Clinical Research

This is a listing of Loyola University Health System clinical research that is open and actively recruiting patients. Please click on the name of the research for a brief description, eligibility requirements and contact information. All research listed below have been approved by Loyola's Institutional Review Board chairman for promotion on our Web site.

For more information call (888) LUHS-888.

Randomized, Prospective study on Counseling strategies for Childhood Obesity

Bladder Health

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS)
The primary aims of this study are to compare costs and short-term outcomes of laparoscopic and robotic assisted ASC with respect to patient convalescence. Secondary aims will include a direct comparison of patient safety, costs through a cost-effectiveness analysis and post-operative pain. Intermediate-term efficacy of each surgical technique with respect to cure of prolapse also will be compared.

Anticholinergic Versus Botulinum Toxin Comparison Study: Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence
The primary aim of this randomized clinical trial is to compare the change in urge incontinence episodes over six months between women receiving a single intra-detrusor injection of 100 units of botulinum toxin A plus daily oral placebo tablets versus women receiving a single intra-detrusor injection of saline plus daily anticholinergic therapy. Secondary aims are to compare efficacy of both treatments arms in reducing urgency and urge incontinence, to assess duration of effect of each treatment arm, to compare safety and tolerability (urinary retention requiring catheterization, incomplete bladder emptying, dry mouth, dry eyes, constipation) between botulinum toxin A and anticholinergic medication, to compare compliance with placebo versus active pills and to compare cost-effectiveness between botulinum toxin A and anticholinergics management of urge incontinence.

Nocturia and Chronic Medical Illness
To determine whether the severity of nocturia is related to renal function, glucose control and fluid intake, in samples of patients with and without diabetes mellitus. The use of this data may help to develop a valid, clinically useful algorithm for the evaluation and treatment of patients with nocturia.

UITN ValUE ( Value of Urodynamic Evaluation)
To determine if women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only without preoperative urodynamic studies ( No UDS arm) have non-inferior treatment outcomes compared to women who receive both office evaluation and preoperative UDS (UDS arm).

Cancer

A Multi-center, Randomized, Double-blind, Phase III Trial Evaluating Corticosteroids with Mycophenolate Mofetil versus Corticosteroids with Placebo as Initial Systemic Treatment of Acute Graft Versus Host Disease (GVHD) [BMT CTN 0802]
The primary objective is to estimate graft-versus-host disease-free survival (acute or chronic) at Day 56 after randomization to steroids plus mycophenolate mofetil or steroids plus placebo without additional therapy.

An International, Non-interventional Study of Sorafenib to Evaluate the Safety in Patients With Unresectable Hepatocellular Carcinoma
The primary objective of this international, non-interventional surveillance study is to evaluate the safety of sorafenib in all patients with unresectable hepatocellular carcinoma who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made under real-life practice conditions and in a variety of patient subsets regionally and globally.

An Open Label, Double Arm, Single Center Pilot Study to Evaluate the Safety and Efficacy of Transplantation of either StemEx®, Umbilical Cord Blood (UCB) Stem and Progenitor cells Expanded Ex vivo, or an Unmanipulated Cord Blood Unit in the Elderly Population with Hematologic Malignancies using a Reduced Intensity Regimen.
To assess the safety of StemEx® vs unmanipulated UCB transplantation following RIC regimen in the elderly population on overall 100 day survival. To assess the efficacy of StemEx® vs. unmanipulated UCB transplantation following RIC regimen in the elderly population on full donor chimerism at Day 100.

Assessment of Health Behaviors in Cancer Survivors
To assess the nutritional and health habits of cancer survivors.

Cancer: Bladder and Urinary

A Randomized, Double-blinded Phase III Study Comparing Gemcitabine, Cisplatin and Bevacizumab to Gemcitabine, Cisplatin and Placebo in Patients With Advanced Transitional Cell Carcinoma of the Urinary Tract
The purpose of this study is to determine if patients with advanced transitional cell carcinoma treated with bevacizumab, gemcitabine and cisplatin will have increased overall survival when compared to patients treated with gemcitabine, cisplatin and placebo.

Cancer: Bone

A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 (NSC-751448) in Patients with Bone Metastases
The purposes of this study are to assess the urinary n-telopeptide (NTX) response to MLN1202 in patients with bone metastases; to assess the feasibility of performing cross-disease site trials within the Southwest Oncology Group; to explore the effect of MLN1202 treatment on markers of tumor cell proliferation, monocytes/macrophage trafficking, and osteoclast maturation; and to estimate allele frequencies of defined SNPs occurring in the CCL2 and CCR2 genes in the study population.

A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment
The primary objective of this study is to prospectively assess the cumulative incidence of osteonecrosis of the jaw (ONJ) at three years in cancer participants with bone metastasis receiving zoledronic acid treatment.

Cancer: Bone Marrow Transplant

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability and Activity of 12-week Treatment with a New Antiviral Human Cytomegalovirus (HCMV) Drug
The purpose of this study is to compare the safety and efficacy of three different doses of AIC090027 with matching placebo. The incidence and time to onset of HCMV prophylaxis failed for the prevention of an active HCMV replication within an 84-day treatment period in HCMV sero-positive allogeneic HBPC transplant recipients will be compared between each treatment group versus placebo.

