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Clinical Trials Week

Susan Hasty, Publisher

Table of Contents . . . December 26th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Clinical Trials Week | Other Publications

Clinical Trials - Olanzapine has greater efficacy but more side effects than ziprasidone

Clinical Trials - Once weekly dalbavancin as effective as twice daily linezolid for complicated SSSIs

Drug Development - Enrollment completed in phase III study of Entereg in postoperative ileus

Urology - Intradetrusor botulinum toxin B effective for patients with adverse reactions to toxin A

Actinic Keratosis - Phase IIa trial results show PEP005 gel effective on precancerous skin condition

Allergy & Immunology - Olopatadine eyedrop treatment ameliorate ocular symptoms in most patients

Bladder Cancer - Urine telomerase activity levels used to diagnose bladder cancer

Breast Cancer - Alliance to study use of magnetic resonance focused ultrasound to eliminate breast tumors

Breast Cancer - Company announces phase II data on E7389, a new therapy for the treatment of breast cancer

Breast Cancer - Delivery of radiotherapy in the DBCG 82 b&c trials analyzed

Diabetes Therapy - Research add new data to diabetes therapy body of knowledge

Breast Cancer - Dose-dense chemotherapy for early breast cancer was found to be safe, similar to standard regimen

Breast Cancer - Non-uniform classification practices in breast cancer resulted in distorted statistics

Breast Cancer - Revision of the T4 category of breast cancer needed

Breast Cancer - Study shows superior response rate of Abraxane in women with metastatic breast cancer

Breast Cancer Vaccine - HER2/neu vaccine prevents recurrence in high-risk breast cancer patients

Business & Finance - Proposed acquisition of Cita NeuroPharmaceuticals announced

Cancer Research - Study of paclitaxel-based chemo/radiation therapy for LANSCLC finds long-term survival regimen

Cancer Therapy - Administration of dexrazoxane during treatment with doxorubicin resulted in less cardiotoxicity

Cancer Therapy - Gemcitabine and irinotecan treated patients with carcinoma of an unknown primary site

Cancer Therapy - Inerleukin-12 plus interferon reported to be safe as an experimental therapy for some cancers

Cancer Therapy - U.S. FDA accepts IND application for ENMD-1198

Cancer Therapy - U.S. FDA grants IND clearance for eniluracil

Cardiology - Cilostazol therapy increased luminal diameter and lowered restenosis rate

Cardiovascular Research - Patient enrollment complete in study of bioabsorbable collagen matrix technology

Cervical Cancer - FDG-PET used to detect metastases of uterine cervical cancer when surgical staging is inappropriate

Cervical Cancer - Researchers suggest FIGO guidelines be reassessed to better reflect clinical practice

Chronic Hepatitis Infections - Paraoxonase-1 polymorphisms are associated with chronic HCV infection

Clinical Trials - Agreement reached with U.S. FDA on statistical analysis plan for anxiety drug

Clinical Trials - Antiviral activity shown in one of two antibodies comprising hepatitis C drug candidate

Clinical Trials - Bronchitol dose finding study for cystic fibrosis commences

Clinical Trials - Company expands monoclonal antibody SGN-40 program into chronic lymphocytic leukemia

Clinical Trials - Enrollment complete in phase I clinical trial of SB-509 for diabetic neuropathy

Clinical Trials - Enrollment complete in trial of beta-estradiol eluting stent system

Clinical Trials - Enrollment completed ahead of schedule in phase II trial of ozarelix for BPH

Clinical Trials - First patient completes treatment in phase I of Provecta trial

Clinical Trials - INNO-105 clinical trial initiated for treatment of advanced solid malignancies

Clinical Trials - Jacob P. Lalezari, MD, at Quest Clinical to lead next trial of new immunotherapy

Clinical Trials - New research company to help address chronically under-represented minorities in clinical trials

Clinical Trials - Pharma development company completes phase II study of low estrogen contraceptive patch

Clinical Trials - Phase II trial to evaluate synthetic epothilone for cancer treatment

Clinical Trials - Study finds xyrem relieves pain, improves function in fibromyalgia patients

Clinical Trials - Study shows improved FEV(1) in pediatric asthma patients treated with HFA inhaler

Clinical Trials - U.S. FDA gives approval for full expansion of COSTAR II drug-eluting stent trial

Colon Cancer - Hartmann reversal associated with more complications than loop ileostomy reversal

Colon Cancer - Women and the elderly with stage III colon cancer should also receive chemotherapy, say researchers

