bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MP-424 (Telaprevir)
Intervention description: Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Protease Inhibitor

Summary:

      The purpose of this study is to assess the efficacy and safety after administration of MP-424
      to patients with chronic hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with genotype 1b chronic hepatitis C

          -  Patients naive to the concomitant medications with interferon

        Exclusion Criteria:

          -  Patients diagnosed with decompensated cirrhosis

          -  Patients diagnosed with positive HBs antigen in the test
Cangrelor Ticagrelor Transition Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: cangrelor; Ticagrelor
Intervention description: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.; Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion
Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion.
Intervention MeSH terms: Ticagrelor; Cangrelor
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To demonstrate that patients treated with cangrelor can be directly switched to oral
      ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a
      significant decrease in the extent of inhibition of platelet aggregation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  greater than / equal to 18 and less than 75 years of age

               1. Previous myocardial infarction defined by admission to the hospital with
                  elevation of markers of injury or the presence of pathologic q waves on at least
                  2 contiguous electrocardiogram (ECG) leads.

                  OR

               2. Previous revascularization by percutaneous coronary intervention (PCI) or
                  coronary artery bypass graft (CABG) surgery.

                  AND

               3. Treatment with aspirin (ASA) 81 mg daily.

                  Exclusion Criteria:
Study of Tocilizumab to Treat Polymyalgia Rheumatica
Condition: Polymyalgia Rheumatica (PMR)
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis
Intervention: Tocilizumab
Intervention description: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: PMR; POLYMYALGIA RHEUMATICA; Tocilizumab; Hospital for Special Surgery; HSS; Robert Spiera

Summary:

      This is a fifteen-month open label, Phase IIa clinical trial is being conducted to assess the
      tolerability, safety and efficacy of a medication called Tocilizumab (Actemra®) in patients
      with polymyalgia rheumatica (PMR).
    

Eligibility criteria:

        Disease- Specific Inclusion Criteria:

        Patients must meet the following inclusion criteria to be eligible for study entry:

        Diagnosed with polymyalgia rheumatica and enrolled within one month of diagnosis.

        Disease Specific Exclusion Criteria:

        Patients will be excluded from the study based on the following criteria:

          -  Symptoms or diagnosis of temporal arteritis, including headache, jaw claudication,
             hyperesthesia of scalp, abnormal palpated temporal artery, visual disturbances,
             temporal artery biopsy positivity

          -  Concurrent rheumatoid arthritis

          -  Presence of rheumatoid factor and CCP

          -  Other inflammatory arthritis or other connective tissue diseases, such as but not
             limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, polymyositis,
             dermatomyositis, mixed connective tissue disease

          -  Treatment of polymyalgia rheumatica with more than 20mg of daily prednisone or its
             equivalent at the time of screening

          -  Treatment with more than 30mg of daily prednisone or its equivalent since diagnosis.
             Treatment with 30mg of daily prednisone or its equivalent since diagnosis for more
             than 2 weeks.

          -  More than 4 weeks of corticosteroid therapy prior to enrollment

          -  History of bowel perforation within the past five years.

          -  Active diverticulitis.

          -  Pre-existing or recent onset demyelinating disorders
A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C
Condition: Irritable Bowel Syndrome With Constipation (IBS-C)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: SYN-010
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Subjects from the study SB-2-010-001 (NCT02495623) were given either SYN-010 21 mg, SYN-010 42 mg, or Placebo. The subjects were offered the opportunity to roll over into SB-2-010-002 and receive SYN-010 42 mg. Some of the analyses were done from day one of SYN-010-001.
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of
      SYN-010 in Patients with Irritable Bowel Syndrome with Constipation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed Study SB-2-010-001.

          -  Subject must be willing to abstain from or discontinue the use of any laxatives and
             any prescription and over-the-counter medications or supplements intended to treat
             constipation from the time of Screening to the end of the study, except as permitted
             in this protocol.

          -  Subject must agree to refrain from making any lifestyle changes that may affect IBS-C
             symptoms from the time of Screening to the end of the study.

