15 Clinical Trials for Various Conditions
1.0 Title: "The Efficiency and Effectiveness of Video-Based Education for Dermatology Patients Qualifying for Chronic Treatment with Systemic Corticosteroids" 2.0 Background: Past studies have shown that the use of educational videos has been effective in increasing patient education and satisfaction. These studies suggest that such video tools may enable an office to be significantly more efficient. 3.0 Objective: The Emory University Department of Dermatology has created an educational video as part of clinical care. The objective for Phase I of the study is to collect information about dermatology patients' baseline knowledge about corticosteroid and/or corticosteroid sparing medication treatment using an online (or written copy) questionnaire. The objective for Phase II of the study is to determine the effect of a video on dermatology patient knowledge. The objective for Phase III of the study is to determine the office efficiency of the video in patients requiring long-term oral corticosteroid and/or corticosteroid sparing medications. Secondary objectives of the study are to determine patient and physician satisfaction with the video as an educational tool. 4.0 Patient Selection: Phase I and Phase II: Patients who arrive to clinic during a participating physician's clinic day at the Emory Dermatology Department. Phase III: Patients who require treatment with long term oral corticosteroids at the Emory University Department of Dermatology Clinic as determined by their treatment physician. 5.0 Recruitment: All patients arriving to clinic on a study day will be given an informational opt-out sheet. All patients will be eligible to complete Phase I and Phase II: (steroid questionnaire only and steroid video or verbal education plus questionnaires). Only patients who require long term oral corticosteroid treatment will proceed to Phase III: of the study. Physicians will be recruited from the Emory Dermatology Department. 6.0 Assessment: Patients in Phase I will complete to the pre-education questionnaire online (or a written copy). Their results will be compared with baseline results from patients in Phase III: who undergo treatment with steroids. Patients in Phase II or III will be randomized to two groups. Control patients will receive verbal discussion of corticosteroid treatment. Phase II control patient education will be using a script developed by study physicians and delivered by study personnel. Phase III patients who qualify for long term systemic steroid will have verbal education by their doctor as usual. Video patients will receive an educational video instead, and will write down any remaining questions after viewing for their doctor to address as soon as possible. After verbal or video education, both groups will take a post-education questionnaire and patient satisfaction surveys online. Phase II is then complete. In Phase III, both groups will follow-up at least 1, 3, and 6 months after beginning treatment. At follow-up, their doctor will ask about current corticosteroid dose and frequency, willingness to transition to a steroid-sparing method, and compliance with preventative measures during treatment. Patients will complete the same post-education questionnaire online again at these visits. Physicians will also complete satisfaction surveys online at 1, 3, and 6 months from study start, and then every 6 months. 6.1 Sample size: The sample size for Phase I is unlimited until the last Phase II patient completes enrollment. Emory plans to recruit a total of 80 patients to participate in Phase II of this study (40 per group). 6.2 Participant time burden: Phase I only: 5-10 minutes Phase II and III: 30-35 minutes Physicians: 20 minutes
Background: Psoriasis causes chronic inflammation in the body. Researchers want to see if a kind of vitamin B3 dietary supplement can help. This might lead to more treatment options. Objective: To test if the dietary supplement nicotinamide riboside can improve immune system function in the blood and skin of people with mild to moderate psoriasis. Eligibility: People ages 18-80 with mild to moderate active psoriasis not currently treated with biological therapy Design: Participations will be screened with: * Medical and medication history * Physical exam * Measure of body mass index * Skin exam * Blood and urine tests Participants will have visit 1. They will have repeats of the screening tests. They may also have 2 skin biopsies, which are optional. These will be from both lesions and unaffected areas. The areas will be injected with a numbing medicine. A round cutting device will remove small pieces of skin from each area. Participants will take the study supplement or a placebo starting at the first visit. Neither participants nor the study team will know which they receive. Participants will take capsules twice daily for a total of 4 weeks. Participants will then have visit 2. This will include the tests performed at visit 1. Participants may by contacted by phone or email between visits to see how they are doing. If participants develop any side effects in the 7 days after they stop taking the capsules, they may have another visit.
This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis
Background: Chronic granulomatous disease (CGD) is a disease of the immune system, which is how the body fights germs. People with CGD get infections easily and have other health problems. Some medicines to treat CGD have a lot of side effects and do not always work. Researchers want to see if a new drug can help. Objective: To see if tofacitinib is safe to use for treating chronic CGD. Eligibility: Adults aged 18 and older with CGD who have not had success with other treatments and who are enrolled on NIH study # 93-I-0119. Design: Participants will be screened with the following: Physical exam Medical history Blood, urine, and stool tests Pregnancy test, if needed An upper gastrointestinal endoscopy and/or colonoscopy, if needed for their symptoms. Tissue samples will be collected. Skin assessment, if needed Participants will repeat some screening tests at visits. Participants will complete questionnaires about their general health and how CGD affects their daily life. Photographs will be taken of their skin, if needed. They will have lung function tests, if needed. They will have a computed tomography (CT) scan of the chest, abdomen, and pelvis, if needed. A CT scan uses X-rays to create pictures of the inside of the body. Participants will gradually reduce the amount of some CGD medicines they take. Then they will take tofacitinib as a pill twice a day or once a day for 3 months. They will keep a drug diary. They will have monthly study visits. They will have a follow-up visit about 1 month after their last study drug visit. Participation will last for about 6 months.
CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.
This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.
TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
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Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).