Complementary & Alternative Medicine - Green tea polyphenols did not affect glucose levels or insulin resistance

Complementary & Alternative Medicine - Study cites use of glucosamine, chondroitin combination as being effective for joint health

Diabetes Complications - V.A.C. Therapy shown effective and safe for healing diabetic foot amputation wounds

Diabetes Therapy - Findings describe new data in diabetes therapy research

Diabetic Nephropathy - Researchers detail new studies and findings in the area of diabetic nephropathy

Diagnostics - Basic fibroblast growth factor reflects renal cell cancer invasion and metastasis

Diagnostics - Data support the potential of breast-specific gamma imaging in reducing benign biopsies

Diagnostics - Real-time PCR improves diagnostic yield, but raises treatment costs

Diet & Nutrition - Consumption of cruciferous vegetables could prevent lung cancer

Diet & Nutrition - Diet with oat beta-glucans improved lipid and glucose metabolism, barley beta-glucans did not

Diet & Nutrition - Low-allergen maternal diet reduced distressed behavior among breastfed infants with colic

Diet & Nutrition - Role of diet and nutrition in cervical carcinogenesis discussed

Disease Associations - Poorer quality of life in breast cancer survivors might be related to untreated symptom cluster

Drug Delivery - Separate intravenous access recommended for fat emulsion infusion in neonates

Drug Development - ACP-103 reduced haloperidol-induced akathisia in phase II trial of patients with schizophrenia

Drug Development - Alzheimer disease patients demonstrate statistically significant benefits with Phenserine

Drug Development - Bermuda-based firm completes acquisition of exclusive worldwide rights to Xerecept

Drug Development - Dosing of first multiple dose cohort of AEOL 10150 in ALS patients completed for phase I trial

Drug Development - ERK protein activation assists in adipocyte maturation and regulation of lipid blood level

Drug Development - FR177391 is promising treatment option for management of hypertriglyceridemia

Drug Development - Health Canada issues notice of non-compliance for Marqibo

Drug Development - New drug application submitted to U.S. FDA for once-daily analgesic tramadol

Drug Development - Patient enrollment completed in phase III trial for CellCept in myasthenia gravis

Drug Development - Phase I/II trial initiated for bone formation therapy in the spine

Drug Development - Trial results suggest Albuferon, with RBV, safe for chronic hepatitis C patients

Drug Development - U.S. IND filed for selective oral c-Met inhibitor, ARQ 197

Drug Safety - Mechanism for acute hyperglycemia induced by ketamine/xylazine anesthesia was investigated

Dyslipidemia - Low HDL-C suggested as secondary target of dyslipidemia therapy

Dysphagia - Metal stents were associated with prolonged improvement of malignant dysphagia

End-Stage Renal Disease - U.S. FDA approves new higher dose formulation of chewable Fosrenol

Esophageal Cancer - Surgical intervention improved survival in patients with esophageal cancer

Gallstone Therapy - Short-term ursodeoxycholic acid treatment improves gallbladder bile turnover

Gastric Electrical Stimulation - Gastric electrical stimulation treats lower esophageal sphincter pressure in dog model

Geriatrics - Comprehensive geriatric assessment predicted survival and chemotherapy tolerance

Geriatrics - Flexible sigmoidoscopy used for colorectal cancer screening in the elderly

Gliomas - No changes in cognitive function observed after radiotherapy for supratentorial low-grade glioma

Goiters - Surgical treatment of multinodular goiter in young patients resulted in low rate of morbidity

HIV/AIDS HAART - Stavudine dose reductions may ameliorate complications without compromising antiviral activity

HIV/AIDS Research - Study shows HIV patient adherence may improve with fixed-dose combinations

HIV/AIDS Therapy - Enrollment initiated for HIV patients into XACT study for AMD070, a CXCR4 HIV entry inhibitor

HIV/AIDS Vaccine - Agreement signed for manufacture of AIDS vaccine candidate for clinical trials

Hepatitis C Therapy - Interferon-ribavirin therapy does not affect bone density in chronic hepatitis C

Hereditary Spastic Paraplegia - Hereditary spastic paraplegia disease-related phenotypes are ameliorated by vinblastine

Hodgkin Lymphoma - Factors affecting amenorrhea in women with advanced-stage Hodgkin lymphoma are identified

Imaging - Alliance formed to develop medical equipment and contrast agents for optical imaging

Imaging - LightSpeed VCT can capture images of the heart in as few as five beats

Imaging - Medical device company recaps radiofrequency ablation treatment presentations