        Exclusion Criteria:

          -  Subject has taken IBS treatments (prescription or over-the-counter), proton pump
             inhibitors, laxatives, antibiotics.

          -  Subject did not complete Study SB-2-010-001 or more than 7 days have elapsed since the
             subject's last dose of study drug in that study.

          -  Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale [BSFS] score
             of 6 or 7) in the absence of any laxative, or has a BSFS score of 6 for more than 1
             spontaneous bowel movement (SBM) or a BSFS score of 7 for any SBM during the last 7
             days of diary reporting for Study SB-2-010-001.

          -  Subject has any abnormal laboratory results, electrocardiogram (ECG) findings, or
             physical examination findings deemed clinically significant by the investigator at the
             Study SB-2-010-001 End-of-Study Visit.
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective
      treatment for ulcerative colitis after 52 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who completed the APD334-003 (NCT02447302) study

        Exclusion Criteria:

          -  Participants who did not complete the APD334-003 study
Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: Placebo; Gymnema Sylvestre
Intervention description: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.; Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Gymnema Sylvestre; Insulin Secretion; Insulin Sensitivity; Central Obesity

Summary:

      Gymnema sylvestre has demonstrated promising effects in the treatment of obesity,
      dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings
      show that Gymnema sylvestre has an excellent potential for the prevention and treatment of
      metabolic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Letter of consent and release signed by each patient

          -  Body mass index: 25-34.99 kg/m2

          -  Body weight without variations above or under 5% during the three months prior to the
             study

          -  Diagnostic of metabolic syndrome according to the modified International Diabetes
             Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in
             women and ≥ 90 cm in men)

        Plus any two of the following four factors:

          -  Triglycerides: 150-499 mg/dL.

          -  High density lipoprotein: Woman < 50 mg/dL, man < 40 mg/dL.

          -  Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg

          -  Fasting glucose: 100-125 mg/dL

        Exclusion Criteria:

          -  Type 1 or 2 diabetes mellitus

          -  Previous pharmacological treatment for components of metabolic syndrome

          -  Mental or physical illness interfering with the study

          -  Thyroid or cardiovascular disease

          -  Pregnant or suspected pregnant women

          -  Woman breastfeeding

          -  Index of body mass: ≥ 35 kg/m2

          -  Treatments known to affect metabolism of glucose, fats and affecting arterial tension

          -  Patients with hepatic or renal diseases background

          -  Patients diagnosed with kidneys disease

          -  Calcined magnesium intolerance

          -  Gymnema Sylvestre intolerance
Dasatinib in Relapsed Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Dasatinib
Intervention description: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dasatinib; BMS-354825; CLL; SLL; LYN kinase

Summary:

      The purpose of this research study is to see if Dasatinib is effective and safe to give to
      people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the
      drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme
      in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory
      studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells.
      Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on
      CLL cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23 and
             CD. Patients may be CD23 negative as long as they are also cyclin D1 negative.

          -  Must have failed at least 1 prior fludarabine containing regimen or have failed at
             least 2 non-fludarabine containing regimens or have a contraindication to fludarabine
             use

          -  ECOG performance status of 2 or better

          -  Adequate organ function to tolerate chemotherapy

          -  Adequate method of contraception

        Exclusion Criteria:

          -  Pregnant or breast-feeding women

          -  Uncontrolled angina within 3 months

          -  Diagnosed or suspected congenital long QT syndrome

          -  History of clinically significant ventricular arrhythmias

          -  Prolonged QTc interval on pre-entry electrocardiogram

          -  Uncontrolled hypertension

          -  Drugs that are generally accepted to have a risk of causing Torsades de Pointes

