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NCT ID: NCT05259033 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)

COMBINE 2
Start date: April 11, 2022
Phase: Phase 3
Study type: Interventional

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls. At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

NCT ID: NCT05258786 Completed - Pregnancy Related Clinical Trials

Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education

Start date: February 18, 2022
Phase: N/A
Study type: Interventional

The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on pelvic floor training and maternal-coached pushing with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological effects.

NCT ID: NCT05256342 Completed - Clinical trials for Knee, Osteoarthritis (OA)

Biomarkers for Prediction of Analgesic Efficacy in Knee OA.

Start date: December 30, 2021
Phase: N/A
Study type: Interventional

With high NNTs for indiscriminative use in chronic pain, treatment unavoidably entails frustrating long trial and errors. It is timely to identify biomarkers that can predict analgesic efficacy for the individual patient. The investigators propose a framework of interrelations between patient's pain modulation profile (PMP) and the drug's mode of action (MOA) based on two principles: (1) 'fix the dysfunction', relevant for drugs whose main mode of action is to modulate central pain processing; the more the dysfunctional the better the modulating drug efficacy. For example, patients with pro-nociceptive PMP due to reduced endogenous pain inhibition, as expressed by less efficient CPM will benefit from drugs that fix this dysfunction such as SNRIs, relative to patients whose pain inhibitory capacity is well functioning. Thus, for the modulating drugs, pro-nociceptivity predicts better efficacy. (2) 'bear with the dysfunction', relevant for drugs which are mostly non-modulating, acting mainly in the periphery; the more dysfunctionalת the less the non-modulating drug efficacy. This is since efficacy is limited by the dysfunctional modulation system, despite the drug's MOA-like reduction of peripheral pain mediators. Thus, for the non-modulating drugs, for example NSAIDs, pro-nociceptivity predicts less good efficacy. The likely protocol suggests that patients with anti-nociceptive PMP should be treated primarily by non-modulating drugs, while pro-nociceptive ones should be given modulating drugs. EEG is an additional source of relevant data on brain pain processing. Being objective and stable along time, EEG based parameters are, thus, very attractive candidates to be useful biomarkers for prediction of analgesia efficacy. This study will focus on the patients with painful knee osteoarthritis. The aims of this study are: 1. To identify psychophysical and neurophysiological biomarkers that can serve as predictors of response to analgesic pain modulating and non-pain modulating drugs. 2. To establish a conceptual framework of individualized pain therapy based on inter-relations between patient's parameters of pain modulation and drugs' mode of action.

NCT ID: NCT05247294 Completed - Parkinson Disease Clinical Trials

Assessment of Fluctuating Parkinson's Disease With Sensor-based Home Monitoring

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

The aim of this study is to implement home-based monitoring (HBM) using remote-capture wearable devices and patient reported outcomes (PROs) in a rather homogeneous subgroup of advanced Parkinson's Disease (PD) patients, suffering from significant motor fluctuations (MF) and Levodopa-induced dyskinesia (LID), over a two-week period. The investigators aim to provide a more comprehensive picture of patient symptoms, severity, and fluctuations and compare these data to interview-derived clinical data.

NCT ID: NCT05242263 Completed - PTSD Clinical Trials

ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD). It seems that the most efficient ABMT method to balance attention bias variability (ABV) among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in patients with PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015). The purpose of the current study is to examine the efficacy of ACT that also includes feedback. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.

NCT ID: NCT05241821 Completed - Stroke Clinical Trials

Acute STROke Complicating TAVI - Management and Outcomes

ASTRO-TAVI
Start date: June 1, 2021
Phase:
Study type: Observational

Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not been systematically described. We therefore aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and to describe the safety and efficacy of emergent interventions to treat acute stroke complicating TAVI.

NCT ID: NCT05238675 Completed - Bronchiectasis Clinical Trials

A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis

Start date: March 21, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day. Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff. The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05235243 Completed - Clinical trials for Internet-Based Intervention

Can Mindfulness and Self-monitoring Improve Control Over Maladaptive Daydreaming?

Start date: December 20, 2018
Phase: N/A
Study type: Interventional

Maladaptive daydreaming (MD) is a compulsive form of daydreaming that causes distress and functional impairment among tens of thousands of self-diagnosed sufferers. This is the first controlled treatment trial for MD. The investigators built an internet-based self-help program for MD and tested the effectiveness of mindfulness and self-monitoring in improving control over MD, comparing three groups across three measurement points in time.

NCT ID: NCT05226767 Completed - COVID-19 Clinical Trials

Effect of Daily Oral Administration of Food Supplement NLC-V in Patients Diagnosed With COVID-19

Start date: January 30, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the safety and efficacy of NLC-V in patients diagnosed with COVID-19.

NCT ID: NCT05224622 Completed - COVID-19 Clinical Trials

Detection of COVID-19 Using Breath Analysis - Validation Study.

Start date: January 18, 2022
Phase: N/A
Study type: Interventional

Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.