bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Placebo; Placebo; RG1507; RG1507; erlotinib [Tarceva]
Intervention description: iv 9mg/kg weekly; iv 16mg/kg every 3 weeks; iv 9mg/kg weekly; iv 16mg/kg every 3 weeks; 150mg oral daily
Intervention MeSH terms: Erlotinib Hydrochloride; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who
      failed at least one standard chemotherapy regimen will determine the proportion of patients
      with progression-free survival at 12 weeks following combination therapy with R1507 and
      Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to
      receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks.
      Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related
      endpoints including overall survival, objective response rate, time to response, time to
      progressive disease and duration of response will also be evaluated. The anticipated time on
      study treatment is 1-2 years, and the target sample size is <500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients >=18 years with histologically documented inoperable, locally
             advanced or metastatic (stage IIIB or IV) NSCLC;

          -  patients must have failed at least one but no more than two standard chemotherapy
             regimens;

          -  measurable disease according to the RECIST criteria;

          -  Eastern Cooperative Oncology Group (ECOG) performance status;

          -  life expectancy >12 weeks.

        Exclusion Criteria:

          -  patients with active central nervous system (CNS) lesions;

          -  prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R)
             inhibition or epidermal growth factor receptor (EGFR) targeting;

          -  administration with high doses of systemic corticosteroids;

          -  radiotherapy in the 4 weeks prior to study start;

          -  surgery or significant traumatic injury with in the last 2 weeks prior to study start.
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: INC280; Gefitinib
Intervention description: During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.; Gefitinib 250 mg taken once daily
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: EGFR; c-MET; Lung cancer; Gefitinib; Erlotinib; Non-small cell lung cancer (NSCLC); lung adenocarcinoma; large-cell lung carcinoma

Summary:

      This study assessed the safety and efficacy of escalating doses INC280 when added to
      gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET
      pathway and who had failed after benefiting on a prior treatment with either gefitinib or
      erlotinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented EGFR mutation

          -  Documented c-MET dysregulation

          -  Prior clinical benefit on EGFR inhibitors and then subsequent progression

             -≥ 18 year old

          -  Life expectancy of ≥ 3 months

          -  ECOG performance status ≤ 2

        Exclusion Criteria:

          -  Unable to swallow tables once or twice daily

          -  Previous treatment with c-MET inhibitor

          -  Any unresolved toxicity from previous anticancer therapy greater than grade 1

          -  History of cystic fibrosis

          -  History of acute or chronic pancreatitis

          -  Unable to undergo MRI or CT scans

          -  Known history of HIV

          -  Undergone a bone marrow or solid organ transplant

          -  Clinically significant wound or lung tumor lesions with increased likelihood of
             bleeding

          -  Pregnant or nursing
Faslodex in McCune Albright Syndrome
Condition: Puberty, Precocious; McCune-Albright Syndrome
MeSH terms: Fibrous Dysplasia, Polyostotic; Puberty, Precocious; Syndrome
Intervention: Fulvestrant
Intervention description: intramuscular injection
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 1 Year
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Progressive Precocious Puberty; PPP; McCune-Albright Syndrome; MAS

Summary:

      The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a
      study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty
      (early puberty) in girls with McCune-Albright syndrome (MAS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females less than or equal to 10 years of age (prior to 11th birthday)

          -  Diagnosis of McCune-Albright syndrome (MAS)

          -  Progressive precocious puberty (PPP) associated with MAS

        Exclusion Criteria:

          -  Received any prior treatment for PPP associated with MAS with fulvestrant

          -  Abnormal platelet count or liver function tests

          -  Bleeding disorders

          -  Long term anticoagulation therapy

          -  Known hypersensitivity to any component of the study drug
Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: GZ/SAR402671
Intervention description: Pharmaceutical form:capsule
Route of administration: oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease
      who previously completed study ACT13739 (NCT02489344).

      Secondary Objective:

      To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy
      endpoints in adult male participants with Fabry disease who previously completed study
      ACT13739.
    

Eligibility criteria:

        Inclusion criteria :

          -  Male participant with Fabry disease who previously completed study ACT13739.

          -  Participants, willing and able to provide signed informed consent.

          -  Sexually active participants, willing to practice true abstinence in line with their
             preferred and usual lifestyle or using two acceptable effective methods of
             contraception.

