Hartford, CT Paid Clinical Trials

There is established evidence that patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Imipenem/cilastatin/relebactam is a novel broad spectrum intravenous beta-lactam/beta-lactamase inhibitor combination antibiotic with potent activity against multidrug resistant Gram-negative bacteria, including imipenem non-susceptible Pseudomonas aeruginosa. Relebactam has also been shown to restore imipenem activity in Burkholderia cepacia complex, a group of opportunistic multidrug resistant pathogens that commonly infect patients with CF. This study will determine the pharmacokinetics and tolerability of imipenem/cilastatin/relebactam in 16 adolescent and adult patients with CF acute pulmonary exacerbations at one of seven participating hospitals in the US, with exploratory aim of reporting relative percent increase in FEV1 from pre- to post-treatment and return to baseline FEV1 after treatment with imipenem/cilastatin/relebactam for acute pulmonary exacerbations due to P. aeruginosa in patients with CF. Patients will receive a 10-14 day course of imipenem/cilastatin/relebactam, dosed according to renal function every 6 hours over 30 mins, with or without adjunctive aminoglycoside or fluoroquinolone therapy per local hospital guidelines. Blood will be sampled during one dosing interval at steady-state (i.e. after at least 3 doses) to determine concentrations and pharmacokinetics of imipenem and relebactam. Relative change in pulmonary function will be assessed two weeks after end of therapy. Safety and tolerability will be assessed throughout the duration of the study. Read Less

There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study. Read Less

This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder. Read Less

Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. Using a 2X2 factorial design to maximize efficiency and reduce overall trial costs, the SAFETY trial will randomize 830 extremity soft-tissue sarcoma (STS) patients to determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs). Read Less

Alcohol is one of the most widely used intoxicants. The effects of driving while intoxicated are well documented, leading to the laws and regulations behind drunk driving. Marijuana is also a commonly abused drug, whose use is increasing with widespread legalization/decriminalization in many US states and use of medical marijuana. Marijuana use is linked to cognitive impairment and is likely be the cause of intoxication-induced accidents. The effects of marijuana intoxication on driving impairments are less documented than those of alcohol. However, most marijuana users also consume alcohol when smoking cannabis, and preliminary data strongly suggest that driving impairment from both drugs used together is synergistic rather than just additive. This study will aim to investigate the brain and behavior in the same individuals, using a similar design to the current Neuroscience of Marijuana Impaired Driving and the prior Alcohol and Driving Grant, that used similar techniques and measures to quantify drunk automobile driving. We hypothesize that alcohol and marijuana use combined will lead to greater impairment in a simulated driving task, as well as other driving-related cognitive impairments. In a randomized, counterbalanced, double-blind study, we will dose participants with alcohol to a legal level of 0.05% blood alcohol content, then we will administer a moderate inhaled dose of THC marijuana or placebo marijuana, using paced inhalation that employees a vaporizer. Participants will comprise 10 regular alcohol and marijuana consumers aged 21 to 40 years of age; all participants must report smoking marijuana and drinking alcohol together. Of the 10, 5 will be occasional marijuana smokers and 5 frequent marijuana smokers. Following this dosing, we will assess impairment through cognitive testing as well as a simulated driving test through fMRI and neuropsychological tests. Samples of breath, blood and oral fluid will also be collected at multiple time points throughout the study visits to be measured for alcohol and THC concentration and its metabolites. This allows clarification between the relationship of impairment, as well as subjective and objective intoxication, and levels of THC and its metabolites in the users system. Read Less

It is estimated that 48 out of 10,000 people, in the United States, will tear their anterior cruciate ligament (ACL) annually and undergo ACL reconstruction (ACLR). Surgeons have several graft options, surgical techniques, and fixation methods to consider when planning how to reconstruct a patient's ACL. Graft options vary greatly and include allografts and autografts with good evidence that are good choices. Further, autografts include several different specific grafts including; bone-patellar tendon-bone (BPTB), hamstring tendons, and quadriceps tendon. There is no clear consensus on which graft type is superior, as each graft has associated positives and negatives. Historically, autologous BPTB grafts have been the preferred choice of surgeons given its ability to restore rotational stability for the knee, the robust healing with direct bone-to-bone contact at both ends of the graft, and low failure rates. However, there are drawbacks to ACLR using a BPTB graft. Complications following BPTB graft harvesting include patella fractures, patellar tendon ruptures, increased risk of patellofemoral osteoarthritis, lack of terminal extension, and donor-site morbidity. The majority of these complications are associated with low-risk rates, except for donor-site morbidity which may be prevalent in 37-51% of BPTB graft patients. Donor-site pain can manifest as anterior knee, patellofemoral pain, loss of sensory input, or discomfort with kneeling and can negatively influence subjective as well as objective measures of knee function. Filling bony defects with bone graft is a procedure that is commonly conducted within orthopedics. However, its use in treating the bony defects caused during BPTB graft harvesting is less common as patella and tibial harvest sites are routinely left unfilled. Significant methodological differences in treatment interventions for the patella harvest site, the tibial harvest site, or both and conflicting results have made it difficult to determine if these treatments have clinical utility. To the best of the investigators' knowledge, there has been no investigation looking at the incidence of donor site morbidity treated with autologous bone grafting of the harvest sites. Therefore, the purpose of this study is to determine if filling the harvest site defect is associated with a lower rate of donor site morbidity and better patient reported functional outcomes compared to patients whose harvest site remains unfilled. The purpose of this study is to compare the rate of donor site morbidity between patients who have their harvest sites bone grafted with autologous bone (BG) and those whose harvest sites remain unfilled (nBG). Read Less

This study is designed to evaluate clinical outcomes and spine fusion rates for patients undergoing transforaminal lumbar interbody fusion using the CONDUIT 3D printed titanium TLIF cage. Read Less

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL. Read Less

This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a CGX1321 Single Agent Dose Escalation Phase in solid tumors, CGX1321 Single Agent Dose Expansion Phase in GI tumors and Roll-over Cohort of CGX1321 and pembrolizumab in subjects who have progressed on single agent CGX1321 and Phase 1b consisting of CGX1321 in combination with pembrolizumab in colorectal tumors and CGX1321 in combination with encorafenib + cetuximab in BRAFV600E mutated colorectal tumors. Both phases are to evaluate safety, pharmacokinetics, and clinical activity. Read Less