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Discover 11,431 clinical trials near Miami, Florida. Find research studies in your area.
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NCT00219557
This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \[AG-013736\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.
NCT02217475
The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.
NCT02195570
The long-term goal of this research is to reduce tobacco-related disparities in maternal and infant health outcomes by improving smoking cessation and relapse prevention interventions for minority pregnant and postpartum women, who have been significantly underrepresented in smoking cessation research. This study will examine the feasibility and efficacy of a prize-based contingency management approach for increasing smoking cessation and preventing relapse among socioeconomically disadvantaged minority pregnant smokers. First, the intervention will be pretested with 10 pregnant low-income minority smokers and then refined based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60 highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a large teaching hospital, who report daily smoking and who meet other eligibility criteria will be enrolled and randomized to one of two study conditions: 1) Standard Psychoeducational Intervention (6-week, individually-administered, pregnancy-specific Quit Smoking Now curriculum, as currently implemented in the clinic; QSN Only); 2) Standard Psychoeducational Intervention plus Contingency Management (provision of incentives contingent on biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide and salivary cotinine levels will occur in both groups beginning on the first quit day and continuing through 3-months postpartum. Only participants in the QSN-CM group will be reinforced for biochemically-verified abstinence with chances to win prizes ranging in value from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study outcomes will be assessed through follow-up research exams (delivery and 6-months postpartum) and hospital chart reviews. The primary hypothesis is that that women randomized to the QSN-CM condition will have higher rates of abstinence during pregnancy and postpartum compared to women receiving standard of care alone. Results should advance scientific knowledge regarding effective methods for promoting and maintaining smoking abstinence among pregnant disadvantaged women and provide preliminary feasibility and efficacy data needed to support a larger randomized controlled trial.
NCT00130923
The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.
NCT01669421
The current treatment of individuals with alpha-1 antitrypsin deficiency (AATD) who develop lung disease (COPD) is the administration of intravenous purified alpha-1 antitrypsin (augmentation therapy) at a fixed dose of 60 mg/kg per week. This dose aims at increasing the deficient AAT serum levels just above a predetermined "safety threshold" of 11 uM. However, normal levels of AAT are between 25-50 uM. AAT has shown not only to inhibit lung proteases such as neutrophil elastase, but also to modulate inflammation. Given that many subjects with AATD who receive augmentation therapy still have significant lung disease and inflammation, this study will evaluate whether doubling the dose to 120 mg/kg/week has an effect in decreasing lung inflammation. Only the dosing of 60 mg/kg /week has received FDA approval. FDA has granted an IND number to this study to test the higher dose of 120 mg/kg/week. The study will evaluate systemic (serum) and pulmonary (bronchoscopy samples)markers of inflammation in 3 phases: standard dose (4 weeks), double dose (4 weeks) and standard dose (4 weeks).
NCT01984398
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
NCT03627754
This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.
NCT01856309
The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
NCT03222817
The proposed study will examine the implementation of a Human Papillomavirus (HPV) self-sampling intervention for unscreened and under-screened transgender men and transmasculine individuals living in South Florida. The study will enroll participants to receive this cervical cancer screening intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.
NCT01520545
Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump
NCT03090464
Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. The purpose of this study is to evaluate if the use of a digital disease management tool (Smart phone- web portal-based tool), in addition to Standard of Care for T2DM, will improve glycemic control. Other variables important in T2DM (such as weight, blood pressure, and lipid levels), will also be evaluated along with patient-reported outcomes, such as satisfaction with treatment and adherence to their antihyperglycemic treatment. Study duration is 6 months
NCT03051607
Phase 3, international, multicenter, open-label 12 month safety study.
NCT01926444
GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative to i.v. sedation during full colonoscopy. It will be evaluated for efficacy and safety in a multi-center, randomized, double-blind, placebo controlled, dose-ranging, proof of concept Phase 2a trial. Up to 240 patients will receive one of 3 doses of GIC-1001 or its matching placebo. A pharmacokinetic evaluation will be carried out on a subset of patients (N: 24).
NCT03288792
The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8 result will improve ROC area under the curve. The study is prospective, multi-center, sequential, control trial with the woman serving as her own control. Women determined to have heterogeneously or extremely dense breast based on her previous mammogram and are undergoing routine screening mammography at one of the clinical sites assigned for this study will be eligible to join the study.
NCT01161524
This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.
NCT01969851
SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in children with epilepsy syndromes associated with generalized seizures. LCM will be added to current antiepileptic treatment.
NCT02780167
Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.
NCT00784758
The purpose of this study is to investigate the effects of Fenzian™ treatment on symptoms (such as shortness of breath), lung function (how well the lungs work), and albuterol/salbutamol (rescue medication) use in people with asthma. This will be done by comparing the effects of Fenzian™ treatment to the effects of a sham treatment, which looks the same as the Fenzian™ device but doesn't do anything. The Fenzian™ device is an electrical instrument that the investigators hope will help reduce airway inflammation associated with asthma symptoms by stimulating the nerves with very low electrical currents. The study device will be applied directly to the skin on the back, working along the ribs toward the spine, alternating between left and right sides, and on your face.
NCT00858377
This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK of oral AMG 900 in subjects with advanced solid tumors. Up to 50 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 42 subjects in three taxane-resistant tumor types. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study
NCT01745120
This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in up to 18 participants (including at least 3 adolescents between 12 and 17 years of age, inclusive) with β-thalassemia major. The study will evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product \[autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human βA-T87Q-globin gene\].
