bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Moroctocog alfa
Intervention description: Patients will receive Moroctocog alfa according to their investigator's prescription.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 0 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: hemophilia A; Xyntha; ReFacto; moroctocog alfa; bleeding disorder

Summary:

      This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC))
      in male patients less than 6 years old. Annualized bleeding rates and physician / caregiver
      assessments of responses to treatment will be characterized. FVIII inhibitor levels will be
      assessed throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients less than 6 years of age with moderately severe to severe hemophilia A
             (FVIII less than or equal to 2%).

          -  Treatment history of less than 50 exposure days to prior recombinant or plasma-derived
             FVIII replacement products.

          -  Not receiving treatment for HIV or hepatitis infection, or the patient is on a stable
             antiviral regimen at the time of enrollment in the study.

        Exclusion Criteria:

          -  Presence of any bleeding disorder in addition to hemophilia A.

          -  Inhibitor titer of greater than or equal to 5 Bethesda Units (BU) at screening.

          -  Treated with immunomodulatory therapy during the screening period

          -  Treatment history of more than 5 exposure days (ED) to Xyntha.

          -  Known hypersensitivity to hamster protein.
Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
Condition: Long QT Syndrome Type 3
MeSH terms: Long QT Syndrome; Syndrome
Intervention: Eleclazine; Eleclazine placebo
Intervention description: Tablets administered orally; Tablets administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 3 long QT syndrome (LQT3); Long QT syndrome; Congenital long QT; Sudden cardiac death

Summary:

      The primary objective of this study is to evaluate the effect of oral eleclazine on mean
      daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long
      QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will
      receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period,
      participants who have not permanently discontinued study drug will be eligible, at the
      discretion of the investigator, to continue receiving eleclazine during an open-label
      extension (OLE) phase.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals with an established diagnosis of LQT3 (by genotype testing)

          -  Mean (of triplicate) QTc interval ≥ 480 msec (or ≥ 460 msec, for individuals who are
             currently taking ranolazine or Class I antiarrhythmic drugs such as mexiletine) at 3
             or more time points, determined by standard 12-lead ECG, at screening

        Key Exclusion Criteria:

          -  Known mutations associated with type 1 long QT syndrome (LQT1) or type 2 long QT
             syndrome (LQT2)

          -  Known or suspected history of seizures or epilepsy

          -  History of heart failure defined as New York Heart Association (NYHA) Class IV and/or
             known left ventricular ejection fraction (EF) ≤ 45%

          -  Body mass index (BMI) ≥ 40 kg/m^2 at screening

          -  Severe renal impairment at screening (defined as an estimated glomerular filtration
             rate (eGFR) < 30 mL/min/1.73m^2, using the 4 Variable Modification of Diet in Renal
             Disease (MDRD) equation, as determined by the study center)

          -  Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT)
             or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN), or total
             bilirubin > 1.5 x ULN

          -  An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD)
             implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to
             screening

          -  Any other condition or circumstance that in the opinion of the investigator would
             preclude compliance with the study protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: RoActemra/Actemra (tocilizumab)
Intervention description: Tocilizumab 8 mg/kg every 4 weeks for 104 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This long-term, interventional, open-label extension study will evaluate the safety and
      efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with
      polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients
      will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study treatment
      is 104 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed 104 weeks of study WA19977 with at least a JIA ACR30 clinical
             response to RoActemra/Actemra and no serious adverse event or adverse event

          -  Written informed consent obtained from patient if patient is 18 years of age and
             older, or if under the age of 18 years from parents or legal guardian

        Exclusion Criteria:

          -  Patient did not benefit from RoActemra/Actemra therapy in study WA19977

          -  Treatment with any investigational drug since the last administration of study drug in
             the core study WA19977

          -  Patients developed any other autoimmune rheumatic disease other than the permitted JIA
             subsets

          -  Any significant medical or surgical condition that would jeopardize patient's safety

          -  Current serious uncontrolled concomitant disease or infection
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Dabrafenib; Vemurafenib; Trametinib
Intervention description: Dabrafenib 150 mg twice daily orally; Vemurafenib 960 mg twice daily orally; Trametinib 2 mg once daily orally
Intervention MeSH terms: Trametinib; Dabrafenib; Vemurafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 704.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BRAF inhibitor; Metastatic Melanoma; Cancer; MEK inhibitor

