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NCT ID: NCT04980443 Completed - Colorectal Cancer Clinical Trials

Evaluation of a New Blood-based Test to Detect Colorectal Cancer and Its Precursors

CELTiC
Start date: August 3, 2021
Phase: N/A
Study type: Interventional

The CELTiC panel is a potential blood-based test for detecting colorectal cancer (CRC) and precursors of CRC. This can be useful for CRC screening, since this requires tests that detect cancer in an early stage to maximize the chances of successful treatment. CELTiC combines four markers that can be detected in blood. These markers are composed of so-called messenger RNA (mRNA) and can be viewed as the instructions of our genes to the cell to make certain proteins. Cancer is the result of mutation in these genes. Thus, the mRNA in cancer patients is, depending on the type of mRNA, often abnormal. In earlier studies, the developers of CELTiC found four mRNA's that are different in patients with CRC compared to healthy individuals. However, CELTiC has not yet been extensively studied in individuals for whom the test is intended: a population undergoing CRC screening. The current study aims to fill this gap. We will assess the ability of CELTiC to detect CRC and precursors of CRC in a population of individuals between 50 and 75 years old in the Netherlands and Italy. This population has already been preselected by having a positive fecal immunochemical test (FIT), a test that is frequently used in CRC screening. This population will undergo a colonoscopy, a procedure where a doctor enters the large bowel through the anus using a flexible camara to assess whether the patient has cancer. Prior to this colonoscopy, we will collect blood samples from the individuals to assess their CELTiC score. After the colonoscopy and the blood analysis, we can assess whether the test adequately detects CRC and precursors of CRC in this population.

NCT ID: NCT04980391 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers

Start date: August 3, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.

NCT ID: NCT04979741 Recruiting - Clinical trials for Intensive Care Unit Syndrome

Recovery After Intensive Care Study

RAI
Start date: January 1, 2021
Phase:
Study type: Observational

Post-ICU long term sequelae- defined as "post intensive care syndrome" (PICS) manifest with a wide spectrum of psychological and cognitive impairments, affecting over two-thirds of ICU survivors and leading to increased rehospitalization, health care costs, impaired quality of life (QoL), inability to return to work and burden for families. The prevalence of post-traumatic stress symptoms (PTSD), anxiety symptoms, and depression after ICU stay is high and has been demonstrated in up to 50% of post-ICU population. Therefore, over the last years, an important effort has been made for the development of ICU aftercare and follow-up clinics with the aim to detect and to minimize post-ICU sequelae and improve outcomes. However, the utility of these follow-up programs and their effect on outcome has not been completely demonstrated.

NCT ID: NCT04979468 Recruiting - HIV-1-infection Clinical Trials

Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study)

EDOLAS
Start date: March 23, 2021
Phase: Phase 3
Study type: Interventional

Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mL

NCT ID: NCT04979442 Terminated - Clinical trials for Dedifferentiated Liposarcoma

Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

MANTRA
Start date: July 14, 2021
Phase: Phase 3
Study type: Interventional

Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.

NCT ID: NCT04978493 Active, not recruiting - Crohn Disease Clinical Trials

A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease

Start date: October 4, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease. The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease. BI 706321 is a medicine being developed to treat Crohn's disease. Ustekinumab is a medicine already used to treat Crohn's disease. Participants are put into 2 groups randomly, which means by chance. One group gets BI 706321 and ustekinumab. The other group gets placebo and ustekinumab. Participants take BI 706321 or placebo as tablets every day. Placebo tablets look like BI 706321 tablets but do not contain any medicine. Ustekinumab is given as an infusion into a vein once at the beginning of the study. After that, ustekinumab is given as an injection under the skin every 2 months. Participants take BI 706321 or placebo in combination with ustekinumab for 3 months. After that, participants receive only ustekinumab for another 9 months. Participants are in the study for about 1 year. During this time, they visit the study site about 13 times. At 3 of the visits, doctors do a colonoscopy to examine the bowel. The results from the colonoscopies are compared between the 2 groups. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT04978337 Terminated - Clinical trials for Respiratory Syncytial Virus

A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection

PRIMROSE
Start date: November 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.

NCT ID: NCT04977882 Completed - Colon Cancer Clinical Trials

Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer

Start date: October 1, 2020
Phase: Early Phase 1
Study type: Interventional

Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata, Rome, Italy.

NCT ID: NCT04977778 Completed - Gingivitis Clinical Trials

Effectiveness in Dental Plaque Reduction of Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Comparative study on the efficacy of two mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride in the reduction of plaque score in individuals with spontaneous gengivitis

NCT ID: NCT04977609 Recruiting - Hemiparesis Clinical Trials

A Music-based VR Intervention for Upper Limb Motor Rehabilitation in Hemiparetic Patients

Start date: July 2021
Phase: N/A
Study type: Interventional

Hemiparesis affects the majority of stroke patients in the acute phase. In post-stroke motor rehabilitation patients can re-learn motor sequences through repetitive training. Research showed that virtual reality (VR) can be effectively used in upper limb motor rehabilitation by training motor coordination and gestures in an immersive virtual environment. Another promising line of intervention in post-stroke rehabilitation is the use of music, with evidence supporting the notion that a rhythmic accompaniment promotes the recovery of motor coordination in patients with hemiparetic stroke. Furthermore, studies showed a beneficial effect of the observation of movements performed by a third person in patients with post-stroke hemiparesis. Based this evidence, the present study aims at testing the feasibility and efficacy of a novel music-based VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients. The treatment consists in upper limb repetitive training activities through the imitation of movements synchronized with a musical accompaniment and is delivered in 10 sessions over 2 weeks, supervised by a physical therapist. Participants wear a VR headset through which they observe egocentric 180° 3D videoclips. The experimental condition (group A) will be compared with a no-music condition (group B), to test the specific effect of music, and with traditional physiotherapy rehabilitation (group C), to test the efficacy of the approach. The investigators expect that the patients undergoing the experimental intervention (group A and group B) will show a greater upper limb motor function improvement, as compared to the active control group. As a secondary endpoint the investigators expect the music component to induce a greater motor improvement as compared to the experimental condition without music.