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NCT00241722
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.
NCT02200133
This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare, improve health behaviors and reduce HCT-related emotional distress.
NCT01385787
This is a non-therapeutic study. Pediatric AML patients undergoing HCT with a myeloablative preparative regimen may be enrolled. Subjects can be enrolled 10-40 days prior to HCT. Three samples for MRD (measured by WT1 PCR and flow cytometry) will be collected from peripheral blood and bone marrow: 1) pre-HCT (\<3 weeks prior to starting the preparative regimen), 2) day 42 +/- 14 days post HCT (early post-engraftment), and 3) day 100 (+/-20 days) post HCT. For two years after transplant, the subject's follow-up data will be collected using the Research Level Forms in the CIBMTR Forms Net internet data entry system. The main objective is to determine whether there is any association between level of pre-transplant and post-transplant bone marrow MRD using WT1 and flow cytometry with 2-year event-free-survival, and to estimate the strength of that association in terms of the predictive accuracy of MRD. The investigators hypothesize that measurable MRD at either time point will be associated with decreased 2-year event-free survival.
NCT00071643
This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.
NCT01369940
Normal growth and development of twins are important for the long-term health of the children. The purpose of this study was to empirically define the trajectory of fetal growth in dichorionic twins using longitudinal two-dimensional ultrasonography and to compare the fetal growth trajectories for dichorionic twins with those based on a growth standard developed by our group for singletons. This knowledge may lead to interventions that could minimize or prevent pregnancy and newborn health problems in the future.
NCT01052480
This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.
NCT02236195
Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced urothelial carcinoma that has specific changes in tumor genes. Patients must have previously received treatment with chemotherapy that included a "platinum-containing agent" such as cisplatin. The study will enroll in stages, with 15 patients in the first stage. More patients will be added to the study if enough patients having beneficial responses are observed. Mocetinostat will be administered using oral capsules three times each week (eg, Monday, Wednesday and Friday). The study is designed to evaluate whether the number of patients responding to treatment is substantially higher than would be expected with other available treatments.
NCT00061438
This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems. It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful. This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication). Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis. It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis. Approximately 240 patients will take part in this study. Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.
NCT00511238
To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma. Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.
NCT00179478
The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development of further attacks (CDMS) and the development of neurological disability over a 10 year period of observation. The initial 5 year extension study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX) after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment (usually with AVONEX) either at the time of a second attack or at the end of the phase III study (24 months). The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability.
NCT01000493
This is a 12-week, randomized, multicenter, double-blind, placebo controlled, fixed-dose parallel group study to assess the efficacy and safety of orvepitant (60 mg/day) versus placebo in subjects with a diagnosis of noncombat-related Posttraumatic Stress Disorder (PTSD), whose symptoms are considered moderate or severe. Following an initial screening visit, subjects fulfilling the study inclusion and exclusion criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory and ECG assessments and to confirm eligibility for inclusion into the study. This screening phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the screening period, eligible subjects will be randomized at the baseline visit to receive either orvepitant 60mg/day or placebo (1:1 ratio). Those subjects randomized to receive placebo will receive study medication identical in appearance to that received by subjects assigned to receive orvepitant. Efficacy will be assessed using the Clinician Administered PTSD Scale (CAPS) as the primary efficacy measure. Key secondary efficacy endpoints will be based on the Davidson Trauma Scale (DTS), the Short PTSD Rating Interview (SPRINT), the Clinical Global Impression- Global Improvement and Severity of Illness Scales (CGI-I and CGI-S, respectively), the Hamilton Depression Rating Scale (HAM-D), the Cognitive and Physical Functioning Questionnaire (CPFQ) and the Pittsburgh Sleep Quality Index (PSQI). Safety will be assessed by monitoring for adverse events (side effects) and through periodic laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart rate, temperature) and heart function measurements (electrocardiograms, or ECGs).
NCT02546700
Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.
NCT01662492
To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
NCT02654418
SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare.
NCT00050401
The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
NCT00410605
This phase II trial is studying how well giving bevacizumab together with lenalidomide and dexamethasone works in treating patients with relapsed or refractory stage II or stage III multiple myeloma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Dexamethasone may stimulate the immune system in different ways and stop cancer cells from growing. Giving bevacizumab together with lenalidomide and dexamethasone may kill more cancer cells.
NCT01893346
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to \<18 years.
NCT01327976
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity. The Maestro Rechargeable System delivers intermittent, electrical blocking signals to the anterior and posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to reduce sensations of hunger and produce satiety leading to weight loss. After approval from the institutional review board, subjects provided written consent and were randomized in a 2 to 1 allocation to vBloc group (with laparoscopic placement of the leads and neuroregulator) or the sham group (placement of a custom sham neuroregulator only) on double-blinded basis. Both groups received similar diet and exercise counseling. Weight, adverse events, clinical laboratories, ECGs, eating questionnaires and quality of life data were evaluated throughout the 12 month study duration.
NCT01715987
Nucleotide anti-viral analogues, including adefovir and TDF, have demonstrated kidney toxicity in HIV/HBV co-infected patients and HBV mono-infected European patients. Investigators suspected similar kidney proximal tubular injury can also occur in HBV mono infected Asian patients receiving TDF treatment.
NCT00519480
This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.