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NCT02382406
This is a phase I/II study for previously untreated subjects with advanced NSCLC. The study will take place in two phases. First, a cohort of twelve participants will be enrolled in phase I part and will be treated with carboplatin, nab-paclitaxel and pembrolizumab. A cohort of twelve subjects will be evaluated for safety and tolerability after 2 cycles of therapy. All subjects who receive either nab-paclitaxel or pembrolizumab will be evaluable. If 33% of subjects or less have unacceptable toxicity in the first cohort or any subsequent cohort (if necessary), the study will proceed to the Phase II part. If more than 33% have unacceptable toxicity, 12 additional subjects will be enrolled in a second cohort, if necessary. If unacceptable toxicity is seen in more than 33% in Cohort 2, the study will end due to unacceptable toxicity of this drug combination. The phase II part of the study is a single arm study. All subjects will be treated with carboplatin, nab-paclitaxel, and pembrolizumab in 21-day cycles for up to 4 cycles. Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all subjects (only if adequate archived samples are unavailable). Mandatory tumor biopsies will be obtained in the Phase II part of the study after 4 cycles of study treatment or at the time of progression, whichever comes first. For subjects without progression of disease after Cycle 4, pembrolizumab will continue every 3 weeks for up to 2 years or until unacceptable toxicity.
NCT00602459
This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic leukemia.
NCT03115567
This randomized, controlled, phase II clinical study is designed to assess the efficacy of preemptive treatment with topical steroids in preventing the papulopustular eruption induced by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients. Participants will be followed up for 6 weeks of twice daily application of triamcinolone cream to the face, chest, and back.
NCT04357041
The aim of this research is to collect dietary intake, physical activity, mood and stress data during and after the Illinois shelter-in-place and social distancing orders for the COVID-19 pandemic. The study's intent is to capture data during this unprecedented time to understand the non-infection consequences of social distancing and shelter-in-place, including duration of affect after orders are lifted.
NCT02600507
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
NCT02053831
In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.
NCT02203773
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of venetoclax (ABT-199) in combination with posaconazole.
NCT04151251
While many interventions have targeted hospital staff to improve sleep, few have been successful, and often suffer from limited adherence to staff protocols. Given preliminary data that suggests that empowered patients are more likely to obtain better sleep and have objectively lower noise levels in their rooms, it is plausible that partnering directly with patients can mitigate sleep loss and improve health outcomes. Patients will be randomized to receive the I-SLEEP education and empowerment program and test the effectiveness of this program on patient sleep and health outcome in the hospital and post-discharge. The aim of the project is to reduce environmental, healthcare-related, and patient-related factors that disrupt sleep of hospitalized patients by use of patient education and empowerment intervention.
NCT03764878
The objective of this study is to evaluate functional MRI as a tool to study placental transfer of oxygen and nutrients during the third trimester of pregnancy in obese women, women with pregestational diabetes and healthy low risk women without these conditions (controls). The investigators hypothesize that altered placental function, including diminished placental oxygenation and enhanced placental transport of lipids and metabolites will be seen in obese and pregestational diabetics as compared to controls.
NCT05580640
For patients with a history of knee surgery, especially knee arthroplasty, the persistence of abnormal gait kinematics is a frequently encountered issue that can hinder their ability to return to normal daily living. Muscular imbalances and leg length discrepancy (LLD) following knee arthroplasty can impact a patient's ability to return to a normal gait pattern. In a study of 98 patients who underwent total knee arthroplasty, leg lengthening on the side of the operative knee was reported in 83% of patients as determined by comparing pre- and postoperative leg-length radiographs (Lang JE et al; J. Arthroplasty. 2012;27(3):341-346). LLD can lead to compensations in surrounding joints, muscles, and myofascial structures. Compensatory musculoskeletal changes, including changes in pelvic tilt and curvature of the lumbar spine can alter gait mechanics, lead to mechanical low back pain, and increase the risk of degenerative disc disease (Sheha EDM et al; J. Bone and Joint Surgery, Inc. 2018;6(8)(e6)). In addition, neurologic compensations can occur and include changes in muscular timing and muscular activation patterns. The mainstay of gait rehabilitation following knee surgery is physical therapy (PT) (O'Connor DP et al; J Orthop Sports Phys Ther. 2001;31(7):340-352), where LLD can be addressed with heel lift therapy. The use of Osteopathic Manipulative Treatment (OMT) to address chronic compensatory musculoskeletal changes following knee surgery in order to improve gait has not been extensively studied. Both OMT and PT have been shown to improve gait imbalances in a variety of neurological conditions such as Parkinson's disease, multiple sclerosis, and Prader-Willi syndrome. Previous studies of these neurologic conditions have demonstrated increases in walking velocity, step length, stride length and range of motion of the lower extremities following OMT. It remains to be determined whether OMT can improve gait pattern abnormalities caused by compensatory musculoskeletal patterns that persistent after traditional postoperative knee rehabilitation. The purpose of this study is to determine if OMT of chronic, compensatory, musculoskeletal issues associated with knee surgery improves gait parameters. In addition to providing objective parameters to assess and validate OMT, future patients recovering from knee surgery might benefit from OMT
NCT02908074
Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH)
NCT04909723
The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers. The second stage of this study is a prospective, randomized, single-blinded, placebo-controlled study of safety, tolerability, and early efficacy in patients with enteric hyperoxaluria.
