860 Clinical Trials for Various Conditions
The availability of biological samples from individuals with alcoholic liver disease (ALD), as well as samples from appropriate heavy drinking, yet healthy controls and non-drinking healthy controls, is an essential first step in the translation of basic research advances to the clinic. The purpose of the Clinical Core component of the P50 Northern Ohio Alcohol Center (NOAC) is to provide biological samples (plasma/serum, buffy coats, and urine) from patients with different stages of alcoholic liver disease, as well as healthy control subjects, to members of the NOAC. These samples can then be used to test specific hypotheses related to the presence of specific biomarkers in the serum, functional immune activity in PBMCs and/or genetic polymorphisms that may predict severity of disease, short- and long-term morbidity and mortality and/or responsivity to specific therapeutic interventions commonly used in clinical practice. This study is building on the established biorepositories and the diversity of outstanding clinical expertise at the Cleveland Clinic. This biorepository included clinical samples (plasma, serum, buffy coats, and urine) from patients with different stages of ALD and subjects who are heavy drinkers without ALD, recruited from the Cleveland Clinic alcohol use disorder treatment clinic. This study will be responsible for collecting more data to help build the CCF-ALD biorepository via subject recruitment and communication and specimen collection.
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.
The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. The investigators will be measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse events and fracture union. The investigators hypothesize that this multimodal regimen will lead to improved pain, less narcotic use and improved satisfaction as compared to the standard regimen.
The purpose of this study is to find if direct peritoneal resuscitation helps blood flow through important organs in a person's body after they have had a traumatic injury with massive blood loss. Sometimes after severe injuries requiring operation, surgeons cannot close the muscles and skin of a patient's belly, because of swelling. This study will also try to find if direct peritoneal resuscitation decreases tissue swelling and allows for quicker closure of of a patient's belly.
The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on: * the number and intensity of adhesions, * whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure, * rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and * whether there is any difference between treatment groups regarding patient functional recovery.
This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib. Both retrospective and prospective data will be utilized. No sampling methods apply.
Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity of disease and survival.
This project includes testing circadian reset technology (CRT) on frequency of binge eating in a sample of 40 individuals with binge eating disorder. Participants will be randomized to one of two groups. Both groups use a VR headset for 10 minutes (5 upon waking, 5 before sleep) daily for 1 month. One group will use the CRT software on the headset and the other group will use a software intended to be a control. Measures will be taken at baseline and 1-month. The researchers anticipate that use of CRT will improve sleep quality leading to increased appetitive control.
This is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.
Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of back pain. A total of 150 patients age 18-65 presenting to the emergency department with chief complaint of backpain will be enrolled from April 2024 - April 2025. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.
This phase I/II trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back after a period of improvement (recurrent). Fluorescence image guided surgery uses a drug named aminolevulinic acid hydrochloride. Aminolevulinic acid hydrochloride is a photosensitizing agent, meaning that is activated by light and, is converted to another drug in cancer cells more than in normal cells. The converted drug emits fluorescence red light when activated with low power blue light. It is used to assist the surgeon to see cancer cells and small cancerous tissue that may have been missed during routine surgery. In addition to emitting fluorescence light, the converted drug in the cancer cells and tissue can be activated with red laser light to kill cancer cells. This procedure is called photodynamic therapy (PDT). Performing fluorescence image guided surgery followed by intraoperative photodynamic therapy after the surgical removal of the colorectal tumor before the surgical site will be closed may be effective and improve outcomes in patients with locally advanced or recurrent colorectal cancer.
This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting. The type 1 and type 2 diabetic subjects in this study will have their glucose controlled to a range of 100-140 mg/dL by a novel artificial intelligence based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals during the 24 hour study period.
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.
This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting. The type 2 diabetic subjects in this study will have their glucose controlled to a range of 100-140 mg/dL by a novel artificial intelligence based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals during the 24 hour study period.
Blunt chest trauma is the second most common form of unintentional trauma in the US and is associated with significant morbidity and mortality. Thoracic injuries are the third most common cause of death in trauma patients. Rib fractures have an increased associated risk of pneumonia, prolonged hospitalization, and cost. The associated severe pain leads to poor pulmonary mechanics, which contributes to additional complications. Treatment for rib fractures is focused on optimizing analgesia and intense pulmonary hygiene. Most common strategies utilize early mobilization, incentive spirometry (IS), and multimodal pain regimens. A variety of techniques for analgesia after blunt chest trauma exist. Epidural analgesia is one of the best-studied methods and can often provide significant pain relief. However, this method is invasive, has associated complications, and often can be contraindicated due to coagulopathy or other injuries. Most often a form of multimodal pain strategy is utilized which incorporates acetaminophen, Nonsteroidal anti-inflammatory drugs (NSAIDs), trans-dermal lidocaine, and muscle relaxants. Opioids remain an important adjunct to control severe pain, however, narcotics have their own associated complications. The aim of our study is to use an infusion of dexmedetomidine (Precedex) to aid in pain management in patients presenting with 3 or more rib fractures. The investigators hypothesize that dexmedetomidine will decrease patient pain and opioid use.
