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NCT ID: NCT04058756 Recruiting - Clinical trials for Advanced Solid Tumors

Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

Start date: October 31, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

NCT ID: NCT04058496 Completed - Inflammation Clinical Trials

The Importance of Wnt-signaling After Cardiac Surgery

Start date: November 1, 2018
Phase:
Study type: Observational

Cardiac surgery saves lives when patients suffer from cardiac disease. Local inflammation is important for tissue repair and wound healing after such an operation. Inflammation starts already when the patient is treated in the intensive care unit. When inflammatory proteins (cytokines) are released into the circulation, they cause also a systemic inflammation, which alerts the immune system of the body and activates defence mechanisms (=adaptive response). In some patients, systemic inflammation is out of control thereby causing organ dysfunctions, shock, and in the most severe cases even death (=maladaptive response). The aim of this study is to investigate the early phase of inflammation after the operation. Repeated blood samples will be taken of patients undergoing cardiac surgery to describe the patterns and dynamics of inflammation proteins. A better understanding of these mechanisms will potentially lead to improved treatment of patients after cardiac surgery.

NCT ID: NCT04057664 Recruiting - Depression Clinical Trials

A Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic and Chronic Belly Pain

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

The project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy.

NCT ID: NCT04057209 Recruiting - Larynx Cancer Clinical Trials

VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer

VoiceS
Start date: November 20, 2019
Phase: N/A
Study type: Interventional

Laser surgery and radiotherapy are well-established standards of care for unilateral stage 0 & I carcinoma in situ (Cais) and squamous cell carcinoma of glottic larynx (SCCGL). Based on meta-analyses, functional and oncological outcome after both treatment modalities are comparable1-5. However, no properly conducted randomized trials comparing these treatments exist. The only such trial with the endpoint of voice quality had to be prematurely closed due to low accrual6. The traditional radiotherapy involves the treatment of the whole larynx. Recently, a new radiotherapy technique was introduced by a team of researchers from Netherlands, where the treated target volume consists of involved vocal cord and therefore 8 to 10-fold smaller than the target volumes used for traditional whole larynx irradiation. The treatment is reduced to 16 fractions which corresponds to 3 weeks and a day7-12. The results of a prospective cohort (n=30) with single vocal cord irradiation (SVCI) were compared with the results of a historical prospective cohort previously treated with whole larynx radiotherapy (n=131) in the same institute. The median follow-up was 30 months. The voice handicap index (VHI) at all time points beginning from the 6th week after SVCI was significantly superior to the same time points with conventional radiotherapy. Moreover, a comparable local control with SVCI (100%) vs. conventional radiotherapy (92%) was reported at two years, p=0.2412. Based on this information, the investigators' main aim is to compare SVCI to Transoral CO2-Laser Microsurgical Cordectomy (TLM) with the main focus of patient-reported voice quality.

NCT ID: NCT04056793 Completed - Birth; Prolonged Clinical Trials

Acceptability Assessment of an Optimized Birthing Position

Start date: August 6, 2019
Phase: N/A
Study type: Interventional

This qualitative study evaluates the acceptability of positioning pregnant women in labour in an optimized position, which consists in the hyperflexion of the legs and the loss of the lumbar lordosis. Twenty patients in situation of dystocia will adopt the described position for a limited amount of time.

NCT ID: NCT04055545 Completed - Low Back Pain Clinical Trials

High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects

Start date: September 25, 2019
Phase: N/A
Study type: Interventional

The current guidelines for non-specific CLBP, recommend a conservative approach with exercise therapy, as first line treatment. Endurance and resistance training are two examples of recommended exercise therapies. However, it appears that none is recommended as superior over the other.

NCT ID: NCT04055480 Completed - Type 1 Diabetes Clinical Trials

Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions

AP@Home04_P3
Start date: August 10, 2019
Phase: N/A
Study type: Interventional

The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is non-inferior to home use of closed-loop applying standard insulin aspart. This is a double-blind, multi-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using standard rapid acting insulin analogue or by an automated closed-loop system using faster insulin aspart in random order. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.

NCT ID: NCT04055298 Completed - Triage Clinical Trials

Is Self-triage by Patients Using a Symptom-checker Safe?

Start date: November 21, 2019
Phase: N/A
Study type: Interventional

This is a prospective, non-randomized, no placebo-controlled interventional study. The study aims to assess the safety of the web-based symptom checker SMASS-Triage and its tolerability in terms of incidence of under-triaged self-assessments and the potential risk to be life-threatening or harmful. The patient's self-triage using a symptom checker will be compared with the urgency assessments conducted sequentially by three interdisciplinary panels of physicians (panel A, B and C). The risk assessments will be based on the structured reports generated by the symptom checker and the discharge summaries of the WIC/ED.

NCT ID: NCT04053738 Completed - Snoring Clinical Trials

The Anti-snoring Bed

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

Habitual snoring is a widespread complication. Most snorers snore predominately when sleeping in supine position. Therefore, therapeutic interventions force snorers to avoid supine position. Devices that restrict the sleeping position or raise alarms when the user obtains the supine position cause discomfort or disrupt sleep resulting in low compliance. Therefore, anti-snoring mechanisms, which lift the trunk of the user without disturbing sleep, have been proposed. We set out to investigate whether individual interventions provided by beds with lifting mechanisms are able to stop snoring within three minutes (success rate) and whether the bed reduces the snoring index (number of total snores divided by total time in bed). In addition, we investigat whether the trunk elevation provided by the bed is interfering with the subjective sleep quality assessed using the Groningen Sleep Quality Score. Subjects are observed for four nights (adaptation, baseline, and two intervention nights). During intervention nights, the bed lifts the trunk of the user in closed-loop manner. Subjects are divided in three groups (non-snorers, snorer group one, and snorer group two). Non-snorers are lifted by the bed at random time points during the night. In snorer group one, a stepwise increase of the bed inclination is compared with going directly to a randomly selected angle. In snorer group two, the influence of a small inclination angle (10°) and a big inclination angle (20°) is compared..

NCT ID: NCT04053088 Active, not recruiting - Clinical trials for Cardiovascular Diseases

SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.

IMPACT
Start date: December 12, 2019
Phase:
Study type: Observational

The IMPACT Registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valveā„¢. The IMPACT Registry will be performed in up to 25 participating sites across Germany, Austria and Switzerland. A minimum number of 500 patients (20 patients per center) will be enrolled. Patients will undergo follow-up visits at baseline, surgery, pre-discharge, year 1, year 3 and year 5.