        Exclusion criteria :

        -Participants, in the opinion of the Investigator, unable to adhere to the requirements of
        the study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma
Condition: Synovial Sarcoma
MeSH terms: Sarcoma; Sarcoma, Synovial
Intervention: ipilimumab
Intervention MeSH terms: Antineoplastic Agents, Immunological; Ipilimumab; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: synovial sarcoma; immunotherapy; cancer-testis antigen; cancer-germ cell antigen; soft tissue sarcoma; SYT-SSX chromosomal translocation

Summary:

      The purpose of this study is to determine whether immune therapy with anti-CTLA-4 antibody is
      effective in people with advanced synovial sarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented synovial sarcoma.

          -  Patients with metastatic disease or locally recurrent disease who have failed or
             refused standard treatment. The disease must be measurable by RECIST.

          -  Expected survival of at least 6 months.

          -  Weight at least 35 kg.

          -  ECOG performance scale 0-2.

          -  At least 3 weeks since major surgery, and at least 3 weeks since completing radiation
             therapy or chemotherapy (6 weeks for patients receiving mitomycin C).

          -  Resolution of toxicity from previous treatment to NCI-CTC grade 1 or less before
             treatment.

          -  Adequate bone marrow, renal and hepatic function.

          -  Able and willing to give valid written informed consent.

        Exclusion Criteria:

          -  Clinically significant heart disease (NYHA Class III or IV).

          -  Other serious illnesses, e.g. serious infections requiring antibiotics or bleeding
             disorders.

          -  History of autoimmune disease.

          -  Serious intercurrent illness, requiring hospitalization.

          -  Patients with a second cancer diagnosis in the last five years, except for basal cell
             carcinoma, completely resected, or cervical carcinoma in situ (CIN), completely
             resected.

          -  Known HIV positivity.

          -  Metastatic disease to the central nervous system for which other therapeutic options,
             including radiotherapy, may be available.

          -  Chronic use of immunosuppressive drugs such as systemic corticosteroids.

          -  Mental impairment that may compromise the ability to give informed consent and comply
             with the requirements of the study.

          -  Lack of availability for immunological and clinical follow-up assessments.

          -  Participation in any other clinical trial involving another investigational agent
             within 3 weeks prior to enrollment.

          -  Pregnancy or breast feeding.

          -  Refusal or inability to use effective means of contraception (all men, and women with
             childbearing potential).
Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: EC-17
Intervention description: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer

Summary:

      Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete
      surgical resection, also known as a R0 resection. At present, the ability to perform a
      complete resection with negative margins is limited by the surgeon's ability to palpate and
      visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and
      costs while maintaining or improving surgical and oncologic outcomes, the investigators must
      develop technologies that improve visualization of the primary tumor and occult metastases,
      real time, during surgery. Recent research has demonstrated that the use of fluorescent
      probes that recognize cancer specific antigens can be used for this purpose when visualized
      using a prototype near-infrared multispectral imaging system.

      This investigation will determine if folate-FITC, a fluorescent probe that recognizes the
      folate receptor (present in > 90% of ovarian cancers) can facilitate surgical resection and
      detect tumor nodules not visible to the naked eye.
    

Eligibility criteria:

        Inclusion Criteria:

        Women who are:

          -  Diagnosed with or at high clinical suspicion of primary ovarian cancer by either
             radiologic imaging or physical examination or biopsy or serum tumor markers

          -  Scheduled to undergo surgical cytoreduction via laparotomy

          -  At least 18 years of age

          -  Capable and willing to provide informed consent

        Exclusion Criteria:

        Women with:

          -  Known sarcomatous histologies

          -  Recurrent ovarian cancer

          -  Planned surgical approach via laparoscopy or robotic surgery

          -  A history of anaphylactic reactions to Folate-FITC or insects

          -  Inability or unwillingness to provide informed consent
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
Condition: Hyperphosphatemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: Placebo; Sevelamer carbonate
Intervention description: Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets; 0.8 g sachets of powder for oral suspension or 800 mg tablets
Intervention MeSH terms: Sevelamer
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Pediatric; Sevelamer Carbonate; Hyperphosphatemia

Summary:

      Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to

        -  Evaluate the safety and tolerability of sevelamer carbonate

        -  Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant had CKD requiring dialysis or CKD not on dialysis with an estimated
             glomerular filtration rate (GFR) <60 mL/min/1.73 m^2 based on central laboratory
             results.