Cancer: Brain

Phase III Double-blind Placebo-controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma.
The purposes of this study are to determine whether the addition of bevacizumab to temozolomide and radiation improves efficacy as measured by progression-free and/or overall survival; to determine whether the tumor molecular profile conferring a mesenchymal/angiogenic phenotype is associated with a selective increase in benefit, as measured by either overall survival or progression-free survival, from the addition of bevacizumab; and to compare and record the toxicities of the conventional and bevacizumab-containing regimens.

RTOG -0525 A Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma
The purpose of this study is to determine if dose-intensifying adjuvant temozolomide during chemoradiation treatment enhances treatment efficacy as measured by overall survival.

Cancer: Breast

A Double Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Participants with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
To determine the disease-free survival of participants.

A Phase II Study Evaluating the Role of Sentinel Lymph Node (SLN) Surgery and Axillary Lymph Node Dissection (ALND) Following Preoperative Chemotherapy in Women with Node-positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis
The purpose of this study is to determine the false-negative rate for SLN surgery. False-negative rate is defined as the number of patients declared to have no evidence of cancer in the SLN and are found to have at least one positive lymph node in the ALND divided by the total number of patients with at least one positive axillary lymph node by ALND.

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-positive Ductal Carcinoma In Situ Resected by Lumpectomy
The purpose of this study is to determine the value of trastuzumab given during radiation therapy compared to radiation therapy alone in preventing the subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence or ipsilateral ductal carcinoma in situ (DCIS) in women with HER2-positive DCIS resected by lumpectomy.

A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer
To compare disease-free survival and overall survival in participants with HER2 overexpressing and/or amplified breast cancer randomized to trastuzumab for one year versus lapatinib for one year versus weekly trastuzumab (12 weeks) followed by a six-week treatment-free interval followed by lapatinib (34 weeks) versus trastuzumab in combination with lapatinib for one year. To evaluate the safety and tolerability of all four treatment groups.

A Randomized Phase II Trial of Weekly Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) As Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
The purposes of this study are to compare the pathologic complete response (pCR) rates in patients randomized to bevacizumab versus no bevacizumab, to compare the overall survival of patients randomized to the bevacizumab arm versus no bevacizumab and to explore molecular biomarkers related to biology and outcome of inflammatory breast cancer.

AA Phase Ib/II, Open-Label Study of the Safety, Tolerability, and Efficacy of Trastuzumab-MCC-DM1 in Combination with Pertuzumab Administered Intravenously to Participants with HER2-Positive, Locally Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Prior Therapy
To characterize the safety and tolerability of the combination of T-DM1 and pertuzumab administered every 3 weeks to participants with HER2-positive locally advanced or metastatic breast cancer who have previously received trastuzumab in any line of therapy, have received chemotherapy combined with HER2-targeted therapy for advanced disease, and have progressed while receiving their most recent therapy.

An Open-label, Expanded Access Protocol of BSI-201 in Combination with Gemcitabin/Carboplatin in Patients with ER-, PR- and HER2-negative Metastatic Breast Cancer
The purpose of this study is to offer peri-approval drug access to BSI-201 in combination with gemcitabine and carboplatin in adult patients with histologically documented breast cancer that is ER-negative, PR-negative and HER2-non-over expressing.

I SPY 2 Trial Investigation of Series Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2
The purpose of this study is to determine whether adding experimental agents to standard neoadjuvant paclitaxel (with or without trastuzumab), doxorubicin and cyclophosphamide increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry, and to determine for each experimental agent used the predictive probability of success in a subsequent phase III trial for each possible biomarker signature.

NSABP B-40, A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens
The purpose of this study is to determine whether the addition of bevacizumab to docetaxel with or without capecitabine or gemcitabine then AC, will increase the rate of pathologic complete response in the breast (pCR breast) relative to docetaxel then AC with or without bevacizumab and to determine whether the addition of bevacizumab to the docetaxel/anthracycline-based regimens (docetaxel then AC, docetaxel/capecitabine then AC and docetaxel/gemcitabine then AC) will increase the rate of pCR breast relative to the same docetaxel/anrthracycline-based regimens without bevacizumab.

Phase II Study to Evaluate Efficacy and Safety of Adjuvant High-Dose Rate Brachytherapy (delivered using the mammosite applicator) as the Sole Method of Radiation Therapy for Selected Women with Stage I Breast Cancer-Small Volume DCIS
The study seeks to test whether radiation to part of the breast using brachytherapy after the removal of cancer gives similar results to those obtained when the whole breast receives RT. The study also seeks to assess safety of the mammosite device in this setting, including the quality of life.

Phase II study of Carboplatin, Nanoparticle Albumin-bound Paclitaxel (ABI-007) and Bevacizumab (Avastin) as the first line therapy in metastatic breast cancer.
The purpose of this study is to determine the progression free survival of this regimen in the first line metastatic breast cancer setting.

Phase III Randomized Trial of Anastrozole vs. Anastrozole and Fulvestrant as First-Line Therapy for PostMenopausal Women with Metastatic Breast Cancer
The study seeks to compare the time to tumor progession in postmenopausal women with metastatic breast cancer treated with anastrozole vs. anastrozole and fulvestrant as first-line therapy.

Phase III Trial of Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
The purpose of this study is to determine the best hormonal treatment for premenopausal women. Patients are randomized to tamoxifen, tamoxifen plus ovarian suppression function (OFS) or exemestane plus OFS.

RTOG 0413 NSABP B-39 A Randomized Phase III Study of Conventional Whole Breast Radiation vs. Partial Breast Radiation for Women with Stage 0, I or II Breast Cancer
The purpose of this study is to determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast cancer.

Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapatinib or Both as Neoadjuvant Treatment of HER2-positive Primary Breast Cancer
The purpose of this study is to determine if the pathologic complete response (pCR) in the breast to neoadjuvant weekly paclitaxel with trastuzumab plus lapatinib or to neoadjuvant weekly paclitaxel plus lapatinib (THL) is 20 percent greater than the pCR to weekly paclitaxel with trastuzumab alone (TH) in HER2-positive operable breast cancer.

Randomized Placebo-controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane-induced Neuropathy, Phase III
To assess if Acetyl-L-Carnitine (ALC) as compared to a placebo prevents symptoms of taxane-related neuropathy as measured by an 11-item neurotoxicity component of the FACT-Taxane at 12 weeks after registration in patients treated with adjuvant taxanes for breast cancer.

SWOG S0230 Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Standard Adjuvant Chemotherapy in Early Stage, Hormone Receptor Negative Breast Cancer
The purpose is to compare the rate of premature ovarian failure at two years following standard adjuvant chemo with/without ovarian supression with LHRH analog during chemo in premenopausal women with early stage, hormone-receptor negative breast cancer.

Targeting Notch Signaling and Hepatocyte Growth Factor in Breast Cancer
To analyze tumor specimens from breast cancer participants in order to further elucidate mechanisms of cancer stem cell activation and inhibition.

Cancer: Cervical or Endometrial

A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865, IND #7921) Versus the Non-Platinum Doublet Topotecan Plus Paclitaxel With and Without NCI-Supplied Bevacizumab in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix
The purpose of this study is to determine whether the addition of bevacizumab to chemotherapy improves overall survival and to determine if a regimen involving paclitaxel and topotecan improves overall survival in comparison to a regimen involving cisplatin and paclitaxel. Another purpose of this study is to determine and compare the frequency and severity of adverse events for the regimens administered in this study

RTOG 0418 A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-Operative Patients with Either Endometrial or Cervical Carcinoma
The purpose of this study is to determine the transportability of IMRT to a multi-institutional setting, and to test the hypothesis that there is a reduction in short-term bowel injury with this regimen compared to standard treatments. Adverse events related to this treatment regimen will be assessed. The rates of local regional control, distant metastasis, disease free and overall survival will be evaluated. Chemotherapy compliance with this regimen for the cervical carcinoma patients will observed.

Cancer: Chemotherapy-Induced (CIPN)

A Phase III Double-blind Trial of Oral Duloxetine for Treatment of Pain Associated with Chemotherapy-induced Peripheral Neuropathy (CIPN)
The purposes of this study are: - To assess in a randomized, double-blind, placebo-controlled, crossover phase III study whether duloxetine 60 mg daily decreases peripheral neuropathy-related nerve pain caused by prior treatment with paclitaxel or oxaliplatin, as measured by the Brief Pain Inventory (Short Form). - To determine the influence of duloxetine 60 mg daily on peripheral neuropathy-related functional status and QOL as measured by the FACT-NTX and EORTC QLQ-C30.

Cancer: Colorectal

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly-diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
To evaluate the efficacy of pegfilgrastim as compared with placebo in reducing the incidence of grade 3/4 febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer treated with bevacizumab and either FOLFOX or FOLFIRI. Grade 3/4 FN is defined as a temperature = 38.0°C (= 100.4°F) and ANC < 1.0 × 109/L, where ANC is measured the same day or within a 24-hour window of a temperature = 38.0°C or (= 100.4°F).

Cancer: Gallbladder or Bile Duct

A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC).
The purpose of this study is to estimate the stratum-specific (RO and R1) and overall two-year survival probabilities of EHCC participants treated with adjuvant capecitabine/gemcitabine followed by capecitabine and radiotherapy.

Phase II Study of Sorafenib and Erlotinib in Patients with Advanced Gallbladder Carcinoma or Cholangiocarcinoma
The purposes of this study are to assess the progression-free survival in patients with unresectable or metastatic gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib and erlotinib and to assess the overall survival in patients with unresectable or metastatic gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib and erlotinib.

Cancer: Gastric and Gastroesophageal Junct'n (GEJ)

A Randomized, Double-blind, Placebo-controlled, Phase II Study of FOLFOX Plus or Minus GDC-0449 in Patients With Advanced Gastric and Gastroesophageal Junction (GEJ) Carcinoma
The purpose of this study is to determine if the addition of GDC-0449 to FOLFOX chemotherapy improves median progression-free survival (PFS) in the first line treatment of patients with advanced gastric and GEJ adenocarcinoma and to determine if the addition of GDC-0449 to FOLFOX chemotherapy affects: 1) Overall survival 2) Response rate 3) Toxicity rates in the first line treatment of patients with advanced gastric and GEJ adenocarcinoma.

Cancer: Head and Neck

A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent Or Metastatic Head and Neck Cancer
The purpose of this study is: • To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard cisplatin-based chemotherapy with or without bevacizumab. • To assess toxicities with the addition of bevacizumab to each cisplatin-doublet (cisplatin/docetaxel and cisplatin/5-FU). • To compare the objective response rates and the progression-free survival achieved with the above therapies. • To collect blood samples before and after therapy for future correlative studies. • To collect tumor tissue samples available at baseline from prior diagnostic procedures for future correlative studies.

