bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: neratinib; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2840.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER-2/erbB-2 positive breast cancer; breast cancer; adjuvant therapy; neratinib; HKI-272; Nerlynx; PB-272

Summary:

      The purpose of this study is to investigate whether neratinib can further reduce the risk of
      recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment
      with trastuzumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.

          -  Been treated for early breast cancer with standard of care duration of trastuzumab.

          -  Could have been treated neoadjuvantly but have not reached pathologic complete
             response.

        Exclusion Criteria:

          -  Positive clinical and radiologic assessments for local or regional recurrence of
             disease at the time of study entry.

          -  History of heart disease.

          -  Corrected QT (QTc) interval >0.45 seconds

          -  History of gastrointestinal disease with diarrhea as the major symptom.
A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: Turoctocog alfa pegol; Turoctocog alfa pegol; Turoctocog alfa pegol
Intervention description: Turoctocog alfa pegol 75 IU/kg body weight will be administered once weekly as intravenous injections for a duration of 2 years.; Turoctocog alfa pegol 60 IU/kg body weight (for patients younger than 12 years) and 50 IU/kg body weight (for patients, 12 years or older) will be administered twice weekly as intravenous injections for a duration of 2 years.; Turoctocog alfa pegol 50 IU/kg body weight will be administered three times weekly as intravenous injections for a duration of 2 years.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: Male
Healthy volunteers: No

Summary:

      This study will look at how a known study medicine N8-GP works in previously N8-GP treated
      people with haemophilia A. The aim is to look at how N8-GP works during regular use.
      Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A
      for several years. Participants will get an injection of N8-GP into a blood vessel, one, two
      or three times weekly. Participants will get more doses if they bleed or if they will need a
      surgery. The study will last for about 2 years. Participants will have at least 9 visits with
      the study doctor. If participants agree to be in this study, they will get their first
      injection (in this study) at the first visit. Participants will also get an injection at
      visit 3, 5 and 7. Participants will be trained to give all other injections themselves.
      Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood
      thinners) during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients of all ages with the diagnosis of severe congenital haemophilia A
             (coagulation Factor VIII [FVIII] activity less than 1%) based on medical records

          -  On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at
             the time of transfer

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to trial product including allergy to hamster
             protein or related products

          -  Any disorder, except for conditions associated with haemophilia, which in the
             investigator's opinion might jeopardise patient's safety or compliance with the
             protocol - Current participation in any clinical trial (except NN7088-3859
             (pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved
             investigational medicinal product
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
Condition: Congenital Hyperinsulinism
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hyperinsulinism
Intervention: Dasiglucagon; Standard of Care
Intervention description: Glucagon analog; Standard of care according to site and/or country
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 3 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to evaluate the efficacy and safety of dasiglucagon
      administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established and documented diagnosis of CHI based on standard of care

          -  Experiencing ≥3 events of hypoglycemia per week (plasma glucose [PG] <70 mg/dL [<3.9
             mmol/L]) according to the investigator's evaluation

          -  Previously undergone near-total pancreatectomy or being treated with a non-surgical
             approach, having been evaluated as not eligible for pancreatic surgery

          -  If somatostatin analogues or sirolimus are used, the therapy should be well
             established as judged by the investigator, especially when considering their
             biological half-life

        Exclusion Criteria:

          -  Previous administration of dasiglucagon

          -  Known or suspected allergy to the trial drug or related products

          -  Previous participation (randomization) in this trial

          -  Circulatory instability requiring supportive medication or presence of
             pheochromocytoma

          -  Requires exogenous insulin

          -  Body weight of <4 kg (8.8 lbs.)

          -  Documented HbA1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior
             to screening

          -  Known or suspected presence of significant central nervous system disease/injury such
             that in the investigator's opinion will affect trial participation

          -  Use of systemic corticosteroids, e.g., hydrocortisone >20 mg/m2 body surface area or
             equivalent in the 5 days before screening

          -  Use of anti-inflammatory biological agents, or other immune modulating agents in the 3
             months prior to screening

          -  Any clinically significant abnormality identified on echocardiogram that in the
             opinion of the investigator would affect the patient's ability to participate in the
             trial

          -  Any recognized clotting or bleeding disorders

          -  Has participated in an interventional clinical trial (investigational or marketed
             product) within 3 months of screening or 5 half-lives of the drug under investigation
             (whichever comes first), or plans to participate in another clinical trial.
CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: Ivermectin 1% cream; Metronidazole 0.75% cream
Intervention description: Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.; Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Intervention MeSH terms: Metronidazole; Ivermectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 962.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study objectives:

        -  To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream
           in subjects with papulopustular rosacea after 16-week topical treatment.

