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NCT ID: NCT03992404 Recruiting - Clinical trials for Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury

Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury

PATTERN
Start date: September 16, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.

NCT ID: NCT03991728 Recruiting - Clinical trials for Temporomandibular Joint Disorders

Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Start date: October 15, 2019
Phase:
Study type: Observational [Patient Registry]

Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications). This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.

NCT ID: NCT03990675 Recruiting - Pancreas Cancer Clinical Trials

Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive forms of cancer. Despite advances in the understanding of the mechanisms underlying PDAC pathogenesis, the impact on patient benefit is lagging. As a result, new model systems are being developed and used to fill this gap with the hope of translation into improved diagnostics and therapeutics. Organoids represent a powerful tool for research with the capacity to be applied to many key aspects of pancreatic tissue pathology. 3D organoids can be generated from endoscopic fine-needle aspiration or fine needle biopsy samples. In this study, we will evaluate and compare the growth rate of pancreatic cancer patient-derived organoids generated from matched fine needle Aspirations (FNA) and fine needle biopsies (FNB).

NCT ID: NCT03984084 Recruiting - Anxiety Clinical Trials

Biological Classification of Mental Disorders

BeCOME
Start date: June 9, 2015
Phase:
Study type: Observational

BeCOME intends to include at least 1000 individuals with a broad spectrum of affective, anxiety and stress-related mental disorders as well as 500 individuals unaffected by mental disorders. After a screening visit, all participants undergo in-depth phenotyping procedures and omics assessments on two consecutive days. Several validated paradigms (e.g., fear conditioning, reward anticipation, imaging stress test) are applied to stimulate a response in a basic system of human functioning (e.g., acute threat response, reward processing, stress response) that plays a key role in the development of affective, anxiety and stress-related mental disorders. The response to this stimulation is then read out across multiple levels. Assessments comprise omics, physiological, neuroimaging, neurocognitive, psychophysiological and psychometric measurements. The multilevel information collected in BeCOME will be used to identify data-driven biologically-informed categories of mental disorders using cluster analytical techniques. A subgroup of affected individuals (patients of the outpatients clinic of the Max Planck Institute of Psychiatry) are longitudinally observed regarding the stability of omics markers, vital parameters and symptom severity.

NCT ID: NCT03982953 Recruiting - Parkinson's Disease Clinical Trials

Predicting Cognition After DBS for Parkinson's Disease

Start date: June 12, 2019
Phase:
Study type: Observational

The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to - avoid risk factors by optimizing peri- and intraoperative management - personalize therapeutic strategies for optimal long-term benefit The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3 and 12 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures.

NCT ID: NCT03982524 Recruiting - Clinical trials for Somatic Symptom Disorder (DSM-5)

CBT Enriched With Emotion Regulation Training for Multiple Somatoform Symptoms (ENCERT) - A 3-year Follow-up

ENCERT-3YFU
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether 3 years after the end of therapy cognitive-behavioral therapy complemented with strategies from emotion regulation training leads to better improvement in somatic symptoms and comorbid problems in patients with chronic multiple somatoform symptoms than cognitive behavioral therapy alone.

NCT ID: NCT03982329 Recruiting - Clinical trials for Transcranial Magnetic Stimulation, Repetitive

Impact of nrTMS Therapy on the Progress of Neurorehabilitation

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

Low-frequency navigated repetitive transcranial magnetic stimulation (nrTMS) of the non-damaged hemisphere to increase cortical excitability of the damaged hemisphere and to reduce the increased neuronal inhibition in patients suffering from new surgery-related paresis after brain tumor resection

NCT ID: NCT03981575 Recruiting - Clinical trials for Myotonic Dystrophy 1

Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)

Start date: January 1, 2019
Phase:
Study type: Observational

Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by examining strategies to improve the reliability by making further refinements in our sample collection and analysis procedures by developing strategies for managing patient heterogeneity going forward. Funding Source- FDA OOPD

NCT ID: NCT03981276 Recruiting - Clinical trials for Hereditary Spastic Paraplegia

Phenotypes, Biomarkers and Pathophysiology in Hereditary Spastic Paraplegias and Related Disorders

HSP-PBP
Start date: October 14, 2019
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias (HSP) and related disorders in a prospective multicenter natural history study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the genetic etiology and molecular mechanisms of these diseases.

NCT ID: NCT03979963 Recruiting - Depression Clinical Trials

Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy

Start date: June 3, 2019
Phase:
Study type: Observational

This study investigates depressive symptoms and the use of emotion regulation strategies over the course of a two-year period in participants terminating outpatient cognitive behavioral therapy for depression. The main objective of the study is to examine if changes in the use of certain emotion regulation strategies (e.g. reappraisal, rumination) predict depression relapse or changes in depressive symptoms after the completion of outpatient cognitive behavioral therapy.