Cancer: Kidney (Renal)

An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of Everolimus as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line Everolimus in the Treatment of Patients With Metastatic Renal Cell Carcinoma
The purpose of this study is to assess the probability that progression-free survival during or after first-line of treatment (PFS-1L) in patients who receive Everolimus is non-inferior to the PFS during or after first-line of treatment in patients who receive sunitinib as treatment for metastatic renal cell carcinoma.
The key secondary objective is to compare the two treatment arms for a composite endpoint referred to as progression-free survival combined (PFS-C) and defined as the shorter time between randomization and a radiologically documented progression of disease during/after the second line or between randomization and death.

Mechanistic Evaluations of Sorafenib-induced Hypophosphatemia in Patients With Advanced Renal Cell Carcinoma (RCC)
The purpose of this study is to better understand how treating RCC patients with sorafenib may be linked to low phosphorous level in the blood, and how this low phosphorous level may or may not affect bone mineral density (BMD). Bone mineral density is a way of measuring bone strength. By measuring BMD it is possible to predict bone fracture risk in the same manner that measuring blood pressure can help predict the risk of stroke. The effect of sorafenib treatment on the heart’s ability to pump blood efficiently also will be studied.

Cancer: Leukemia

A Phase III Randomized, Double-blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-dose Cytarabine) Chemotherapy Plus Midostaurin (PKC412) (IND # 101261) or Placebo in Newly Diagnosed Patients Under 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)
The purpose of this study is to determine if the addition of midostaurin to daunorubicin/cytarabine induction, high-dose cytarabine consolidation and continuation therapy improves overall survival (OS) in both mutant FLT3-ITD and FLT3-TKD AML patients.

A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor Entinostat for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type) and Acute Myeloid Leukemia With Multilineage Dysplasia
The purpose is to estimate the overall response rate to azacitidine and entinostat and to estimate the major response rate to a 10-day regimen of azacitidine and to the same regimen of azacitidine in combination with entinostat administered orally on days 3 and 10 of each cycle in patients with de novo myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (dysplastic type) (CMMol) and acute myeloid leukemia with multilineage dysplasia (AML-TLD), as well as in patients with treatment-induced MDS, CMMol and AML-TLD.

Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
The purpose of this study is to determine patient outcomes following high dose combination chemotherapy treatment and to compare higher dose vincristine with compared to standard dose vincristine

Phase II Study of Azacitidine in Combination With Gemtuzumab Ozogamicin for Patients With Relapsed or Refractory Acute Myeloid Leukemia
The purpose is to estimate the overall response rate of patients with relapsed and refractory non-M3 acute myeloid leukemia treated with azacitidine in combination with gemtuzumab ozogamicin.

Cancer: Lung

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) -IIIA Non-Small Cell Lung Cancer (NSCLC)
This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur. The purpose of this study is to determine if adding bevacizumab to chemotherapy improves the chance for cure for participants who have had complete surgical resection of their Stage IB-IIIA NSCLC.Bevacizumab is considered investigational drug in this study.

A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept; NSC-724770) in Patients With Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)
The purpose of this study is to evaluate the efficacy of weekly topotecan as a single agent and the combination of AVE0005 and weekly topotecan in previously treated platinum-sensitive and platinum refractory patients with extensive stage small cell lung cancer (E-SCLC) in terms of progression-free survival (PFS) at three months.

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without COncurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Protocol S0819 Version Date: 7/29/09
The primary objective of this study is, in patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare overall survival (OS) in the entire study population and progression-free survival (PFS) by institutional review in EGFR FISH-positive patients. The secondary objectives are, in patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare OS and PFS by centralized review in EGFR FISH-positive patients and PFS by centralized image review and by institutional review in the entire study population; to compare the response rate (confirmed plus unconfirmed, complete and partial responses) in the subset of patients with measurable disease in EGFR FISH-positive patients and the entire study population; to assess the toxicities of these treatment regimens; to prospectively test EGFR FISH as a predictive marker for the selection of patients for cetuximab plus chemotherapy; to evaluate the role of KRAS mutations in terms of cetuximab efficacy; and to compare the results of EGFR FISH with KRAS mutations, EGFR mutations, EGFR IHC and other purported EGFR-related biomarkers.

Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer (E5597 Phase III)
The purpose of this study is to find out if a high selenium yeast tablet can prevent lung cancers in participants following surgical removal of a Stage I Non Small Cell Lung Cancer

Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the RECIST criteria (version 1.1). A subject is defined as a responder if he/she sustains a complete response (CR) or a partial response (PR) for at least four weeks at any time during treatment. A subject without a post-baseline assessment of response will be considered a non-responder.

Randomized, Phase III Trial of Gemcitabine/Carboplatin with or without BSI-201 (SAR240550) (a PARP1 Inhibitor) in Patients with Previously Untreated Stage IV Squamous Non-small-cell Lung Cancer (NSCLC)
The purposes of this study are to evaluate the overall survival (OS) of patients with stage IV squamous NSCLC receiving gemcitabine/carboplatin either with or without BSI-201 and to evaluate progression-free survival (PFS), time-to-progression (TTP), objective response rate (ORR), safety and tolerability of the treatment regimen, and quality of life as measured by EORTC QLC-30 and QLQ-LC13 in patients with stage IV squamous NSCLC receiving gemcitabine/carboplatin either with or without BSI-201.

