Clinical Trials Logo

Filter by:
NCT ID: NCT03945916 Completed - Hypoxia Clinical Trials

Dark Chocolate and Exercise Performance in Hypoxia

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

Nitrate supplements (beetroot juice, pure sodium nitrate) have become common among endurance athletes because the ingestion of exogenous nitrate leads to increased levels of nitric oxide (NO) in the body. Increased NO has been shown to have various performance enhancing effects such as increased muscle contractility, increased blood flow through vasodilation, mitochondrial biogenesis, and improved glucose uptake. Supplementation with exogenous forms of nitrate has also been shown to improve cycling performance in the oxygen deprived environment of simulated altitude through increased muscular oxygenation. Further research is emerging that suggests that dark chocolate (DC) may have similar effects through flavonoids, a bioactive micronutrient that increases the synthesis of NO and reduces the rate at which NO is removed from the blood. In addition to performance enhancement, the flavonoids in DC also have anti-inflammatory and antioxidant effects, which could reduce muscle damage after a bout of exercise and increase the rate at which the muscle recovers. The purpose of this research is to investigate the effects of DC on cycling performance and recovery in cyclists at altitude. it is hypothesised that the DC condition will result in superior metabolism during exercise and increase muscular oxygenation, leading to improved performance while enhancing recovery from exercise. Methods: 12 trained cyclists will be randomized to supplement with 160g of DC or an isocaloric placebo per day for 2 weeks in a cross-over study. After the 2-weeks of supplementation participants will attend a lab session in which they will cycle 90 minutes at 60% VO2max followed immediately by a 10km time trial (TT) at a simulated altitude of 1500m (15% O2). Plasma levels of blood glucose and lactate will be measured before, throughout, and after exercise while muscular and cerebral oxygenation will be measured continuously throughout exercise. Recovery of the knee extensors will be assessed before and immediately after exercise as well as 24 and 48 hours later by determining knee extensor strength and muscle pain.

NCT ID: NCT03945188 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 52
Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

NCT ID: NCT03945162 Recruiting - Clinical trials for Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive/Intolerant to BCG

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients

Start date: August 30, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with NMIBC CIS (with or without resected papillary disease (Ta, T1)) that are considered Bacillus Calmette-Guerin ("BCG")-Unresponsive or who are intolerant to BCG therapy. BCG-Unresponsive is at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; or, at least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Patients experiencing disease relapse within 12 months after finishing the second course of BCG therapy are considered BCG-Unresponsive. The Study will consist of approximately 100 to 125 patients who will undergo two (2) PDT treatments employing 0.70 mg/cm^2 of Ruvidar® (TLD-1433) at Day 0 and Day 180.

NCT ID: NCT03944889 Completed - Clinical trials for Central Sensitisation

Quantitative Ultrasound Response of Capsaicin

QUROC
Start date: July 1, 2019
Phase: Early Phase 1
Study type: Interventional

Central Sensitization is an aspect of chronic pain and is associated with over-excitability of the central nervous system. Central Sensitization normally presents itself with other chronic syndromes such as Myofascial Pain Syndrome, so it is difficult to separate the characteristics of the two. The purpose of this study is to determine whether sensitizing healthy muscle using capsaicin, a chilli pepper extract, induces a regional change in ultrasound texture features of the targeted muscle, or the muscles in that are in close proximity. This regional change will be accompanied by electromyography (EMG) recordings to confirm the presence of abnormality. Topical capsaicin and injectable capsaicin will be applied at three different concentrations, 0ug(placebo effect),50ug and 100ug. Research Questions: Does sensitization cause a significant regional change in the texture features of the targeted muscle or surrounding muscles? Is this regional change confirmed by abnormality of motor unit firing rates or EMG amplitudes? Is the response dose dependent? Does the induced central sensitization cause a change in force steadiness? Experimental Protocol: The physician on site will apply surface and intramuscular EMG sensors to the trapezius. A goniometer will be placed on the subjects arm to detect position. Following this, an ultrasound image of the trapezius, supraspinatus and infraspinatus will be taken.The participant will perform an increasing and decreasing contraction.The subject will then have capsaicin injected into their trapezius or applied onto their skin. The exercise and measurements will then be repeated. The ultrasound will be acquired by the Sonosite ultrasound system. The EMG data will be acquired by the Delsys Trigno EMG system for the surface EMG and the Cadwell Sierra Wave system for the intramuscular EMG. The data will be processed through Delsys EMGworks software and MATLAB. Texture features of the pre and post injection ultrasound images will be compared. Decomposition of motor units will allow for the analysis of motor unit action potential firing rate and amplitudes. Analysis of force steadiness will also be calculated via the goniometer. Overall, the findings from this study should present preliminary evidence to inform central sensitization's effects on regional muscle structure changes, functional changes and motor unit activity.

