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NCT ID: NCT05687539 Recruiting - Clinical trials for Functional Dyspepsia

Mastiha or Mastiha Water in Functional Dyspepsia

Start date: April 27, 2021
Phase: N/A
Study type: Interventional

The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.

NCT ID: NCT05687266 Recruiting - NSCLC Clinical Trials

Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin for First-Line Treatment of Patients With Advanced NSCLC Without Actionable Genomic Alterations

AVANZAR
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

NCT ID: NCT05686070 Not yet recruiting - Clinical trials for Acute Non-cardioembolic Ischemic Stroke

A Study to Learn More About Asundexian (Also Called BAY2433334) for Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older Who Already Had Such a Stroke Due to a Blood Clot That Formed Outside the Heart and Travelled to the Brain, or Temporary Stroke-like Symptoms

OCEANIC-STROKE
Start date: February 16, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - a stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - temporary stroke-like symptoms with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Ischemic strokes or transient ischemic attacks result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or temporary stroke-like symptoms when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo as tablets once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

NCT ID: NCT05683912 Completed - Clinical trials for Diabetic Macular Edema

Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece

ADMIRE
Start date: September 1, 2019
Phase:
Study type: Observational

ADMIRE was a prospective, observational cohort study of patients with diabetic macular edema (DME). Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to months 12, 24 and 36 after treatment with intravitreal aflibercept in treatment-naïve patients and previously treated patients. Safety was evaluated by recording any patients-reported events.

NCT ID: NCT05680467 Active, not recruiting - Clinical trials for Chronic Low Back Pain

Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Individuals With Chronic Low Back Pain

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

Chronic low back pain is defined as back pain that lasts longer than 12 weeks. The aim of this clinical study is to investigate the efficacy of combining a program of manual techniques with the application of Capacitive and Resistive Electric Transfer (TECAR) therapy to treat chronic low back pain. Sixty adults with chronic low back pain will be randomly divided into three groups of 20 each. In the participants of the first group, a therapeutic protocol of manual soft tissue mobilization in the lumbar region will be applied. To the participants of the second group, the same protocol of manual techniques will be applied in combination with TECAR therapy, which will be applied through a conventional capacitive electrode as well as an antistatic electrode bracelet (making the hand of the physical therapist an antistatic electrode). The third group participants will receive no treatment. Both programs will include six treatments over two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), functional ability with the Roland-Morris Disability Questionnaire (RMDQ), Pressure Pain Threshold (PPT) in the lumbar region with an algometer, and lumbar flexion range of motion through fingertip-to-floor distance (FFD) test will be evaluated before and after the intervention with a follow-up one month later. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, while the statistical significance index will be set at p < .05.

NCT ID: NCT05679310 Completed - Inflammation Clinical Trials

Innovative Biotechnological Production of Antioxidant Products

Antiox-Plus
Start date: February 10, 2022
Phase: N/A
Study type: Interventional

Several natural compounds have been explored as immune-boosting, antioxidant, and anti-inflammatory dietary supplements. Amongst them, hydroxytyrosol a natural antioxidant found in olive products, and endemic medicinal plants have attracted the scientific's community and industry's interest. The safety and biological activity of a standardised supplement containing 10 mg of hydroxytyrosol synthesized using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum in an open-label, single-arm, prospective clinical study were studied. The supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks.

NCT ID: NCT05675397 Recruiting - Prematurity Clinical Trials

Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is insufficient, has a positive impact on infants' protein intake, growth and morbidity.

NCT ID: NCT05675176 Completed - Clinical trials for Non-muscle-invasive Bladder Cancer

Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer

Start date: April 12, 2020
Phase:
Study type: Observational

The study compares the complications caused after the BCG intravesical instillation in patients treated for non invasive bladder cancer.The patients are divided into two groups one receiving IVI (intravesical Instillations) with the use of latex catheter while in the other silicone catheter is used.The two groups are compared in terms of fever, hematuria, LUTS and other complications following IVI.

