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NCT ID: NCT03483532 Completed - Lithiasis Clinical Trials

Study of the Crystallization Inhibition Capacity of the Uric Acid in Urine in a Group of Lithiasic Patients After Intake of a Food Supplement

Start date: September 6, 2017
Phase:
Study type: Observational [Patient Registry]

Renal lithiasis affects a wide range of the population, ranging from 4 to 15% according to the population sample studied. Among all stones, it is estimated that uric stones account for between 10 and 15% of all cases and especially affects men over 50 years, while mixed lithiasis of calcium oxalate monohydrate and uric acid affects a 2.5% of all cases. Lithiasis generated by uric acid is a highly recurrent pathology, even repeating itself several times during the year, and is related to other pathologies such as diabetes and obesity. It is evident that the medical problem that lithiasis originates should not be treated only by eliminating the calculus formed, through the different surgical techniques available, but also that the alterations responsible for its formation should be modified and corrected. If these alterations are not modified, the risk of the genesis of new calculations persists. The pharmacological treatments used until now to treat uric lithiasis are based on the powerful alkalinization of the urine (through the use of citrate or bicarbonate); These treatments tend to have a low rate of adherence and, taken long term, can cause the development of stones of another composition (eg, Phosphate), which are much more difficult to treat. There are natural substances, such as theobromine (natural component of cocoa) that has been found to have the ability to inhibit the formation of uric acid crystals: this substance has been tested in laboratory experiments and therefore would be useful to prevent the formation of uric acid stones and / or mixed calcium oxalate monohydrate / uric acid stones. Theobromine corresponds to a phytocomponent alkaloid that is found in high concentrations in chocolate. The starting hypothesis of this study corresponds to the possible increase in the capacity of inhibition of the crystallization of uric acid by urine in subjects who have ingested food or food supplements containing cocoa or cocoa extract. Therefore, the relationship between the intake of a specific food supplement and the ability to inhibit the crystallization of uric acid by the urine will be studied. An increase in the ability to inhibit the crystallization of uric acid from urine would be useful to prevent the formation of uric acid crystals in urine, which are the origin of uric acid stones or mixed calcium oxalate monohydrate / acid uric. Currently there is no information on the relationship between the ability to inhibit the crystallization of uric acid in the urine due to the intake of certain foods or food supplements and the concentration of theobromine in urine and urinary pH. The present study is carried out to evaluate the relationship between the intake of a specific food supplement and the ability to inhibit the crystallization of uric acid by urine, which would be useful to prevent the formation of uric acid stones and / or mixed calculations of calcium oxalate monohydrate / uric acid. The study will be carried out in two stages. The first will consist in the intake of 1 capsule of a food supplement based on citrate and plant extract without cocoa extract, twice a day for 14 days. The second will consist in the intake of 1 capsule of a food supplement based on citrate and plant extract with cocoa extract, twice a day for 14 days. Before the start of the study a blood sample will be obtained and on the last day of each stage, the patient will be asked to collect the 24-hour urine and another 2-hour morning urine sample. Between each stage will be a period of 7 days without receiving any food supplement. During the study there will be no risk due to the tests that will be performed, since they are among those performed in routine clinical practice. Regarding the possible risks associated with the intake of food supplement, to minimize them, any patient with chocolate or theobromine allergy, pregnant or lactating women and patients with insufficiency are excluded from the study participation. chronic kidney The daily amount of theobromine ingested as cocoa extract is similar to a quantity of dark chocolate between 11-25 g. This consumption of chocolate can be considered normal within a diet. In fact a piece of 50 g of dark chocolate contains between 237 and 519 mg of theobromine and daily many people consume more of this amount without presenting side effects to be a food.

NCT ID: NCT03483376 Completed - Dental Plaque Clinical Trials

aPDT for the Remediation of Dental Black Stain

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

In today's society cosmetic dentistry plays an important role in social relationships and in important aspects of life such as job applications and recruitment processes. Currently, the only available treatment option for patients suffering from black dental pigmentation of bacterial origin is repetitive professional dental cleanings every two or three months, which involve a significant financial outlay, and have been found to be psychologically detrimental due to the lack of a perceived cure. These pigmentations are of unknown etiology, although there has been reported the presence of black-pigment producing bacteria, such as Porphyromonas gingivalis, Tannerella forsythia and Aggregatibacter actinomycetemcomitans in such black plaque. These bacteria are found in a group known as periodontopathogens, bacteria responsible for the appearance of periodontitis, an oral chronic disease with high prevalence. In this context, photodynamic therapy, which uses the application of diode light with a wavelength between 400-500 nm for the elimination of periodontal pathogenic bacteria, has demonstrated effectiveness and absence of adverse effects on the management of patients with periodontitis. The proposed study seeks to evaluate the effect of photodynamic therapy on teeth with extrinsic black pigment, in order achieve an eradication of the stains. The investigators will also proceed to analyze in depth the bacterial composition of these stains before the application of photodynamic therapy, in order to stablish the aetiological agents of this black plaque.