Cancer: Lymphoma

A Multi-center, Phase II, Single-arm, Open-label Exploratory Study of Individually Optimized Conditioning Using Pharmacokinetics [PK]-directed Dose Adjustment of Once Daily Intravenous Busulfan, Followed by Autologous Hematopoietic Stem Cell Transplant in Subjects With Non-Hodgkin’s Lymphoma and Hodgkin’s Lymphoma
The purpose of this study is to evaluate the clinical outcomes of subjects with Non-Hodgkin’s Lymphoma and Hodgkin’s Lymphoma receiving an intravenous busulfan-based conditioning regimen with PK-guided intravenous busulfan dosing, followed by autologous hematopoietic stem cell transplant.

A Multicenter Phase II Study Incorporating Doxil and Rituximab into the Magrath Regimen for HIV-Negative and HIV-Positive Patients with Newly Diagnosed Burkitt’s and Burkitt-like Lymphoma
The primary objective of this study is to evaluate the response rate for patients with Burkitt’s and Burkitt-like lymphoma

A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging
The purpose of this study is to estimate the two year progression-free survival in patients with advanced stage Hodgkin lymphoma treated with response-adapted therapy based on FDG-PET imaging after two cycles of ABVD.

A Phase II, Multi-center, Open-label Study of YM155 Plus Rituximab in Previously Treated Subjects with CD20-positive B-cell Non-Hodgkins Lymphoma (NHL) Who are Ineligible for or Who Have Previously Received an Autologous Stem Cell Transplant (ASCT)
The purposes of this study are to determine objective response rate and to evaluate the following:
Safety and tolerability of YM155 given in combination with rituximab; complete response (CR) rate; partial response (PR) rate; time to response; duration of response; clinical benefit rate; progression-free survival and overall survival.

A Phase II, Multicenter, Single-Arm, Open-Label Study to Determine the Efficacy and Safety of Single-Agent Lenalidomide (Revlimid) in Participants with Mantle Cell Non-Hodgkin’s Lymphoma Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib.
To determine the tumor response and duration of response of lenalidomide monotherapy in participants with Mantle Cell Non-Hodgkin’s Lymphoma (MCL) who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.
To evaluate the safety of lenalidomide monotherapy in participants with MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.
To determine the CR, time to progression, time to treatment failure, progression-free survival and overall survival of lenalidomide monotherapy in participants with MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.

A Phase IV, Multi-center, Randomized, Comparator Trial Evaluating the Standard Weight-based Dose (0.24 mg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination with G CSF to Mobilize and Collect =5 x 106 CD34+ cells/kg in = Four Days and to Evaluate the Difference in Total Systemic Exposure in Patients with Non-Hodgkin’s Lymphoma (NHL) Weighing =70 kg
The purpose of this study is to examine whether lower weight (=70 kg) NHL patients are more likely to achieve a target collection of =5 × 106 CD34+ cells/kg in = four days of apheresis following administration of a fixed 20 mg dose as compared with the standard weight-based dose of 0.24 mg/kg plerixafor in combination with G CSF.

A Randomized, Double-blind, Placebo-controlled Phase III Study of SGN-35 (Brentuximab Vedotin) and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin’s Lymphoma (HL) Following Autologous Stem Cell Transplant (ASCT)
Primary: • To compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC Secondary: • To compare overall survival (OS) between the two treatment arms • To evaluate the safety and tolerability of SGN-35 compared to placebo • To characterize the incidence of anti-therapeutic antibodies (ATA)

A pivotal study of SGN-35 in treatment of patients with relapsed or refractory lymphoma (ALCL)
Primary objective is to determine the antitumor efficacy of single-agent SGN-35 as measured by the overall response rate in patients with relapsed or refractory systemic ALCL.

CALGB 50303/CTSU50303 Phase III Randomized Study of R-CHOP v. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-cell Lymphomas
The purpose of this study is to compare the effects of two treatments; R-CHOP with Dose-Adjusted EPOCH-R for untreated de novo DLBC lymphoma and to develop molecular predictor of outcome using molecular profiling.

CRAD001N2301 A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Complete Response (CR) With First-line Rituximab-chemotherapy (R-CHOP) Achieved
The purpose of this study is to compare the efficacy and safety of RAD001 10 mg p.o. daily dose against matching placebo as adjuvant therapy in poor risk patients with DLBCL who have achieved CR after first-line R-CHOP.

Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients with Relapsed Follicular Non-Hodgkin’s Lymphoma Beyond First Complete Response BMT CTN PROTOCOL 0701
The primary objective of this study is to measure progression-free survival at two years after non-myeloablative HSCT with a pre-transplant conditioning regimen of fludarabine, cyclophosphamide and rituximab (FCR).

S0350 A Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell non-Hodgkin’s Lymphoma
To estimate the 2-year overall survival of patients with peripheral T-cell non-Hodgkin’s Lymphoma (NHL) treated with a regimen of cisplatin, etoposide, gemcitabine, and solumedrol (PEGS). To assess toxicity, response rate (complete unconfirmed, complete and partial responses), and progression-free survival in patients treated with this regimen

S0801 A Phase II Study of Iodine-131 Labeled Tositumomab in Combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy For Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma
To evaluate response rate and toxicity in participants with advanced stage follicular NHL treated with R-CHOP + I-131 tositumomab with rituximab maintenance; to estimate the three-year and five-year progression-free survival rate; to assess the safety profile of rituximab maintenance following the R-CHOP + I-131 tositumomab regimen.

