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NCT ID: NCT03977961 Completed - Clinical trials for Lumbar Spinal Stenosis

The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.

6MWT-DDD
Start date: May 1, 2019
Phase:
Study type: Observational

The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).

NCT ID: NCT03977493 Recruiting - Focal Hand Dystonia Clinical Trials

IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia

Start date: February 21, 2018
Phase: Phase 3
Study type: Interventional

This study is a multicenter, double-blind, randomized placebo controlled, parallel group, superiority trial in order to test the superiority of intramuscular injections of IncobotulinumtoxinA against placebo using a 1:1 allocation ratio.

NCT ID: NCT03975647 Recruiting - Clinical trials for HER2-positive Breast Cancer

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Start date: October 2, 2019
Phase: Phase 3
Study type: Interventional

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

NCT ID: NCT03975582 Completed - Blood Pressure Clinical Trials

Somnotouch-NIBP Compared to Standard Ambulatory 24-hours Blood Pressure Measurement

Start date: July 4, 2019
Phase:
Study type: Observational

Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.

NCT ID: NCT03972735 Recruiting - Schizophrenia Clinical Trials

Assessment of the Effectiveness of the NECT Program

NECT
Start date: February 10, 2020
Phase: N/A
Study type: Interventional

Self-stigma refers to the transformation process wherein a person's previously held social identity is progressively replaced by a devalued and stigmatized view of oneself termed "illness identity". Self-Stigma is a severe problem in Serious Mental Illness (SMI). Self-stigma prevalence is high (41.7% of the 1229 participants with SZ and 21.7% of the 1182 participants with mood disorders had moderate to high levels of IS in the GAMIAN-Europe study). Self-stigma was negatively associated with self-esteem, social function, wellbeing, quality of life or personal recovery and positively associated with psychiatric symptoms and depression. Several psychosocial interventions (mostly combinations of psychoeducation and cognitive behaviour therapy) have been designed to reduce self-stigma and its impact on clinical and functional outcomes, with preliminary effects on self-stigma, insight and self-efficacy. Narrative Enhancement and Cognitive Therapy (NECT) is a manualized structured 20-session group-based intervention . Conducted by two trained facilitators the sessions combine psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma. Developed in USA, NECT was adapted in Israel and Sweden. NECT showed effectiveness in reducing self-stigma and in improving self-esteem and quality of life. Despite being effective on changing coping strategies, NECT effectiveness on social function is still unclear. The present study aims to validate NECT French adaptation and to evaluate its effectiveness on social function, self-stigma, psychiatric symptoms, self-esteem, wellbeing, quality of life and personal recovery in SMI participants (schizophrenia, bipolar disorder, borderline personality disorder)

NCT ID: NCT03972436 Not yet recruiting - Clinical trials for Advanced Solid Tumors

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors.

Start date: August 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy. Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an injection of IP-001. IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to thermally liberated tumor antigens. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn 'cold' tumors into 'hot' tumors, inducing a systemic immune response and resulting in shrinkage of the treated tumor including long-term response mediated by the patient's immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) even those that are outside or distant from the treated area. This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors ('all comers', Part 1 - safety run in). Further information on safety and tolerability and as well preliminary antitumor activity will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1) and addition, in melanoma patients the anti-tumor activity will be defined as a primary objective (Part 2, Cohort 2). The trial treatment consists of an Ablation + IP-001 in 4-week intervals for up to six scheduled treatments. Thermal ablation will be performed according to the instruction of the medical device and IMP IP-001 will be administered in different dose levels according to the trial design. A follow up of all patients until progression of disease or until start of a subsequent treatment is part of the trial.

NCT ID: NCT03972072 Recruiting - Clinical trials for Head and Neck Cancer

MRI - Guided Adaptive RadioTHerapy for Reducing XerostomiA in Head and Neck Cancer (MARTHA-trial)

MARTHA
Start date: October 15, 2019
Phase: N/A
Study type: Interventional

Radiotherapy is the main treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Many advances regarding tumor control and patient survival have been made over the past decades. However, treatment-induced toxicity remains a crucial problem, leading to reduced quality of life and permanent impairment for many survivors. Xerostomia is up to this day the leading cause of late toxicity for these patients. Toxicity has been reduced by implementation of modern image guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT), but the low soft-tissue contrast of routine x-ray image guidance does not allow exact planning adaptation and daily imaging is associated with high radiation exposure. Furthermore, despite the routinely use of IMRT, rates of clinically relevant xerostomia (i.e. grade 2 or worse) are still common and reported in approximately 38%. Recently developed hybrid machines (MRidian®-CE approval since 2016), consisting of a linear accelerator and an integrated low-field MRI, could allow a) better visualization of tumor and organs at risk, such as parotid glands during patient positioning and daily treatment, b) daily imaging without additional radiation exposure, c) narrowest established safety margins for the treatment volumes, and finally d) repetitive adaptation of target volumes according to changes in patient weight and tumor anatomy during the radiotherapy course. These procedures would facilitate a high-precision treatment and help reduce dose exposure of critical structures.

NCT ID: NCT03970447 Recruiting - Glioblastoma Clinical Trials

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

GBM AGILE
Start date: July 30, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

NCT ID: NCT03970187 Completed - Clinical trials for Fear of Public Speaking (Subclinical)

Investigation of the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking

ASSIST-2019
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Investigation of the efficacy of an eye contact training App in virtual reality, based on principles of exposure therapy for the treatment for subjects with fear of public speaking.

NCT ID: NCT03969602 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Cognitive Behavioral Therapy (CBT) After Lumbar Spinal Fusion in Patients With High Pain Catastrophizing

TRIBECA
Start date: January 23, 2020
Phase: N/A
Study type: Interventional

Catastrophizing has emerged as the strongest independent predictor for persistent postsurgical pain. Although behavioral interventions, including Cognitive Behavioral Therapy (CBT), have been shown to reduce the impact of persistent pain, postsurgical patients have not historically been offered these interventions. The aim of our study is to examine whether an intervention targeting pain catastrophizing can reduce the risk of persistent pain and disability after spinal fusion. Our primary hypothesis is that a perioperative cognitive behavioral intervention with the goal to decrease anxiety and pain catastrophizing will decrease the risk of persistent pain and disability after spinal fusion surgery in high catastrophizing patients. To study this hypothesis the investigators will perform a prospective, randomized, controlled multicenter trial with 1:1 allocation, comparing 2 cohorts. Patients aged > 18 years/old, with a primary diagnosis of spinal stenosis, degenerative or isthmic spondylolisthesis or degenerative disc disease (DDD) determined by expert spine surgeons and selected for lumbar spinal fusion surgery with decompression will be screened for high levels of pain catastrophizing using the Pain Catastrophizing Scale (PCS). Patients with a score of ≥ 24 on the PCS who will consent to the study will be randomized to CBT (2 sessions preoperatively and 4 sessions postoperatively) plus usual care (experimental group) or usual care (control group). To limit expectation bias, an educational intervention will be added in the control group. Primary outcome is the Core Outcome Measure Index (COMI) at 12 months. Secondary outcomes are scores on 11-point Numeric Rating Scale (NRS) for back and leg pain, Oswestry Disability Index (ODI), Patient-reported outcomes measurement - depression (PROMIS-D), Patient Global Impression of Change (PGIC), Pain Catastrophizing (PCS), reliance on analgesics and employment status. NRS will be measured on the 4th postoperative day, at 8 weeks, 6 months and 1 year, while all other outcomes will be measured at 8 weeks, 6 months and 1 year.