bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Chemotherapy
Intervention description: Erlotinib was supplied as tablets.; Cisplatin and gemcitabine were locally sourced with commercial products.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva
      (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in
      patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor
      (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg
      orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8
      plus cisplatin 75 mg/m^2 iv on Day 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, ≥ 18 years of age.

          -  Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell
             lung cancer.

          -  Presence of epidermal growth factor receptor (EGFR) mutations in tumours.

          -  Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
             version 1.1 criteria.

          -  European Cooperative Oncology Group (ECOG) performance status ≤ 2.

        Exclusion Criteria:

          -  Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but
             not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).

          -  Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.

          -  Lack of physical integrity of the upper gastrointestinal tract, or malabsorption
             syndrome, or inability to take oral medication, or active gastroduodenal ulcer
             disease.

          -  Any inflammatory changes of the surface of the eye.

          -  ≥ Grade 2 peripheral neuropathy.

          -  History of any other malignancies within 5 years, except for adequately treated
             carcinoma in situ of the cervix or basal or squamous cell skin cancer.

          -  Brain metastasis or spinal cord compression that has not yet been definitely treated
             with surgery and/or radiation, or treated but without evidence of stable disease for
             at least 2 months.

          -  Human immunodeficiency virus (HIV) infection.

          -  Pregnant, nursing, or lactating women.
An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CB-03-01 cream, 1%
Intervention description: Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 609.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: acne; clascoterone; anti-androgen

Summary:

      The primary objective of this study is to determine the long-term safety of CB-03-01 cream,
      1% applied twice daily for an additional nine months in study participants with acne vulgaris
      that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has successfully completed participation in one of the Phase 3 pivotal
             studies [CB-03-01/25 and CB-03-01/26].

          -  Participant agrees to use effective method of contraception throughout study, if
             applicable.

          -  Participant has provided written informed consent or assent.

          -  Participant is willing to comply with study instructions and return to the clinic for
             required visits.

        Exclusion Criteria:

          -  Participant is pregnant, lactating, or is planning to become pregnant during the
             study.

          -  Participant has any skin disease or condition that could interfere with the safety
             evaluation of the test products or requires the use of interfering topical or systemic
             therapy.

          -  Participant has any condition which, in the investigator's opinion, would make it
             unsafe or unsuitable for the participant to participate in this research study.

          -  Participant plans to use any other investigational drug or device during participation
             in this study.

          -  Participant has known hypersensitivity or previous allergic reaction to the drug or
             any of its ingredients.

          -  Participant is or plans to use any restricted systemic and/or topical anti-acne
             preparations or medications during the study
Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: T2345; Prostaglandin
Intervention description: One drop of T2345; One drop
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 404.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of T2345 versus active
      comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients diagnosed with glaucoma

        Exclusion Criteria:

          -  Under 18.
Chloroquine for Malaria in Pregnancy
Condition: Malaria
MeSH terms: Malaria
Intervention: Chloroquine; Sulfadoxine-pyrimethamine
Intervention description: Chloroquine tablets contain 300 mg chloroquine base per tablet. Dosages: Chloroquine 1,500 mg base over 3 days twice during pregnancy or Chloroquine 600 mg loading dose followed by 300 mg orally once per week. Intermittant preventative treatment in pregnancy (IPTp) doses will be administered between weeks 20-28 and weeks 28-34 gestation, 4 weeks apart. Participants randomized to IPTp with chloroquine will require their second and third doses of chloroquine after the initial dose given in the clinic and those assigned to chloroquine chemoprophylaxis will require weekly doses.; Sulfadoxine-pyrimethamine 3 tablets (1,500 mg sulfadoxine and 75 mg pyrimethamine) twice during pregnancy. Intermittant preventive treatment in pregnancy (IPTp) doses will be administered between weeks 20-28 and weeks 28-34, 4 weeks apart.
Intervention MeSH terms: Chloroquine; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 900.0
Sex: Female
Maximum age: 99 Years
Healthy volunteers: No
Keywords: malaria,Malawi,pregnancy

Summary:

      The purpose of this study is to test prevention strategies for pregnancy-related malaria.
      Researchers will compare different malaria treatments and treatment schedules which include
      chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each
      time) to the standard practice of preventive treatment intervals in pregnancy (with the drug
      sulfadoxine-pyrimethamine given twice during pregnancy). Participants will include 900
      pregnant women, who will be assigned to one of three treatment groups. Blood samples will be
      collected at every visit before birth and any time the participant is ill to determine if
      malaria is present. Pregnant women will be monitored during pregnancy and newborns will be
      assessed at birth and followed until about 14 weeks. Participant involvement in the study is
      expected to last about 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

        Women who present to the Ndirande Antenatal Clinic (ANC) and meet the following inclusion
        criteria will be enrolled in the study: -Before the end of 27th week of gestation -First or
        second pregnancy -Anticipate remaining in Blantyre until 14 weeks after delivery -Agree to
        deliver at the Ndirande Health Centre or Queen Elizabeth Central Hospital (QECH) -Provision
        of informed consent

        Exclusion Criteria:

        -Chronic use (>14 days) of any medication with antimalarial or antifolate activity -Human
        immunodeficiency virus (HIV) infection -Known high-risk pregnancy requiring regular
        supervision of an obstetrician -Allergy to any of the study drugs
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Dapagliflozin; Placebo for dapagliflozin
Intervention description: Tablets; Tablets
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 815.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Dapagliflozin; Efficacy; Safety; Add on to insulin; Oral Antidiabetic; Type 1 diabetes

Summary:

      The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and
      effective therapy to improve glycemic control in patients with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 Diabetes mellitus (T1DM)

          -  Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)

          -  Insulin use for at least 12 months per patient reported or medical records

          -  Method of insulin administration (MDI or CSII) must have been unchanged for at least 3
             months prior to screening

          -  Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior
             to screening

          -  If on MDI insulin administration, subject must be on ≥ 3x injections per day

          -  Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%

          -  Body mass index (BMI) ≥ 18.5 kg/m2

        Exclusion Criteria:

          -  History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young
             (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased
             beta cell capacity

          -  Taking any non-insulin antihyperglicemic agent within 1 month prior to screening

          -  Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly
             administration and within 1 month prior to screening for once or twice daily
             administration

          -  Taking metformin and/or thiazolidinediones within 2 months prior to screening

          -  History of diabetes ketoacidosis requiring medical intervention within 1 month prior
             to screening

          -  History of hospital admission for glycemic control (either hyperglycemia or
             hypoglycemia) within 1 month prior to screening

          -  Frequent episodes of severe hypoglycemia (more than one episode requiring medical
             assistance, emergency care), and/or glucagon therapy administered by a third-party
             individual within 1 month prior to screening

          -  History of Addison's disease
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Ravulizumab OBDS; Ravulizumab
Intervention description: The ravulizumab OBDS is a biological-device combination product consisting of a prefilled cartridge containing ravulizumab SC and an on-body injector.; Administered by IV infusion. Ravulizumab IV doses will be based on participant body weight.
Intervention MeSH terms: Ravulizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH

Summary:

      The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab
      administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously
      administered ravulizumab in adult participants with PNH who are clinically stable on
      eculizumab for at least 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 years of age

          -  Treated with eculizumab for PNH for at least 3 months prior to Day 1

          -  LDH level ≤1.5 × upper limit of normal (ULN) at screening

          -  PNH diagnosis confirmed by documented high-sensitivity flow cytometry.

          -  Documented meningococcal vaccination not more than 3 years prior to, or at the time
             of, initiating study treatment.

          -  Body weight ≥40 to <100 kilogram (kg)

          -  Female participants of childbearing potential must use highly effective contraception
             starting at screening and continuing until at least 8 months after the last dose of
             ravulizumab.

          -  Willing and able to give written informed consent and comply with study visit
             schedule.

        Exclusion Criteria:

          -  LDH level ≤ 2 × upper limit of normal (ULN) within 3 months prior to Day 1

          -  History of bone marrow transplantation.

          -  History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease
             that, in the opinion of the Investigator or Sponsor, would preclude participation.