NCT ID: NCT03483064 Completed - Lower Back Clinical Trials

Interferential Current in Lower Back

IF-HRV
Start date: May 7, 2018
Phase: N/A
Study type: Interventional

In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain. Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, among which all those included in electrotherapy stand out, as commented by McKenzie et al. The use of electric currents for therapeutic purposes is widespread and studied in the field of physiotherapy. However, the use of medium frequency currents, and more specifically interferential currents, provides participants with a series of important advantages, both for the patient and for the therapist.The study of low back pain in relation to treatment with interferential currents has a series of obstacles, among which the quantification of such pain and the establishment of the different parameters of the therapeutic procedure stand out. The first problem the investigators face are to objectify something that, in itself, is completely subjective: pain. In addition, pain measurement is our only guide to follow the evolution of the patient who suffers it. Another important problem, as discussed by Ward and Lucas-Toumbourou, has to do with the controversy between the different studies related to the treatment of low back pain with interferential currents. For all the above, the approach to low back pain is complex and affects the social, labor and economic scale of the individual and society. Low back pain is the main cause of public spending for welfare and work concepts. It suffers at some point in life up to 80% of the general population and each year generates a cost equivalent to approximately between 1.7 and 2.1% of its gross domestic product in a European countries. There is a lack of valid scientific studies on some aspects of the clinical management of low back pain and the usual clinical practice does not seem to be based strictly on the results of the researches carried out. The available data suggest that there are abuses of procedures whose benefits and risks are uncertain, while others that have proven to be more effective, safe, effective and / or efficient are underutilized. For this reason, clinical practice guidelines for non-specific low back pain have been developed in several countries in recent years. Since the first clinical practice guidelines developed in America and the United Kingdom (Quebec Task Force in 1987. In 1994, more than 30 guides who claim to be based on scientific evidence have been developed. Electroanalgesia is a set of procedures consisting of the application of an electric current through electrodes placed on the skin of the patient in order to stimulate myelinated nerve fibers, fast driving. This activation triggers, at the central level, the implementation of descending analgesic systems of an inhibitory nature on nociceptive transmission, transported by small-caliber unmyelinated fibers. In this way, a reduction in pain is obtained. In other words, it is a question of carrying out a "differential" sensory stimulation, transcutaneously, of the tactile proprioceptive fibers, with a high speed of conduction, with the minimum response of the nociceptive fibers, of slow conduction, and of the efferent motor fibers. The application of medium frequency interferential currents (4,000 Hz), in addition to reducing the pain caused by the stimulation of thick nerve fibers, produces the normalization of the neurovegetative balance. According to De Domenico, this means a cushioning of the orthosympathetic system, which is reflected in muscle relaxation and improved circulation, which also helps to reduce pain. But the clinical impact of interferential currents on non-specific chronic low back pain remains poorly studied. Thus, clinical trials show some controversy and support its efficacy in combination with other treatments. A systematic review found that the interferential current demonstrates advantages over placebo and without treatment when associated with exercises and massages. In contrast, the European clinical practice guideline for the treatment of chronic low back pain concluded that there was no evidence of its effectiveness compared to sham intervention or placebo. However, recent studies of a randomized clinical trial with interferential currents on patients with nonspecific chronic low back pain report very favorable results in terms of the reduction of perceived pain and functional disability.

NCT ID: NCT03482635 Completed - Colitis, Ulcerative Clinical Trials

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

Start date: March 27, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are - to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) - to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) - To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

NCT ID: NCT03482401 Completed - Breast Cancer Clinical Trials

Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients

POLYSEN
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.

NCT ID: NCT03482232 Completed - Adverse Event Clinical Trials

Consequences of Doing What Should Not be Done in Primary Care

SOBRINA
Start date: October 14, 2018
Phase:
Study type: Observational

Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them and study reviewing a random selection of cases previously identified to determine whether patient suffered adverse events and their over-cost.

NCT ID: NCT03481634 Completed - Clinical trials for Diabetic Macular Edema

Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

KESTREL
Start date: July 23, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

NCT ID: NCT03480763 Completed - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)

PNEU-PATH
Start date: June 22, 2018
Phase: Phase 3
Study type: Interventional

This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.

NCT ID: NCT03479658 Completed - Adiposity Clinical Trials

Dose-effect of HIIT on Cardiovascular Health of Children

Start date: February 27, 2018
Phase: N/A
Study type: Interventional

An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children. The adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases. School-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.

NCT ID: NCT03479138 Completed - Neutrophilic Asthma Clinical Trials

Non-Eosinophilic Neutrophilic Asthma

ANNE
Start date: February 21, 2018
Phase:
Study type: Observational

Define and characterize the neutrophilic phenotype of severe asthma.