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NCT ID: NCT05138679 Completed - Acute Limb Ischemia Clinical Trials

Evaluation of Acute Lower Limb Ischemia

PROMOTE-ALI
Start date: December 1, 2021
Phase:
Study type: Observational

The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.

NCT ID: NCT05136521 Completed - Healthy Clinical Trials

Bioavailability Study of 300 mg Trazodone Hydrochloride (New Polymer) vs. 300 mg Trazodone Hydrochloride (Contramid® Prolonged-release Tablets) Under Fasting Conditions

Start date: February 17, 2020
Phase: Phase 1
Study type: Interventional

This study was designed to investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions.

NCT ID: NCT05135884 Completed - Stroke Clinical Trials

Lucerne Fall Risk Prediction Score for Stroke Rehabilitation

L-PRESTO
Start date: September 1, 2019
Phase:
Study type: Observational [Patient Registry]

In Switzerland, every year around 16'000 people suffer a stroke. Stroke represents the third most common cause of death in Switzerland and leads to impairments (e.g., motoric, cognitive, sensory) resulting in disability. People with disabilities after stroke should have access to specialised interprofessional rehabilitation settings. During inpatient rehabilitation, 15-36% of the patients experience one or more falls. It is well known that stroke is an important risk factor for falls. On average stroke patients fall 1.77 times more than the age- and gender-matched controls over 13 months. Falling events during inpatient stroke rehabilitation result in an extension of rehabilitation stay of about eleven days. Wong et al. (2016) suspect that a reduction in the activity level due to falls, fear of falling again as well as changes in discharge conditions could be the reason for this extended length of stay. Walsh et al. (2018) demonstrate that patients who fall once within the first year after stroke cause € 8'600 and recurrent fallers € 12'700 higher healthcare costs. Fall risk factors after stroke are well investigated. Campbell & Matthews (2010) have collected multiple factors for falls in inpatient stroke rehabilitation from 1990 to 2009 in an integrative review. A newer systematic review points out physical function, hemi-attention, and stability as the most important factors for falls in inpatient stroke rehabilitation. However, none of the included studies showed a validated prediction model with acceptable performance. Hence, further investigations regarding the impact of various valid and reliable fall risk assessments at admission in inpatient rehabilitation are needed. The neurorehabilitation team of LUKS systematically assesses the patient's functions and activity to design patient-specific, evidence-based rehabilitation. Therefore, a population-specific fall risk model based on standardized assessments performed in the clinical routine would help to identify patients with a high risk of falling during rehabilitation without the need of implementing an existing model with a low performance. Aim of the study The main aim of this study is to establish a multivariable prediction model for falls during inpatient rehabilitation in acute and subacute stroke patients admitted to the Clinic for Neurology and Neurorehabilitation of the Kantonsspital Luzern (LUKS) in Lucerne, Switzerland. The secondary aim is to explore the value of the mini-BESTest as a fall predictor in a subgroup consisting of patients who are ambulatory at admission to the Clinic for Neurology and Neurorehabilitation.

NCT ID: NCT05134402 Completed - Clinical trials for Obstructive Sleep Apnea

Recording of Multiple Nights Using a New Contactless Device (Sleepiz One Connect) in Obstructive Sleep Apnea

