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Humans clinical trials

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NCT ID: NCT05107947 Suspended - Inflammation Clinical Trials

Light in Frail Elderly - the Effect of a Dynamic Light for Sleep and Circadian Rhythm

LIFE
Start date: October 31, 2022
Phase: N/A
Study type: Interventional

The aim of this project is to evaluate the effect of a dynamic light in order to improve the circadian rhythm, provide a better sleep and well-being, and in the long run an improved recovery. The primary question is whether dynamic artificial light with circadian stimulus can affect the circadian rhythm. The secondary question is whether this also provides better sleep and well-being. The group that is particularly interesting to study is a geriatric population that is more sensitive to circadian rhythm disorders, sleep disorders and confusion in connection with hospitalization and that can be of particular benefit from this intervention.

NCT ID: NCT04744233 Completed - Humans Clinical Trials

Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.

Start date: October 2001
Phase: N/A
Study type: Interventional

Commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and texture) and can modify their bioavailabilities. Thus, the traditional thermal processing is being replaced by less intense thermal technologies (e.g. low-temperature pasteurization / refrigerated storage) and non-thermal treatments such as the high-pressure processing (HPP) and the pulsed electric fields (PEF) as an alternative to enhace food safety and shelf-life without compromising organoleptic qualities (retain the flavour, color healthiness of fresh foods) and keeping their health-promoting capacity. The beneficial health effect derived from the orange juice intake is partly related to the bioavailability of their bioactive compounds. The aim of this study was to assess the effect of the intake of freshly squeezed orange juice (Citrus sinensis L.) and processed orange juice elaborated with different treatments (low pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects using multiple dosis.

NCT ID: NCT04699500 Completed - Humans Clinical Trials

Spanish Validation and Cross-cultural Adaptation of the QoR-15E

Start date: December 2, 2020
Phase:
Study type: Observational [Patient Registry]

The satisfactory recovery of the patient after a surgery with an anesthetic request is very important for a quality and excellence assistance. The quality of recovery questionnaire QoR-15 was validated by their authors in 2013 with the study titled development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. This questionnaire allows a comprehensive assessment by associating the physiological parameters until then assessed with the subjective personal perception of the patient of his state of health. With the consent of its original author, this study is carried out to validate the questionnaire in Spanish and adapted to our environment.

NCT ID: NCT04561050 Completed - Bleeding Clinical Trials

Prediction of Massive Transfusion in Trauma Patients

MTP
Start date: August 1, 2020
Phase:
Study type: Observational

Since the 2000s, many prognostic scores were developed to predict traumatic haemorrhage. Most of these studies were retrospectives based on registers. Due to missing data on death due to bleeding, these studies chose to predict the massive transfusion risk as a surrogate of haemorrhagic death. These scores include clinical parameters (vital signs), laboratory values (Haemoglobin, lactate, Base excess) and/or imaging (CT or ultrasound) values. The scores showing best performance are the Trauma Associated Severe Haemorrhage (TASH) score, developed and validated on the German register (DGU-Register) and the ABC score developed and validated in the United States of America. However, the majority of these scores cannot be applied at the trauma scene due to the unavailability of laboratory and imaging values. Therefore, their clinical utility remains unclear. To overcome the need for diagnostic tests, authors have developed and recently validated a clinical prognostic score in identifying trauma patients with, or at risk of, significant haemorrhage based on predicted probabilities of death due to bleeding: BATT score. This score was developed from an international cohort using data from 271 Trauma Centres in 41 countries on 5 continents and uses first clinical parameters at initial assessment. The BATT score predicts death due to bleeding and has been validated on a large population in England and Wales. It could also predict massive transfusion, as a surrogate of haemorrhagic death, earlier at the trauma scene. Its feasibility and external validation would make its clinical utility superior to other scores while identifying a greater number of patients requiring early management. Our study is an external validation of pre-existing prognostic scores of traumatic haemorrhages (TASH , ABC and BATT score) at different times of care (Scene of Injury, admission at the trauma room) in order to assess their overall performance, discrimination and calibration in the prediction of massive transfusion, and haemorrhagic death. The objective of the study is to assess a comparison of score performances (Overall performance, discrimination and calibration). Due to the study population (STR), which is partly integrated into the German DGU-Register, the investigators expect good transportability of the TASH score to the Swiss Trauma Registry in terms of overall performance, discrimination and calibration. The ABC score should show lowers results in terms of discrimination due to its validation on small cohorts exclusively in North America. The new BATT score predicting death due to bleeding has been validated on a large English cohort of more than 100,000 patients. It identifies all patients with haemorrhage and not only patients who have received a massive transfusion subject to survival bias. In this context, the BATT score provides good discrimination with only simple physiological variables available at the trauma scene. In case of its external validation on the STR as part of our study, its feasibility would make its clinical utility superior to other pre-existing scores, while identifying a greater number of patients requiring early management. Its application would activate a massive transfusion plan directly at the trauma scene and save precious time.