NCT ID: NCT03944837 Recruiting - Clinical trials for Congenital Heart Disease

Acute Maternal Hyperoxygenation in CHD

Start date: April 26, 2019
Phase: N/A
Study type: Interventional

Congenital heart disease (CHD) is predominantly detected before birth. Using echocardiography and MRI, this study will determine whether acute exposure to maternal hyperoxygenation (MH) leads to measurable increases in fetal cerebral oxygenation from baseline in fetuses with CHD. The study aims to determine whether MH could be used as a chronic in-utero treatment strategy to promote brain growth/maturation to birth and to improve postnatal neurodevelopmental outcomes, and identify the types of CHD most likely to benefit from chronic MH.

NCT ID: NCT03944798 Recruiting - Soft Tissue Sarcoma Clinical Trials

Surveillance AFter Extremity Tumor surgerY

SAFETY
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. Using a 2X2 factorial design to maximize efficiency and reduce overall trial costs, the SAFETY trial will randomize 830 extremity soft-tissue sarcoma (STS) patients to determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs).

NCT ID: NCT03944538 Terminated - Multiple Sclerosis Clinical Trials

Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

Start date: July 21, 2019
Phase: N/A
Study type: Interventional

Vascular comorbidities, such as high cholesterol, obesity, high blood pressure, and diabetes, are common among people with multiple sclerosis (MS), and can negatively impact disease diagnosis, treatment, and progression. Physical inactivity may be one possible reason for this increased risk and may occur through changes in cardiorespiratory fitness (the ability of the body to transport and use oxygen during sustained physical activity). While exercise training is effective for improving fitness, factors such as accessibility to facilities and financial cost may not make it a viable option for most people with MS. An alternative approach for improving fitness is by increasing daily physical activity levels. The research team has developed and tested an Internet-delivered lifestyle physical activity intervention that has been shown to improve physical activity levels among people with MS. This lifestyle intervention is a promising approach for also increasing fitness and managing vascular comorbidity risk in persons with MS. This randomized clinical trial will examine the efficacy of a 6-month lifestyle physical activity intervention on cardiorespiratory fitness and vascular comorbidity risk in persons with MS.

NCT ID: NCT03944005 Withdrawn - Knee Arthroplasty Clinical Trials

Comparing Two Regional Anesthesia Interventions for Knee Arthroplasty.

Start date: July 2020
Phase: N/A
Study type: Interventional

Osteoarthritis of the knee is a common disease of the elderly and knee arthroplasty is indicated in severe cases to improve long term pain and function. Along with perioperative quality analgesia, functional recovery is paramount in the postoperative period.Loco-regional techniques provide effective analgesia and can mitigate several side effects of systemic opioids administration. Also, adequate motor sparing analgesia( to prevent weakness of the thigh muscle) following total knee arthroplasty (TKA) is therefore paramount to ensure effective rehabilitation, early recovery, readiness to discharge or timely hospital discharge. There are several motor sparing regional technique described in literature. Adductor canal block (ACB), use of intrathecal ( IT) morphine and local infiltration by the surgeons (LIA) are such examples. Previous studies have shown the combination of ACB and IT morphine to be superior than LIA in providing analgesia. Posterior knee infiltration (IPACK), involves blocking the branches of the tibial nerve which provides sensory innervation for the posterior aspect of the knee. In combination with ACB, a motor sparing analgesic intervention is possible for knee arthroplasty. Rationale for doing the study is to evaluate 1. The effectiveness of IPACK block as a part of multimodal analgesic approach to knee arthroplasty surgery. 2. Enhanced recovery from superior motor sparing analgesia. 3. early hospital discharge We hypothesize that, following total knee arthroplasty surgery, the combination of continuous adductor canal catheter and I-PACK blocks will achieve a decrease in the time to readiness to hospital discharge as measured by the following four criteria: (1) adequate analgesia; (2) independence from intravenous opioids; (3) ability to independently stand, walk 3 m (metres), return, and sit down; and (4) independently ambulate 30 m without limitation of time. We postulate this will occur by providing superior motor-sparing analgesia compared to LIA for knee arthroplasty surgery.

NCT ID: NCT03943290 Terminated - Clinical trials for Charcot-Marie-Tooth Disease

Extension Study to Evaluate the Long-Term Effects of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie Tooth (CMT) Disease Types 1 and X (CMT1 and CMTX)

Start date: May 10, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, phase 2 extension study to evaluate the safety, tolerability, PK, PD, and efficacy of ACE-083 in subjects with FSHD previously enrolled in Study A083-02 and subjects with CMT1 and CMTX previously enrolled in Study A083-03. This study will be conducted in two Parts: Part 1, which is a loading phase of 6 months' duration, and Part 2, the maintenance phase, which will last up to 24 months.

NCT ID: NCT03943147 Terminated - Lupus Nephritis Clinical Trials

An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

Start date: July 15, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).