16 Clinical Trials for Various Conditions
Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in patients after recent antibiotic use. The current standard of care treatment for severe C. diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is unsuccessful, it can lead to need for removal of the entire colon or even death. In fact, mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted mortality rate is 14% for severe infection. It is believed that the failure of treatment may stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin functions by direct contact with the colon. It is presumed that this paralysis of the small intestine is present but has never been proven. The objective of the study is to prove that there is an adynamic ileus present in c. diff colitis and therefore lead to investigations into improved treatment.
The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and small bowel and colonic transit in female patients with functional constipation as compared to placebo.
The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.
The protocol described herein is designed to provide clinical evidence of the substantial equivalence of SmartPill GI Monitoring System (SP) to the Sitzmarks (Konsyl Pharmaceuticals, Easton, MD) radio-opaque markers (ROM). The trial will enroll symptomatic subjects who meet Rome III criteria (1) for chronic functional constipation.
Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.
This research study was being done to study the effect of codeine and Naloxegol for 3 days compared to placebo on the movement of food through the colon of healthy individuals. Codeine is a commonly used pain-relieving drug that often causes constipation as an unwanted side effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation induced by Codeine. The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and colonic transit induced by codeine in healthy participants.
Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there is potential for off label use in chronic pain. Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in pain relief. While its action reflects aspects of tramadol and morphine, its ability to control pain is more on the order of hydrocodone and oxycodone. Its dual mode of action provides analgesia at similar levels of more potent narcotic analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect profile. Clinical studies showed that tapentadol effectively relieves moderate to severe pain in various pain care settings. In addition, it was reported to be associated with significantly fewer treatment discontinuations due to a significantly lower incidence of gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The combination of these reduced treatment discontinuation rates and tapentadol efficacy for the relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in pain therapy by increasing patient compliance with their treatment regimen.
The purpose of this study is to determine if lubiprostone may change the rate of movement of food and activities in the stomach and intestines in subjects whose gastrointestinal (GI) tract is slower due to constipation. To be able to measure the time difference in the duration of transit of the FDA approved SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to lubiprostone. The investigators anticipate to capture the possibility to reduce/eliminate the small intestinal bacterial overgrowth in chronically constipated patients after administration of study drug- lubiprostone.
Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a contributing factor. Changes in motor patterns in the small bowel in IBS patients are quantitative rather than qualitative with no distinct patterns to distinguish patients from healthy individuals. Changes in motor patterns can affect transit of bowel contents. Indeed, variation in intestinal transit was reported in patients with IBS. Lubiprostone is a novel agent that is Food and Drug Administration (FDA) approved for the treatment of chronic constipation. More recently 2 randomized double-blind, placebo-controlled trials showed the drug to be effective in relieving symptoms in patients with constipation-predominant Irritable Bowel Syndrome (C-IBS), resulting in approval for female patients with C-IBS at a dose of 8 micrograms twice a day. The investigators hypothesize that lubiprostone works not just as a laxative, but by actually altering motility patterns in the small intestine of female patients with C-IBS. These alterations can be measured through High Resolution Manometry (HRM), a new technique that uses catheters with multiple closely spaced sensors and special software that uses color schemes to portray a pressure gradient. This technique allows a detailed assessment of the direction and spread of contractions. The investigators would like to use HRM to see if lubiprostone affects intestinal contractions by giving blinded participants lubiprostone and placebo while they are undergoing High Resolution Manometry and seeing if any changes in contractions occur. Participants will be recruited from investigator's clinic. If interested, potential subjects will be provided with a copy of the consent form for review. Patients will be informed that after they have had an opportunity to review the consent form, they may contact the study team to further discuss the research and address any questions/concerns they have. Participants will undergo a screening visit and a manometry visit. During the screening visit investigators will determine eligibility, including application of inclusion/exclusion criteria and administration of a pregnancy test. Then during the manometry visit patients will receive two capsules, lubiprostone and placebo, three hours apart during HRM. Patients will receive each capsule only once and will not know which order they're receiving them in.
Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.
The primary purpose of this exploratory study is to measure orocecal transit time using the SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath test. Additionally, the ability of the SmartPill GI Monitoring System to discriminate between healthy human subjects and patients with small bowel bacterial overgrowth will be explored using analyses of both pH and pressure patterns within the stomach and small intestine. The study will be performed in both normal subjects and patients with and without small bowel bacterial overgrowth.
Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not responded to previous therapy
RATIONALE: Palliative care may help patients with advanced cancer live more comfortably. PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.
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.
Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.