        -  And to compare, for subjects initially successfully treated by 16 weeks treatment,
           Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period
           by assessing, the time of first relapse, the relapse rate, and the number of days free
           of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to
             the Investigator Global Assessment (IGA),

          -  Subjects with at least 15 but not more than 70 inflammatory lesions (papules and
             pustules) on the face.

        Exclusion Criteria:

          -  Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant,
             isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that
             may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial
             keratosis pilar, or seborrheic dermatitis and acne,

          -  Subjects with rosacea with more than two nodules on the face.
Maintaining Nonsmoking: Older Smokers - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine polacrilex, Bupropion
Intervention description: Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Intervention MeSH terms: Bupropion; Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 403.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking cessation; Tobacco

Summary:

      The purpose of this study was to examine pharmacological and psychological interventions for
      smokers over 50.
    

Eligibility criteria:

        smokers of at least 10 cigarettes per day

        Inclusion Criteria:

        MULTIPLE

        Exclusion Criteria:

        MULTIPLE
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Alogliptin; Placebo to alogliptin; Metformin; Pioglitazone
Intervention description: Alogliptin tablets; Alogliptin placebo-matching tablets.; Stable metformin dose; Stable pioglitazone dose
Intervention MeSH terms: Metformin; Pioglitazone; Alogliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Drug Therapy

Summary:

      The purpose of the study is to determine the efficacy of alogliptin compared to placebo when
      given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without
      metformin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a historical diagnosis of Type 2 Diabetes Mellitus.

          -  Has a body mass index between acceptable range.

          -  Is experiencing inadequate glycemic control.

          -  Body weight keeps constant.

          -  Females of childbearing potential and males who are sexually active agree to use
             routinely adequate contraception from signing of informed consent throughout the
             duration of the study and for 30 days after last dose.

        Exclusion Criteria:

          -  Has participated in another clinical study within the past 90 days or has received any
             investigational compound within 30 days prior to randomization.

          -  Has a systolic blood pressure beyond the acceptable range at Screening visit.

          -  Has New York Heart Association Class III or IV heart failure regardless of therapy.

          -  Has any major illness or debility that in the investigator's opinion prohibits the
             subject from completing the study.

          -  Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.
Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients
Condition: Renal Transplantation
Intervention: Enteric-coated mycophenolate sodium (EC-MPS)
Intervention description: Tablets for oral administration
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Keywords: Renal transplantation, mycophenolate

Summary:

      This study will assess the association of an initially intensified dosing regimen of
      enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal
      transplantation with acute rejections relative to the rapid achievement of an MPA
      (mycophenolic acid) exposure of ≥ 40 mg*h/L compared to a standard dosing regimen of EC-MPS.
      Additionally, this study will assess safety and tolerability of the intensified dosing
      regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).
    

Eligibility criteria:

        Inclusion criteria

          1. Recipients of de novo cadaveric, living unrelated or living related kidney transplants

          2. Females capable of becoming pregnant must have a negative serum pregnancy test within
             7 days prior to or at baseline, and are required to practice an approved method of
             birth control for the duration of the study and for a period of 6 weeks following
             discontinuation of study medication, even where there has been a history of
             infertility.

          3. Patients who are willing and able to participate in the study and from whom written
             informed consent has been obtained.

        Exclusion criteria

          1. More than one previous renal transplantation

          2. Graft loss due to immunological reasons in the first year after transplantation (in
             case of secondary transplantation)

          3. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any
             other organ, different from kidney

