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NCT ID: NCT05054868 Recruiting - Arthrodesis Clinical Trials

Ketorolac vs Oxycodone for Great Toe Arthrodesis

Start date: April 14, 2020
Phase: Phase 1
Study type: Interventional

This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

NCT ID: NCT02814864 Recruiting - Clinical trials for Radiation-induced Hemorrhagic Cystitis

Trial Evaluating the Efficacy of Systemic Mesenchymal Stromal Cell (MSC) Injections for the Treatment of Severe and Chronic Radiotherapy-induced Abdomino-pelvic Complications (Pelvic Radiation Disease, PRD) Refractory to Standard Therapy

PRISME
Start date: April 14, 2021
Phase: Phase 2
Study type: Interventional

Patients receiving radiation therapy are still at risk for side effects due to off-target radiation damage of normal tissues The number of cancer patients is expected to increase from 14.1 million around the world in 2012 to 19.3 million in 2025. Up to ten percent will develop late severe gastrointestinal complications (i.e. Pelvic Radiation Disease - PRD). Symptoms are proctopathy (5-20%) and radiation-induced cystitis (3,5%) that affect quality of life. The treatment of PRD is limited to managing the symptoms; new alternatives should be proposed. Clinical trials using MSCs to treat hemorrhagic cystitis, proctopathy have demonstrated the feasibility to used MSCs in these pathologies : - MSCs successfully repair hemorrhagic cystitis, and perforated colon in patients with hemorrhagic cystitis, perforated colon and peritonitis. - Six clinical trials are currently ongoing for proctopathy, 3 are phase III. Results suggest an inhibition of chronic inflammation and fistulization and interruption of hemorrhagic syndromes. - Clinical trials to evaluate the efficacy of MSCs to treat hemorrhagic cystitis is in progress. - A decrease in pain after the injection of MSCs was observed in patients treated by radiotherapy for breast cancer, radiation burns, and radiotherapy over-dosage. - Four patients, were treated with MSCs after receiving overdose pelvic irradiation for prostate cancer. A decrease in pain (EN score), bleeding and diarrhea was observed. MSCs will represent a promising alternative strategy in the treatment of severe enteritis, rectitis and cystitis after radiotherapy, and may avoid surgical treatment and may diminish the adverse effect of PRD in terms of chronicity, morbidity, mortality and health costs.

NCT ID: NCT04065802 Recruiting - Clinical trials for Stereotactic Radioablation for Ventricular Tachycardia

Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

STAR VTM
Start date: April 14, 2021
Phase: N/A
Study type: Interventional

Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia. STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.

NCT ID: NCT04117074 Recruiting - Surgery Clinical Trials

Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery

Start date: April 14, 2021
Phase: Phase 3
Study type: Interventional

The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using a non-inferiority randomized trial design. The impact of TEA and surgical site infiltration with LB on neuroendocrine and inflammatory mediators of surgical stress response (SSR) will also be investigated as a translational endpoint.

NCT ID: NCT04167033 Recruiting - Clinical trials for Premature Ovarian Insufficiency

Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QT-IOP)

QT-IOP
Start date: April 14, 2021
Phase: N/A
Study type: Interventional

Ventricular repolarization, measured by corrected QT interval (QTc), is influenced by sex hormones. A QTc above 460msec predisposes to the risk of "torsades-de-pointes"(TdP). The investigators have recently shown that estradiol determines an increase in QTc elongation and progesterone shortens it. In addition, high gonadotropin levels (FSH or LH) are associated with QTc prolongation. Hypergonadotropic hypogonadisms (low progesterone and high gonadotropins) are therefore hormonal situations that promote QTc prolongation. Premature ovarian insufficiency (POI) is one of them. Its management is based on the prescription of hormone replacement therapy (HRT). Epidemiological studies have shown that these patients would be at increased risk of cardiovascular mortality. Our team is interested in the effect of this pathological hormonal situation and its HRT on ventricular repolarization in order to define whether this is a population at risk for long QTc.

NCT ID: NCT04270175 Recruiting - AL Amyloidosis Clinical Trials

Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab

Start date: April 14, 2021
Phase: Phase 2
Study type: Interventional

This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment.