          -  Patient known to be HIV positive

          -  Known significant bleeding disorder unrelated to CLL

          -  Drugs that interfere with platelet function or coagulation must be stopped at least 7
             days prior to entry
Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke
Condition: Stroke; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: Intravenous Thrombolysis; Endovascular Arterial Reperfusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot trial will be the first step toward direct comparison of delivery of endovascular
      reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a
      time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A
      randomized trial is justified for the following reasons: 1) The high rate of death and
      disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates
      critical analysis of alternate therapies with therapeutic potential, 2) endovascular
      treatment for acute ischemic stroke is expanding in North America without compelling evidence
      of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness
      analysis cannot be done without acquiring pertinent outcomes data from controlled studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Definite or probable ischemic stroke

          -  CT angiographic (CTA) evidence of intracranial vascular occlusion (internal carotid,
             middle cerebral - M1 or M2 divisions, anterior cerebral, posterior cerebral, or
             basilar artery) within 3.5 hours of symptom onset

          -  Able to receive assigned treatment within 4.5 hours of symptom onset

          -  Written informed consent from patient or surrogate, if unable to provide consent

        Exclusion Criteria:

          -  CT evidence of early infarction in >1/3 of middle cerebral artery distribution

          -  Blood pressure > 185/110 mmHg refractory to anti-hypertensive therapy

          -  History of intracranial hemorrhage

          -  History of ischemic stroke within past 3 months

          -  History of major surgical procedure within past 14 days

          -  Gastrointestinal or genitourinary bleeding within past 14 days

          -  Glucose <50 or >400mg/dL

          -  Platelet count <100,000

          -  International normalized ratio (INR) ≥ 1.7

          -  Known history of bleeding diathesis
An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
Condition: Geographic Atrophy
MeSH terms: Geographic Atrophy; Atrophy
Intervention: Lampalizumab
Intervention description: Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 60 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label extension study of safety and tolerability of lampalizumab
      administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who
      have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week
      treatment in Study GX29455 (NCT02288559).
    

Eligibility criteria:

        Inclusion Criteria:

          -  For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of
             Study CFD4870g without early treatment discontinuation (lampalizumab or sham)

          -  For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study
             GX29455 without early treatment discontinuation (lampalizumab or sham)

          -  Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit
             quality fundus imaging

        Exclusion Criteria:

          -  Early treatment and/or study discontinuation prior to completion of study CFD4870g
             (GX01456) and GX29455

          -  Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related
             macular degeneration (AMD) in the study eye

          -  Subfoveal focal laser photocoagulation in the study eye

          -  Treatment with Visodyne, external-beam radiation therapy, or transpupillary
             thermotherapy in the study eye

          -  Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection,
             anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye.
             Lampalizumab in study eye and ranibizumab in either eye are permitted

          -  Any concurrent ocular or intraocular condition in the study eye that contraindicates
             the use of an investigational drug or may affect interpretation of the study results
             or may render the participant at high risk for treatment complications
Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation
Condition: Brain Neoplasms
MeSH terms: Brain Neoplasms; Inflammation
Intervention: Ferumoxtran-10 (Combidex); Neurosurgery
Intervention description: 2.6 mg/kg; neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 5 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Combidex; Diagnostic imaging

Summary:

      Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating.
      It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such
      as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to
      compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent
      to the tumor location. Combidex may provide the ability to better see brain tumors and
      inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its
      ability to cross blood vessels into brain tumors, and because of its size and ability to get
      into the area next to brain tumors, could assist in the treatment of brain tumors with other
      drugs in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Brain tumor or CNS inflammatory lesion including stroke or MS

          -  5 yrs old or older

          -  Able to undergo MRI without general anesthesia

          -  Agree to be followed for 1 month following infusion of Combidex

          -  Sign a written informed consent

          -  If female and of child-bearing potential, be postmenopausal, sterile, or be on birth
             control for 1 month prior to study

          -  Must have a pre-treatment MRI within 28 days before study

        Exclusion Criteria:

          -  Clinically significant signs of uncal herniation

          -  Allergy to study drug, Combidex

          -  Hepatic insufficiency

          -  Stage IV or V renal insufficiency

          -  If female, pregnant or lactating

          -  Require anesthesia for MRI scanning

          -  Hemachromatosis