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Found 7 Actively Recruiting clinical trials

A

RECRUITING

EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 \[NCG03325439\] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 \[NCT01364597\]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

1+ yearsAll GendersPHASE3
36 locations
C

RECRUITING

Healthy Volunteer

De novo motor learning is a specific learning paradigm that allows investigation of how a new motor skill is learned from scratch. Motor task learning can induce increased corticospinal excitability and reorganization of connectivity observed within the motor cortex (M1). Several studies have investigated the plasticity mechanisms underlying motor learning using simple paradigms. The results obtained have been variable, with a major trend toward increased corticospinal excitability, while other results show no increase. We expect to observe a significant increase in excitability and enhanced intracortical reorganization mechanisms within M1 in our subjects during our de novo motor learning sessions. The primary objective of this study is to measure changes in corticospinal excitability of the motor system across 3 de novo motor learning sessions separated by different time intervals. The secondary objectives will be: 1) to measure learning across the three practice sessions, 2) to measure changes in inhibition and facilitation across the 3 learning sessions, and 3) to measure correlations between subjects' motor performance and corticospinal and intracortical changes.

18-35 yearsAll GendersNA
1 location
E

RECRUITING

Single-center, randomized, controlled study in adolescents living with type 1 diabetes. This study aims to evaluate the effect of exercise timing (morning vs. afternoon) and exercise type (continuous vs. intermittent) on blood glucose levels during and after exercise, as well as to assess the effect of exercise timing (morning vs. afternoon) and type of exercise (continuous vs. intermittent) on blood glucose during and after exercise

10-16 yearsAll GendersNA
1 location
E

RECRUITING

Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. However, no study has ever used phone contact as a relapse prevention intervention tool in AN. Objective: To evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for AN, by comparison to standard medical follow-up. Secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to AN, rate of usual follow-up visit, and medico-economic impact. Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of AN. Patients randomized in EATLINE group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. Patients in control group will benefit from usual follow-up. Expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. Results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of AN.

15+ yearsAll GendersNA
6 locations
G

RECRUITING

Healthy Volunteer

Elite-level sports expose athletes to training loads designed to induce muscle damage, aiming to achieve optimal physiological adaptations. However, the repetitive nature of such damage increases the risk of injury. The ability to assess an athlete's susceptibility to fragility is therefore crucial for optimizing their training and performance. Genetic factors appear to play a significant role in the occurrence of these injuries, particularly through subtle variations in DNA sequences. Depending on the location of these variations within a gene, they may or may not alter the expression or function of the associated protein. The investigators aimed to investigate the relationship between genetic polymorphisms and biological parameters in the context of exercise-induced muscle damage.