NCT ID: NCT04326205 Recruiting - Clinical trials for Cerebrovascular Accident

Neural Mechanisms and Efficacy of Dual Neurotechnology-aided Mirror Therapy in Chronic Stroke: Neural and Motor Plasticity, Movement Performance, Daily Function, and Quality of Life

Start date: April 14, 2021
Phase: N/A
Study type: Interventional

Mirror therapy (MT) has been demonstrated, in terms of neuroplasticity, to improve sensorimotor function of paretic upper extremity (UE) in chronic stroke patients. Central and peripheral electrical stimulation techniques such as ranscranial direct current stimulation (tDCS) and functional electrical stimulation (FES) can individually enhance effects of MT, combining both of them with MT can be a potentially valuable approach to maximize neural and functional recovery post stroke. To our knowledge, no studies combined central and peripheral neural network reorganization technique with motor behavioral learning approach to investigate its possible benefit after stroke. This project will be the first to design a "dual neurotechnology-aided MT (DNA-MT)", which combines tDCS and FES with contemporary neurorehabilitation approaches (i.e., MT) to stimulate both central and peripheral nervous systems to maximize neural and functional recovery post stroke. Investigators will determine the efficacy and neurophysiological and motor mechanisms related to this novel DNA-MT approach and identify potential responders to this novel intervention.

NCT ID: NCT04620759 Recruiting - Clinical trials for Major Depressive Disorder

Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder

PsiloMDDAUD
Start date: April 14, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether psilocybin, a hallucinogenic drug, is effective in reducing depressive symptoms and amount of drinking in patients with co-occurring Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD).

NCT ID: NCT04683003 Recruiting - Clinical trials for Thrombotic Thrombocytopenic Purpura (TTP)

A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura

Start date: April 14, 2021
Phase: Phase 3
Study type: Interventional

Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can also occur. People who have TTP may bleed underneath the skin forming purple bruises, or purpura. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them, leading to fewer red blood cells than in normal. TTP is caused by a lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in controlling clotting of the blood. The ADAMTS13 enzyme breaks up another blood protein called von Willebrand factor that forms blood clots by clumping together with platelets. Some people are born with this condition, while others develop the condition during their life. Many people who are born with TTP experience frequent flare-ups that need to be treated right away. TAK-755 is a medicine that replaces ADAMTS13 and may prevent or control TTP flare-ups, called acute TTP events. The main aim of the study is to check for side effects of long-term treatment with TAK-755. Treatment will be given in 2 ways: 1. TAK-755 treatment given either every week or every other week to prevent acute TTP events from happening (the "prophylactic" cohort). 2. TAK-755 treatment given to control an acute TTP event when it happens (the "on-demand" cohort). Participants in the prophylactic cohort will receive treatment in the clinic or at home for up to approximately 3 years. They will visit the clinic at least every 12 weeks. Participants in the on-demand cohort will receive daily treatment for the acute TTP event until the flare-up has gotten better. They will have a follow-up visit at the clinic 4 weeks later.

NCT ID: NCT04717102 Recruiting - Anesthesia Clinical Trials

Evaluating the Use of 0.5 and 0.75 MAC Desflurane in Patients Undergoing Spinal Surgery

Start date: April 14, 2021
Phase: Phase 4
Study type: Interventional

Background: Somatosensory- (SSEPs) and motor-evoked potentials (MEPs) are commonly used as an intraoperative neurophysiologic monitoring tool to detect aberrations to the spinal cord integrity during spinal surgery. Inhalational anaesthetic agents have a significant influence on evoked potentials by suppressing the amplitude and prolonging the latency. Evidences suggest that total intravenous anaesthesia (TIVA) is superior to inhalation anaesthesia for neuromonitoring in spinal surgery, and support the use of up to 0.5 minimum alveolar concentration (MAC) of inhalational anaesthetic agents in these procedures. Methods: Patients undergoing spinal surgeries will be prospectively recruited and be induced with TIVA at baseline of the evoked potentials. They will be randomized to receive balance anaesthesia with A) Desflurane MAC 0.5+remifentanil, or B) Desflurane MAC 0.75+remifentanil until the end of surgery. Influence of 1.0 MAC desflurane on the evoked potentials after the completion of surgery will also be studied. Desired Results: Endpoints include the changes to the amplitude and latency of SSEPs and MEPs with 0.5 and 0.75 MAC desflurane. The findings will indicate the safety of desflurane at the studied concentrations for spinal surgeries, and substantial savings with the use of desflurane instead of TIVA.