The utilization of patient reported outcome measures (PROMs) during in-person care allows for on-going assessment of the severity of mental illness and patient outcomes across treatment. Additionally, it provides immediate feedback on the patient's psychiatric status to both the patient and practitioner. Carilion Clinic - Psychiatry \& Behavioral Medicine ambulatory clinic implemented PROMs prior to the start of the COVID-19 (Coronavirus Disease 2019) pandemic and continues to utilize them as part of patient care. All new patients are asked to complete an initial PROM bundle of assessments 24 hours before their initial appointment, including the Brief Adjustment Scale, Patient Health Questionnaire, Generalized Anxiety Disorder survey, US Alcohol Use Disorder Identification Test, and Drug Assessment Screening Test. Automatic monthly reminders to complete the assessments continue after the first visit with the clinician. Over the last 2 years, research members of Carilion Clinic Psychiatry and Virginia Tech Psychology have been actively using PROM data to assess psychiatric health outcomes before and after the outbreak of COVID-19 in the United States. Initial results indicate that patients who received care via telepsychiatry not only did not experience worsening symptoms, but showed improvements in depression, anxiety and psychological functioning. However, without a control group of untreated patients to compare, the impact of telepsychiatry plus PROMs remains unclear. A waitlist control group design would allow investigators to compare patients receiving telepsychiatry and repeated completion of PROMs (current practice) to patients referred to psychiatry, but not receiving telepsychiatry treatment or completing PROMs during the same period. In this study, investigators plan to randomize individuals on the waitlist to one of two groups to assess the influence of time alone awaiting initial psychiatric clinician assessment (no intervention) versus minimal intervention using repeated PROMs and microlearning patient education videos while awaiting initial psychiatric clinician assessment. This kind of design allows assessment for the influence of time and the type of health service contact that replicates the basics of measurement-based psychiatric services (measurement of symptomology and well-being), but with none of the benefits of psychiatric supports, interventions, and techniques.
Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting
To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score.
The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.
Acute pancreatitis (AP) represents a critical health concern nationwide, with estimated 274,000 admissions annually and at a cost of 2.6 billion dollars. Current treatment strategies for AP are limited to supportive care with fluid resuscitation, analgesia, nutrition and prevention of end organ damage. Abdominal pain is often the predominant symptom in patients with AP and is treated with analgesics. As there is currently no disease-specific medical treatment to change the natural history of pancreatitis, pain control remains central to the treatment of AP. Among the analgesics, opioids have been shown to be provide safe and effective pain control in patients with AP. Current literature shows that there is no difference in the risk of pancreatitis complications or clinically serious adverse events between opioids and other analgesia options. Among hospitalized AP patients, adequate pain control often requires the use of intravenous (IV) opiates in the first 24-48 hours, which can later be transitioned to oral (PO) opioids. While there are various methods of delivering opioid medications such as IV, PO, and transdermal to name a few, IV opioids are commonly administered, either on a scheduled and/or on an as needed (PRN) basis as directed by the attending physician. In contrast to the conventional, method of physician directed IV opioid delivery, patient-controlled analgesia (PCA) is a form of IV opioid medication delivery in which the patient can rapidly titrate the opioid dose to manage variable levels of pain. This modality of opioid administration is often preferred by patients and has been widely used in postsurgical and obstetric patients to effectively treat their pain. PCA allows for faster intervention on pain limiting time to treatment and peak pain levels and has also been shown to decrease total opioid dose. However, there is limited evidence in published literature assessing the feasibility of using PCA to treat the pain of AP or comparing its efficacy and safety profile compared to the more traditional physician directed analgesia. One retrospective study has shown that use of PCA was surprisingly associated with longer hospital stays and higher rates of outpatient opioid use when compared to routine physician-directed analgesia (PDA), however there are no prospective trials to study this comparison. Hence, in this study, the investigators will compare the effects of using PCA among patients with AP to that of conventional PDA.
The purpose of this research is to determine the effects of penile ring block for local anesthesia with liposomal bupivacaine vs ropivacaine mixture in subjects undergoing surgery for Penile Prosthesis Placement.
The primary objective of this study is to assess the percentage of time patients were in normal glucose control.
A randomized, multicenter, open-labeled, parallel, three group pilot study to evaluate the impact of a diabetes-specific nutritional shake on glucose control.
This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement.
This study aims to determine the neural correlates of knee motor control in young females with patellofemoral pain (PFP). Each participant will attend a single study visit which may last up to 3 hours.
This was a proof-of-concept study to evaluate the efficacy of LOU064 in patients with inadequately controlled asthma. All subjects were randomized with 3:2 ratio to receive LOU064 100 mg once daily or LOU064 matching placebo for 12 weeks with standard background therapy of budesonide 80 µg/formoterol 4.5 µg two inhalations twice a day (b.i.d).
The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.
Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. However, these patients are also particularly vulnerable to poor transitions of care for a variety of reasons, including the complexity of therapy, inadequate patient education, differences in patient and provider expectations, and insufficient resources. Disruption of insulin therapy following hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and medical costs. In a Society of Hospital Medicine Survey, only one fourth of hospitals were supported with written protocols to standardize medication, education, equipment, and follow-up instructions. However, discharge order sets have largely been limited to the inpatient setting and have not been utilized to guide insulin use at hospital discharge. This study will assess whether a nurse supported diabetes focused inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized patients with poorly controlled insulin-requiring diabetes.
Diabetes control is often assessed by tests of glucose levels over time, such as the glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney disease (CKD) there is limited data available on the utility of these tests. There are reasons to believe that the tests may be less accurate in this population. Continuous glucose monitoring (CGM) offers an effective method for understanding the totality of glucose exposure and incidence of both hyperglycemic and hypoglycemic excursions.
This clinical trial will identify exercise-related and emotional stress related effects on glycemic control in patients with type 1 diabetes using sensor-augmented pump (SAP) therapy.