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NCT ID: NCT04908969 Active, not recruiting - Tourette Syndrome Clinical Trials

Internet-based Cognitive Behavioral Therapy for Chronic Tic Disorder and Tourette's Disorder: a Feasibility Trial

TICNET
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

Tic disorders, including Tourette's Disorder (TD) and Chronic Motor or Vocal Tic Disorder (CTD), are neurodevelopmental motor disorders characterised by motor and/or vocal tics. TD/CTD are impairing conditions with onset during childhood that often persist into adulthood. Behaviour therapy (BT) is an effective treatment for TD/CTD and is recommended as a first-line intervention in both in children and in adults. However, most adults with TD/CTD do not have access to BT due to a lack of trained professionals and geographical barriers. The objective of the study is to adapt and extend existing face-to-face BT treatment protocols for adults with TD/CTD to an internet-delivered format and evaluate its feasibility and preliminary efficacy. A total of 30 adult TD/CTD adult patients deemed eligible for the study through the recruitment process involving both psychologist and physician assessment will be enrolled in the project. The 8-modues treatment program, mainly based on exposure with response prevention with addition of other techniques will be made available for the participants in a secure treatment platform. The participants will keep in touch with a therapist using two-ways written communication in the same platform. The therapist's role will be to introduce the treatment and its modules, give feedback on the homework assignments and open the new modules as well as monitor the participants psychiatric symptoms and activity in the plattform. The measures will include tic severity secifically and disease severity in general, anxiety and depression symptoms, quality of life, treatment credibility and therapeutic alliance. The measures will be administrated at baseline, min- and post-tretment, as well at 3 and 12 months follow-up. Upon completion, this project will be the first crucial step towards the implementation of internet-delivered behaviour therapy (I-BT) for adults with TD/CTD in regular health care.

NCT ID: NCT04908956 Active, not recruiting - NSCLC Stage IV Clinical Trials

Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO)

STEREO
Start date: August 4, 2022
Phase: Phase 2
Study type: Interventional

STEREO is single-arm phase II study, which aims to evaluate the safety and efficacy of osimertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS and OS without added high-grade toxicity.

NCT ID: NCT04895358 Active, not recruiting - Breast Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

Start date: June 18, 2021
Phase: Phase 3
Study type: Interventional

The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.

NCT ID: NCT04886154 Active, not recruiting - Clinical trials for Infections, Meningococcal

A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

Start date: June 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, effectiveness and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study will be conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and will serve as a safety lead-in to the Phase II study. The Phase II part of the study will be conducted in 2 parts: The 'formulation and schedule-finding' part will follow in healthy adolescents and young adults and it is designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part will be conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.

NCT ID: NCT04879563 Active, not recruiting - Breast Cancer Clinical Trials

Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project

ASCAPE
Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

ASCAPE (Artificial intelligence Supporting CAncer Patients across Europe) is a collaborative research project involving 15 partners from 7 countries, including academic medical centers, SMEs (small and medium-sized enterprises), research centers and universities, aiming to leverage the recent advances in Big Data and AI (Artificial Intelligence) to support cancer patients' Quality of Life (QoL) and health status. Specifically, ASCAPE aims to provide personalized- and AI-based predictions for QoL issues in breast- and prostate cancer patients as well as suggest potential interventions to their physicians. This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 875351.

NCT ID: NCT04878185 Active, not recruiting - Colorectal Cancer Clinical Trials

Optimizing Physical Function Before Cancer Surgery in Older People at Risk

CanOptiPhys
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

This randomized controlled trial is a multicentre study designed to explore the effects of preoperative exercise on physical fitness, postoperative complications, recovery, and health-related quality of life in older individuals at risk scheduled to undergo colorectal cancer surgery. The hypothesis is that older patients with low preoperative physical capacity will benefit from preoperative exercise in terms of lower risk for postoperative complications and improved recovery after surgery.

NCT ID: NCT04876092 Active, not recruiting - Clinical trials for Lymphoma, Non-Hodgkin

A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL

Start date: July 28, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and recommended Phase 2 dose (RP2D) of JNJ-67856633 and ibrutinib in combination in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

NCT ID: NCT04868955 Active, not recruiting - Stroke Clinical Trials

Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke

Start date: April 26, 2019
Phase: N/A
Study type: Interventional

Purpose The purpose of the study is to evaluate if training with oral screen IQoro® improves swallowing in patients with dysphagia after stroke. Method Inpatient from a stroke unit in Sweden who have been assessed with fiberoptic endoscopic evaluation of swallowing(FEES) which proves swallowing difficulties (dysphagia) were recruited. The participants were randomise to control- or intervention group. Both groups received usual care. The intervention group were instructed to oral screen (IQoro®) training for 13 weeks. Follow up with FEES was made 13 weeks post of recruitment. The assess with FEES was recorded and the recordings are going to be analyzed afterwards to compare the swallowing ability between baseline and follow up in group and between group.

NCT ID: NCT04853004 Active, not recruiting - SARS-CoV 2 Clinical Trials

Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare With Regard to Vaccinations

Start date: April 1, 2021
Phase:
Study type: Observational

To investigate the incidence of SARS-CoV-2 infections after vaccination, to monitor the development of SARS-CoV-2 antibody levels after vaccination and to compare this in relation to both previous health & disease, previous antibody responses and in relation to future disease occurring after vaccination.

NCT ID: NCT04846868 Active, not recruiting - Schizophrenia Clinical Trials

Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)

Start date: June 16, 2021
Phase: Phase 3
Study type: Interventional

This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.