Temsirolimus for Relapsed/Refractory Hodgkins Lymphoma
The primary objective of this study is to estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus, evaluate the toxicity of temsirolimus in this patient population, estimate the time to progression and overall survival after treatment with temsirolimus

The Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-positive Malignancies (SGN35-007)
The purpose of this study is to evaluate the effect of treatment with SGN-35 (brentuximab vedotin) on cardiac ventricular repolarization in patients with CD30-positive malignancies.

The Effects of SGN-35 (brentuximab vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-positive Malignancies (SGN35-007)
The purpose of this study is to evaluate the effect of treatment with SGN-35 (brentuximab vedotin) on cardiac ventricular repolarization in patients with CD30-positive malignancies.

Cancer: Multiple Myeloma

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study of Panobinostat in Combination with Bortezomib and Dexamethasone in Patients with Relapsed Multiple Myeloma
The purpose of this study is to compare progression-free survival in patients treated with panobinostat in combination with bortezomib and dexamethasone versus patients treated with placebo in combination with bortezomib and dexamethasone.

A Phase IIa Study of Once Daily Intravenous Busulfan with Bortezomib, Followed by an Autologous Hematopoietic Stem Cell Transplant (HSCT) in Subjects with Relapsed Multiple Myeloma after Prior Autologous HSCT
The purpose of this study is to evaluate the six-month response (stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) by International Myeloma Working Group uniform response criteria for multiple myeloma after current autologous HSCT with this conditioning regimen.

A Prospective Observation Biologic Study of Asymptomatic Patients with Monoclonal Gammopathy and Plasma Proliferative Disorders
The purpose of this study is to establish a serum, cell and tissue bank of prospectively collected samples from patients with asymptomatic plasma proliferative diseases in a national cooperative group setting.

Phase I/II Study Utilizing High Dose Busulfan and Melphalan Followed by Escalating Bortezomib as Conditioning in Autologous Peripheral Blood Stem Cell Transplantation for Participants With Multiple Myeloma
The purpose is to evaluate efficacy as measured by response rate through a phase I/II non-randomized trial that utilizes a preparative regimen consisting of intravenous busulfan plus melphalan, both at standard dosages, followed by escalating doses of bortezomib, supported by transplantation of autologous hematopoietic stem cells.

Cancer: Myelodysplastic Syndrome

Phase I Dose-ranging Study of Ezatiostat Hydrochloride (TLK199 Tablets) in Combination With Lenalidomide in Patients With Non-deletion (5Q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
The primary objectives are to establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide and to determine the safety of ezatiostat in combination with lenalidomide.

Cancer: Ovary, Fallopian Tube, Primary Peritoneal

A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma: NCI-supplied Agent: Bevacizumab (NSC #704865, IND #7921)”
The purpose of this study is to determine if one or both of the proposed intraperitoneal chemotherapy regimens improves the progression-free survival event rate compared to standard intravenous chemotherapy for first-line treatment of patients diagnosed with advanced stage ovarian, peritoneal or fallopian tube cancer. If both intraperitoneal regimens significantly improve the progression-free survival event rate compared to the standard regimen, then a second study objective is to determine whether intraperitoneal cisplatin and IV paclitaxel on Day 1 plus intraperitoneal paclitaxel on Day 8 improves the progression-free survival event rate when compared to the intraperitoneal carboplatin and IV paclitaxel.

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-Sensitive Ovarian Cancer in First Relapse
The purpose of this study is to assess the effect of two dose levels of MORAb-003 or placebo in combination with carboplatin and taxane on progression-free survival (PFS) as determined by RECIST, in subjects with platinum-sensitive ovarian cancer in first relapse.

Cancer: Pancreatic

A Multi-center, Double-blind, Placebo-controlled, Randomized Phase II Trial of Gemcitabine Plus GDC-0449 (NSC 747691), a Hh Pathway Inhibitor, in Patients With Metastatic Pancreatic Cancer
The purposes of this study are to compare the median progression-free survival of advanced pancreatic cancer patients treated with the combination of gemcitabine plus GDC-0449 versus gemcitabine plus placebo; to compare median overall survival of advanced pancreatic cancer patients treated with the combination of gemcitabine plus GDC-0449 versus gemcitabine plus placebo; to compare the objective response rate of advanced pancreatic cancer patients treated with the combination of gemcitabine plus GDC-0449 versus gemcitabine alone; to determine the toxicity experienced by pancreatic cancer patients treated with the combination of gemcitabine plus GDC-0449; and to determine the activity, in an exploratory analysis, of gemcitabine plus GDC-0449 in patients who progress on gemcitabine plus placebo.

Cancer: Prostate

A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal-related Events in Men With Prostate Cancer to Bone
The purpose of the study is to determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal-related event.

Cancer: Rectal

A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer
The purpose of this study is to assess the pathologic complete response rate in participants with adenocarcinoma of the rectum, Stages II and III with wild-type K-ras treated with the combination of oxaliplatin, capecitabine and cetuximab given alone and given concomitantly with external beam radiation (EBRT), followed by surgery.

Cancer: Skin (Melanoma)

A Phase I Dose Escalation Trial of Dendritic Cell-Based Vaccination for Stage IV Melanoma Patients.
The purpose of the study is to assess the dose limiting toxicity for dendritic cells pulsed with autologous tumor lysate and matured using a Dendritic Maturation Cocktail composed of IL-1 beta, IL-6, TNF alpha, and PGE2, injected intranodally with KLH in Stage IV melanoma patients.

