bioihbjkbjnl/mcl2 huggingface dataset:
THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab; Chemotherapy
Intervention description: 2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks; Schedule and dose at the investigator's discretion
Intervention MeSH terms: Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of continuation or discontinuation of
      Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive
      metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus
      Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment
      (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line
      chemotherapy of the investigator's choice. The anticipated time on study treatment is until
      disease progression, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >=18 years of age;

          -  metastatic breast cancer;

          -  HER2 overexpression (IHC 3+ and/or FISH positive);

          -  disease progression during or after previous 1st line chemotherapy plus Herceptin;

          -  scheduled to receive 2nd line chemotherapy.

        Exclusion Criteria:

          -  incompatibility with previous Herceptin therapy;

          -  pregnancy.
Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
Condition: Lambert-Eaton Myasthenic Syndrome
MeSH terms: Lambert-Eaton Myasthenic Syndrome; Syndrome
Intervention: Amifampridine Phosphate; Placebo Oral Tablet
Intervention MeSH terms: Amifampridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LEMS

Summary:

      This study evaluates the effect of withdrawing amifampridine phosphate treatment from
      patients with LEMS. One half of the patients will continue to receive amifampridine phosphate
      and the other half will receive placebo, during this double-blind study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥18 years of age and currently receiving amifampridine phosphate for
             LEMS.

          2. Diagnosis of LEMS by antibody testing or electromyography (EMG).

          3. Completion of anti-cancer treatment at least 3 months (90 days) prior to Screening.

          4. If receiving peripherally acting cholinesterase inhibitors (e.g. pyridostigmine), a
             stable dose of cholinesterase inhibitors is required for at least 7 days prior to
             randomization and throughout the study.

          5. If receiving permitted oral immunosuppressants (prednisone or other corticosteroid), a
             stable dose is required for at least 30 days prior to randomization and throughout the
             study.

          6. Female patients of childbearing potential must practice an effective, reliable
             contraceptive regimen during the study.

          7. Able to perform all study procedures and assessments.

          8. Willing and able to travel to study site and attend all clinic study visits.

          9. Willing and able to provide written informed consent.

        Exclusion Criteria:

          1. Clinically significant long corrected QT (QTc) interval on ECG in previous 12 months.

          2. Seizure disorder.

          3. Active brain metastases.

          4. Unable to ambulate.

          5. Pregnant or lactating females.

          6. Any other condition which, in the opinion of the Investigator, might interfere with
             the patient's participation in the study or confound the assessment of the patient.
Clinical Study Comparing Two Models of a Travoprost Intraocular Implant
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Intervention: G2-TR intraocular implant containing travoprost; Sham surgery + active-comparator eye drops
Intervention description: Provided in Arm/Group descriptions; Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Intervention MeSH terms: Travoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase III study to compare the safety and efficacy of intraocular implants containing
      Travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5%
      (Timolol) in reducing elevated intraocular pressure in subjects with open angle glaucoma
      (OAG) or ocular hypertension (OHT)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open-angle glaucoma or ocular hypertension

          -  C/D ratio ≤ 0.8

          -  Zero to two preoperative ocular hypotensive medications

        Exclusion Criteria:

          -  Active corneal inflammation or edema

          -  Retinal disorders not associated with glaucoma
Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery
Condition: Cardiac Complication During Procedure
Intervention: Fibrinogen
Intervention description: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibrinogen; cardiac surgery; high risk; cardiopulmonary bypass; bleeding; blood transfusion

Summary:

      The aim of the study is to show that first line treatment with concentrated fibrinogen has
      superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and
      cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        All patients who are scheduled for elective complex cardiac surgical procedures including

          -  double procedures (aortic valve replacement (AVR)+CABG, mitral valve
             repair/replacement (MVR)+CABG, AVR+MVR)

          -  Redo-sternotomies

          -  Aortic root repair +/- AVR

        Exclusion Criteria:

          -  Any known congenital or pre-existing bleeding disorder

          -  pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)

          -  severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150
             U/l)

          -  inability to provide informed consent

          -  emergency surgery

          -  pregnancy or nursing

          -  age under 18 years

          -  intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)

          -  allergy to concentrated fibrinogen or other components in the product

          -  anemia (Hgb < 110)

          -  diagnosed deep vein thrombosis (DVT)

          -  pulmonary embolism

          -  acute stroke

          -  acute myocardial infarction
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
Condition: Meningococcal Meningitis; Human Papillomavirus Infection; Pertussis; Tetanus
MeSH terms: Whooping Cough; Tetanus; Papillomavirus Infections; Meningitis, Meningococcal; Meningitis
Intervention: Novartis Meningococcal ACWY Conjugate Vaccine; Tdap Vaccine; Novartis Meningococcal ACWY Conjugate Vaccine
Intervention description: One dose of vaccine administered intramuscularly; One dose of vaccine administered intramuscularly; One dose of vaccine administered intramuscularly
Intervention MeSH terms: Lactitol; Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1620.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; meningitis; vaccine; adolescents

Summary:

      This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY
      conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adolescents 11-18 years of age

          -  virgins (both male and female) with no intention of becoming sexually active during
             the study period

          -  who have been properly vaccinated against diphtheria, tetanus, pertussis

        Exclusion Criteria:

          -  who had a previous confirmed or suspected disease caused by N. meningitidis;

          -  who have previously been immunized with a meningococcal vaccine

          -  who have received prior human papillomavirus (HPV) vaccine;

          -  who have any serious acute, chronic or progressive disease

          -  who have epilepsy, any progressive neurological disease or history of Guillain-Barre
             syndrome;

          -  who have a known or suspected impairment/alteration of immune function, either
             congenital or acquired

