bioihbjkbjnl/mcl2 huggingface dataset:
A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.
Condition: Non-Small-Cell Lung Carcinoma; Adenocarcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab; Carboplatin; Paclitaxel; AG-013736 (axitinib); Carboplatin; Paclitaxel
Intervention description: Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.; Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg*min/ml, iv infusion, every 3 weeks.; Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks; AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-; Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg*min/ml, iv infusion, every 3 weeks.; Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with
      advanced lung cancer who have not been previously treated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced non squamous cell, lung cancer

          -  No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12
             months prior to enrollment

        Exclusion Criteria:

          -  Prior therapy for advanced lung cancer

          -  The need for blood-thinners

          -  Coughing up blood
Effects of Botox in Obstructed Defecation Syndrome
Condition: Obstructed Defecation Syndrome (ODS)
MeSH terms: Syndrome
Intervention: Botulinum Toxin-A; Normal Saline
Intervention description: 100 Units diluted in a 5 cc syringe at a concentration of 20U/mL; Dispensed in a 5 cc syringe
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Botox; Obstructed Defecation Syndrome; ODS; Outlet-Type Constipation; injection

Summary:

      The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve
      symptoms of constipation in obstructed defecation syndrome (ODS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 years or older of all races and backgrounds

          -  Competent to give informed consent

          -  Meet the Rome III diagnostic criteria for functional constipation

          -  Inability to relax the puborectalis muscle at electromyography

          -  Altomare Obstructed Defecation Syndrome score of 15 points or above

          -  Failure of treatment with 2 conservative measures which may be as follows:

               -  1 laxative (osmotic or stimulant) for 2 weeks

               -  1 fiber supplement for one month

               -  And/or trial of biofeedback for at least 4 sessions

        Exclusion Criteria:

          -  Previous treatment with Botox (possible antibodies)

          -  Known hypersensitivity to any of the components of the toxin

          -  Medication regimen includes narcotics

          -  Previous radiation therapy to the anal canal and rectum

          -  Prior proctectomy

          -  Presence of unhealed and symptomatic anal fissure

          -  Presence of anal pain

          -  Presence of fecal incontinence

          -  Presence of full thickness rectal prolapse

          -  Presence of internal sphincter myopathy

          -  Inflammatory bowel disease or proctitis

          -  Pregnancy or breast-feeding

          -  Subject is currently enrolled/ just finished participating in a clinical trial in
             which the intervention/ its carry-over effect may interact with the intervention in
             this trial
Study of Promethazine for Treatment of Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Intervention: Promethazine; Sugar pill
Intervention MeSH terms: Promethazine; Diphenhydramine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetic Gastroparesis; Promethazine

Summary:

      Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed
      gastric emptying will be recruited to participate in the study. Using double-blinded
      methodology, study participants will be randomly assigned to one of two treatment arms:
      promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days.
      The primary outcome will be the change in gastroparesis symptom severity, as measured by the
      Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants
      will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores,
      adverse events and treatment compliance will be assessed. It is hypothesized promethazine
      treatment will be superior to placebo in improving symptoms of gastroparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-65 years of age

          -  clinical diagnosis of diabetic gastroparesis.

          -  EGD without evidence of gastric outlet obstruction within the past five years

          -  gastric emptying scintigraphy test demonstrating >10% solid food retention at 4 hours
             within the past three years.

        Exclusion Criteria:

          -  the inability or unwillingness to provide informed consent

          -  currently pregnant or breast feeding

          -  prior placement of a gastric stimulator

          -  pyloric botulinum toxin injection within the past 12 months

          -  prior gastric surgery

          -  history of a connective tissue disorder

          -  use of narcotic medication within the past four weeks

          -  hemoglobin A1C >12 mg/dL within the past 3 months

          -  current or recent (within past 4 weeks) use of promethazine, metoclopramide or
             domperidone

          -  hypersensitivity or prior adverse reaction to promethazine

          -  concomitant use of phenothiazines (i.e. prochlorperazine, chlorpromazine) or other
             agents likely to increase extrapyramidal reactions

          -  concomitant use of tiotropium or ipratropium

          -  narrow angle glaucoma

          -  urinary retention

          -  Parkinson's disease

          -  significant psychiatric disease

          -  history of seizure.
Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
Condition: Adenocarcinoma; Non-small Cell Lung Cancer
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Intervention: Erlotinib
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tarceva; Erlotinib; OSI-774; Adenocarcinoma; Advanced Lung Cancer

Summary:

      The purpose of this trial is to figure out what effects (good or bad) the investigational
      drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated
      adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Diagnosis of adenocarcinoma of the lung

          -  Patient has had at least one core biopsy of her tumor

          -  Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of
             her tumor

          -  Stage four (IV) or three (III) B non-small cell lung cancer

          -  Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less
             cigarettes in her lifetime while a former smoker is defined as a person who has quit
             smoking one or more years ago.

