bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: CHF 5074 1x; CHF 5074 2x; CHF 5074 3x; Placebo
Intervention description: oral tablet, 1x, once a day in the morning for 12 weeks; oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks; oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks; oral tablet, once a day in the morning for 12 weeks
Intervention MeSH terms: 1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once
      per day for up to 12 weeks to patients with mild cognitive impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.

          -  Mini-Mental State Examination score higher than 24 at screening.

          -  MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR)
             and T2*-weighted gradient-recalled-echo (GRE) sequences.

        Exclusion Criteria:

          -  Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA
             criteria.

          -  Any medical condition that could explain the patients cognitive deficits.

          -  CT or MRI brain imaging results obtained within 12 months prior to baseline showing
             evidence of infection, infarction, or focal lesions of clinical significance

          -  MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with
             diameter ≤ 10 mm).

          -  Geriatric Depression Scale (30-point scale) score > 9 at screening.

          -  History of stroke.

          -  Modified Hachinski ischemic scale score > 4 at screening.

          -  Women of childbearing potential.

          -  Vitamin B12 or folate deficiency.

          -  Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar
             disorders) within 3 years of screening.

          -  Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year
             and/or chronic inflammatory bowel disease.

          -  Concomitant use of donepezil at doses > 5 mg/day or other cholinesterase inhibitors
             (rivastigmine or galantamine) at any dose.

          -  Concomitant use of memantine at dose > 20 mg/day.

          -  Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)
Condition: CLL; Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Eltrombopag
Intervention description: Starting dose 75 mg by mouth (PO) daily for 28 day cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; CLL; Thrombocytopenia; Small lymphocytic lymphoma; SLL; Eltrombopag; Promacta; thrombopoietin (TPO)-receptor agonist; platelets

Summary:

      The goal of this clinical research study is to learn if eltrombopag can help to increase the
      number of platelets in patients with CLL. The safety of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

          2. Age >/= 18 years

          3. PLT transfusion-dependent, defined as need for transfusion to maintain PLT count
             >/=20K/µL, or the average of two (non-transfused) PLT counts taken within 2 weeks of
             the screening period </=50K/µL, with no individual count >55K/µL

          4. Patients with ITP must have failed at least 1 prior treatment for ITP including one of
             the following: corticosteroids, rituximab, splenectomy, cyclosporine

          5. At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL

          6. ECOG performance status (PS) </=2

          7. Adequate liver function (total bilirubin </=2* upper limit normal (ULN); ALT </=2.5*
             ULN)

          8. Adequate renal function (serum creatinine Cr </=2.2 mg/dL)

          9. For patients with ITP on corticosteroids or cyclosporine, dose of corticosteroids or
             cyclosporine must be stable for 2 weeks prior to enrollment and planned to be tapered
             in patients responding to eltrombopag

         10. Able to provide informed consent

        Exclusion Criteria:

          1. Concurrent chemotherapy for CLL

          2. Diagnosis of Richter's transformation

          3. Uncontrolled autoimmune hemolytic anemia i.e. patients with AIHA that is not
             controlled with treatment such as corticosteroids or cyclosporine. This would include
             patients who require PBRC transfusions or who do not have a stable hemoglobin (HGB)
             due to ongoing hemolysis.

          4. Concurrent treatment for ITP (except for corticosteroids and cyclosporine)

          5. Diagnosis of myelodysplastic syndrome or acute myeloid leukemia

          6. Active infection or significant medical illness as determined by the treating
             physician

          7. Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate
             or Promacta)

          8. Pregnant or breast feeding subjects and subjects not willing to use adequate
             contraceptive precautions
A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-0941; Placebo; Insulin
Intervention description: MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.; Placebo tablets, taken 3 times daily.; Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking
      insulin for Type 2 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has Type 2 Diabetes Mellitus

        Exclusion Criteria:

          -  Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis

          -  Participant is on a weight loss program and is not in the maintenance phase or is
             taking a weight loss medication