18-35 yearsAll GendersNA
1 location
I

RECRUITING

Healthy Volunteer

Aging is associated with structural and functional changes in the central nervous system that may negatively impact motor control, postural stability, upper-limb coordination, and adaptive motor behavior. These functional alterations are partly attributed to changes in cortical excitability and reduced efficiency of intracortical inhibitory and sensorimotor circuits within the primary motor cortex (M1). Such modifications may contribute to a decline in neuroplasticity, defined as the capacity of the brain to reorganize in response to internal or external stimuli. Neuroplasticity plays a critical role in motor learning and adaptation and is therefore essential for maintaining functional autonomy in older adults. Identifying interventions capable of enhancing or preserving neuroplasticity with aging represents an important clinical and societal challenge. Aerobic physical exercise has emerged as a promising non-pharmacological strategy to modulate cortical excitability and promote neuroplasticity. The primary objective of this study is to assess the effect of a single session of moderate aerobic exercise on neuroplasticity induced by transcranial direct current stimulation (tDCS) in older adults, compared with young adults. The secondary objective is to examine the influence of exercise on intrinsic intracortical circuits and sensorimotor integration mechanisms within M1. Study Design : This is a monocentric exploratory study where each participant will complete three experimental sessions separated by at least one week : Session 1 and Session 2 (randomized crossover design): * Condition A : 20 minutes of moderate aerobic exercise followed by tDCS. * Condition B : 20 minutes of seated rest followed by tDCS. The order of these two conditions will be randomized. Each participant serves as their own control. Session 3: * Assessment of the effects of aerobic exercise alone (without tDCS). Experimental Procedures : After providing written informed consent, participants undergo baseline assessments including questionnaires documenting physical activity level, handedness, and pain level. Participants are comfortably seated, and surface electromyography (EMG) electrodes are placed over the abductor pollicis brevis (APB) muscle of the dominant hand. Transcranial magnetic stimulation (TMS) is delivered over M1 corresponding to the dominant hand representation. The optimal stimulation site (hotspot) and resting motor threshold (RMT) are determined. Corticospinal excitability is assessed using single-pulse TMS at increasing intensities to construct input-output (I/O) recruitment curves. Motor evoked potentials (MEPs) are recorded from the APB muscle. A Boltzmann sigmoidal function is used to model I/O curves and extract parameters including slope, plateau, and S50. The primary outcome measure is the slope of the I/O curve, reflecting corticospinal recruitment gain. Neuroplasticity is evaluated by comparing corticospinal excitability before and after a 20-minute session of anodal tDCS applied over the dominant M1 (2 mA). Changes in I/O curve parameters after tDCS, with or without prior physical exercise, serve as indicators of induced plasticity. Intracortical inhibitory and facilitatory mechanisms are assessed using paired-pulse TMS protocols : * Short-interval intracortical inhibition (SICI) * Intracortical facilitation (ICF) * Long-interval intracortical inhibition (LICI) Sensorimotor integration is evaluated using paired peripheral nerve stimulation (median nerve at the wrist) combined with TMS to measure : * Short-latency afferent inhibition (SAI) * Long-latency afferent inhibition (LAI) * Afferent-induced facilitation (AIF) Outcome measures are expressed as ratios of conditioned to unconditioned MEP amplitudes. Aerobic Exercise Intervention : Moderate aerobic exercise consists of 20 minutes of cycling on an ergometer at 60 to 70 revolutions per minute. Exercise intensity is individualized to correspond to approximately 50% of heart rate reserve (moderate intensity), monitored throughout the session. The estimated duration of each experimental session is as follows : * Session 1 (2h05) : Information, consent, and questionnaires (10 minutes), electrode placement (5 minutes), baseline recordings (35 minutes), 20 minutes of aerobic exercise or seated rest (randomized), 20 minutes of tDCS, and 35 minutes of post-intervention recordings. * Session 2 (1h05) : Same procedure as Session 1 without information, consent, or questionnaires. Participants complete the alternate condition (exercise or rest), followed by tDCS and post-intervention recordings. * Session 3 (1h35) : Preparation (5 minutes), baseline recordings (35 minutes), 20 minutes of aerobic exercise, and 35 minutes of post-exercise recordings.

20-80 yearsAll GendersNA
1 location
V

RECRUITING

Relapse of AML is driven by chemotherapy resistant stem cells. One mechanism of chemotherapeutic resistance in AML is the overexpression of the protein B-cell lymphoma 2 (BCL-2), an anti-apoptotic protein which sequesters intracellular activators of apoptosis. Venetoclax is a selective, potent, orally bioavailable, small molecule inhibitor of BCL-2 that restores programmed cell death in cancer cells. This is a trial for children, adolescents and young adults with 2nd relapsed AML or 1st relapsed AML unable to receive additional anthracycline. This is randomized trial of venetoclax in combination with intensive chemotherapy (fludarabine/cytarabine/gemtuzumab ozogamicin) for the first two cycles (42-day-cycles) that would inform and evaluate if this agent is an effective option for this population to improve its poor prognosis. Participants can receive up to two cycles of induction chemotherapy before hematopoietic stem cell transplantation (HSCT). If participants who have perceived clinical benefit cannot be transplanted after the 2 cycles, maintenance treatment may be given at the discretion of the investigator. In Arm B (experimental arm), participants can continue venetoclax if they have perceived clinical benefit, and maintenance therapy will combine venetoclax with azacitidine for a maximum of 24 cycles. In Arm A (control arm), participants will receive azacitidine in monotherapy. Maintenance is continued until clinical progression or unacceptable toxicity with a maximum of 24 cycles.

29-21 yearsAll GendersPHASE3
89 locations
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