Clinical Trials Logo

Filter by:
NCT ID: NCT04614610 Not yet recruiting - Sickle Cell Disease Clinical Trials

Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis

RELIEF-SCC
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

Sickle cell crisis continues to be a frequent presentation to emergency departments. Patients presenting will often require immediate treatment for their pain and often times this will include opioids. The opioid epidemic has cost thousands of lives; and continues to be a significant problem posing several challenges when treating patients presenting with sickle cell disease. Primarily, opioids remain the mainstay of treatment for these patients and the push to address the opioid crisis may present challenges for adequate opioid administration in patients suffering from a sickle cell crisis while hospitals find ways to curb the opioid crisis overall. Opioid treatment for patients in acute vaso-occlusive crisis has significantly contributed to quality of life and life expectancy of patients with this diagnosis. Measures should continue to attempt to administer a multi-model approach to sickle cell patients to minimize the morphine milligram equivalents in these patients while also successfully addressing the patient's pain. IV lidocaine is a pain medication that has been evaluated in several painful experiences, such as in renal colic. A few case reports have shown IV lidocaine use in sickle cell can be a potential effective adjunct medication to opioids to treat pain and reduce further opioid requirements. Currently, no prospective controlled trial exists to evaluate the true benefit of IV lidocaine in this population. Our study aims to evaluate IV lidocaine as an adjunct to opioid treatment in the emergency department to determine if improved pain is achieved and if there is a reduction in overall morphine milligram equivalents throughout the emergency department visit.

NCT ID: NCT04611659 Not yet recruiting - Contraception Clinical Trials

Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine

NAS-MIET
Start date: November 2020
Phase: N/A
Study type: Interventional

The primary objective of this study is to test the efficacy of a Motivational Interviewing and Educational Training intervention with immediate linkage to long acting reversible contraception (LARC) (hereafter known as MIET). MIET will be delivered to women of childbearing age (18-44) through the Meharry Addiction Clinic to women residing in Nashville, Tennessee. There are two aims associated with this study. The primary aim is to determine the efficacy of MIET, to promote insertion of LARC among young, urban dwelling, low income women living with OUD and at-risk of unplanned pregnancy. The primary endpoint of this aim are: 1) meeting with a provider regarding initial assessment for LARC, 2) having a LARC implant. Because of potential contraindication for LARC insertion (i.e. obesity) the first endpoint of meeting with a LARC provider is most proximal to aim 1. However, determining the number of willing women that go on to receive the implant is also critical in that it reflects potential decreases in cost to the health care system through reduction of unintended pregnancy and related subsequent NAS in the newborn. The second aim for the study is to utilize qualitative and quantitative data collected for the study to modify the MIET intervention to more effectively meet the needs of the women in the study. Survey data for the study will be collected at baseline, one and six months. Of note, the baseline, one and six month survey data collections will provide potential co-variates to consider in analysis of aim one and two. The primary endpoints however will come from the six month records review. We will gain consent to access records at the baseline consent, and will gather these data from the Meharry Electronic Health Record.

NCT ID: NCT04606342 Not yet recruiting - Breast Cancer Clinical Trials

ATI-450 in Combination With Paclitaxel or Capecitabine in Patients With Hormone Receptor-positive and HER2 Negative Metastatic Breast Cancer With Bone Metastasis

Start date: December 31, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a dose-escalating phase I using a rolling 6 design and randomized phase II study of ATI-450 in combination with chemotherapy testing the hypothesis that the combination of chemotherapy (paclitaxel or capecitabine) and ATI-450 will improve progression-free survival and reduce bone turnover, improve patient bone density, improve patient quality of life, and improve clinical efficacy.