          -  Three or more weeks since last radiation therapy

          -  Three or more weeks since last major surgery

          -  Must at least be able to walk and capable of taking care of herself although unable to
             carry out work activities

          -  Life expectancy of 8 weeks or more

          -  Blood tests that show kidneys, liver and bone marrow to be working adequately

          -  Women of child-bearing potential must agree to use adequate contraception prior to
             study entry and for the entire time enrolled in study

        Exclusion Criteria:

          -  Prior exposure to Tarceva (OSI-774, erlotinib)

          -  Uncontrolled central nervous system problems

          -  Prior chemotherapy regimen

          -  Difficulty swallowing

          -  A disease or disorder that interferes with ability to digest and absorb food

          -  Incomplete healing of previous oncologic or other major surgery

          -  Significant medical history or unstable medical condition such as heart failure,
             active infection, uncontrolled high blood pressure

          -  Pregnant or breast feeding

          -  A medical condition that could make it unsafe for patient to participate in this study
A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study
Condition: Major Cutaneous Abscess; Cellulitis; Erysipelas
MeSH terms: Abscess; Cellulitis; Erysipelas
Intervention: TR701 FA
Intervention description: 1 tablet 200 mg once daily
Intervention MeSH terms: Tedizolid
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major
      cutaneous abscess or cellulitis/erysipelas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years of age

          -  Suspected or documented gram-positive infection from baseline Gram stain or culture.

          -  Cellulitis/erysipelas or major cutaneous abscesses at Screening

        Exclusion Criteria:

          -  Postsurgical or open wound infections

          -  Severe sepsis or septic shock

          -  Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (<
             75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous
             lesions

          -  Infections associated with, or in close proximity to, a prosthetic device

          -  Known bacteremia or osteomyelitis at time of screening
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
Condition: Hyperoxaluria; Nephrolithiasis
MeSH terms: Kidney Calculi; Nephrolithiasis
Intervention: ALLN-177
Intervention description: ALLN-177 is orally administered oxalate decarboxylase (OxDc). The goal of oral therapy with ALLN-177 is to enzymatically degrade both dietary oxalate and endogenously produced oxalate secreted in the gastrointestinal tract resulting in decreased absorption and reduced urinary oxalate excretion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Healthy volunteers: No
Keywords: Urine Oxalate; Nephrolithiasis; Kidney Stones; Hyperoxaluria; Enteric Hyperoxaluria; Idiopathic Hyperoxaluria; Urological Diseases; Kidney Diseases

Summary:

      The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate
      excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  Able to comply with study procedures

          -  History of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney
             stone

          -  Hyperoxaluria >36mg of oxalate/24-hr

          -  May be taking drugs for the prevention of stone disease as long as there have been no
             changes in these medications for at least 3 months

        Exclusion Criteria:

          -  Uric acid ≥1.5g/24-hr

          -  Estimated glomerular filtration rate of < 60 mL/min

          -  Positive results from drug urine screen

          -  Requires daily vitamin C (defined as >10 days of >300 mg/day)

          -  Diagnosis of hypercalcemia or hypothyroidism

          -  Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis,
             primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones,
             and/or medullary sponge kidney.

          -  Auto-immune disorder requiring high dose steroids or other immunosuppressant drugs.

          -  Subjects who are pregnant. Women of childbearing potential must have a negative
             pregnancy test prior to enrollment and must practice approved methods of birth control
             during the trial

          -  History of cancer diagnosis except for within the past 5 years excluding dermal
             squamous and/or basal cell carcinoma or cervical carcinoma in situ.

          -  Taken investigational compound within 30 days prior to the first day of the study

          -  Treatment with cholestyramine

          -  Average daily dietary intake of <75 mg oxalate per day calculated from diet recalls
A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
Condition: Acneiform Eruptions
MeSH terms: Acneiform Eruptions
Intervention: Imsidolimab; Placebo
Intervention description: Humanized monoclonal antibody; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IL-36 receptor; Interleukin 36; Imsidolimab

Summary:

      Efficacy and Safety of imsidolimab in participants with epidermal growth factor receptor
      inhibitor (EGFRi)/mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK)
      kinase inhibitor (MEKi)-associated acneiform Rash
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has cancer

          -  Participant is treated with an oral or injectable Food and Drug Administration
             (FDA)-approved EGFRi or MEKi therapy

          -  Participant has EGFRi/MEKi-related acneiform rash of Grade ≥ 2 as per common
             terminology criteria for adverse events (CTCAE) version 5.0, and ≥ 20 inflammatory
             lesions on the face at screening and Day 1.

