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NCT ID: NCT05259917 Completed - Clinical trials for Hereditary Angioedema

A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Start date: February 23, 2022
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients

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: NCT05257408 Active, not recruiting - Clinical trials for Peritoneal Neoplasms

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Start date: June 29, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate progression-free survival (PFS) by blinded independent central review (BICR) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

NCT ID: NCT05257096 Recruiting - Child, Only Clinical Trials

Performance of EEG in Children With Medical Clowns

MECLEES
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

EEG is an important test in the diagnosis epilepsy. The test does not hart, however many electrodes are attached to the child's scalp and situation is stressful. In order to achieve cooperation some use sedative drugs such as Chloralhydrate in young children. The investigetors believe that the integration of medical clowns in the EEG test can distract the children from the stressful environment and encourage them to cooperate. This can prevent the need of using sedation, can improve the quality of the test and improve the child's and parent's experience. One hundred children ages 1-10 years of age performing EEG test at the Bnai Zion medical center will be randomly divided into two groups. One group will the perform the test in the regular practice, and in the other half, medical clowns will be part of the test. The process will be rated by the child, his parents, the EEG technician and the physician reading the EEG. The two groups will be compared in all assessed measures through a statistical analysis.

NCT ID: NCT05257083 Recruiting - Multiple Myeloma Clinical Trials

A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

CARTITUDE-6
Start date: October 10, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

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: NCT05256212 Active, not recruiting - Healthy Clinical Trials

Occupational Exposure of Firefighters to Environmental Pollutants

Start date: August 15, 2017
Phase:
Study type: Observational

The aim of the current trial is to assess the exposure of firefighters (FF) to environmental pollutants emitted from fires, to explore the association of exposure with their health status and to compare these data with those of non-FF participants

NCT ID: NCT05256121 Recruiting - Alzheimer Disease Clinical Trials

HAPPCAP-AD (Human-APPlication Combined Approach for Prevention of Alzheimer's Disease)

HAPPCAP-AD
Start date: June 4, 2019
Phase: N/A
Study type: Interventional

Currently, Alzheimer's disease (AD) has no cure putting prevention-strategies in the forefront for impeding the public health and personal consequences of this devastating disease. Seven major potentially modifiable risk factors show consistent association with AD (midlife type 2 diabetes [T2D], midlife hypertension, midlife obesity, physical inactivity, depression, smoking, and low educational attainment), with combined population-attributable risk of 30%1. A recent extensive literature review of randomized control trials on single lifestyle interventions for AD yielded negative results. The multidomain preDIVA2,3 (Prevention of Dementia by Intensive Vascular Care) and MAPT4,5 (Multidomain Alzheimer Prevention Trial) studies raised concerns regarding the multidomain approach. The multidomain lifestyle model approach of the FINGER6,7 study (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) brought some optimism after it presented positive results; several replication trials around the world have been launched8. However, 1) all trials focus on the elderly, 2) the impact of midlife risk factors on dementia risk is stronger than late life, and 3) the neurodegenerative changes in AD begin decades before its clinical manifestations9. A recent study showed that 2 or more cardiovascular risk factors in midlife (but not late life) predicted amyloid aggregation10. Main goals: To examine the feasibility and provide pilot data on effectiveness of a novel "real-life" personalized 18-months intervention for prevention of cognitive decline in middle-aged individuals (age 40-65-year-old) at high AD risk due to AD parental family history. We will implement an approach "diary-monitoring" ("Risk factors log" which will filled daily by participants, using the REDCap (Research Electronic Data Capture) software's survey) with study team guidance. We hypothesize that daily risk-factors documentation in personal "Risk factors log" will increase participant's engagement in the intervention and will enable the study team to accumulate health information, in order to improve support and counselling for improvement of risk factors. In addition to examining the feasibility of our approach, we will explore its effectiveness in both improving risk factors values, as well as improving cognitive function by comparing the HAPPCAP-AD intervention group to "control group". Last, our study will lay the foundations for a strong long-term large-scale preventive intervention in the future. We will compare this group to a partially passive control.

NCT ID: NCT05255991 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

TETON-2
Start date: October 4, 2022
Phase: Phase 3
Study type: Interventional

Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.