NCT ID: NCT05671627 Recruiting - Clinical trials for Rheumatoid Arthritis

Cortisol Circadian Rhythm in Patients With RA

CortRyRA
Start date: February 2, 2022
Phase:
Study type: Observational

The European League Against Rheumatism (EULAR), acknowledging the critical issue of the complications, of long term treatment with glucocorticoids in the most recent update of the management guidelines for Rheumatoid arthritis, recommends tapering (on sustained clinical remission) of oral glucocorticoids treatment at the earliest feasible time point of therapeutic course and to the lowest daily dose, preferably <7.5mg/day (prednisone equivalent), until the final target of withdrawal is succeeded. In clinical practice, these guidelines are often difficult to follow due to the high risk of disease flares after tapering or stopping glucocorticoids administration. This inability of tapering oral glucocorticoids below 7.5mg/day of prednisone or an equivalent synthetic glucocorticoid is included in the recent definition of difficult-to-treat Rheumatoid arthritis. SΕΜΙRΑ (Steroid EliMination In Rheumatoid Arthritis) study, a double-blind, multicentre, randomised controlled trial, compared oral glucocorticoids tapering with the continuation of low dose oral glucocorticoids. The population study consisted of 259 RA patients with low disease activity on treatment with 5mg per day prednisone and tocilizumab, an anti-interleukin (IL)-6 receptor antibody. The study demonstrated that the continued-prednisone regimen provided better maintenance of disease remission than did the tapered-prednisone regimen for the study period of 24 weeks with no symptoms suggestive of AI. However, the study protocol did not include biochemical assessment of adrenocortical function. Experimental and clinical data have suggested that inadequate production of endogenous cortisol relative to enhanced clinical needs associated with the systemic inflammatory response, coined as the 'disproportion principle', may operate in Rheumatoid arthritis. Although the underlying molecular mechanisms remain unknown, both chronic overexpression of proinflammatory cytokines and chronic stress may contribute in the hyporesponsiveness of the hypothalamic-pituitary-adrenal axis and the target tissue glucocorticoid resistance that have been described, but not systematically studied. Thus, a precise longitudinal assessment of endogenous cortisol production may be needed for optimal management of patients with Rheumatoid arthritis. Based on the above, the investigators seek to investigate the hypothesis that an impaired functional reserve of adrenal cortex, due to chronic over-expression of pro-inflammatory cytokines and/or chronic stress may contribute to the development of Rheumatoid arthritis and/or associate with difficult-to treat RA. If this is the case, then a disturbed cortisol circadian rhythm reflecting this impairment may serve as a predictor of difficult-to-treat RA during the first diagnosis. In order to address this issue, the investigators designed a prospective cohort study including adult patients with Rheumatoid arthritis who require drug treatment for the first time or escalation of existing treatment due to active disease. Patients will be treated as per clinician's judgement with any kind or combination of DMARDs with or without corticosteroids (corticosteroid regimens when started will not exceed 15 mg/day, and will be given for at least 3 months), following EULAR recommendations for RA treatment. Patients will be monitored at baseline, 3 months, 6 months and 12 months, assessing disease response to treatment, the need for continuing glucocorticoid treatment, inflammatory indexes, and diurnal salivary cortisol levels. Patients' classification will be based on EULAR response to treatment criteria for RA and cortisol circadian rhythm will be comparatively assessed (at baseline and at 3/6/12 months) between groups based on treatment response (EULAR guidelines).

NCT ID: NCT05670613 Completed - Clinical trials for Clinical Decision Support System

Does a Clinical Support System for Parenteral Nutrition (PN) Facilitate the Judgement on Choosing the Most Effective Commercial Solution Per Patient (and Modify it, if Necessary)?

CDSS
Start date: February 12, 2021
Phase: N/A
Study type: Interventional

Standard formulas of PN have been developed and provided to patients. Only few randomized controlled studies compared standardized vs individualized PN. Individually tailored PN, only if standard PN solutions do not meet patient's nutritional needs. ASPEN society recommends the use computerized prescribing. Technology has enabled the incorporation of medical guidelines in CDSSs. New approach: Comparison of patient's calculated nutritional needs with commercial available solutions.