NCT ID: NCT04544124 Completed - Clinical trials for Substance Use Disorders

Delivering Contingency Management in Outpatient Addiction Treatment

PRISE
Start date: January 25, 2021
Phase: N/A
Study type: Interventional

Methamphetamine misuse has become a growing concern in Alberta, creating a burden on the health care system. Further, individuals who use methamphetamine in Alberta exhibit significant difficulty remaining in treatment. These troubling patterns necessitate the provision of evidence-based practices (EBPs)-those grounded in empirical evidence-to ensure the best possible care and outcomes for those struggling with this addiction. Within the field of substance use (SU), contingency management (CM) is an extensively studied evidence-based treatment (EBT) for addictive disorders. CM is an intervention that provides incentives to encourage positive behavioural change. Compared to standard care (treatment-as-usual (TAU)), CM has resulted in improvements in abstinence, attendance, adherence, retention, and quality of life. The efficacy of CM has largely been investigated in the context of reinforcing abstinence, though the literature suggests that CM which reinforces attendance may be as effective. Research from the US has examined the cost-effectiveness of CM and found that although CM costs more, it was associated with greater abstinence, treatment completion, and substance-absent urine compared to TAU. Despite the promising literature, the uptake of CM in Canada is limited making it difficult to understand whether this EBT is equally efficacious as compared to the US. This study will implement and evaluate the efficacy of virtually delivered attendance-based CM in outpatient addiction treatment in Alberta. Participants (N=544) will be individuals seeking treatment for methamphetamine use (n=304) and individuals seeking treatment for substance use issues other than methamphetamine use (n=240). It is hypothesized that compared to participants in TAU, participants in CM will evidence: (1) greater retention, (2) greater attendance, (3) greater abstinence from methamphetamine and less methamphetamine use, (4) greater abstinence from other SU and less SU, and (5) greater improvement in quality of life over the intervention and follow-up periods. Exploratory aims include understanding how: outcomes differ based remote versus in-person delivery of CM; outcomes differ between participants who use methamphetamine and participants who use substances other than methamphetamine; the costs of CM differ from TAU; CM changes health service use.

NCT ID: NCT04525833 Recruiting - Clinical trials for Hepatocellular Carcinoma

Liver Disease and Other Systemic Diseases

Start date: January 1, 2020
Phase:
Study type: Observational

Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.

NCT ID: NCT04456478 Recruiting - Pregnancy Clinical Trials

Impact of pH Values of the Embryo Culture Medium on Success of In Vitro Fertilization (IVF)

ACIDOFIV
Start date: October 14, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to compare, through a multicentric randomized trial, the impact of two pH values in the embryo culture medium on the clinical results of In Vitro Fertilization (IVF) process and especially the impact on live birth delivery rate.

NCT ID: NCT04220697 Recruiting - Hyperalgesia Clinical Trials

Central Sensitisation and Postoperative Pain

Start date: January 29, 2020
Phase: N/A
Study type: Interventional

One out of 10 patients undergoing surgery develops persistent post-surgical pain (PPSP). Unfortunately, available therapies for treating this pain have limited success. It is therefore of great importance to find strategies to prevent PPSP. The goal of this project is to find new screening tools that identify patients that are at risk for developing PPSP. Tissue injury and inflammation following surgery increase the excitability of spinal nociceptive neurons ("central sensitisation", CS) with pain hypersensitivity as consequence. It is thought that CS plays an important role in persistent pain. The first objective of this project is to assess in human patients if the propensity to develop CS manifested as secondary hyperalgesia before surgery is predictive for PPSP. In addition, we will test if the frequency content of the resting-state EEG reflecting the initial state of the brain will be related to the propensity for developing CS and to the presence of PPSP at two months after surgery.

NCT ID: NCT03961997 Completed - Healthy Volunteers Clinical Trials

Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants

Start date: August 22, 2019
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to characterize the safety profile of lorlatinib in the presence of a moderate CYP3A4/5 inducer, modafinil. In another drug-drug interaction study for lorlatinib coadministered with a strong CYP3A4/5 inducer, rifampin, all participants experienced increases in liver enzymes after receiving the combination of a single dose lorlatinib (100 mg) with rifampin (600 mg daily (QD)) after multiple doses of rifampin. The AST and ALT continued to increase over the next 24-48 hours, but recovered below the upper limit of normal for all participants upon discontinuation of rifampin. We hypothesize the combination of lorlatinib with the moderate CYP3A inducer modafinil will not have a safety findings related to liver enzyme elevation similar to what occurred in the study with rifampin and lorlatinib.

NCT ID: NCT03846102 Terminated - Pain Clinical Trials

MORphine Use in the Fascia Iliaca Compartment Block With UltraSound

MORFICUS
Start date: January 28, 2019
Phase: Phase 4
Study type: Interventional

Appropriate management of analgesia for proximal femoral fractures is a common problem in the emergency department (ED). Side effects from morphine usage such as nausea, vomiting, respiratory depression, sedation, and obstipation are especially pronounced in elderly. Fascia Iliaca Compartment Block (FICB) holds promise as a simple and safe, and effective alternative method to reduce pain. Local anaesthetic injected in the anatomic space underlying the fascia iliaca, spreads to block the nerves traversing it. This regional anaesthesia includes the femoral nerve. Previous studies in the ED showed promise but lacked blinding, involved low numbers of subjects, or did not use ultrasound localisation of the injection site. The latter is becoming common practice. In this randomised placebo controlled trial the FICB with ultrasound localisation of injection of levobupivacaïne will be compared to the FICB with placebo. It aims to prove that less morphine is used in the intervention group. Other research parameters are pain scores and minor adverse events related to morphine use.