          -  Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal
             bleed, severe congestive heart failure, anticipated need for major surgery within 6
             months of randomization, coexisting chronic anemia unrelated to PNH).

          -  Females who are pregnant, breastfeeding or who have a positive pregnancy test at
             screening or Day 1.

          -  Participation in another interventional clinical study or use of any experimental
             therapy within 30 days before initiation of study drug on Day 1 in this study or
             within 5 half-lives of that investigational product, whichever is greater.
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
Condition: Stage III Kidney Wilms Tumor; Stage IV Kidney Wilms Tumor
MeSH terms: Neoplasms; Wilms Tumor
Intervention: 3-Dimensional Conformal Radiation Therapy; Conventional Surgery; Cyclophosphamide; Dactinomycin; Doxorubicin Hydrochloride; Etoposide; Vincristine Sulfate Liposome
Intervention description: Given IV; Given IV; Given IV; Given IV; Given IV
Intervention MeSH terms: Dactinomycin; Cactinomycin; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Etoposide phosphate; Podophyllotoxin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 395.0
Sex: All
Maximum age: 29 Years
Healthy volunteers: No

Summary:

      This phase III trial is studying how well combination chemotherapy with or without radiation
      therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms'
      tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Radiation therapy uses
      high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy)
      with or without radiation therapy may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed Wilms' tumor meeting 1 of the following criteria:

               -  Stage IV disease with favorable histology with or without loss of heterozygosity
                  (LOH) for 1p and 16q

               -  Stage III disease with favorable histology with LOH for 1p and 16q transferring
                  from clinical trial COG-AREN0532

          -  Patients must begin therapy within 14 days after surgery or biopsy, unless medically
             contraindicated

          -  No bilateral Wilms' tumors (stage IV)

               -  Patients should be referred to COG-AREN0534

          -  Previously enrolled in clinical trial COG-AREN03B2

          -  Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky
             PS 50-100% (for patients ≤ 16 years of age)

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST or ALT < 2.5 times ULN

          -  Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide
             angiogram

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical
             trial COG-AREN0532 OR treatment for emergent issues, as medically indicated

          -  No concurrent aprepitant
The Fibrin Pad CV Phase III Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: EVARREST™ Fibrin Sealant Patch; Topical hemostat
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiovascular Diseases; Fibrin Sealant; Hemostatics; Coagulants

Summary:

      The objective of this study is to evaluate the safety and effectiveness of the EVARREST™
      Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical
             procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20
             years of age will require consent by the subject's legal representative

          -  Subjects must be willing to participate in the study and provide written informed
             consent.

          -  Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture
             line, involving a synthetic aortic graft, as identified intra-operatively by the
             investigator;

        Exclusion Criteria:

          -  Subjects with known intolerance to blood products or to one of the components of the
             study product or unwilling to receive blood products;

          -  Exposure to another investigational drug or device in a clinical trial within 30 days
             prior to surgery or anticipated in the 60 day follow up period after surgery.

          -  Female subjects who are pregnant or nursing.

          -  TBS is from a large defects in visible arteries or veins where the injured vascular
             wall requires repair and maintenance of vessel patency or where there would be
             persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure
             during absorption of the product;

          -  TBS with major arterial bleeding requiring suture or mechanical ligation;

          -  TBS involves an expanded polytetrafluoroethylene (ePTFE) graft

          -  TBS within an actively infected field;

          -  Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony
             confine;

          -  Subjects with any intra-operative findings identified by the investigator that may
             preclude conduct of the study procedure;
V260 Registration Study (V260-013)(COMPLETED)
Condition: Rotavirus
Intervention: Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Placebo
Intervention description: 3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2; 3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 178.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gastrointestinal Rotavirus

Summary:

      Immunogenicity and Safety of V260 in Healthy Infants in Korea
    

Eligibility criteria:

        Inclusion Criteria:

          -  At first study vaccination, age 6 weeks through exactly 12 weeks

        Exclusion Criteria:

          -  History of congenital abdominal disorders, intussusception, or abdominal surgery

          -  History of known prior rotavirus disease

          -  Ongoing chronic diarrhea or failure to thrive

          -  Clinical evidence of active gastrointestinal illness