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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: NCT04625725 Completed - COVID-19 Clinical Trials

Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.

PROVENT
Start date: November 21, 2020
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

NCT ID: NCT04625348 Completed - Pressure Ulcer Clinical Trials

A Multicentre Clinical Test of the Ultracore Repose® Mattress to Prevent Pressure Ulcers Cat. II-IV in Nursing Homes

Start date: February 15, 2020
Phase: N/A
Study type: Interventional

A mixed method desgin study will be conducted to study pressure ulcer incidence Cat. II-IV (including deep- tissue injury,unstageable), not associated with the use of medical devices, on the Ultracore Repose® mattress (Frontier therapeutics Ltd) and to study differences in caretakers' experiences and perceptions when using the Ultracore Repose® mattress versus the Repose overlay mattress®

NCT ID: NCT04625309 Completed - Clinical trials for Spinal Cord Injuries

Effect of Adaptive Sports After Acquired Physical Disability

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

This study is a cross-sectional trial which aims to evaluate the effect of practicing a physical activity on different domains of the ICF among individuals with an acquired physical disability. Two different groups of individuals with a spinal cord injury will be enrolled: one composed of subjects who manage to reach the WHO's recommendations regarding physical activity, and the other of subjects who do not.

NCT ID: NCT04624529 Completed - Stroke, Acute Clinical Trials

Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke

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

Cognitive disorders are common early after stroke but can be overseen in patients with mild stroke who seem to be functionally recovered but are at risk to experience difficulties in advanced daily activities affecting social, vocational and family responsibilities. Acute stroke units admit a large number of patients and adequate referral to rehabilitation services is essential in terms of quality of care. A self-evaluation tool to evaluate cognitive function was developed by the occupational therapy department. Patients with mild strokes and pre-stroke independent for instrumental daily activities fill out this self-evaluation tool, which is a paperwork task. Semi-structured interpretation is performed by physician and may result in referral to the occupational therapist for comprehensive evaluation. In this study the validity and reliability of the self-evaluation tool will be examined.

NCT ID: NCT04622735 Completed - Acute Pain Clinical Trials

Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction

Start date: February 22, 2020
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.

NCT ID: NCT04622215 Completed - Clinical trials for End Stage Renal Disease

Diuresis, Functional Bladder Capacity and LUTS in CKD and ESRD Patients.

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the prevalence of LUTS in patients with moderate to severe (Stage IIIb), severe (Stage IV) CKD and ESRD : Stage V CKD) without renal transplantation (both pre-dialysis and dialysis patients). The study will also investigate the correlation between the diuresis, functional bladder capacity and LUTS in this population. By means of the obtained results, the investigators hope to be able to predict at which values of diuresis and functional bladder capacity these patients will start to develop LUTS. The investigators will also evaluate the impact of LUTS on the quality of life of these patients.

NCT ID: NCT04620733 Completed - Clinical trials for Primary Biliary Cholangitis

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

NCT ID: NCT04618159 Completed - Eradication Clinical Trials

Does Helipyl Eradicate

Helipyl
Start date: February 10, 2019
Phase: Phase 4
Study type: Interventional

Helipyl is on the market; actually it is a post-biotic because it is a killed Lactobacillus reuteri DSMZ 17648. The aim is to demonstrate (or not) that this product eradicates helicobacter, which it claims to do.

NCT ID: NCT04616339 Completed - Clinical trials for Overweight and/or Obesity

STUDY TO COMPARE PHARMACOKINETICS (PK) OF SINGLE ORAL DOSES OF DIFFERENT PF-06882961 FORMULATIONS IN PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY

Start date: November 4, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the effect of formulation on relative bioavailability of PF-06882961.