Summary:

      This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436)
      and trametinib (GSK1120212) combination therapy with vemurafenib.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  >= 18 years of age

          -  Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma

          -  Measurable disease according to RECIST 1.1

          -  Women of childbearing potential with negative serum pregnancy test prior to
             randomisation

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Adequate baseline organ function

        Key Exclusion Criteria:

          -  Any prior use of a BRAF or MEK inhibitor

          -  Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior
             systemic treatment in the adjuvant setting is allowed

          -  History of another malignancy (except subjects who have been disease free for 3 years
             or with a history of completely resected non-melanoma skin cancer)

          -  Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which
             will be allowed)

          -  Brain metastases (except if all known lesions were previously treated with surgery or
             stereotactic radiosurgery and lesions, if still present, are confirmed stable for >=
             12 weeks prior to randomisation or if no longer present are confirmed no evidence of
             disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for
             >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4
             weeks prior to randomisation

          -  History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood
             pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by
             anti-hypertensive therapy)

          -  History or current evidence/risk of retinal vein occlusion (RVO) or central serous
             retinopathy (CSR)
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Condition: Traumatic Hemorrhage
MeSH terms: Hemorrhage
Intervention: Tranexamic Acid; Saline control
Intervention description: 1 gram of prehospital Tranexamic Acid; Saline Control
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 903.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Tranexamic acid; randomized; hemorrhage; blinded

Summary:

      The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given
      during emergency medical transport to a level 1 trauma center in patients at risk of
      hemorrhage is associated with lower 30 day mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Blunt or penetrating injured patients at risk of bleeding being transported via air or
             ground medical services from the scene of injury or from referring hospital to a
             definitive trauma center that is participating in the trial AND

          2. Within 2 hours of time of injury AND

          3. Hypotension (Systolic Blood Pressure (SBP) < 90mmHg)

               -  At scene of injury or during air or ground medical transport

               -  Documented at referring hospital prior to air or ground medical transport arrival

             OR

          4. Tachycardia (heart rate >110 beats per minute)

               -  At scene of injury or during air or ground medical transport

               -  Documented at referring hospital prior to air or ground medical transport arrival

        Exclusion Criteria:

          1. Age > 90 or < 18 years of age

          2. Inability to obtain intravenous access or intraosseous

          3. Documented (radiographic evidence) cervical cord injury with motor deficit

          4. Known prisoner

          5. Known pregnancy

          6. Traumatic arrest with > 5 minutes CPR without return of vital signs

          7. Penetrating cranial injury

          8. Traumatic brain injury with brain matter exposed

          9. Isolated drowning or hanging victims

         10. Wearing an opt out bracelet.

         11. Isolated fall from standing

         12. Patient or Family Objection at scene
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Condition: Autoimmune Diseases; Renal Disorders; Hematologic Disorders; Oncologic Disorders
MeSH terms: Hematologic Diseases; Autoimmune Diseases
Intervention: Therapeutic plasma exchange
Intervention description: Patients are randomized to either Therapeutic plasma exchange procedures on AMICUS or Spectra first. The second procedure (based on time interval determined by physician) will be completed on the other instrument.
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Therapeutic plasma exchange; Autoimmune diseases; Kidney transplant; Hematologic disorders; Monoclonal gammopathy; Neurologic disorders

Summary:

      This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma
      Exchange (TPE) is prescribed by their physicians.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Medically stable patients undergoing more than one TPE procedure who have provided
             signed informed consent prior to participation.

          2. A physician's prescription for TPE for various non-emergent conditions.

          3. Test and Control TPE procedures that would be expected to be completed within
             approximately five weeks.

        Exclusion Criteria:

          1. Patients under 18 years old.

          2. Patients on an ACE inhibitor medication should discontinue use of this medication in
             accordance with institutional practices.

          3. Patients with altered mental status that would prohibit the giving and understanding
             of informed consent.

          4. Patients who have experienced a serious adverse event associated with the first TPE
             clinical study procedure.
Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart; insulin detemir; insulin aspart
Intervention description: Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart; Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart; Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Biphasic Insulins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 708.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe.