Immunology - Immunostimulation alone is insufficient to enhance antiviral T-cell reactivity

Infectious Diseases - Amphora selected for microbicide clinical trial

Inflammatory Bowel Disease - Inflammatory bowel disease can be treated with NF-kappa B decoy oligonucleotides

Information Technology - COPD trial to use radio frequency ID smart sensor labels

Kidney Cancer - Update presented on phase III sorafenib trial in advanced kidney cancer patients

Leishmaniasis Vaccine - Multi-subunit leishmanial vaccine fails to protect dogs from infection

Leukemia - AMN107 shows benefits in some patients with Gleevec-resistent leukemia

Lipid Research - Trial data on hyperlipidemia drug mevalotin show artery disease significantly suppressed

Lung Cancer - Gefitinib plus best supportive care used to treat patients with non-small cell lung cancer

Lung Cancer - Race and gender may affect lung cancer clinical trial participation

Lung Cancer - Systematic node dissection by VATS is feasible for clinical stage I lung cancer

Lymphoma - Regular use of hair dyes not associated with risk of lymphoma in Spain

Medical Devices - Biventricular pacing in non-heart failure patients improves exercise and functional capacity

Medical Devices - Configurable computerized self-monitoring system useful for researchers

Medical Devices - Heart valve company to restart U.S. percutaneous heart valve feasibility study

Medical Devices - Medical image analysis company to provide services for cartilage repair device clinical trial

Mental Healthcare - Selective cholinergic modulation affects visuospatial and memory function

Mesothelioma - Residential proximity to naturally occurring asbestos linked to mesothelioma risk

Molecular Biology - New muscle-building agent reported effective in mouse model

Multiple Myeloma - Combination of Quadramet and new proteasome inhibitor to be evaluated in new clinical trial

Non-Hodgkin Lymphoma - Positive data announced on all evaluable patients in HuMax-CD20 NHL phase I/II study

Non-Small Cell Lung Cancer - Phase III clinical trials of PF-3512676 for advanced NSCLC begins

Obesity Complications - TLR after coronary stenting is more prevalent in obese than normal-weight patients

Osteoporosis - Studies add new findings to osteoporosis body of knowledge

Osteoporosis - Vertical fracture risk is reduced by oral ibandranate in women with osteoporosis

Ovarian Cancer - Biotech company announces phase Ib/IIa phenoxodiol plus docetaxel study plans

Pain Management - Intradiscal electrothermal therapy safe, but no more effective than placebo

Pediatric Malaria Therapy - Methylene blue plus chloroquine safe for young African children, but has limited efficacy

Personnel - Data management company board adds Gary Haroian and Dennis Shaughnessy

Prognostics - A staging score is useful in hepatits C prognostic evaluation in hepatocellular carcinoma

Prognostics - New research in the area of prognostics detailed

Prostate Cancer - Exposure to metalworking fluids linked to prostate cancer risk among autoworkers

Prostate Cancer - Low fat local vegetarian diet protected against prostate carcinoma in thin men

Prostate Cancer Therapy - U.S. FDA agrees to special protocol assessment amendment to D9902B IMPACT study of Provenge

Pulmonary Embolism - Prevention of venous thromboembolism in cancer surgical patients posed a clinical challenge

Renal Cell Cancer - Palliative radiotherapy used to manage metastatic renal cell carcinoma

Smallpox Vaccines - Preclinical studies provide safety and efficacy evidence for smallpox vaccine candidate

Statins - Recent findings in statins provide new insights

Stents - Four-year patient follow-up data support durability of Powerlink System

Stents - Late lumen loss is more reliable for assessing new drug-eluting stent systems across studies

Stroke - Risk factors linked to stroke-related headache are examined in lacunar infarction patients

Surgical Technology - Benefits of short-term postoperative drainage following axillary lymph node dissection studied

Surgical Technology - Moxifloxacin 0.5% ophthalmic solution has higher antibiotic activity than gatifloxacin 0.3%

Thrombocytopenia - Angiomax label expansion approved to include patients with or at risk of HIT/HITTS undergoing PCI

Thymoma - Videothoracoscopic resection used to treat stage II thymoma

Transplant Medicine - Studies add new findings to transplant medicine body of knowledge

Uterine Fibroids - Trial shows high-intensity ultrasound treatment shrinks fibroids

Vaccines - Phase I trial of C. difficile vaccine in elderly subjects begins

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