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NCT ID: NCT05654961 Recruiting - Heart Failure Clinical Trials

REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study

RELEASE-HF
Start date: January 1, 2022
Phase:
Study type: Observational

Telemedicine is gradually becoming accepted in heart failure (HF) management. Meta-analyses show a positive effect of telemedicine on hospital admission, length of stay, mortality, and costs. However, the magnitude of the effect is heterogeneous because of the variety in the HF population using telemedicine, components of telemedicine, and variety in considered costs. Despite the lack of clear guidance how to implement telemedicine within routine HF management, implementation of telemedicine is advocated by payers, private companies, and patient organizations. In this nationwide study the investigators aim to identify in which subgroup of HF patients telemedicine is (cost-)effective, and which intervention components of telemedicine are most (cost-)effective.

NCT ID: NCT05654675 Recruiting - Lung Cancer Clinical Trials

Evaluation of the Use of the FUR to Quantify Tumor Glucose Consumption in Oncologic PET

Start date: August 1, 2023
Phase:
Study type: Observational

The goal of this study is to evaluate the use of new method to quantify the amount of sugar a tumor consumes using PET/CT. The main questions it aims to answer are: - Is the new quantification method superior with respect to the method currently used in the clinic? - Does the new quantification method provide accurate assessment of the sugar consumption of tumours? Participants who will undergo a standard care FDG PET/CT scan will in additional receive a dynamic PET/CT scan prior to the standard care scan. In addition blood samples will be drawn at three time points during the examination.

NCT ID: NCT05653219 Recruiting - Clinical trials for Primary Immune Thrombocytopenia

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

VAYHIT2
Start date: January 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

NCT ID: NCT05652699 Recruiting - Respiratory Failure Clinical Trials

Effect of HFNO Therapy on Respiratory Effort After Extubation

T-REX
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Rationale: Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is used as post-extubation respiratory support. Although HFNO seems to reduce the need for re-intubation, scepticism on its use persists as the mechanism of action in post-extubation patients remains undefined. Monitoring weaning from invasive mechanical ventilation while monitoring respiratory effort might help to determine the added value of HFNO surrounding extubation. We hypothesize that HFNO, compared to conventional oxygen therapy (COT), prevents de-recruitment of the lung and reduces respiratory effort, and so provides a physiologic clarification for the reduction in the need for reintubation. Objective: Determine the physiological effect of HFNO compared to COT in the extubation phase regarding respiratory effort and lung aeration. Study design: A physiologic, randomized clinical study comparing two standard of clinical care therapies. Study population: Adult patients on invasive mechanical ventilation (IMV) for >72 hours, who are scheduled for extubation. Intervention (if applicable): Before extubation, patients are randomized to receive COT (reference group) or HFNO as oxygenation regimen after extubation. Main study parameters/endpoints: The main outcome is the difference in change in lung respiratory muscle effort (mean ΔPES) at 24 hours post-extubation between the study groups. Secondary parameters are differences in changes in respiratory effort at 2 and 4 hours post-extubation, difference in change in lung aeration (mean ΔEELI), differences in tidal volume, Lung Ultrasound (LUS) score, dyspnea score, and respiratory and sputum parameters between patients undergoing different post-extubation oxygenation regimens.

NCT ID: NCT05652673 Recruiting - Immunotherapy Clinical Trials

Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab

NCT ID: NCT05652374 Recruiting - Clinical trials for Recurrent Urinary Tract Infection

Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study

GT RACING
Start date: October 20, 2022
Phase: Phase 4
Study type: Interventional

The GT RACING is a study comparing the efficacy of HA-CS bladder installations with prophylactic antibiotics in the prevention of recurrent urinary tract infections (rUTI).

NCT ID: NCT05652335 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Start date: November 22, 2022
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

NCT ID: NCT05652205 Recruiting - Clinical trials for Functional Constipation (FC)

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide. Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05649930 Recruiting - Clinical trials for Cerebral Palsy, Spastic

Effect of Functional Power Training on Calf Muscle Length and Strength in Children With Spastic Paresis

MegaMuscle
Start date: June 20, 2022
Phase:
Study type: Observational

Spastic paresis (SP) is a common motor condition in children and is often caused by cerebral palsy. Skeletal muscles develop differently in children with SP due to brain damage in early development; muscle strength and muscle length are reduced compared to typically developing (TD) children. Especially, the calf muscles are affected, which particularly affects their ability to walk and to run, hindering participation in society. There are several treatments aimed to increase the range of motion of the joint by lengthening the muscle, for example botulinum toxin injections. However, these treatments can have a weakening effect on the muscle due to deconditioning from immobilization and due to paralysis. In rehabilitation centers in the Netherlands functional power training (MegaPower) is offered to children with SP who want to walk and run better. It has been shown that this training improves calf muscle strength and performance during functional walking tests. However, the effect of MegaPower training on muscle morphology (i.a. muscle volume and length) is still unknown. Therefore, the aim of this study is to assess the effect of MegaPower training on the muscle morphology of the medial gastrocnemius in children with SP using 3D ultrasonography. It is expected that MegaPower training results in an increase of muscle volume as well as elongation of the muscle belly. Muscle volume could increase due to hypertrophy of the muscle fibers induced by the training, which could elongate the muscle belly length due to the pennate structure of the medial gastrocnemius. A double-baseline design will be applied for this study with three different measurement times (T0-T1-T2) to compare the training period (12 weeks) with a period (12 weeks) of usual care.

NCT ID: NCT05648864 Recruiting - Dementia Clinical Trials

Viamigo for People With Dementia and Their Informal Caregivers

Start date: February 7, 2023
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate the feasibility of the Geographic Information System (GIS)-based mobile application 'Viamigo' among people with dementia living in the community and their informal caregivers. Viamigo aims to support the independent out-of-home mobility of the user and to reduce informal caregiver's burden by teaching users a known individual route, which they can accomplish independently while being monitored by an informal caregiver. Although Viamigo was initially developed for persons with intellectual disabilities, it is expected that it can also support and improve out-of-home mobility and thereby the social participation of people with dementia. The design of the study is a mixed methods single-arm pre-post design with a baseline assessment, a 3-month intervention period, and a post-intervention assessment. Dyads (n=24) of people with mild to moderate dementia living in the community and their informal caregivers will use the mobile application for 3 months. The main study parameter is the feasibility of the Viamigo intervention for people with dementia and their informal caregivers. Secondary study parameters for people with dementia include out-of-home mobility and social participation. Secondary study parameters for informal caregivers include quality of life, caregiver burden, and gains in dementia caregiving.