Start date: December 1, 2021
Phase:
Study type: Observational

The need for multiple night testing is well recognized in sleep medicine because of a considerable and relevant night-to-night variability. In a study with multiple recordings using WatchPAT®, the OSA severity of 24% of patients was misclassified when using one night compared to the average of three nights. On average, pAHI varied by 57% from night-to-night. The variability of pAHI could partially be explained by the variability of time spent in the supine position with more time supine leading to a higher pAHI (Tschopp et al 2021). Smith (2007) suggested that the AHI should be indicated with a confidence interval to indicate the uncertainty regarding its true value. The Minimal Detectable Difference (MDD) is of special interest in sleep medicine, especially when assessing treatment effects. MDD was found to be 12.8/h and the standard error of measurement was 4.6/h for 4 nights of polysomnography (Aarab et al. 2008). For WatchPAT®, measuring two and three nights showed a small reduction in MDD from 19.1/h to 18.0/h (Tschopp et al. 2021, in press). Only one study using pulse oximetry assessed the night-to-night variability over 14 days (Stöberl A. et al 2017). The study confirmed the enormous variability and focused mainly on its impact on OSA severity. While the night-to-night variability has been extensively studied for polysomnography, respiratory polygraphy, and WatchPAT®, little is known about the optimal number of nights to be recorded. There is convincing evidence from the literature, that the recording of multiple nights is the only way to assess the severity of the patient's disease with clinically reasonable accuracy. Moreover, the MDD with only one night's recording is astonishingly high. The question is how many nights should be recorded to achieve acceptable diagnostic accuracy. The precision of the OSA measurement depends on the clinical situation. For example, to diagnose severe OSA, a higher variability might be acceptable without influencing the treatment decision. However, when comparing treatment effects, the MDD should be as small as possible. The recording of multiple nights might be cumbersome for patients (e.g. with polysomnography or respiratory polygraphy) as well as costly. These factors have to be taken into consideration for the clinically feasible number of recordings. Sleepiz One Connect offers the unique opportunity for a contactless recording of breathing combined with conventional pulse oximetry and is a minimally invasive diagnostic tool that allows measurements over several nights. Studies with multiple night recordings will offer a basis for diagnostic recommendations in future guidelines. The study aims to investigate the variability of obstructive sleep apnea at-home sleep apnea testing. By investigating the variability, we want to quantify the improvement in diagnostic accuracy by additional measurements. The hypothesis is that additional recordings offer a significant improvement in diagnostic accuracy by reducing the variability. The reduction in variability will diminish with each additional recording.

NCT ID: NCT05131737 Completed - Clinical trials for High Altitude Pulmonary Hypertension

Exercise Endurance Time on the 2nd Day at 2500 m High Altitude

Start date: October 18, 2021
Phase: N/A
Study type: Interventional

The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension

NCT ID: NCT05125497 Completed - IVF Clinical Trials

Natural Cycle, Minimal Stimulation and Conventional IVF: a Registry-based Study

IVF-Regsitry
Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

International prospective registry-based study of different types of In Vitro Fertilisation (IVF) and their outcome.

NCT ID: NCT05120427 Completed - Stunting Clinical Trials

The Impact of Growth Charts and Nutritional Supplements on Child Growth in Zambia

ZamCharts
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

According to the latest estimates, 144 million children under age five experience growth faltering. Early life growth faltering or stunting is predictive of a wide array of negative long-term outcomes, including reduced adult height and productivity, diminished health and reduced lifetime incomes. This study builds on a previous pilot study, which suggests that providing parents with tools to measure children's growth at home may be an effective way to prevent early life growth faltering. The objectives of this study are to assess 1) the impact of growth charts on early childhood linear growth; and 2) whether the impact of growth charts can be increased with the provision of food supplements to parents.

NCT ID: NCT05117671 Completed - Clinical trials for Periprosthetic Joint Infection (PJI)

Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice?

Start date: April 16, 2021
Phase:
Study type: Observational

This retrospective multi-center, multi-national cohort study is to validate the European Bone and Joint Infection Society (EBJIS) Definition of Prosthetic Joint Infection. Specifically, it is to analyze the outcome of the Infection Likely group and compare it to the Infection Unlikely group as well as other subgroups within previous validated definitions (Musculoskeletal Infection Society (MSIS)/International Consensus on Musculoskeletal Infection (ICM) 2013 and ICM 2018).

NCT ID: NCT05116020 Completed - Clinical trials for Musculoskeletal Pain

Swiss Chiropractic Cohort (Swiss ChiCo) Study: Patient Cohort

Start date: March 28, 2022
Phase:
Study type: Observational

The Swiss chiropractic patient cohort (Swiss ChiCo) study is a nationwide research project which aims to describe the characteristics of patients presenting to Swiss chiropractors, assess the clinical course of patients with musculoskeletal pain, and examine the feasibility for performing a larger subsequent cohort study.

NCT ID: NCT05113862 Completed - COVID-19 Clinical Trials

A Phase-I Study of a Nanoparticle-based Peptide Vaccine Against SARS-CoV-2

Start date: January 10, 2022
Phase: Phase 1
Study type: Interventional

This trial is Stage 2 of a 2-part adaptive trial. The study aims to investigate the safety of 2 doses of a T-cell priming specific cocktail of Coronaviruses peptides mounted on a gold nanoparticle. Note: Stage 1 of the 2-part adaptive trial, testing a specifically selected mix of Dengue virus peptides, commenced Aug 2021. This is now in follow up (NCT04935801).