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NCT ID: NCT04172922 Recruiting - Vascular Anomaly Clinical Trials

Topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and Other Susceptible Lesions

NOVA
Start date: April 1, 2020
Phase: Phase 1
Study type: Interventional

Proposed Study: Treatment protocol for the use of the topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and other susceptible lesions 1. Aim The aim of this treatment study is to evaluate the benefit and tolerability of topical sirolimus applied to cutaneous vascular anomalies in pediatric patients. The primary end point will be individually determined based on improvement in lesional clinical characteristics over baseline 2. Rationale for topical sirolimus use in VA The rationale for the use of topical sirolimus is to minimize these potential side effects and risks. Data for the use of topical sirolimus for vascular anomalies at this time are anecdotal and case reports only. As such, this prospective protocol seeks to determine the effectiveness and tolerability of topical sirolimus on patients with vascular anomalies that have a cutaneous component. 3. Experimental design This is an open-labeled efficacy trial with the aim to determine if topical sirolimus can be safe and efficacious in treating the cutaneous component of complicated vascular anomalies. Patients who meet eligibility criteria with a diagnosis of vascular anomaly (VA) with cutaneous component will be offered treatment with the investigational topical sirolimus. Patients will receive topical sirolimus therapy for a total of six months and will be monitored regularly at the research site for clinical response. Response will be based on pre-determined clinical criteria. Patients will be removed from study if there is no response at three months after initiation of therapy. Clinical response will be defined as improvement in measurable parameters defined at the time of initiation of therapy. These include 1. Size of lesions, measured in two parallel longest diameters 2. Flattening of lesion 3. Number of vesicles 4. Episodes of superinfection or bleeding 5. Improvement in pain 4. Drug Information The topical sirolimus formulation will be made at a concentration of 1% sirolimus ointment. Bulk sirolimus powder will be compounded in a liposomal base in a GMP level pharmaceutical company. This base will enhance drug penetration into the skin. It ensures adequate adhesion to the application area and a low degree of systemic absorption. Due to limited absorption only mild side effects are expected.

NCT ID: NCT04173871 Recruiting - Children Clinical Trials

Effects of Systematic Proprioceptive-tactile Stimulation With Use of the Protac MyFit®

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Children with sensory impairment (SPD) are often unable to sit still and focus their attention. This can affect the children by limiting their opportunities for participation in school activities. Previous studies indicate a link between childhood SPD, childhood anxiety, and obsessive-compulsive disorder (OCD) in adulthood. Research and clinical experience suggest that systematic use of proprioceptive-tactile stimulant aids may have a positive effect for children with SPD. The aim of the project is to investigate and describe the effects of a systematic use of proprioceptive-tactile stimulating vest, MyFit®, for children 6-12 years with SPD in the form of sensory-seeking behaviour. Research questions: - Can systematic use of MyFit® for children with sensory seeking behaviour increase their participation in school activities? - Can systematic use of MyFit® support children with sensory seeking behaviour to increase their awareness, concentration and focus on tasks? - Can systematic use of MyFit® affect children's feelings of confidence and self-efficacy? The project seeks to answer these questions to contribute to knowledge on how children with sensory seeking behaviours can be supported for better participation in school activities. The study will be a randomized controlled trial of 240 children with SPD and sensory seeking behaviour.

NCT ID: NCT04209790 Recruiting - Surgery Clinical Trials

Neoadjuvant Chemoradiation for Resectable Glioblastoma

NeoGlio
Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes. This Phase II study design would be used to proceed with the study treatment after meeting pre-specified events in the initial phase, with goal being to determine whether the new treatment paradigm is sufficiently promising to warrant a major controlled clinical evaluation against the standard therapy.

NCT ID: NCT04231370 Recruiting - Clinical trials for NK/T Cell Lymphoma Nos

Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma

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

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.

NCT ID: NCT04233255 Recruiting - Ultrasound Clinical Trials

Role of Ultrasound in Diagnosis of Muscle Diseases

Start date: April 1, 2020
Phase:
Study type: Observational

The study aims to provide a timely update on the role of combining clinical and neuromuscular ultrasound assessments in diagnosis and follow-up of various muscle diseases in clinical practice over 12 months period, and correlating US findings with functional scales, biochemical and electrophysiological studies.

NCT ID: NCT04239248 Recruiting - Crohn Disease Clinical Trials

"Tasty&Healthy" Dietary Approach for Crohn's Disease

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Despite the advent of multiple novel medications, many patients with Crohn's disease (CD) fail to achieve mucosal healing (MH). Exclusive enteral nutrition (EEN) has been shown to induce clinical remission accompanied by MH in many of CD patients. The aim of this proposal is to explore the effectiveness of the "Tasty&Healthy" dietary approach based on avoiding "pro-inflammatory" and processed ingredients, for inducing and maintaining remission and MH in children and young adults. This approach is based on the previously published charity cook-book "Tasty&Healthy" and might be more feasible than currently available nutritional treatments in CD. It does not offer a rigid diet with specific nutrients and does not require concurrent use of a formula feed. The investigators hypothesize that a flexible dietary intervention of excluding processed and pro-inflammatory ingredients will improve the rate of clinical remission and MH without the need for liquid formula or structured rigid diet which are more difficult to adhere to. The investigators also hypothesize that home kits of Fecal calprotectin (FC), can personalize the diet thereby increasing feasibility for maintenance therapy in some patients.

NCT ID: NCT04267926 Recruiting - Multiple Sclerosis Clinical Trials

MitoQ for Fatigue in Multiple Sclerosis (MS)

MitoQ
Start date: April 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if MitoQ has a significant change in fatigue.

NCT ID: NCT04269980 Recruiting - Mean Blood Pressure Clinical Trials

Phentolamine Versus Magnesium Sulphate Infusion During Elective Lumbar Spine Surgery: a Randomized Double Blind Comparative Study

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the efficacy of controlled hypotensive anesthesia with phentolamine versus Magnesium sulfate in patients undergoing lumbar spine fusion surgery on blood loss, total dose of hypotensive agents and quality of surgical field.

NCT ID: NCT04276220 Recruiting - Clinical trials for Transthyretin Amyloidosis

Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

CACTuS2
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin. If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test. Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.

NCT ID: NCT04279327 Recruiting - Ascites Clinical Trials

Cell Block Immunohistochemistry in Effusion Cytology

Start date: April 1, 2020
Phase:
Study type: Observational

Cytology is usually the first step in investigating serous effusions, to either detect or exclude an underlying malignancy. This study will try to answer the need for improved diagnostic yield of cytologic examination by cell block technique and immunohistochemical testing of three markers which are EZH2, Claudin-4 and MOC-31.