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NCT ID: NCT03681184 Not yet recruiting - Clinical trials for Primary Hyperoxaluria Type 1 (PH1)

Phase 3 Study to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1

Start date: September 26, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Lumasiran in Children and Adults with Primary Hyperoxaluria Type 1 (PH1).

NCT ID: NCT03681080 Recruiting - Clinical trials for Cognitive Impairment

Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

People with POTS, autoimmune autonomic neuropathy (AAN), pure autonomic failure (PAF), SFN and Ehlers Danlos Syndrome (EDS) do not only suffer from orthostatic symptoms such as dizziness, headache, neck pain, blurred vision or (pre-) syncope. They also experience deficits in attention and concentration (more precisely deficits in selective perspective, operating speed, executive functions and memory performance) mainly in upright position. Only few studies concerning cognitive impairment in autonomic neuropathies, their frequency, aetiology and therapy exist. Many patients concerned, especially with POTS, report attention deficits and "brain fog" with problems in their everyday life and work, predominantly in upright posture. Specific symptomatic or medical therapies do not exist. Medical treatment with Modafinil is discussed and part of a current study at Vanderbilt Autonomic Dysfunction Centre (1-5). The investigators want to investigate if problems of concentration, attention and/or cognitive dysfunction exist in people with POTS, AAN, SFN and EDS compared to healthy controls (HC). Thus the investigators use detailed clinical, autonomic and neuropsychological tests in different body positions (lying, sitting and standing) as also acute therapy (leg crossing).

NCT ID: NCT03680742 Recruiting - Clinical trials for Intracranial Aneurysm

Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

Start date: September 18, 2018
Phase: N/A
Study type: Interventional

Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular Systemâ„¢ ("Contour"). The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.

NCT ID: NCT03679429 Not yet recruiting - Clinical trials for Colorectal Carcinoma

NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum

Start date: November 2018
Study type: Observational

Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This approach enables the conduction of microscopic investigations of the lesions. By today, only the pathological diagnosis can distinguish exactly between these three polyp entities. Some studies have investigated the value of the optical characterization approach which is based on visual assessment of the polyp' surface structures. Based upon optical polyp features users are encouraged to predict histopathological polyp diagnoses solely on behalf of optical or endoscopical criteria. This method is conducted in real time during colonoscopy. If it could be shown, that endoscopist using the optical characterization approach are able to predict histopathological diagnoses of colonic polyps sufficiently this would possibly lead to simplification of diagnostic procedures. For instance, it would be conceivable to resect small polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions. In this study we want to investigate whether the use of narrow-band imaging (NBI) would be capable to rise accuracy of optical polyp predictions compared to standard HD white light endoscopy. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. In a prospective randomised multicenter setting we plan to conduct colonoscopy in 370 patients. Half of the patients will be examined without the use of NBI (control arm). In these cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI tool. If polyps are detected in patients belonging to the intervention arm NBI will be used and optical diagnosis will be determined using the WASP (Workgroup serrAted polypS and Polyposis) classification. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial we aim to compare accuracy of the optical diagnosis in both groups. Our hypothesis is, that by using NBI accordance between optical and histopathological diagnosis can be increased from 80% to 90%.

NCT ID: NCT03677401 Recruiting - Pruritus Clinical Trials

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis

Start date: August 29, 2018
Phase: Phase 3
Study type: Interventional

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis

NCT ID: NCT03676504 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR

Start date: September 7, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (1-20×10^6 transduced cells/m^2) after lymphodepletion with fludarabine and cyclophosphamide.

NCT ID: NCT03676322 Not yet recruiting - Healthy Clinical Trials

Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants

Start date: September 18, 2018
Phase: Phase 1
Study type: Interventional

The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.

NCT ID: NCT03676036 Completed - Atopic Dermatitis Clinical Trials

Efficacy and Steroid Sparing Potential Study of DGLA Cream in Patients With Moderate to Severe Atopic Dermatitis

Start date: June 2015
Phase: Phase 2
Study type: Interventional

This study will investigate the steroid sparing potential of DS107E to vehicle in patients with moderate to severe atopic dermatitis. DS107E or vehicle will be topically administered with a steroid twice a day for the first 7 days. For the following 28 days DS107E or vehicle will be topically administered twice a day. This study will enrol approximately 40 adult patients.

NCT ID: NCT03675919 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

TeLIPro Health Program - Active With Diabetes

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

In a randomized-controlled trial the hypothesis should be tested that the Telemedical Lifestyle Intervention Program TeLIPro could significantly improve HbA1c (primary outcome), body weight and composition, cardiovascular risk factors, quality of life, eating behavior, and medication demand (secondary outcomes) in type 2 diabetes mellitus (T2DM) patients.

NCT ID: NCT03674151 Recruiting - Clinical trials for Split-skin Grafted Third-degree Burn Wound

Trial of Different Wound Dressings in Split-skin Grafted Third Degree Burns

Start date: July 2015
Phase: N/A
Study type: Interventional

In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from newer wound dressings, only a few studies comparing different wound dressings can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology, handling and costs of different wound dressings in patients with split-skin grafted third-degree burn wounds.