          -  Participant has had surgery within 30 days of starting the study or has planned major
             surgery
Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ZD6474 (Vandetanib); Bicalutamide; Placebo
Intervention description: 300mg orally, once daily; 150mg orally, once daily; orally, once daily
Intervention MeSH terms: Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 95.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind phase II trial is to assess the efficacy and safety of
      bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with
      castration-refractory metastatic prostate cancer without any clinical symptom related to
      disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to
      either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection
      and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is
      acceptable in this subject population where all subjects will also received bicalutamide 150
      mg o.d. Subjects will continue study treatment until they reach objective biological disease
      progression or unacceptable toxicity or withdrawal of consent or until end of trial (which
      event occurs first). The end of study is fixed 12 months after the last randomised patient's
      first dose of study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males presented with a confirmed histological diagnosis of adenocarcinoma of the
             prostate with evidence of metastases (including bone, lymph nodes, or other site)
             radiologically or histologically documented and despite a serum testosterone ≤1.73
             nmol/L (50 ng/dL) proving castration, evidence of biochemical progression of prostate
             cancer, documented by a rise in PSA .

        Exclusion Criteria:

          -  Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral
             orchiectomy within the 30 days preceding Visit 1. Incompletely healed surgical
             incision.

          -  Concomitant anticancer therapy other than surgical castration or continuous medical
             castration.

          -  Biology restriction.

          -  Clinical significant cardiovascular event or presence of cardiac disease that in the
             opinion of the Investigator increases the risk of ventricular arrhythmia.

          -  History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3),
             symptomatic despite treatment, or asymptomatic sustained ventricular tachycardia.
             Subjects with atrial fibrillation controlled on medication are permitted.

          -  Hypertension not controlled by medical therapy

          -  ECG /QTc prolongation

          -  Presence of left bundle branch block (LBBB).
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
Condition: Geographic Atrophy; Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: 400 µg Brimonidine Implant; Sham
Intervention description: 400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.; Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of the brimonidine intravitreal implant in
      participants with geographic atrophy due to age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Geographic atrophy due to age-related macular degeneration in the study eye

          -  Visual acuity better than or equal to 20/125 Snellen equivalent in the study eye and
             20/200 Snellen equivalent in the fellow eye.

        Exclusion Criteria:

          -  Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in
             the last 3 months

          -  Infections in either eye in the last 3 months
Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma
Condition: Kidney Neoplasms
MeSH terms: Kidney Neoplasms
Intervention: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor
Intervention MeSH terms: Mitogens; Endothelial Growth Factors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this protocol is to determine the activity of AG 013736 in patients
      with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented RCC with metastases.

          -  Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to
             disease progression or unacceptable treatment-related toxicity

        Exclusion Criteria:

          -  Any prior systemic treatment for Renal Cell Carcinoma [RCC] other than 1 prior
             cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an
             anti-angiogenesis agent are not allowed.

          -  Inability to take oral medication
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
Condition: Advanced Malignant Neoplasm; Dermatologic Complication
MeSH terms: Neoplasms
Intervention: Doxycycline; Management of Therapy Complications; Placebo; Questionnaire Administration; Spironolactone; Sunscreen; Therapeutic Hydrocortisone
Intervention description: Given PO; Moisturizer given topically; Given topically; Ancillary studies; Given topically; Given topically; Given topically
Intervention MeSH terms: Doxycycline; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Spironolactone; Sunscreening Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well giving spironolactone works in preventing
      rash in patients with cancer that has spread to other places in the body and are receiving
      panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor
      (EGFR) inhibitor-induced skin rash.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR
             agent prior to randomization

          -  Ability to reliably apply topical spironolactone/placebo twice a day to the face

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  For study 2 only, patients must be willing to avoid sun exposure for one month from
             registration

          -  Creatinine =< 1.5 x upper limit of normal (UNL)

          -  For Study 2 only, ability to apply topical creams to the entire face and body

        Exclusion Criteria:

          -  Prior allergic reaction or severe intolerance to spironolactone

          -  Any rash at the time of randomization

          -  Cutaneous metastases

          -  Any other disorder that may predispose to hyperkalemia in the opinion of the treating
             oncologist

          -  Use of topical corticosteroids at the time of study or their anticipated use in the
             next 8 weeks; (it is acknowledged that patients may be starting these agents
             pre-emptively as part of this protocol)

          -  For study 2 only, previous intolerance of sunscreen or any of the other components of
             the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: SelG1; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: SelG1; P-selectin; monoclonal antibody; sickle cell disease; sickle cell anemia; sickle cell; pain crisis; pain crises; vasoocclusion; vaso-occlusion; priapism; hepatic sequestration; splenic sequestration; chest syndrome; SCD

Summary:

      The purpose of this study was to determine whether the investigational drug SelG1 when given
      to sickle cell disease patients either taking or not taking hydroxyurea was effective in
      preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the
      bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may
      prevent small blood vessels from becoming blocked and therefore reduce the occurrence and
      severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the
      drug and how long it stayed in the blood stream.