          -  who are known to have a bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time;

          -  who have Down's syndrome or other known cytogenic disorders;
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Amrubicin Hydrochloride; Etoposide-Cisplatin combined chemotherapy
Intervention description: Amrubicin Hydrochloride combined with cisplatin; combined chemotherapy
Intervention MeSH terms: Etoposide; Amrubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extensive Disease-Small Cell Lung Cancer

Summary:

      This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from
      growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with
      cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease
      small cell lung cancer The subject, who is randomized to AP group may be involved into a
      pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically/cytologically proven small cell lung cancer

          -  Extensive disease

          -  No prior chemotherapy regimen

          -  Age 18 years or older

          -  ECOG performance status of 0-1

        Exclusion Criteria:

          -  Brain metastasis requiring treatment

          -  Treatment (Surgical or radiotherapy)of primary tumor

          -  Interstitial pneumonia or pulmonary fibrosis

          -  Abnormal cardiac function or myocardial infraction within 6 months before study
             enrollment
Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Intervention: Ruxolitinib
Intervention description: supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Polycythemia Vera; Hematologic Diseases; Myeloproliferative Disorders; INC424; Ruxolitinib; hydroxyurea resistant; adult

Summary:

      The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP)
      was to provide early access to ruxolitinib and evaluate safety information in patients with
      polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and who had no other
      standard treatment option, nor did they qualify for another clinical study for PV
    

Eligibility criteria:

        Inclusion Criteria:

        •Confirmed diagnosis of PV according to the 2008 World Health Organization criteria,
        palpable spleen, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1
        or 2; did not have access to a comparable or satisfactory alternative treatment

        Exclusion Criteria:

        •Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral
        infection requiring treatment, Active malignancy within the past 5 years, except treated
        cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell
        carcinoma of the skin, with no evidence for recurrence in the past 3 years., Women who were
        pregnant or nursing.
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema (DME)
MeSH terms: Macular Edema; Edema
Intervention: CT-P42; Eylea
Intervention description: 2mg/0.05 mL by Intravitreal injection; 2mg/0.05 mL by Intravitreal injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 348.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to
      Compare Efficacy and Safety of CT-P42 in comparison with Eylea in Patients with Diabetic
      Macular Edema
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient aged ≥18 years.

          -  Patient with DME secondary to DM involving the center of the macula (defined as the
             Optical Coherence Tomography [OCT] central subfield) in the study eye.

        Exclusion Criteria:

          -  Patient who has only one functional eye.

          -  Patient who currently has, or has a history (where indicated) of active proliferative
             diabetic retinopathy
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
Condition: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ombitasvir/paritaprevir/ritonavir; dasabuvir; ribavirin
Intervention description: ombitasvir/ABT-450/ritonavir tablets; dasabuvir tablets; ribavirin tablets
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Treatment naive; Interferon free; HCV; Chronic Hepatitis C; Hepatitis C Genotype 1a; Hepatitis C; pegylated-interferon (pegIFN)/ribavirin (RBV) experienced

Summary:

      A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic
      hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon
      (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with
      ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a
             infection.

          2. Chronic HCV infection.

          3. Participants must be non-cirrhotic.

          4. Participants must be treatment-naïve or have documentation that they were adherent to
             prior pegIFN/RBV combination therapy and meet the criteria of prior
             pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure.

          5. Participants must meet specific human leukocyte antigen (HLA) allele requirements.

        Exclusion Criteria:

          1. Women who are pregnant or breastfeeding.

          2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human
             immunodeficiency virus antibody (HIV Ab) positive immunoassay.

          3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that
             make the subject unsuitable for this study or treatment.

          4. Current enrollment in another interventional clinical study, previous enrollment in
             this study, prior or current use of any investigational or commercially available
             anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir,
             ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks
             prior to study drug administration.

          5. History of solid organ transplant.

          6. Screening laboratory analysis that shows abnormal results.
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: bexarotene with carboplatin and paclitaxel; carboplatin and paclitaxel
Intervention description: bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.; carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Bexarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 612.0
Sex: All
Healthy volunteers: No
Keywords: NSCLC; Targretin; Retinoid; Bexarotene

Summary:

      This study evaluates the use of Targretin capsules (bexarotene) in combination with standard
      chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients
      who have not yet received chemotherapy for their lung cancer.
    

Eligibility criteria:

        Patients must have:

          -  Pathologic (histologic or cytologic) confirmation of NSCLC

          -  Stage IIIB with malignant pleural effusion or Stage IV disease

          -  At least one measurable or evaluable NSCLC lesion that has not been previously
             irradiated unless radiation therapy was more than three weeks prior to entry in the
             study and the lesion has been shown to have progressed subsequent to the radiation
             therapy

          -  ECOG performance status 0 or 1

          -  Adequate organ system function

          -  Fasting serum triglycerides that are within the age-adjusted normal range (or
             normalized with appropriate intervention such as antilipid therapy prior to the
             initiation of Targretin capsule therapy).

        Patients must be able to complete at least four cycles of combination chemotherapy (i.e.,
        approximately four months)

        Patients must not have had:

          -  Brain metastasis

          -  Prior chemotherapy for NSCLC

          -  Prior platinum-based chemotherapy for any indication
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: NWP09; Placebo
Intervention description: Methylphenidate, variable dose, daily dosing, 1 week duration; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; methylphenidate extended-release

Summary:

      The safety and efficacy of a chewable formulation of extended-release methylphenidate will be
      studied in children with ADHD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this
             condition

        Exclusion Criteria:

          -  Other serious illnesses or conditions that would put the patient at particular risk
             for safety events or would interfere with treatment/assessment of ADHD