Phase II Trial of SCH 727965 (NSC 747135) in Patients with Stage IV Melanoma
The purpose of this study is to find out what effects (good and/or bad) SCH 727965 has on your patients and their Stage IV melanoma. SCH 727965 is an experimental drug. It can affect the cancer's cell cycle (the process in which cells divide and reproduce). Other studies have shown that it might be able to control the growth of some cancers. This study is being done to see if this drug can control the growth of melanoma tumors to a point where it can help people live longer.

Cancer: Soft Tissue Sarcoma

A Multinational, Randomized, Double-Blind Placebo Controlled Study of AVE8062 Administered Every 3 Weeks, in Patients with Advanced-Stage Soft Tissue Sarcoma Treated with Cisplatin After Failure of Anthracycline and Ifosfamide Chemotherapies.
To compare the progression-free survival, overall survival and the objective response rate in the two treatment arms. To assess the safety profile of AVE8062 (in combination with cisplatin). To assess the pharmacokinetics of AVE8062 and its main metabolite RPR258063, using a population approach, in all patients enrolled in selected centers. To assess genotypes of drug metabolizing enzymes in all enrolled patients in blood sampling collected before the first study drug infusion.

Cancer: Uterine

A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma
The purpose of this study is to determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to pelvic radiation therapy.

GOG 0261, A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients With Newly Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus
The purpose of this study is to determine if treatment with a combination of paclitaxel and carboplatin chemotherapy does not result in an inferior mortality rate when compared to ifosfamide, mesna and paclitaxel chemotherapy.

Cardiovadiovascular Health: Arrhythmia

Multidisciplinary Study of Right Ventricular Dysplasia (ARVD)
This is a multidisciplinary, multicenter collaborative study to investigate the cardiac, clinical and genetic aspects of arrhythmogenic right ventricular dysplasia (ARVD). The primary goal is to identify 100 patients with definite ARVD and their family members. The study offers a substantial prospect of expanding the fund of clinical knowledge regarding ARVD and/or localizing the genetic mutation(s) responsible for this disorder.

Cardiovascular

Selective CFAE Targeting for Atrial Fibrillation
The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of freedom from atrial arrhythmia at one year (Efficacy endpoint), and total RF delivery time per procedure (Safety endpoint).

Cardiovascular Health

Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA Trial)
The CABANA trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation. The CABANA trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated atrial fibrillation.

Cardiovascular Health: Aortic Aneurysm

A Phase II, Single-arm, Prospective Study of the Safety and Efficacy of the Aorto-uni-iliac Endoluminal Stent Graft for the Repair of Abdominal Aortic Aneurysms in Patients Who are Not Candidates for Repair With Commercially Available Bifurcated Endovascular Prostheses and High Risk for Conventional Surgical Repair
The primary study objective is to determine the safety and efficacy of the aorto-uni-iliac (AUI) endoluminal stent graft (the study device) for the repair of abdominal aortic aneurysms (AAAs) in patients who are not candidates for repair with commercially available bifurcated endovascular prostheses and high risk for conventional surgical repair

An Evaluation of a Thoracic Endoprosthesis (stent) for the Primary Treatment of Aneurysm of the Descending Thoracic Aorta Protocol Number: TAG 08-03
The purpose of this research study is to determine the safety and effectiveness of a thoracic endoprosthesis (the study device) when used to treat aneurysms of the descending thoracic aorta.

Cardiovascular Health: Heart Failure

Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritede in Subjects with Decompensated Heart Failure (ASCEND-HF)
The primary objective is to evaluate whether treatment with nesiritide improves patient outcomes (as measured by reduction in the composite of heart failure re-hospitalizations and all-cause Mortality through 30 days after randomization or heart failure symptoms (as measured by subject self-assessed Likert dyspnea scale at 6 and 24 hours after study drug initiation) compared with placebo when each is administered in addition to other standard therapies in subjects with acute decompensated heart failure.

Cardiovascular Health: Paroxysmal Atrial Fibr'tn

Selective CFAE Targeting for Atrial Fibrillation
The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of freedom from atrial arrhythmia at one year (efficacy endpoint), and total RF delivery time per procedure (safety endpoint).

Cardiovascular: Marfan Syndrome

Aortic Valve Operative Outcomes in Marfan Patients
The purpose of the study is to: -Evaluate and compare operative outcomes of the aortic valve-sparing (AVS) and aortic valve replacement (AVR) surgical interventions in different categories of patients with Marfan syndrome and estimate predictors of the surgical outcomes; - Compare the outcomes described in above objective in different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention; - Determine predictors that have prognostic importance for the outcomes of surgical interventions in different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention; - Evaluate prevalence of different types of AVR and AVS operations in patients with Marfan syndrome who had surgical intervention for correction of aortic valve abnormalities; - Evaluate indications used to perform AVR and AVS operations in patients with Marfan syndrome; - In different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention, estimate: a) short-term morbidity & mortality in patients with Marfan syndrome undergoing the AVS or the AVR surgical intervention; b) cumulative incidence of selected complications estimated from the 24 month follow-up period; c) freedom from selected complications estimated from the 24 month follow-up period; d) survival rate estimated from the 24 month follow-up period; e) Quality of life score Develop a centralized on-line database for accumulation of data on patients with Marfan syndrome undergoing the AVS or the AVR surgery; - Develop a repository for blood and tissue samples obtained from study participants.

Endocrinology: Diabetes

Vitamin for Metabolic Control and Depressive Symptoms in Women with Diabetes
The purpose of this study is to determine whether taking vitamin D supplementation will help with metabolic control (fasting blood sugar, insulin resistance, HBA1c) and depressive symptoms.

