26 Clinical Trials for Various Conditions
Background: T-shaped tissue anchors have promise to close incisions and perforations of the intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas usually requires invasive open or laparoscopic surgery under general anesthesia and can be complex surgeries due to their reoperative or inflammatory nature. Objective: The proposed use of full thickness tissue anchors adds a new surgical aspect to the endoscopic treatment of fistulas and perforations by offering a robust suture like closure of defects. Instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions with the related postoperative morbidity an endoscopic technique is used which requires no postoperative limitation of activities. Methods: In this study the investigators propose to use an endoscopic technique that eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic repair than is possible with traditional endoscopic tools. Patients who are scheduled to undergo surgery for intestinal fistulas will be screened for study eligibility. Patients who are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for study eligibility and informed about all possible therapies in case of an iatrogenic perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue anchors). A commercially available flexible endoscope will be inserted through the mouth and the fistula or perforation will be closed using the Tissue Approximation System (Ethicon Endo Surgery, Cincinnati, OH). The investigators will initially evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in 5 patients. Expected results: The potential advantages to the patients entered into this study result from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury of organs, post operative wound infection, hernia), shorter hospital stay, reduced postoperative pain, earlier return to work, and cosmetic advantage.
Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.
Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.
This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.
The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).
The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders). 1. To assess the clinical and technical success rates of EUS-Guided interventions 2. To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses. 3. Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.
Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations. Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS. The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.
The iCaRe2 is a multi-institutional resource created and maintained by the Fred \& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.
This phase I clinical trial is studying the side effects and the best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with metastatic or recurrent solid tumors and human immunodeficiency virus (HIV) infection. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells. NOTE: An administrative decision was made by NCI to halt further study of vorinostat in this specific patient population as of February 1, 2013. No patients remain on vorinostat. Going forward this study will determine the safety and tolerability of the paclitaxel and carboplatin combination in this patient population.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of giving pemetrexed disodium and docetaxel together in treating patients with advanced solid tumors.
RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and nicotine replacement therapy may be useful in helping smokers stop smoking. PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to cigarettes.
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking. PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.
RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may help African-American smokers stop smoking. It is not yet known whether health education counseling is more effective with or without bupropion in helping African Americans stop smoking. PURPOSE: This clinical trial is studying health education counseling and bupropion to see how well they work compared with a placebo and health education counseling in helping African Americans smokers stop smoking.
RATIONALE: Bupropion may help people stop smoking by decreasing the symptoms of nicotine withdrawal. Giving bupropion over a longer period of time may be effective in helping people stop smoking. PURPOSE: This randomized phase II trial is studying how well bupropion works in helping adults stop smoking.
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more tumor cells.
RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA damage. PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium levels in smokers.
RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more effective than counseling and the nicotine patch in helping adult smokers quit smoking. PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to see how well they work compared to counseling and the nicotine patch in helping smokers quit smoking.
RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy. PURPOSE: This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy.
This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells from dividing so they stop growing or die.
This phase I trial is studying the side effects and best dose of giving 7-hydroxystaurosporine together with irinotecan hydrochloride in treating patients with metastatic or unresectable solid tumors, including triple-negative breast cancer (currently enrolling only patients with triple-negative breast cancer since 6/8/2007). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving 7-hydroxystaurosporine together with irinotecan hydrochloride may help kill more cancer cells by making tumor cells more sensitive to the drug.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have unresectable locally advanced, metastatic, or recurrent solid tumor.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers.
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with docetaxel may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer.
RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 in treating patients with advanced solid tumors or lymphoma.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of capecitabine combined with cisplatin in treating patients who have locally advanced or metastatic solid tumors .