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NCT ID: NCT06152445 Recruiting - Clinical trials for Non-celiac Gluten Sensitivity

Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

This study aims to assess the differences in tolerability of differently manufactured wheat breads in a target group of individuals with suspected wheat sensitivity. Additionally, it will be verified, if the absence of a response to oral exposure to defined bread types is associated with an absence of mucosal changes following CLE-assisted mucosal provocation with bread.

NCT ID: NCT06169540 Recruiting - Control Clinical Trials

Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)

SEAL-HF
Start date: April 19, 2023
Phase:
Study type: Observational

The purpose of this study is to determine the relationship between the levels of Ribonucleic acid (RNA) circulating molecules, including ones in extracellular vesicles from different organs in the blood and in the saliva of patients with Acute Decompensated Heart Failure (ADHF) and Chronic Heart Failure (CHF) to see if a new, non-invasive diagnostic test can be developed for heart failure exacerbation.

NCT ID: NCT06225869 Recruiting - Parkinson Disease Clinical Trials

Effect of Dopamine on Specific Processing of Shame and Embarrassment in Parkinson's Disease

BioDopa
Start date: April 19, 2023
Phase:
Study type: Observational

Shame and embarrassment are two self-conscious emotions frequently experienced by Parkinson's disease (PD) patients. Shame and embarrassment scores strongly correlate with patient's quality of life, anxiety and depression ratings. However, the neurobiology of shame and embarrassment in PD and the influence of dopaminergic replacement therapy (DRT) is poorly understood. The aim of this study is to characterize how brain structures and neuronal networks involved in Parkinson's disease-related shame, non-Parkinson's disease related shame and neutral control scenarios, are modulated by dopaminergic replacement therapy. For this purpose, functional MRI and connectivity measures between the basal ganglia and shame-related network will be analyzed while PD patients will perform a shame-induction task during both ON- (i.e. during the effect of DRT) and OFF-DRT (i.e. during the withdrawal of DRT) conditions. Correlation with clinical measures will be made.

NCT ID: NCT06325865 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Perception of Unpleasant Sensations During Study Procedures in ALS Patients

PESALS
Start date: April 19, 2023
Phase:
Study type: Observational

Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients. Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state. This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures).

NCT ID: NCT06376097 Recruiting - Lung Cancer Clinical Trials

Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service.

Start date: April 19, 2023
Phase:
Study type: Observational

Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service.

NCT ID: NCT06431477 Recruiting - Hypertension Clinical Trials

Efficacy and Safety of Telmisartan Compared With Losartan

Start date: April 19, 2023
Phase: Phase 4
Study type: Interventional

A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension

NCT ID: NCT05011656 Recruiting - Septic Shock Clinical Trials

Blood Purification for the Treatment of Pathogen Associated Shock

PURIFY-RCT
Start date: April 19, 2024
Phase: N/A
Study type: Interventional

This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the ICU with all of the following: • Pathogen associated shock defined as: - The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation - Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing

NCT ID: NCT05380349 Recruiting - Clinical trials for Newly Diagnosed Glioblastoma

Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Start date: April 19, 2024
Phase: Early Phase 1
Study type: Interventional

Proposed treatment of subjects with newly diagnosed glioblastoma with novel personalized drug regimens identified to be effective in vitro using cancer stem cells derived from their individual tumors, alongside standard of care radiation and TMZ.

NCT ID: NCT05457738 Recruiting - Clinical trials for Intermittent Claudication

Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application

APAISE
Start date: April 19, 2024
Phase: N/A
Study type: Interventional

The main characteristic of PAD is to limit physical activity by the appearance of claudication of the lower limbs which limits the walking distance, or the maximum distance traveled by the patient before the pain forces to stop. In daily practice, the walking distance is rarely measured at the time of treatment. Walking rehabilitation is the first-line treatment for these patients (class 1 recommendation from the AHA 2005 and the ESC 2017 with level A evidence). According to the recommendation, a walking session must last at least 30 minutes at the rate of 3 sessions per week for a minimum of 6 months. Walking rehabilitation should be systematically offered to all claudicating patients, whether operated on or not. It is often sufficient for mild claudication with a walking distance of more than 500 meters. Surgery should be reserved for patients in whom rehabilitation has failed and in whom the claudication is severe (walking distance less than 500 meters). Surgical intervention should not replace rehabilitation, but should be complementary. Supervised rehabilitation in specialized centers is rarely offered because it is not easily available and involves additional expenses and constraints for the patient (transport, fewer work periods for active patients, etc.). In the absence of specialized center, simple advice is most often given to the patient, who then only has to rely on his personal motivation: this is the so-called "go home and walk". Therefore, access to well-conducted rehabilitation is a fundamental element of the management of patients with intermittent claudication, which is currently lacking. In the age of digital health, it is necessary to develop innovative tools allowing self-rehabilitation of the patient in addition with remote monitoring by the doctor. Recent studies have validated and highlighted the interest of using GPS technology for the evaluation of walking activity in claudicants. To date, there are 2 published examples of smartphone applications developed specifically for exercise rehabilitation. The main shortcomings of the solutions proposed in these publications are: - The need to buy a specific GPS box - Discomfort for the patient to carry the box either in a backpack or over the shoulder - The lack of means for the patient to indicate the precise moment when the pain appears - And consequently the absence of clinical analysis centered on the symptom "walk induced pain" Consumer smartphone applications for GPS activity tracking are not intended for medical use and do not indicate when pain occurs. In this study, the University Hospital of REIMS will establish a scientific collaboration with the company VascInnove® for the use of a smartphone application, called E-REVA® which offers: - an assessment of walking activity and claudication parameters (appearance of pain, walking distance, recovery time after pain, total distance travelled, walking speed, etc.) - help with self-rehabilitation - quality of life and walking questionnaires The main innovation is the presence of a button allowing the patient to indicate when the pain appears. The patient will be able to have access via the smartphone application to his statistics and the evolution of his performance over time. The prescribing practitioner will have access, via a secure website, to the statistics of his patient, to whom he will be able to give personalized advice during follow-up consultations. The aim of this study is to carry out a single-centre prospective randomized stratified study (depending on whether or not patient has been revascularized) in patients with intermittent claudication who will or will not use the rehabilitation assistance smartphone application, seen in consultation for vascular surgery and vascular medicine at the University Hospital of Reims.

NCT ID: NCT05988918 Recruiting - Clinical trials for Pancreatic Adenocarcinoma

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Start date: April 19, 2024
Phase: Phase 2
Study type: Interventional

This protocol will enroll patients with pancreatic adenocarcinoma and adenosquamous carcinoma (Cohort 1), gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67 > 20% (Cohort 2) and neuroendocrine prostate carcinoma (Cohort 3)). Each cohort will have its own interim analysis after enrollment of 10 patients. Subjects will be given a one-month (28 day) supply of study drug (ESK981). Subjects will be instructed to take 4 capsules, with or without food, once per day for 5 consecutive calendar days, then take a drug holiday for 2 consecutive days before repeating the 5 days on-2 days off cycle in sets of 4 weeks or 28 calendar days. Subjects will be asked to keep a pill diary noting the date they take their study drug.