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NCT ID: NCT03865901 Withdrawn - Clinical trials for Gestational Diabetes

Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening

Start date: May 2019
Phase:
Study type: Observational

Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)

NCT ID: NCT03865615 Withdrawn - Clinical trials for Alcohol Use Disorder

Oxytocin on Approach Bias and Craving

Start date: November 1, 2023
Phase: Phase 2
Study type: Interventional

This will be a laboratory-based investigation of the behavioral and neural effects of intranasal oxytocin on craving for alcohol and approach bias in moderate to heavy alcohol using subjects. This study uses a within-subject, randomized, placebo-controlled, counterbalanced, crossover design to compare the effects oxytocin and placebo. In this way, all subjects will be scanned twice; once following oxytocin administration and once following placebo administration, and will complete a series of behavioral tasks (both in and out of the scanner) at both visits.

NCT ID: NCT03865563 Withdrawn - Clinical trials for Pancreatic Adenocarcinoma

Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

Start date: July 2019
Phase: Phase 1
Study type: Interventional

Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.

NCT ID: NCT03864367 Withdrawn - Clinical trials for Distal Femur Fracture

Mobile Weight-Support Therapy (MWeST) for Mobility After Geriatric Fracture

MWeST
Start date: January 28, 2019
Phase:
Study type: Observational

This is a two-year study proposal to assess feasibility of MWeST (Mobile Weight-Support Therapy) implementation after geriatric fracture and its effects on functional and patient-reported outcomes. The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.

NCT ID: NCT03862079 Withdrawn - Clinical trials for Graft-versus-host Disease Prevention

Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics

Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination works in preventing graft versus host disease in patients exposed to broad-spectrum antibiotics. Fecal microbiota transplantation is the administration by enema of fecal matter (stool) that includes helpful bacteria from a normal, healthy donor. Total gut decontamination uses antibiotics to remove/reduce the amount of bacteria in the digestive system. It is not yet known if a fecal microbiota transplant with or without total gut decontamination works better in preventing graft versus host disease compared to standard immunosuppressive therapies (therapies that lower the normal function of the immune system).

NCT ID: NCT03862053 Withdrawn - Clinical trials for Allergic Conjunctivitis

Manuka Eye Droops for Treatment of Allergy

Start date: January 1, 2020
Phase: Phase 4
Study type: Interventional

Manuka honey eye drops are used for dry eyes and blepharitis. Manuka honey has been proven to be useful for eczema, atopic dermatitis, wound healing, anti-bacterial, anti-parasitic and anti-inflammatory actions.

NCT ID: NCT03859570 Withdrawn - Lupus Nephritis Clinical Trials

Pentoxifylline in Lupus Nephritis

Pentoxifylline
Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

Glomerulonephritis is an important manifestation in about 1/2 of patients with Systemic Lupus Nephritis (SLE; lupus). Despite recent national guidelines recommending use of induction therapy with high-dose corticosteroids and immunosuppressive agents, followed by prolonged maintenance therapy, up to 1/3 of these patients continue to have active nephritis and ongoing protein in the urine (proteinuria). It has long been recognized that both the level and chronicity of proteinuria in patients with lupus nephritis are associated with disease severity and with long-term prognosis, including the possibility of progression to complete kidney failure, which may occur in about 1/4 of patients. Pentoxifylline (PTX) is an oral medication introduced 45 years ago for treatment of vascular insufficiency. It has also recently been found to reduce proteinuria in patients with diabetic nephropathy. The mechanism of this unexpected and intriguing finding is not certain, but may in part involve inhibiting the production of TNF-alpha, an inflammatory cytokine known to be present in urine and kidneys of patients with lupus nephritis. Our hypothesis is that this inexpensive, generic drug, PTX, can significantly reduce proteinuria in patients with lupus nephritis. To test this hypothesis, we plan to initiate a 6-month, double-blind, placebo-controlled randomized clinical trial of PTX or placebo in 40 patients with active lupus nephritis. This trial will include 6-8 patients from each of 5 different academic medical centers that specialize in the treatment of lupus nephritis. Our primary objective of this trial will be to measure urine protein each month to determine the extent to which PTX is able to reduce urine protein, and how rapidly this occurs. Concurrently, we will carefully follow these patients each month to determine whether PTX administration is also associated with stabilization of renal function, or with improvement in other manifestations of lupus, such as clinical disease activity or abnormal laboratory findings. A major secondary objective will be to explore the possible mechanism(s) whereby PTX reduces proteinuria. For this purpose, we will use the monthly urine specimens to measure TNF-alpha, and levels of several other proteins (IL-1, IL-6, IL-2, MCP-1, TGF-beta, PDGF, and IFN-alpha) that have been shown to contribute to inflammation and scarring in lupus nephritis. Comparison of levels of these inflammatory proteins with level of protein in the urine should help us to determine whether one or more of these proteins is a contributor to the severity or persistence of lupus nephritis. This information may also allow us to learn whether repeated measurements of these proteins can serve as biomarkers to assist in the ongoing management of patients with lupus nephritis. Finally, we hope to eventually measure levels of these inflammatory proteins in blood samples from the patients, to determine if PTX treatment can suppress (or enhance) such levels, and whether these changes are associated with reduced lupus disease activity, or improvement in other manifestations of lupus. Ultimately, it is our hope that the data from this clinical trial using a generic repurposed drug will permit us to conclusively confirm that PTX can significantly reduce proteinuria in patients with lupus nephritis, which would be of great benefit for the thousands of people who suffer with this most severe type of lupus.