NCT04706975
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.
NCT03428932
The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will use either the patient's own insulin routine (injections or insulin pumps) or a closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor (CGM) and an insulin pump to automatically give insulin and may improve control of blood sugars.
NCT03588039
This is an open-label, Phase 1 dose-escalation study followed by a 2-arm expansion cohort of Oraxol administered in combination with pembrolizumab.
NCT00130351
This study is designed to investigate the ability of patients with asthma to properly use a new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.
NCT01924455
Despite effective ART that can suppress both HIV and HBV, HBV-related liver disease remains a significant co-morbidity in this population. Little is known about the histologic spectrum of liver disease, the significance of complete vs. incomplete HBV suppression, the utility of novel virologic and serum markers of disease severity, and the long-term renal and bone effects of TDF-based therapy. This proposal will address these important questions and impact the science and health of those coinfected with HBV-HIV.
NCT04843319
To determine an effective dose of VERU-100 for the treatment of advanced prostate cancer by assessing its effect on testosterone levels by Day 28 and maintenance through Day 91.
NCT04568980
The long-term goal is to study the safety and effectiveness of hormonal contraception for women with cystic fibrosis (CF) and contribute to national guidelines that the Cystic Fibrosis Foundation and the Centers for Disease Control and Prevention (CDC) provide to clinicians. The study objectives are to determine whether hormonal contraceptive methods improve overall pulmonary health, worsen CF-related disease or CF liver disease, or are effective against unwanted pregnancy with concomitant CF transmembrane conductance regulator (CFTR) modulator use. The hypothesis is that hormonal contraceptive methods are safe and do not worsen CF-related complications over time,improve FEV-1 when compared to non-hormonal users, and oral birth control methods with CFTR modulator use.
NCT03028831
Alaska native people (AN) have the highest recorded incidence and death rate from colon cancer in the world (\>90:100,000). We hypothesize that the AN, despite their high consumption of anti-inflammatory and antineoplastic n-3 fish oils, are at increased risk of colon cancer because of colonic butyrate deficiency resulting from their remarkably low consumption of fiber-containing foods. We hypothesize that fiber supplementation of their usual diet will result in a bloom of butyrate producing microbes in the colon, resulting in increased butyrate production, which will suppress their high microbial secondary bile acid production, antagonize the actions of other food (smoked fish) and environmental carcinogens (tobacco, alcohol), and interact with the high circulating levels of n-3 fish oils to suppress colonic inflammation and cancer risk. In order to investigate this, we will conduct a randomized double-blinded 4-week clinical trial in up to 100 randomizable healthy, middle-aged AN undergoing screening colonoscopy, with the objective of obtaining 60 completed interventions. The interventions will consist of either a high-dose soluble fiber supplement given as a drink, together with their usual diet which currently contains about 15g total fiber/d, or to a control digestible starch drink plus their usual diet. The primary endpoint will be a clinically significant reduction in Ki67 proliferative colonic mucosal biomarkers of cancer risk. Microbiome and metabolome mechanisms responsible for the anticipated changes in mucosal biomarkers will also be investigated. Our results in extreme risk AN will be further evaluated by comparison to similar measurements previously made in minimal risk rural Africans and intermediate risk African Americans. Our results will be used to provide the scientific basis for a definitive large-scale high-fiber supplementation study (to achieve \>50g total fiber/d) to suppress adenomatous polyp recurrence following colonoscopy.