NCT ID: NCT04601337 Not yet recruiting - Clinical trials for Infrared Neural Stimulation (INS)

Clinical Safety and Efficacy of Infrared Neural Stimulation During Nerve Transfers

Start date: June 1, 2024
Phase:
Study type: Observational

Many surgical procedures such as brachial plexus reconstruction, nerve repair, and dorsal root rhizotomies rely on the spatial selectivity of their neural stimulation methods to identify specific nerve fascicles or rootlets. Due to the variable distribution of nerves between patients, many times it is not enough to rely on the historical topography of nerves to determine their location and identity.Currently, electrical stimulation (ES) methods are used to stimulate nerves in order to locate and map them intraoperatively. ES, however, is subject to current spread in which the electrical stimulus extends beyond the area proximal to the electrode into the surrounding tissue. This can result in the stimulation of multiple fascicles introducing ambiguity as to the location and/or identity of a specific nerve or fascicle. Our group has shown that infrared neural stimulation (INS), a novel optical and label-free means of exciting neural tissue, is capable of safely stimulating nerves with a higher degree of spatial specificity than traditional ES methods. Our clinical studies have even shown that INS can outperform ES, achieving isolated rootlet responses. The investigators hypothesize that the spatial selectivity of INS can be further utilized in upper extremity surgeries such as brachial plexus reconstruction and nerve transfers to improve intraoperative nerve identification and localization. While the initial clinical work was performed with a costly clinical laser system, our group has demonstrated the efficacy of cost-effective laser diode systems for INS in animal models in vivo.The safety of these lasers, however, has yet to be proven histologically in human patients. The objective of this proposal is two-fold: to demonstrate the efficacy of INS for spatially selective nerve stimulation in the upper extremity and to determine the histological safety of INS using diode laser systems in human patients. To do so, the investigators will recruit patients undergoing brachial plexus reconstruction (BPR) and nerve transfer surgeries wherein both the effectiveness and spatial selectivity of INS can be demonstrated and histological samples can be obtained without detriment to the patients' quality of care or recovery. To accomplish these objectives, the investigators propose the following aims: Aim 1: Design and fabricate a clinical fiberoptic probe for a diode-based INS system Aim 2: Demonstrate the efficacy of INS in nerve transfer cases Aim 3: Determine the histological safety of the diode-based INS system

NCT ID: NCT04601233 Not yet recruiting - Multiple Sclerosis Clinical Trials

Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Start date: June 2024
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine the effects of testosterone treatment on erectile function, fatigue, depression, cognitive function, quality of life, urinary incontinence, pain, and damage to neurons in male Multiple Sclerosis patients with low testosterone, using questionnaires, blood samples and a rectal exam in volunteers 55 years and older.

NCT ID: NCT04599010 Not yet recruiting - Body Composition Clinical Trials

Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

Start date: July 15, 2024
Phase: N/A
Study type: Interventional

Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.

NCT ID: NCT04595981 Not yet recruiting - Clinical trials for Squamous Cell Carcinoma

Chemo-embolization for Head and Neck Cancer

Start date: May 2025
Phase: Phase 2
Study type: Interventional

The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.

NCT ID: NCT04594616 Not yet recruiting - Clinical trials for Major Depressive Disorder

Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).

NCT ID: NCT04592601 Not yet recruiting - Metabolic Syndrome Clinical Trials

The S.L.I.M.M.S. Procedure for Severe Clinical Obesity

SLIMMS
Start date: October 26, 2020
Phase: N/A
Study type: Interventional

Assessment of Gastric Bypass combined with Vertical Sleeve Gastrectomy as primary treatment for patients with severe clinical obesity. Average percentage of total weight loss and percentage excess weight loss will be computed at 6 months, one year and then annually. Comorbid conditions, quality of life measures, appetite and satiety measures and adverse events will be tracked.

NCT ID: NCT04585711 Not yet recruiting - Obesity Clinical Trials

Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis

PRECISE
Start date: July 1, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn more about how adult and children's bodies use etanercept and how bodyweight influences how well etanercept works. This study will help us understand the proper dose of etanercept in obese children and adults.