          4. Patients receiving a kidney from a non-heart beating donor

          5. Patients who are recipients of A-B-O incompatible transplants

        Other protocol-defined inclusion/exclusion criteria may apply
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
Condition: Actinic Keratosis; Organ or Tissue Transplant; Complications
MeSH terms: Keratosis, Actinic; Precancerous Conditions; Keratosis; Skin Diseases
Intervention: 5-Fluorouracil
Intervention description: All patients will receive one cream, 5-Fluorouracil, and will be instructed to apply the cream according to the randomization schema to AKs on either the right or left side of the face/scalp once a day for 6 days prior to PDT. A baseline measurement of the tumor's ability to produce PpIX will be done by applying methyl-aminolevulinic acid (Metvixia® topical cream) to the selected AKs and using the Aurora© dosimeter. Prior to Metvixia, and again 3 hours after application, surface measurements of the PpIX fluorescence will be taken. Then, the two largest precancer lesions (one on the left side, one on the right side) will be biopsied under local anesthesia, followed by red light PDT (lasting ~8 minutes). The biopsy sites will be shielded from the light with a circular spot bandage.
Intervention MeSH terms: Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis; Photodynamic Therapy

Summary:

      This randomized, intra-patient comparative study is designed to investigate the combination
      regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for
      its ability to generate significantly elevated levels of the target photosensitizer,
      protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat
      and prevent recurrence of AKs. The target population comprises patients with solid organ
      transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for
      possible influences of immunosuppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  At least four (4) actinic keratoses, located on face, ears, scalp, forearms and/or
             dorsal hands. - Patients in the solid organ transplant arm of the study must have had
             either a kidney or liver transplant, and the transplantation surgery must have
             occurred at least 2 years prior to enrollment.

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Currently participating in another clinical trial

          -  Using any topical treatment for their actinic keratoses

          -  Currently being treated for other cancers with medical or radiation therapy

          -  Patients with a known hypersensitivity to 5-aminolevulinic acid, 5-fluorouracil or any
             component of the study material

          -  Patients with a history of a photosensitivity disease, including porphyria cutanea
             tarda
Use of a Modified Propofol Emulsion in Adults
Condition: Anesthesia
Intervention: Propofol; Propofol 1%
Intervention description: Propofol (drug), intravenous, induction of anesthesia; Propofol (drug), intravenous, induction of anesthesia
Intervention MeSH terms: Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Anesthesia; Induction; Pain

Summary:

      The purpose of the study is to determine whether a modified propofol preparation shows any
      effect on the incidence of injection pain in adults undergoing elective surgery under general
      anesthesia.

      Study hypothesis: The use of a modified propofol preparation will reduce the incidence of
      injection pain in the study group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults, age ≥ 18 years and ≤ 80 years

          -  Anesthetic risk classified as ASA I-III

          -  Patients undergoing elective surgery under general anesthesia

          -  Signed informed consent

        Exclusion Criteria:

          -  Simultaneous participation in another trial

          -  Known or suspected drug abuse

          -  Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other
             necessary co-medication

          -  Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or
             centrally active analgesics)

          -  Patients taking lipid lowering drugs

          -  History of decompensated renal failure

          -  History of severe hepatic dysfunction, hepatic cirrhosis

          -  Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia

          -  History of convulsive disorders

          -  Decompensated cardiac insufficiency

          -  Hypovolemia

          -  Increased intracranial pressure

          -  Pregnancy (positive ß-HCG test) and lactation

          -  Emergency situation

          -  Patient who receives parenteral fat emulsion, e.g. intralipid

          -  Patients incapable of giving consent personally

          -  Venous access for induction of anesthesia not possible at dorsum of the hand or not
             dorsal
First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia
Condition: Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib; Carboplatin; Paclitaxel
Intervention description: oral tablet; IV; IV
Intervention MeSH terms: Paclitaxel; Carboplatin; Gefitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; Gefitinib

Summary:

      The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet
      chemotherapy given as first line treatment in terms of progression free survival in selected
      NSCLC patients with the objective of demonstrating non-inferiority.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic)
             NSCLC with adenocarcinoma histology.

          -  Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of
             study treatment and 10 pack-years or fewer)

        Exclusion Criteria:

          -  Had prior chemotherapy, biological (including targeted therapies such as EGFR and
             vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.

          -  Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8mg/kg iv every 4 weeks for 24 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the safety and efficacy of tocilizumab in patients with
      moderate to severe active rheumatoid arthritis who have an inadequate response to current
      non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks
      for a total of 6 infusions, either as monotherapy or in combination with their current
      non-biologic DMARDs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  moderate to severe rheumatoid arthritis;

          -  inadequate response to current non-biologic DMARDs

        Exclusion Criteria:

          -  rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid
             arthritis;

          -  previous treatment with other biologics.