravenous injection of CB2679d/Dalcinonacog alfa; Daily subcutaneous injections of CB2679d/Dalcinonacog alfa for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 2b, single-center, open-label study designed to evaluate the pharmacokinetics,
      pharmacodynamics, efficacy and safety of subcutaneous (SC) prophylaxis treatment regimens
      with CB2679d in 6 adult, male subjects with severe congenital hemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of severe (<2%) congenital hemophilia B.

          -  Male, age 18 or older.

          -  Agreement to use highly effective birth control throughout the study.

          -  Affirmation of informed consent with signature confirmation before any trial-related
             activities.

          -  Stated willingness to comply with all study procedures and availability for the
             duration of the study.

        Exclusion Criteria:

          -  History or a family history of FIX inhibitors.

          -  Positive antibody to FIX detected by central laboratory at screening.

          -  Previous participation in and subsequent treatment in a clinical trial within the
             previous 30 days or 3-half-lives, whichever is longer, or absence of clinical effect.

          -  Have a coagulation disorder other than congenital hemophilia B.

          -  Factor IX gene mutation 128G>A.

          -  Significant contraindication to participation.
Celecoxib as a Post-tonsillectomy Pain Medication
Condition: Tonsillitis
MeSH terms: Tonsillitis
Intervention: Celecoxib; Placebo
Intervention description: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery; Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tonsillectomy; Analgesia; Pain measurement; Celecoxib

Summary:

      The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces
      post-operative narcotic use.

      To test this hypothesis, the study is placebo controlled (sugar pill). Half of the
      participants will receive a sugar pill, half will not.

      All participants will receive the standard post-operative pain medications.

      We ask participants to log the amount of medications they use daily, and the amount of pain
      they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain
      medication needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at least 18 years

          -  Indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of
             additional surgical procedures will not be included)

          -  Have the ability to understand and the willingness to sign a written informed consent
             document

        Exclusion Criteria:

          -  History of bleeding disorders

          -  History of liver or kidney dysfunction

          -  History of allergy to sulfa containing medications

          -  History of lactose intolerance

          -  History of asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs

          -  Women who are currently pregnant, nursing, or trying to conceive

          -  History of allergy or intolerance to acetaminophen or hydrocodone

          -  History of allergy to any COX-2 inhibitor, including celecoxib or rofecoxib.

          -  PT, PTT, hemoglobin, or hematocrit values that are outside of institutional limits.

          -  History of cardiovascular disease

          -  Patients currently taking celecoxib
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
Condition: Pneumonia, Bacterial
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: sulopenem and PF-03709270; Sulopenem and PF-03709270; Ceftriaxone and amoxicillin/clavulanate
Intervention description: Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day; Sulopenem - 600 mg infused over 1 hour twice daily for a minimum of 2 days and switch to oral PF-03709270 - 1000 mg twice a day; IV ceftriaxone (2g) infused over 30 minutes QD (once daily) for minimum of 2 days Step down oral amoxicillin/clavulanate potassium suspension (400 mg/5 ml) BID (every 12 hours)
Intervention MeSH terms: Amoxicillin; Ceftriaxone; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination; Lactams
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270
      are safe and effective in patients that are hospitalized with community acquired pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized male or female patients 18 years of age or older.

          -  Female patients of childbearing potential must not be pregnant.

          -  Must exhibit at least two pre-specified clinical symptoms/signs of pneumonia.

          -  Must require hospitalization for the pneumonia.

          -  Chest Xray must be suggestive of a pneumonia.

        Exclusion Criteria:

          -  Hospital or ventilator associated pneumonia.

          -  Patients with cystic fibrosis, pneumocystis carinii pneumonia or active tuberculosis.

          -  Previous treatment for the current pneumonia episode received for more than 24 hours.

          -  Allergies to penems or beta lactams.
Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Intervention: Glatiramer Acetate
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Treatment trial, Rett syndrome, Glatiramer acetate

Summary:

      A phase 2 open label trial to test a potential drug treatment for Rett syndrome, the leading
      known genetic cause of severe neurological impairment in girls. The drug, Copaxone (generic
      name - Glatiramer acetate) is medication FDA approved for the treatment of multiple
      sclerosis. Copaxone's high safety profile has been documented in large cohorts of patients
      for more than 12 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients with genetically confirmed Rett Syndrome (RTT)

          -  Age: 10 or more years old. Selection of the age is based on the available evidence of
             the safety of Glatiramer Acetate (GA) in this group, and the relative
             homogeneity/stability of the phenotype, which is not expected to spontaneously change
             within a 6 month period at this age

          -  Ambulatory (with our without support)

        Exclusion Criteria:

          -  Prolonged Qtc (obtained within 30 days prior to enrollment)

          -  Presence of co morbid non-Rett related disease

          -  Presence of immunodeficiency requiring intravenous immunoglobulin 3 (IVIG 3) months
             prior to enrollment

          -  Allergy/sensitivity to GA or mannitol

          -  Inability or unwillingness of legal guardians to give written informed consent
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Condition: Gout and Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Intervention: RDEA3170; Allopurinol; Placebo
Intervention description: Oral Treatment; Oral Treatment; Oral Treatment
Intervention MeSH terms: Allopurinol; Verinurad
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients
      with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg
      once daily, respectively will result in greater reduction of sUA compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:

               1. sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;

               2. sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with
                  complications (hypertension, ischemic heart disease, diabetes, metabolic
                  syndrome);

               3. sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and
                  complications.

        Exclusion Criteria:

          -  Subject with an acute gout flare that has not resolved at least 14 days prior to the
             baseline visit.

          -  Subject has a history or suspicion of kidney stones.

          -  Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft
             Gault formula

          -  Subject is receiving strong or moderate CYP3A inhibitors
Study of LL-BMT1 in Patients With Elevated Intraocular Pressure
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: LL-BMT1
Intervention description: Drug-printed contact lens in both eyes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, non-comparative
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Prostaglandin; Intraocular pressure

Summary:

      This is an open-label, Phase 2a clinical study of LL-BMT1 in patients with primary open-angle
      glaucoma and ocular hypertension. Study subjects will be treated for 7 days with a single
      dose of LL-BMT1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age at the Screening Visit

          -  Diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes

          -  At least one eye (called the study eye) must have an untreated intraocular pressure
             between 22 mmHg and 34 mmHg (inclusive) as measured at 9 am during the Baseline Visit.

          -  Best corrected visual acuity of Early Treatment Diabetic Retinopathy Study of 50
             letters or better

        Exclusion Criteria:

          -  Glaucoma or optic neuropathy due to anything other than above noted reasons
             Cup-to-disc ratio of >0.8 in either eye

          -  Corneal thickness <480 or >620 μm