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NCT ID: NCT05694247 Not yet recruiting - Corneal Disease Clinical Trials

Pivotal Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

Start date: March 2023
Phase: N/A
Study type: Interventional

A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

NCT ID: NCT05693207 Recruiting - Clinical trials for Evaluation of Muscle Contraction in People With PD

EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease

Start date: October 7, 2021
Phase: N/A
Study type: Interventional

The main goal of this study is to evaluate, via EMG (electromyography) system, the muscle activity in the lower limbs, to understand the contribution of the muscle activity to FOG (freezing of gait) in Parkinson's patients. The phenomenon of FOG appears in advanced cases of Parkinson's disease (PD) and can lead to an increased risk of falls. There are several approaches claiming that there is abnormal activity in the calf muscles and the freezing events in Parkinson's patients. In the clinic, monitoring FOG is done subjectively, usually through observations or through questionnaires. As a result, the information about the phenomenon may be biased and insensitive. With an electromyographic monitor (EMG), objective information about the muscular activity during normal walking and during unusual events can be obtained.

NCT ID: NCT05688644 Enrolling by invitation - Overactive Bladder Clinical Trials

Sacral Neuromodulation in Neurogenic Patients

Start date: December 19, 2021
Phase:
Study type: Observational

The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. [. The main question[s] it aims to answer are: - determine efficacy and safety of the therapy in neurogenic patients. - compare outcomes of the therapy to idiopathic patients. If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.

NCT ID: NCT05688514 Recruiting - Clinical trials for Mitral Valve Regurgitation (Degenerative or Functional)

TVMR With the Innovalve System Trial - First In Human Israel

TWIST-FIHIL
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

NCT ID: NCT05688020 Not yet recruiting - Clinical trials for Esophageal Neoplasms

Tranexamic Acid During Upper GI Endoscopic Resection Procedures

Start date: February 2023
Phase: Phase 4
Study type: Interventional

Endoscopic resection of gastrointestinal lesions may prevent cancer. However, resection is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. The investigators aim to evaluate the effect of local TXA on preventing intraprocedural and postprocedural bleeding in patients undergoing endoscopic mucosal resection (EMR) of upper gastrointestinal lesions.

NCT ID: NCT05687942 Not yet recruiting - Surgical Incision Clinical Trials

The REBUILD Trial: Closure of the Abdominal Wall

Start date: March 2023
Phase: N/A
Study type: Interventional

The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy. The main question it aims to answer are whether the device when used to support suture in abdominal wall closure safely maintains apposition of the abdominis rectus muscles within a pre-defined distance. Participants will undergo standard of care laparotomy and the investigational device will be used to support the suture used to close the abdominal wall. Participants will have an MRI at 1-month after surgery to measure the distance between the abdominus rectus muscles.

NCT ID: NCT05686070 Not yet recruiting - Clinical trials for Acute Non-cardioembolic Ischemic Stroke

A Study to Learn More About Asundexian (Also Called BAY2433334) for Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older Who Already Had Such a Stroke Due to a Blood Clot That Formed Outside the Heart and Travelled to the Brain, or Temporary Stroke-like Symptoms

OCEANIC-STROKE
Start date: February 16, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - a stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - temporary stroke-like symptoms with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Ischemic strokes or transient ischemic attacks result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or temporary stroke-like symptoms when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo as tablets once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

NCT ID: NCT05683548 Available - Clinical trials for Hepatocellular Carcinoma

Replicor Compassionate Access Program

RCAP
Start date: n/a
Phase:
Study type: Expanded Access

The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to response to other other antiviral agents either approved or under development and who are in danger of progressing to decompensated cirrhosis. This compassionate access program will provide access to a once weekly regimen of subcutaneously (SC) administered REP 2139-Mg for a period of 48 weeks with the goal of achieving functional cure of HDV and or HBV, with the reversal of liver disease in the absence of antiviral therapy. The safety, tolerability and efficacy of SC REP 2139-Mg will be monitored during and after therapy

NCT ID: NCT05682157 Not yet recruiting - Clinical trials for Low Anterior Resection Syndrome

Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial

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

Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the usefulness of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

NCT ID: NCT05677555 Recruiting - Clinical trials for End Stage Renal Disease on Dialysis

Colchicine and Inflammation in Hemodialysis Patients

CICI-HP
Start date: November 1, 2022
Phase: Phase 2
Study type: Interventional

Chronic, low-grade inflammation is regarded as a common comorbid condition in chronic dialysis patients. Increased inflammatory markers in chronic dialysis patients are associated with adverse clinical outcomes . Considering the association of low-grade inflammation with high rate of morbidity and mortality we decided to evaluate the anti inflammatory effect of colchicine on inflammatory markers in hemodialysis patients