          -  The participant had a serum phosphorus level greater than the age appropriate upper
             limit of normal based on central laboratory results.

        Exclusion Criteria:

          -  The participant had active dysphagia, swallowing disorders or a predisposition to or
             current bowel obstruction, ileus or severe gastrointestinal motility disorder(s)
             including severe constipation, or major gastrointestinal tract surgery.

          -  The participant had a non-renal case of hyperphosphatemia.
Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation
Condition: Cardiac Allograft Vasculopathy
MeSH terms: Vascular Diseases
Intervention: Pioglitazone; Placebo
Intervention description: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months; placebo taken daily for one year
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac allograft vasculopathy; pioglitazone; insulin resistance; heart transplant

Summary:

      The purpose of this study is to determine the benefit of using the FDA-approved
      insulin-sensitizing agent, Pioglitazone, on human heart transplant recipients. The objectives
      of this project are to (1) determine if pioglitazone effectively treats insulin resistance in
      heart transplant recipients, and (2) to determine whether pioglitazone therapy after heart
      transplantation impacts the development or progression of cardiac allograft vasculopathy
      (CAV), a form of chronic rejection after heart transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Heart transplant recipients, years 1-4 post-transplant

          2. Age >= 18 years

          3. Fasting TG/HDL ratio>=3.0 or Fasting TG>=150 mg/dL

        Exclusion Criteria:

          1. Diabetes mellitus

          2. Severe liver dysfunction (ALT>=2.5 x upper limit of normal)

          3. Severe renal dysfunction (GFR<30 or Stage IV CKD)

          4. Moderate-severe fluid retention

          5. Clinical or echocardiographic signs of left ventricular dysfunction

          6. Contraindication to coronary angiography and/or IVUS
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Factor XIIa antagonist monoclonal antibody; Placebo
Intervention description: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use; Buffer without active ingredient
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are assigned to 1 of 2 or more groups in parallel for the duration of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to
      investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to
      prevent attacks in subjects with HAE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Aged ≥ 18 to ≤ 65 years

          -  A diagnosis of C1-INH HAE or FXII/PLG HAE;

          -  For subjects with C1-INH HAE: ≥ 4 HAE attacks over a consecutive 2-month period during
             the 3 months before Screening, as documented in the subject's medical record.

        Exclusion Criteria:

          -  History of clinically significant arterial or venous thrombosis, or current clinically
             significant prothrombotic risk

          -  History of an uncontrolled, abnormal bleeding event due to a coagulopathy, or a
             current clinically significant coagulopathy or clinically significant risks for
             bleeding events

          -  Known incurable malignancies
Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AC-150 Combo; AC-150A 0.1%; AC-150B 0.005%; Vehicle
Intervention description: 1 drop in each eye for up to 14 days; 1 drop in each eye once per day for up to 14 days; 1 drop in each eye once per day for up to 14 days; 1 drop in each eye once per day for up to 14 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its
      components in the prevention of the signs and symptoms of allergic conjunctivitis in
      Enviro-CAC™ Model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive bilateral conjunctival allergen challenge(CAC) reaction

        Exclusion Criteria:

          -  Known contraindications or sensitivities to the study medication or its components.

          -  Any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety or trial parameters.

          -  Use of disallowed medications during the period indicated prior to study enrollment or
             during the study.
Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: once daily, 12 weeks; once daily, 12 weeks
Intervention MeSH terms: Dapagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Japanese; phase 2; efficacy; safety; dapagliflozin

Summary:

      The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in
      Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of
      dapagliflozin to placebo when given in oral doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese Subjects with type 2 diabetes mellitus.

          -  Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects
             treated with single or two (less than half of the approved maximal dose for each) oral
             anti-hyperglycaemic agent with HbA1c ≤ 8%.

          -  Provision of informed consent.

        Exclusion Criteria:

          -  Having clinically relevant medical history or concurrent disease such as
             cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological
             disease.

          -  The investigator(s) judged that the Subject should not participate in the study
             according to screening test or medical history.