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NCT ID: NCT06030908 Active, not recruiting - Clinical trials for Achilles Tendinopathy

Outcome After Surgical Reconstruction of the Achilles Tendon Insertion.

Start date: September 13, 2022
Phase:
Study type: Observational

The purpose of this study is to evaluate the functional outcomes and sports ability after surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment, debridement, and double-row anchor refixation.

NCT ID: NCT05941715 Active, not recruiting - Clinical trials for Neovascular Age-related Macular Degeneration

Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration

FAN
Start date: July 4, 2023
Phase: Phase 4
Study type: Interventional

Study purpose: To evaluate if previously high-frequent (3-5 weekly) aflibercept treated neovascular age-related macular degeneration (nAMD) can be extended in their treatment interval when switched to faricimab. Primary objective: To assess the efficacy of faricimab compared to aflibercept in terms of durability at 32 weeks by extending treatment interval in previous high-frequent aflibercept treated nAMD.

NCT ID: NCT05933135 Active, not recruiting - Clinical trials for Gastro Intestinal Bleeding

Factor XIII Activity in Gastrointestinal Bleedings

Start date: January 8, 2021
Phase:
Study type: Observational

The aim of this retrospective study is to investigate the relationship between factor XIII activity and the outcome of gastrointestinal bleedings. Since factor XIII is of great importance in haemostasis and plays a key role in stabilizing the fibrin clot, it can be assumed that a deficiency of factor XIII leads to an unfavorable course of gastrointestinal bleedings. Our hypothesis is that early detection of such a deficiency can prevent a more severe course and that substitution of factor XIII contributes to faster cessation of bleeding, improves patient outcome and reduces the number of red cell concentrates required.

NCT ID: NCT05926830 Active, not recruiting - Clinical trials for Chronic Venous Insufficiency

Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study

VEINRESET
Start date: October 12, 2023
Phase: N/A
Study type: Interventional

This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency. Patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will receive treatment with Sonovein for the targeted segments of GSV. At follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 12 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment.

NCT ID: NCT05911360 Active, not recruiting - HIV Infections Clinical Trials

A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF

EYEWITNESS
Start date: July 7, 2023
Phase: Phase 3
Study type: Interventional

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

NCT ID: NCT05911009 Active, not recruiting - Long Covid Clinical Trials

To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID

BLOC
Start date: June 16, 2023
Phase: Phase 2
Study type: Interventional

This study is an interventional, randomized, multinational, multicenter, double-blind, phase 2 study with a follow-up period of circa 12 months. The intension of this clinical trial is to investigate the long-term sequelae (named Long COVID syndrome; post COVID or PASC) of an infection with Corona Virus Type 2 that has resulted in a condition known as Severe Acute Respiratory Syndrome Corona Virus Type 2 (SARS-CoV-2). The purpose of this study is to evaluate the efficacy and safety of BC 007 as a treatment for long-lasting COVID-symptoms in patients who were neither intubated nor supported with extracorporeal blood oxygenation (ECMO) during their acute COVID-19 infection. The study drug acts by neutralizing functional autoantibodies directed against G-protein coupled receptors (GPCRs). Neutralization of the autoantibodies is expected to induce a beneficial effect on symptoms typically seen in patients with long COVID syndrome. Functional autoantibodies are proteins belonging to the class of G-type immunoglobulins that can be synthesized by activation of the immune system and can induce various pathogenic activities by binding to one of the extracellular loops of G-proteins (GPCR-AAB). The study consists of a screening phase of up to 35 days, treatment (two administrations by intravenous infusion at two-week intervals either with the study drug (BC 007) or with placebo (NaCl 0.9%), with an initial follow-up period of 15 days after each administration and an extended follow-up period of 330 days. Patients are required to visit the study center for follow-up visits at specified intervals. For the entire study duration of 395 days from screening to the end of the study, 11 site visits are planned.

NCT ID: NCT05878938 Active, not recruiting - Haemophilia A Clinical Trials

A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)

FRONTIER 5
Start date: June 26, 2023
Phase: Phase 3
Study type: Interventional

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

NCT ID: NCT05817812 Active, not recruiting - Clinical trials for Hemophilia A, Severe

A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa

FREEDOM
Start date: July 31, 2023
Phase: Phase 3
Study type: Interventional

FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis. After a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 IU/kg once-weekly for 24 months (additional preventive dose not permitted). An activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study. The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24. Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.

NCT ID: NCT05752487 Active, not recruiting - Atrial Fibrillation Clinical Trials

A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator

SmartfIRE
Start date: February 27, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

NCT ID: NCT05743530 Active, not recruiting - Clinical trials for Pancreaticoduodenectomy

Effect of Perioperative Neurostimulation in Patients Undergoing Whipple Operation (Pancreaticoduodenectomy) on Acute Postsurgical Inflammatory Response [ENSWAPI-trial]

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to test whether electrical stimulation of the vagus nerve via a device placed on the top of the external ear can reduce the postoperative inflammatory reaction after Whipple's surgery (pancreatoduodenectomy).