NCT ID: NCT03859232 Withdrawn - Clinical trials for Developmental Dysplasia of the Hip

Effectiveness of Cotton vs. Waterproof Cast Padding

Start date: March 29, 2018
Phase: N/A
Study type: Interventional

This study aims to: 1) investigate the effectiveness of waterproof spica cast using Delta-Dry® Pantaloon and cast padding (BSN medical, USA) versus standard gortex pantaloon with cotton cast padding in maintaining the femur fracture and developmental dysplasia of the hip reduction after application of hip spica; 2) evaluate the overall quality ratings of both cast paddings from the perspectives of the patient and the clinicians; and 3) determine the cost difference between the both cast paddings.

NCT ID: NCT03859011 Withdrawn - Clinical trials for Neck Pain, Posterior

Acupuncture Relief for Chronic Neck Pain

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This study will measure the effectiveness of "usual care" for chronic neck pain as defined in the protocol, compared with usual care plus acupuncture for chronic neck pain. This study's hypothesis is that combining acupuncture with usual care will show a clinically relevant increase in the effectiveness of the integrated therapies, compared with usual care alone. This study will also measure the cost-effectiveness of acupuncture for chronic neck pain. the hypothesis is that in economic evaluation terms, integrating acupuncture with usual care will not create significant overall costs, relative to the benefits which study patients obtain.

NCT ID: NCT03857139 Withdrawn - Smoking Cessation Clinical Trials

Opioids and Smoking Cessation

Start date: December 2020
Phase: Phase 4
Study type: Interventional

The selection hypothesis of smoking prevalence posits that smokers who are not able to quit successfully are "burdened" by specific characteristics that make it more challenging to quit1. For example, those less successful in quitting smoking may be more nicotine dependent or more likely to suffer from substance use, psychiatric, or medical conditions. In line with this perspective, smoking prevalence has stabilized in the US, presumably because the remaining population has become increasingly representative of those "at-risk smokers" who are unable to quit2. Emerging evidence suggests that persons who suffer from opioid misuse, defined as opioid use without a prescription, at a dose or frequency higher than prescribed, or for a non-medical purpose (e.g., getting high),3 may constitute such a high-risk group. Opioid misuse affects greater than 16% adults who use opioids4 and up to 29% of those with chronic pain.5 The prevalence of tobacco smoking in this group may exceed twice that observed in the general population, and smokers misusing opioids are almost twice as likely to be dependent on nicotine6,7. Yet, the role of opioid misuse in periods of early abstinence and smoking cessation has yet to be explored. The main objective of the present proposal is to fill existing gaps in knowledge by examining the extent to which opioid misuse is associated with decreased success during early smoking abstinence and over the course of an attempt to quit smoking, and to identify mediators and moderators of opioid-smoking relations in this context. This contribution is clinically-significant from a public health standpoint because it will directly guide the development of novel psychosocial/behavioral smoking cessation interventions to help this high-risk population of smokers quit by targeting unique vulnerability processes that result in poor cessation outcomes.