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NCT ID: NCT05598853 Recruiting - Melanoma Stage IV Clinical Trials

Intrathecal Double Checkpoint Inhibition

IT-IO
Start date: November 25, 2022
Phase: Phase 1
Study type: Interventional

The objective of the present study is to determine the feasibility and to explore anti-tumor activity of intrathecal double immune checkpoint inhibition for patients with newly diagnosed leptomeningeal metastases from non-small cell lung cancer without driver mutation or melanoma.

NCT ID: NCT05598008 Recruiting - Sexual Desire Clinical Trials

Effects of Glucagon-like-Peptide-1 Analogues on Sexuality

Desire PLUS
Start date: November 23, 2022
Phase:
Study type: Observational

This study is to investigate the effects of GLP-1 analogues (combined with lifestyle interventions in comparison to lifestyle interventions only) on sexual desire, mood, quality of life, the reproductive axis, retinal vessel diameters, physical fitness (and semen, for men only) in overweight or obese men and women.

NCT ID: NCT05597969 Completed - Adult Clinical Trials

The Effect of an Application-based Health Intervention (FoodCoach) on Food Purchases in Switzerland

Start date: November 9, 2022
Phase: N/A
Study type: Interventional

The FoodCoach study is a 9-week randomized controlled trial from the University of St.Gallen and the University Hospital of Bern, supported by the Swiss National Science Foundation #188402 and by Sanitas Management AG. Sanitas Management AG supports the recruiting of study participants without interfering with the study content. FoodCoach aims to investigate the effectiveness of improving people's food shopping healthiness by providing automated food shopping recommendations. The results of the study could possibly help improve the health status of the Swiss population and beyond in a low-cost and automated manner. The investigators collect participant grocery data via the loyalty card programs "Migros Cumulus" and "Coop Supercard" after obtaining participants' informed consent. From this data, the investigators generate automated recommendations that are based on the Nutri-Score framework and expertise of dieticians at the University Hospital of Bern. After sign-up, participants are randomized into a treatment and a control group. The treatment group receives automated recommendations via the FoodCoach Web Application, while the control group only receives a report about their food shopping by email after the intervention phase. Both groups need to finish the same onboarding survey where the investigators collect basic demographic information. After the intervention, the treatment group will receive a post-study survey containing two parts via email. Part 1 includes questions about the ease of use, interface and satisfaction and usefulness of the FoodCoach app. Part 2 includes questions about the participants' weight and height, the motivation to shop healthily and sustainably. The control group will receive a post-study survey which only contains part 2 as described before via email.

NCT ID: NCT05597735 Recruiting - Monkeypox Clinical Trials

Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease

UNITY
Start date: March 3, 2023
Phase: Phase 3
Study type: Interventional

The overall purpose of this study is to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents (14 years old and older). The primary objective is to evaluate the clinical efficacy, as assessed by time to all visible lesion(s) resolution, of tecovirimat treatment + Standard of Care (SOC) compared to placebo + SOC for patients with monkeypox. The secondary objective is to evaluate the clinical efficacy, as assessed by mortality, hospitalization, complications, duration of symptoms and virological shedding, and the safety of tecovirimat treatment + SOC compared to placebo + SOC in patients with monkeypox.

NCT ID: NCT05596773 Recruiting - Clinical trials for Non-communicable Diseases (NCDs)

Community-Based Chronic Disease Care in Rural Lesotho

ComBaCaL
Start date: February 22, 2023
Phase:
Study type: Observational

This ComBaCaL cohort study is to assess the impact of community-based, lay-led chronic disease screening and care interventions in rural Lesotho. It aims to establish a prospective research and service delivery platform in rural Lesotho that is managed by eHealth-supported Chronic Care Village Health Worker (CC-VHWs) providing regular chronic disease screening, monitoring and referral services. The implementation outcomes of the cohort as well as the effect of the cohort activities on disease-specific care cascades will be assessed. Subsequently, nested trials to assess the effectiveness of specific chronic disease control interventions will be developed. Measurements and data entry will be conducted by CC-VHWs. The CC-VHWs will be equipped with the essential tools required for chronic disease monitoring in the community (i.e. BP machines, scales, measuring band, glucometers, and urine dipsticks). They will undergo a theoretical and practical training covering all aspects required for correct data collection and chronic disease screening, diagnosing, referral and counselling services. At every visit, the CC-VHW will screen participants for warning signs and symptoms (i.e. shortness of breath, severe headache, chest pain, new-onset confusion, impaired consciousness, severely impaired general state of health) and refer participants to the closest health centre in case of any danger-sign. The CC-VHWs will be continuously monitored and supervised by health centre nurses of the respective village's catchment area, mainly through direct interaction during monthly VHW meetings and by CC nurses through field visits, remote interaction via phone calls or messages sent via the ComBaCaL app and through direct contact during the monthly VHW meetings at the health centre. The CC-VHWs are embedded within the Lesotho MoH VHW program and may during the project period be trained and equipped to provide further routine services in their communities.