Endocrinology: Growth Hormone

The Global Hypopituitary Control and Complications Study (HypoCCS)
The primary objective of the study is to determine whether long-term growth hormone (GH) replacement therapy administered in clinical practice to adults with growth hormone deficiency (GHD) is associated with increased or decreased incidences of clinically significant adverse events (AEs).

Mental Health: Depression

Cardiovascular Risk Biomarkers During Quetiapine Antidepressant Treatment
The purpose of this study is to investigate quetiapine’s ability to reverse those pathophysiological changes occurring in depression and anxiety that have been linked causally to the development of cardiovascular disease.
Arterial stiffness will be measured non-invasively by a procedure called applanation tonometry. The measures serve as markers of subclinical hardening of the arteries and may be able to show a response to therapy, if such hardening is present. The procedure involves positioning of a probe on the skin overlaying certain arteries in the body, namely the radial, carotid and femoral. Heart rate variability similarly is determined non-invasively by placing three leads on the chest and determining heart function. Treatment with quetiapine is expected to restore normal heart function.

Non-invasive pulse-wave analysis to test endoethelial function in depressed subjects.
The purpose of this study is to evaluate endothelial function in patients diagnosed with Major Depressive Disorder (MDD) using applanation tonometry to compute pulse wave velocity and index of augmentation.

Neurology: Arterio-vascular Malformation

A Randomized Multicenter Clinical Trial of Unruptured Brain Arteriovenous malformations (BAVMs)
The study was developed to determine whether medical management improves long-term outcomes of patients with unruptured BAVMs compared to interventional therapy (endovascular procedures, neurosurgery or radiotherapy, alone or in combination). One may reduce the risk of death or stroke.

Neurosciences

Cardiovascular Risk Biomarkers During Quetiapine Antidepressant Treatment
To investigate quetiapine’s ability to reverse those pathophysiological changes occurring in depression and anxiety that have been linked causally to the development of cardiovascular disease.

Pulmonary: Cystic Fibrosis

Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis
The purpose of this study, which involves research, is to determine the safety and effectiveness of an experimental drug/device combination, a dry powder inhaler with ciprofloxacin, in the treatment of this disease, compared with placebo (an inactive substance).

Skin Health: Psoriasis

A Multicenter, Open Registry of Patients With Psoriasis Who Are Candidates for Systemic Therapy Including Biologics, Protocol Number: C0168Z03
The registry study will track the behavior of the disease in response to other therapies, such as adalimumab, alefacept, certolizumab pegol, efalizumab, etanercept and other biologics. The registry also will evaluate clinical outcomes, quality of life and potential risks for patients who may receive standard therapies for psoriasis.

CLINICAL STUDY PROTOCOL P10-023 A 10-Year, Post-marketing, Observational, Registry of Adalimumab in Adult Patients.
The purpose of this registry is to observe the degree of long-term safety of adalimumab and how well it works to treat chronic plaque psoriasis for up to ten years. Adalimumab is a marketed drug for psoriasis. No medication is provided for this registry.

Observational Post-Marketing Safety Surveillance Registry of Etanercept for Treatment of Psoriasis
The purpose of this study is to continue to gather and evaluate information on the long-term safety of etanercept in a large number of participants with plaque psoriasis.

Stroke

Albumin in Acute Stroke (ALIAS) Trial: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke
Neuroprotective agents for acute ischemic stroke have thus far failed to be proven effective. Albumin versus placebo is the next step in trying to find a valid treatment for stroke victims.

Insulin Resistance Intervention after Stroke (IRIS) Trial
Pioglitazone is a medication given to diabetics from blood glucose control. It has not been tested versus placebo for the overall risk of decreasing fatal/non-fatal stroke or fatal/non-fatal MI among non-diabetic men and women with insulin resistance.

The Experience of Family Caregivers of Stroke Survivors
The purpose of this study is to describe how female caregivers of stroke survivors cope with the stress of care-giving.

Transplant: Lung

A Multi-center, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected with Respiratory Syncytial Virus (RSV) ALN-RSV01-109
This purpose of this study is to determine the effects (both good and bad) of ALN RSV01 for the treatment of RSV.

A Multi-center, Randomized, Controlled Study to Demonstrate theEfficacy and Safety of Cyclosporine Inhalation Solution (CIS) inImproving Bronchiolitis Obliterans Syndrome-Free SurvivalFollowing Lung Transplantation
In order to improve long-term survival following lung transplantation, efforts must focus on preventing the development of chronic lung rejection. The objective of this study is to establish the efficacy and safety of inhaled cyclosporine (CIS) in preventing chronic rejection in lung transplant patients. This research study will help to confirm whether or not CIS, in addition to other medications that suppress the immune system, will help to prevent new lung(s) from being rejected by the body’s natural immune system.

A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation
This research study will help to confirm whether or not CIS, in addition to other medications that suppress the immune system, will help to prevent new lung(s) from being rejected by the body’s natural immune system.

Women's Health: Prolapse and Bladder Control

Operations and Pelvic Training in the Management of Apical Support Loss: The Optimal Trial
The OPTIMAL study has two purposes: 1) To compare two standard surgical techniques [sacrospinous ligament fixation (SSLF) and uterosacral ligament (USLS)] for apical vaginal prolapse regardless of the presence of a uterus, and 2) To determine the utility of perioperative pelvic muscle exercises and behavioral on postoperative bladder and bowel symptoms after surgery.