        Exclusion Criteria:

          -  Participant has infected EGFRi/MEKi-associated acneiform rash according to
             investigator's evaluation.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: olodaterol (BI 1744) low; low tiotropium bromide; olodaterol (BI 1744) high; medium tiotropium bromide; high tiotropium bromide; Placebo; Respimat
Intervention description: olodaterol (BI 1744) low; low tiotropium bromide; olodaterol (BI 1744) high; medium tiotropium bromide; high tiotropium bromide; Placebo; Respimat inhaler
Intervention MeSH terms: Bromides; Tiotropium Bromide; Olodaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 233.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL
      and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week
      treatment in patients with COPD.
    

Eligibility criteria:

        Inclusion criteria:

          1. All patients must sign an informed consent

          2. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD)
             must meet the following spirometric criteria:

        a post-bronchodilator forced expiratory flow in 1 second (FEV1) =<30% of predicted normal
        and <80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC)
        <70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be
        current or ex-smokers with a smoking history of more than 10 pack years

        Exclusion criteria:

          -  Patients with a significant disease other than COPD;

          -  Patients with clinically relevant abnormal baseline haematology, blood chemistry, or
             urinalysis;

          -  Patients with a history of asthma or a total blood eosinophil count >=600/mm3.

          -  Patients with any of the following conditions:

        a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a
        diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a
        history of myocardial infarction within 1 year of screening visit a diagnosis of clinically
        relevant cardiac arrhythmia a malignancy for which patient has undergone resection,
        radiation therapy or chemotherapy within last five years

          -  Patients who have undergone thoracotomy with pulmonary resection

          -  Patients being treated with the following concomitant medications:

        medications that prolong the QT/QTc interval oral Beta-adrenergics oral corticosteroid
        medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in
        excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day

        - Pregnant or nursing women
Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery
Condition: Inflammatory Reaction Due to Ocular Lens Prosthesis
MeSH terms: Cataract; Inflammation
Intervention: IBI-10090
Intervention description: Single intraocular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: ocular inflammation cataract surgery; post cataract surgery inflammation

Summary:

      This study will test the efficacy and safety of IBI-10090 for the reduction of ocular
      inflammation after cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients 40 years of age scheduled for unilateral cataract surgery
             (phacoemulsification or extracapsular extraction) with posterior chamber intraocular
             lens implantation.

        Exclusion Criteria:

          -  Patients who have used any ocular, topical or oral corticosteroids within 7 days prior
             to Day 0.

          -  Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to
             screening.

          -  Patients with any signs of intraocular inflammation in either eye at screening.

          -  Patients who have received any prior intravitreal injections in the study eye.
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: KB003; Placebo Comparator
Intervention description: KB003 IV x5 doses; Placebo IV x5 doses
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: Rheumatoid Arthritis; Biologics-Inadequate; KB003; GM-CSF

Summary:

      The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of
      various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who
      have had an inadequate prior treatment outcome from biologic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 6 swollen and at least 6 tender joints

          -  C-reactive Protein (CRP) > Upper Limit Normal (ULN)

          -  Prior inadequate response from biologic therapy

          -  Stable regimens of concomitant RA therapies

        Exclusion Criteria:

          -  Unstable medical conditions
Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CP-690,550; CP-690,550; CP-690,550; Placebo
Intervention description: tablets, 2 mg BID for 12 weeks; tablets, 5 mg BID for 12 weeks; tablets, 15 mg BID for 12 weeks; tablets, BID for 12 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis

Summary:

      The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3
      dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic
      plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with plaque psoriasis for at least 6 months.

          -  Have plaque psoriasis covering at least 15% of their total body.

          -  Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or
             history of previous treatment).

          -  Be willing and able to comply with scheduled visits, treatment plan and other study
             procedures.

        Exclusion Criteria:

          -  Currently have non-plaque forms of psoriasis or drug-induced psoriasis.

          -  Subject cannot discontinue systemic therapies and/or topical therapies for the
             treatment of psoriasis and cannot discontinue phototherapy.

          -  Subject is participating in another trial using an investigational agent or procedure.

          -  Women who are pregnant or breast-feeding or considering becoming pregnant.