      The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood
      glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added
      to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to
      verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and
      side effects).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Insulin naive

          -  On OAD treatment for at least 4 months with metformin, a sulphonylurea or a
             combination

          -  Body Mass Index (BMI) below or equal to 40.0 kg/m2

          -  HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)

        Exclusion Criteria:

          -  Proliferative retinopathy

          -  Recurrent major hypoglycaemia

          -  Cardial problems

          -  Uncontrolled hypertension

          -  Impaired hepatic or renal function
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Daily oral doses administered until disease progression or unacceptable toxicity or death.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center study will evaluate the progression-free survival and safety of
      erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with
      activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor
      (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or
      unacceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating
             mutations in the tyrosine kinase domain of the EGFR

          -  Measurable disease according to RECIST

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy greater than or equal to (>/=) 12 weeks

          -  Adequate hematological, liver and renal function

          -  Participants with asymptomatic and stable cerebral metastases receiving medical
             treatment

        Exclusion Criteria:

          -  Previous chemotherapy or treatment against EGFR for metastatic disease

          -  Treatment with an investigational agent less than 3 weeks before enrollment

          -  History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of
             the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)

          -  Participants with symptomatic cerebral metastases

          -  Any significant ophthalmologic abnormality

          -  Unstable systemic disease

          -  Coumarins use

          -  Evidence of any other disease, neurological or metabolic dysfunction, physical
             examination or laboratory finding contraindicating the use of an investigational drug

          -  Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis,
             lymphangiosis carcinomatosis

          -  Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B
             (HBV), Hepatitis C (HCV)
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder
MeSH terms: Tourette Syndrome
Intervention: Aripiprazole
Intervention description: Aripiprazole tablets orally once daily.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Tourette's Disorder; Tic Disorders

Summary:

      The goal of the current trial is to obtain long term efficacy, safety and tolerability data
      of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participants successfully completed the final assessment visit in either Study
             31-10-272 (NCT01418339) or 31-10-273 (NCT01418352). The participants completed all
             required assessments for the Week 8/Early Termination Visit to be eligible for
             rollover in to this open-label trial.

          -  Written informed consent form (ICF) obtained from a legally acceptable representative
             & informed assent at Baseline as applicable by trial center's Institutional review
             board/independent ethics committee (IRB/IEC).

          -  The participant, designated guardian(s) or caregiver(s) are able to comprehend and
             satisfactorily comply with the protocol requirements, as evaluated by the
             investigator.

        Exclusion Criteria:

          -  The participants experienced adverse events (AEs) during the double-blind study
             31-10-272 (NCT01418339) or 31-10-273 (NCT01418352) that would, in the investigator's
             judgment, preclude further exposure to aripiprazole.

          -  The participants had protocol violations during the double-blind trial considered
             major in the judgment of the investigator which would deem the participant a poor
             candidate for the trial.

          -  A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which
             will result in early termination at Week 1.

          -  Sexually active patients who will not commit to utilizing 2 of the approved birth
             control methods or who will not remain abstinent during the trial and for 90 and 30
             days following the last dose of study drug for male and female respectively.

          -  Participants representing Risk of committing suicide.

          -  Body weight lower than 16 kg.

          -  Abnormal laboratory test results (Platelet, Hemoglobin, Neutrophils, Aspartate
             aminotransferase, Alanine aminotransferase, Creatinine) vital signs and
             Electrocardiogram (ECG) results.
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: Oral iron tablets; VIT-45
Intervention description: 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42; A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: Female
Healthy volunteers: No
Keywords: Anemia; postpartum; Postpartum anemia

Summary:

      This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who
      display postpartum anemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female Subjects able to give consent

          -  Post partum patients

          -  Baseline Hbg< /= 10

          -  Agree to practice birth control

          -  Demonstrate willingness to comply with protocol restrictions

        Exclusion Criteria:

          -  Known hypersensitivity reaction to oral or IV iron (VIT-45)

          -  Documented history of discontinuing oral iron

          -  Significant bleeding

          -  History of anemia other that iron deficiency anemia

          -  Severe Psychiatric disorders

          -  Active severe infection

          -  Known Hepatitis B antigen or Hep C viral antibody or active hepatitis

          -  Known HIV antibody

          -  Received investigational product within 30 days

          -  Alcohol abuse

          -  Hemochromatosis or other iron storage disorder