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NCT ID: NCT03959943 Completed - Breast Cancer Clinical Trials

Nerve Coaptation in LTP Flap Breast Reconstruction

Start date: February 2016
Phase:
Study type: Observational

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated lateral thigh perforator (LTP) flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between February 2016 and April 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

NCT ID: NCT03959722 Completed - Clinical trials for Gastrointestinal Symptoms

The Effect of Probiotics on GI Symptoms

WHOMLF
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

A double-blind randomized, placebo-controlled study will be performed with experienced endurance athletes to assess the effect of probiotics supplementation on the occurrence and intensity of the gastrointestinal symptoms, on performance and on the composition and function of the gut microbiota. The duration of the supplementation period, with Ecologic® PERFORMANCE supplements, is fourteen weeks. Standardized maximum exercise tests on a treadmill are performed before and after the supplementation period, as well as two performance tests (before) and one performance test (after). During the performance tests, the load is first submaximal for 1 hour, after which a time trial of 30 minutes will be performed. The measurements before and after the supplementation period are performed on individual days with at least 48 hours of relative rest in between. During the supplementation period, training diaries, a Profile of Mood States (POMS) questionnaire and a few questionnaires about dietary habits will be completed.

NCT ID: NCT03958357 Completed - Cervical Cancer Clinical Trials

Post Market Clinical Follow-up Study Venezia

Start date: April 10, 2019
Phase:
Study type: Observational

The investigational device is the Advanced Gynecological Applicator (AGA) Venezia configuration, an applicator to treat locally advanced stage cervical cancer. The goal of the study is to assess the performance and the unknown risks or complications of the AGA Venezia configuration during clinical use of the applicator.

NCT ID: NCT03957031 Completed - Cancer, Gastric Clinical Trials

Gastric Cancer Risk Factors Associated With EU and CELAC Populations

LEGACY-1
Start date: May 31, 2019
Phase:
Study type: Observational

The study uses a case-control design that examines the differences in types of exposures between cases defined with a pathological confirmation of GC diagnosis, and controls, defined as patients to whom a gastroscopy was indicated and confirmed absent of GC i

NCT ID: NCT03951740 Completed - Clinical trials for Coronary Artery Disease

Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Cardiac Patients.

Start date: October 11, 2017
Phase: N/A
Study type: Interventional

Improving physical activity is a core component of secondary prevention and cardiac (tele)rehabilitation. Commercially available activity trackers are frequently used to monitor and promote physical activity in cardiac patients. However studies on the validity of these devices in cardiac patients are scarce. The aim of this study is to determine the accuracy and responsiveness of two wrist-worn activity trackers, Fitbit Charge 2 (FC2) and Mio Slice (MS), for the assessment of energy expenditure (EE) in cardiac patients.

NCT ID: NCT03946007 Completed - Melanoma Clinical Trials

Quality of Life and Physical Fitness After Immune Checkpoint Inhibitors

Start date: October 4, 2018
Phase:
Study type: Observational

Rationale: Tremendous anti-tumor effects have been achieved using immune checkpoint inhibitors for melanoma and NSCLC with long lasting responses of more than 2 years in a substantial subgroup of patients. However, we are still largely unaware of the health-related quality of life of these patients. We should carefully and thoroughly assess the long-term burden of disease and treatment toxicity. Objective: Primary Objective: to investigate health-related quality of life (HRQoL) of patients surviving 2 years or more after the first cycle of an immune checkpoint inhibitor for melanoma or NSCLC. Secondary Objectives: to assess neurocognitive function, endocrine function, cardiovascular risk, physical fitness, mood disorders, sexual problems, work participation in patients surviving 2 years or more after the first cycle of immune checkpoint inhibitor; to assess quality of life of the caregivers of these patients. Study design: Observational cross-sectional study. Study population: Patients (age ≥18 years) with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both). Main study parameters/endpoints: health-related quality of life (HRQoL) as measured using the EORTC Quality of life questionnaire (QLQ-C30). Secondary study parameters: possible late effects (neurocognitive dysfunction, endocrine disorders, dermatologic complaints, sexual disorders and infertility, increased cardiovascular risk, and fatigue), physical fitness, psychosocial issues related to work/education, mood disorders (anxiety and depression), patient and treatment-related factors potentially influencing development of late effects, well-being, and quality of life of caregivers.

NCT ID: NCT03945292 Completed - Clinical trials for Alpha 1-Antitrypsin Deficiency

Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)

SEQUOIA
Start date: August 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).

NCT ID: NCT03945188 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 52
Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

NCT ID: NCT03944967 Completed - Respiratory Failure Clinical Trials

Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

AGEAWARE
Start date: March 5, 2020
Phase:
Study type: Observational

A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients. - Single center pilot study. - 100 older patients undergoing cardiac surgery. - Continuous remote monitoring of vital signs after ICU discharge - Main study endpoint is vital sign deterioration.

NCT ID: NCT03943589 Completed - Clinical trials for Guillain-Barré Syndrome (GBS)

A Study of Imlifidase in Patients With Guillain-Barré Syndrome

Start date: November 12, 2019
Phase: Phase 2
Study type: Interventional

The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients. The patients in this study will be treated with the study medicine imlifidase on day 1, and with IVIg on days 3-7. The purpose of this study is to investigate the safety and effectiveness of imlifidase in patients diagnosed with GBS.