      Funding Source - FDA Office of Orphan Products Development (OOPD)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Sickle Cell Disease (HbSS, HbSC, HbSβ⁰-thalassemia, or HbSβ⁺-thalassemia)

          -  If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at
             least 6 months, with the dose stable for at least 3 months

          -  Between 2 and 10 sickle cell-related pain crises in the past 12 months

        Key Exclusion Criteria:

          -  On a chronic transfusion program or planning on exchange transfusion during the study

          -  Hemoglobin <4.0 g/dL

          -  Planned initiation, termination, or dose alteration of hydroxyurea during the study

          -  Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
Condition: Fallopian Tube Cancer; Ovarian Sarcoma; Ovarian Stromal Cancer; Recurrent Cervical Cancer; Recurrent Endometrial Carcinoma; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Uterine Sarcoma; Recurrent Vaginal Cancer; Recurrent Vulvar Cancer; Stage III Cervical Cancer; Stage III Endometrial Carcinoma; Stage III Ovarian Epithelial Cancer; Stage III Ovarian Germ Cell Tumor; Stage III Uterine Sarcoma; Stage III Vaginal Cancer; Stage III Vulvar Cancer; Stage IV Endometrial Carcinoma; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IV Uterine Sarcoma; Stage IV Vulvar Cancer; Stage IVA Cervical Cancer; Stage IVA Vaginal Cancer; Stage IVB Cervical Cancer; Stage IVB Vaginal Cancer
MeSH terms: Carcinoma; Sarcoma; Uterine Cervical Neoplasms; Neoplasms, Germ Cell and Embryonal; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Endometrial Neoplasms; Germinoma; Ovarian Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Recurrence
Intervention: stereotactic radiosurgery; quality-of-life assessment
Intervention description: Radiation will be delivered in 3 fractions. The dose level will range between 500 to 800cGy per fraction at the discretion of the treating radiation oncologist; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less
      damage to normal tissue.

      PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in
      treating women with advanced or recurrent gynecological malignancies.
    

Eligibility criteria:

        Inclusion

          -  Pathologically proven gynecologic malignancy

          -  No prior cryosurgery or radiofrequency ablation, in target lesion

          -  Patient is able to give and sign study specific informed consent

          -  Measurable disease, according to RECIST criteria

          -  Laboratory parameters and appropriate clearance from anesthesia based on other medical
             co-morbidities for placement of fiducials; these would include CBC, basic metabolic
             panel, BUN, and creatinine

          -  >= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy

          -  ECOG performance status of 0-3 as this procedure is minimally invasive and considered
             palliative in these patients

        Exclusion

          -  Any patient with active connective tissue disease such as lupus or dermatomyositis is
             excluded

          -  Any patient with active Crohn's disease or active ulcerative colitis is excluded

          -  Major medical or psychiatric illness, which would prevent completion of treatment or
             interfere with follow-up is excluded
Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Alisporivir; Peginterferon alfa-2a; Ribavirin; Placebo
Intervention description: ALV 200 mg soft gel capsules administered orally; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose; ALV placebo soft gel capsules administered orally
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C; Cyclophilin inhibitor

Summary:

      The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who
      have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may
      benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus
      placebo with PEG and RBV.
    

Eligibility criteria:

        Inclusion criteria:

          -  Chronic HCV genotype 1 viral infection

          -  HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or
             equivalent at screening

          -  Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

        Exclusion criteria:

          -  Treatment with any anti-HCV drug (whether approved or investigational) within 3 months
             prior to screening

          -  Women of child-bearing potential unless using highly effective

          -  Any other cause of relevant liver disease other than HCV

          -  Other protocol-defined inclusion/exclusion criteria may apply