NCT ID: NCT05596578 Recruiting - Lung Cancer Clinical Trials

Role of Intrapulmonary Lymph Nodes in Patients With NSCLC and Visceral Pleural Invasion

Start date: January 1, 2023
Phase:
Study type: Observational

Background: Lung cancer is the leading cause of cancer related death worldwide. More than 80% of all lung tumors are Non-Small Cell Lung Cancers (NSCLC). Lymph node staging has a prognostic value and is crucial to establish the optimal treatment strategy in individual patients. It remains unknown whether dissecting the intrapulmonary lymph nodes (stations 13 and 14) is necessary for accurate staging and prognostication. Although suggested by several guidelines, these peripheral lymph nodes are not routinely examined in clinical routine for several reasons. Moreover, the prognostic significance of the visceral pleural invasion is controversial. Some studies showed a negative impact on OS and DFS in patients with histologic proved visceral pleura invasion. The mechanism to explain this negative effect is not fully understood. Given that the visceral pleura is very rich in lymphatic vessels, with an intercommunicating "network" arranged over the lung surface and penetrating into the lung parenchyma to join the bronchial lymph vessels with drainage to the various hilar nodes, we assume that the worse OS and DFS observed in these patients could be explained with the presence of metastatic lymph nodes (Station 13-14) that are not routinely examined. Methods: This is a prospective, multicenter study based on ad-hoc created prospectively database. The incidence of N1 lymph node metastasis overall and the incidence of metastasis to the different lymph node stations (Hilar 10/11, Lobar 12, Sublobar 13/14) will be calculated by dividing the number of the respective events by the patient years separately. To investigate the association between visceral pleural invasion and the presence of metastatic lymph nodes univariate and multivariate logistic regression models will be fitted to the data. Discussion: The primary outcome is to investigate the incidence of N1 metastases (especially stations 12,13,14) and his relationship with visceral pleural invasion. The secondary outcomes is to evaluate the impact of N1 metastases and/or visceral pleural invasion on long-term outcomes (OS and DFS) along with incidence and pattern of recurrence. DFS is defined as the time of surgical intervention to tumor recurrence or death, and OS is defined as the time of surgical intervention to death

NCT ID: NCT05596526 Recruiting - Shingles Clinical Trials

Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients

MSHINGVAX
Start date: December 1, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to provide evidence as to whether RZV is immunogenic with an acceptable safety profile in Multiple Sclerosis patients on anti-CD20 treatment.

NCT ID: NCT05595954 Recruiting - Clinical trials for Postoperative Delirium

Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery

PRECISION
Start date: January 23, 2023
Phase:
Study type: Observational

This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.

NCT ID: NCT05595642 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

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

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

NCT ID: NCT05594888 Recruiting - Grip Clinical Trials

GRIP: Maximum Isometric Grip Strength Assessed With Three Different Hand-held Dynamometers

Start date: November 17, 2022
Phase:
Study type: Observational

Maximum isometric grip strength (MIGS) is a cost-effective, easily accessible, valid and reliable outcome measure for assessing upper body strength in both, adults and children. The the JAMAR Hydraulic Hand Dynamometer is the current gold standard for measuring MIGS. For certain age- and activity-groups, alternative devices may be more appropriate. To date, the quality criteria (test-retest-reliability and validity) of the JAMAR Smart Hand Dynamometer and the Martin Vigorimeter compared to the current gold standard are not yet investigated. Furthermore, no reference values for different age-, sex-, or activity level groups exist with regard to underlying disease entities for these three devices.