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NCT ID: NCT05040646 Completed - Rectal Cancer Clinical Trials

The Development of a Patient Reported Outcomes Measure Committed to the Watch-and-wait Program for Rectal Cancer

Start date: November 1, 2021
Phase:
Study type: Observational

The purpose of this study to develop an international tool that can be used to assess burden of disease in patients enrolled in the W&W program for rectal cancer

NCT ID: NCT05040373 Recruiting - Polyneuropathy Clinical Trials

Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

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

The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.

NCT ID: NCT05039879 Completed - Hip Fractures Clinical Trials

Life Improving Factors After a Hip Fracture

LIFF
Start date: September 6, 2021
Phase:
Study type: Observational

The primary objective of the proposed research is to investigate the association between protein intake and nutritional status with bone health and physical functioning in older hip fracture patients. In addition, it will be investigated which patient characteristics and modifiable factors can predict mobility, clinical frailty, living situation and mortality. This study will be a 3-month prospective cohort study in adults aged 70 years and older with an acute hip fracture. This study will lead to knowledge about how protein intake and nutritional status in combination with patient characteristics can predict the degree of recovery (bone health and physical functioning) 3 months after the hip fracture. Knowledge on factors related to recovery can contribute to an improved and shorter rehabilitation in the future, which results in a reduction of health care costs.

NCT ID: NCT05039515 Recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva

A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).

FALKON
Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability. This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head. Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).

NCT ID: NCT05039359 Terminated - Clinical trials for Paroxysmal Atrial Fibrillation

Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation

RESTORE-1
Start date: April 26, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF. Approximately 400 patients are expected to be enrolled in this study. Patients will be randomized 3:1 to receive FlecIH-103 at a total dose of up to 120 mg estimated total lung dose (eTLD) (n=300) or placebo inhalation solution (n=100). Randomization will be stratified by geographic region (US and ex-US) and duration of symptoms of the current AF episode (≥1 hour to ≤24 hours and >24 hours to ≤48 hours).

NCT ID: NCT05037929 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Start date: October 5, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

NCT ID: NCT05037916 Completed - Laser Burn Clinical Trials

Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging in Burn Patients

COLA-B
Start date: April 15, 2019
Phase:
Study type: Observational

Timely and accurate estimation of the surface area and depth of a burn injury is essential for determining an appropriate treatment modality. Inappropriate or inadequate treatment may result in complications and increased societal costs. Burn depth is determined by subjective assessing the characteristics of burn injury. Some objective methods are available (e.g., biopsy and histology, thermography and laser doppler imaging), but these are cumbersome. In assessing burn wounds, laser Doppler imaging (LDI) which has a good correlation with histology, is currently the most widely used and validated noninvasive measurement tool. In addition, it is the only technique that has been approved by the U.S. Food and Drug Administration. However, the use of LDI is accompanied by some disadvantages. The current commercial available LDI device is rather costly, cumbersome and has a poor spatial resolution. Another laser-based technique, laser speckle contrast imaging (LSCI), works with a similar principle and might become an alternative for LDI. LSCI has some advantages over LDI such as higher spatial resolution, much easier to position, no valuable time wasted on setting up the instrument, easy to take several images of burns that have a large surface area and/or much curvature, faster measurements, fraction of the time needed for getting a high-quality measurement, able to follow changes in the perfusion in real time. In contrast to the LDI, the LSCI has not been validated in terms of a diagnostic tool for stratifying the severity of a burn (based on LDI color coding). Consequently, we will compare the LSCI with LDI to improve burn care by providing cheaper, faster and higher resolution imaging technique.

NCT ID: NCT05037890 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Effects of Plant Sterols and Stanols on Liver Inflammation

Start date: February 20, 2020
Phase: N/A
Study type: Interventional

This study is a randomized, placebo-controlled, double blinded pilot study to assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 6 months on ALT concentrations in subjects with elevated ALT concentrations, i.e. who are at risk to develop NASH.

NCT ID: NCT05037461 Recruiting - Clinical trials for Multiple Endocrine Neoplasia Type 1

Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients

PRIME
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Patients with the Multiple Endocrine Neoplasia type 1 (MEN1) syndrome are genetically predisposed for developping multiple pancreatic neuro-endocrine tumours (pNET). The management of small (pNET) in both MEN1 and sporadic cases, pose a major clinical challenge. At present, pancreatic surgery is the only curative treatment but it is associated with high morbidity. To reduce the morbidity ascosiated with surgery and thereby potentially improve quality of life for MEN1 patients introduction of less invasive techniques for treatment of pNET is important. High-dose-high precision MR-guided radiotherapy (MRgRT) holds promise as a new less invasive treatment option for pNET. The aim of this study is to assess efficiacy and safety of MRgRT for treatment of pNET in MEN1 patients.

NCT ID: NCT05036135 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

IMPAHCT
Start date: December 2, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.