Clinical Trials Logo

Filter by:
NCT ID: NCT04640831 Completed - Healthy Volunteers Clinical Trials

Safety of GH001 in Healthy Volunteers

Start date: March 13, 2019
Phase: Phase 1
Study type: Interventional

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers. The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.

NCT ID: NCT04640792 Completed - Clinical trials for Screening Colonoscopy

A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy

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

ME-APDS is a device (software-based with hardware) developed by Magentiq Eye LTD and intended to support the decision of the endoscopist on polyps which appear in the colonoscopy video during the colonoscopy procedure. This randomized two arm colonoscopy trial will mainly compare APC and APE between Magentiq Eye Assisted Colonoscopy (MEAC) and Conventional Colonoscopy (CC) in patients referred for either screening or surveillance colonoscopies.

NCT ID: NCT04640194 Completed - Clinical trials for Acute Respiratory Distress Syndrome

A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19

TRISTARDS
Start date: December 16, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster. The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment. Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month. Participants are in the study for 3 months.

NCT ID: NCT04638036 Completed - Rectal Cancer Clinical Trials

Fluorescence Molecular Endoscopy and Molecular Fluorescence-guided Surgery in Locally Advanced Rectal Cancer

TRACT-II
Start date: November 13, 2020
Phase: Phase 1
Study type: Interventional

Treatment of patients with locally advanced rectal cancer (LARC) is multidisciplinary and consists of neoadjuvant chemoradiotherapy (nCRT) followed by surgical removal of the rectal tumor and potentially tumor positive lymph nodes. 1. After surgery, in 15 to 27% of patients that received nCRT no tumor cells can be detected during histopathological examination. In today's clinical practice, all of these patients with a pathological complete response (pCR) are operated upon, with substantial morbidity and mortality. The 5-year survival is 83.3% for patients with a pCR, and 65.6% for those without pCR. Response after nCRT is currently evaluated using magnetic resonance imaging (MRI). However, as MRI cannot differentiate between molecular characteristics of tissue, prediction of treatment response can be inaccurate. In patients with a potential cCR on MRI, additionally a high-definition white-light (HD-WL) endoscopy is performed with biopsies of the previous tumor location. If both MRI and HD-WL endoscopy confirm a potential cCR, patients can also be treated with a watch-and-wait approach, including frequent follow-up with HD-WL endoscopy and MRI. This potentially prevents extensive surgical procedures for patients in which this is not required. However, MRI and HD-WL endoscopy often remain insufficient for identification of cCR. Therefore, novel imaging methods are needed for accurate prediction of treatment response in order to select patients. The investigators believe fluorescence molecular endoscopy (FME) could be a promising technique for evaluation of treatment response. 2. During surgery, tumor-negative resection margins are of great prognostic value. Currently, surgeons rely on visual and tactile inspection for differentiation between malignant and healthy tissue. When in doubt, a frozen section can be obtained, which is time consuming and poses a high risk of sampling error. However, 14.7% of patients still have tumor-positive resection margins, increasing the risk of local recurrence and worsening outcome. Therefore, there is a need for novel imaging techniques that can be used intraoperatively to improve margin assessment. The investigators believe molecular fluorescence-guided surgery (MFGS) could be a promising technique for evaluation of resection margins.

NCT ID: NCT04633421 Completed - Critical Illness Clinical Trials

PRotEin Provision in Critical IllneSs

PRECISe
Start date: November 19, 2020
Phase: N/A
Study type: Interventional

Rapid skeletal muscle wasting during critical illness had a detrimental impact on both short and long term outcomes following ICU admission. Increased dietary protein delivery might attenuate skeletal muscle wasting and its subsequent effects on post-ICU function. The investigators will conduct a 935 patient, randomised controlled, quadruple blinded parallel group trial to determine whether enteral nutrition with increased protein content in mechanically ventilated, critically ill patients is able to improve functional recovery.

NCT ID: NCT04631016 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis

FRONTIER-4
Start date: December 14, 2020
Phase: Phase 2
Study type: Interventional

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.

NCT ID: NCT04626661 Completed - Healthy Clinical Trials

Mitochondrial Oxygen Measurement Variability in Critically Ill Patients (INOX Variability Study)

Start date: June 15, 2020
Phase:
Study type: Observational

To determine the between- and within-subject variability of the mitochondrial oxygenation measurement with the COMET device over time in healthy subjects and in hemodynamically stable subjects admitted to the intensive care unit.

NCT ID: NCT04626349 Completed - Advanced Cancer Clinical Trials

International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families

DIAdIC
Start date: February 24, 2021
Phase: N/A
Study type: Interventional

The overall aim of this project is to evaluate the effectiveness, cost-effectiveness and mechanisms of action of two psychoeducational interventions (a face-to-face nurse-led intervention called FOCUS+ and an eHealth intervention called iFOCUS) aimed at improving the emotional function and self-efficacy of patients with advanced cancer and their family caregiver. Both interventions are compared to care as usual. Both interventions focus on teaching dyads optimal ways to jointly manage the implications of advanced cancer and responding to their priority concerns and are designed to be tailored to the specific needs and wishes of the patient-caregiver dyads. Tailoring is based on information about the dyad obtained at enrollment (e.g. age, relationship, etc.) and the responses in the intervention sessions. The overarching aim is addressed by five core intervention components: 1. supporting family involvement and improving the dyads mutual communication, 2. supporting outlook (i.e. increasing the dyad's capacity to identify positive or meaningful aspects related to their situation), 3. increasing dyads' coping skills, i.e. their capacity to identify their coping strategies and take action 4. help dyads reduce their uncertainty 5. teaching symptom management and giving them confidence to handle specific tasks and problems Project objectives: 1. To compare 1) the face-to-face FOCUS+ intervention and 2) the iFOCUS web intervention to 3) care as usual in terms of their: - Effect on the emotional function and self-efficacy (primary outcomes), appraisal of illness, uncertainty, hopelessness, coping, dyad communication, quality of life and healthcare resource use of patients with advanced cancer and their family caregivers - Cost-effectiveness - Effects on vulnerable subgroups (particularly women and those of lower socioeconomic status) - Effectiveness in different healthcare systems 2. To evaluate the implementation process of the interventions in terms of the acceptability, feasibility, usefulness as perceived by patients, family caregivers and healthcare staff in each country, and their mechanisms of action. Data will be collected three times from patient-caregiver dyads: 1) baseline measure (t0) after which the dyad will immediately be randomized to one of the study arms, 2) first follow-up at 12 weeks after baseline (t1) and 3) second follow-up at 24 weeks after baseline (t2).

NCT ID: NCT04620902 Completed - Clinical trials for Cognitive Impairment

Detection of AD Biomarkers in Tear Fluid

SmartTears
Start date: January 1, 2018
Phase:
Study type: Observational

Detection of AD biomarkers in tear fluid

NCT ID: NCT04619212 Completed - Breast Pumping Clinical Trials

Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card

Initiate
Start date: January 5, 2021
Phase: N/A
Study type: Interventional

The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.