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NCT ID: NCT04264195 Completed - Clinical trials for Weakness of Extremities as Sequela of Stroke

Peer Group Regulated mCIMT Program for Adult Stroke Patients: Effects on Functional Activities

PEPS-MIT
Start date: October 27, 2018
Phase: N/A
Study type: Interventional

Each year more than 17 million people in the world are experiencing a stroke. Stroke is a major cause of mortality and one of the prevalent causes of serious disablement. Stroke sufferers often will have restricted participation in various domains e.g. not being able to fulfill the job requirements. That is why they are losing social contacts and are at risk for social deprivation. They also show limitations in common daily activities, which implies that they often need help or must use assistive devices because of muscle weakness, spasticity and impaired control over one of the hands, which are very common after stroke. Functional hand recovery will be only minimal at 6 months after stroke in most of the patients. Therefore, patients mainly rely on their unaffected hand to perform daily activities and refrain from using the impaired hand. However, it is known that also after a stroke new connection could be made in the brain when training tasks strenuously. This mechanism is applied in our program by constraint induced movement therapy (CIMT). In CIMT using the unaffected hand is hindered by a mitten, so that patients are forced to perform tasks predominantly with the paretic hand. The original CIMT protocol includes three main elements: - Constraining of the non-paretic hand to force the use of paretic hand. - Repetitive task-oriented training of the paretic hand. - Adherence-enhancing behavioral methods, to promote the use of this technique in the daily environment. Although CIMT trials are showing variations in the kind of tasks, the duration of practice per day and the intensity, they all published significant effects of CIMT compared to traditional therapy. Currently CIMT is worldwide considered the most effective rehabilitation treatment for improving the functioning of the paretic hand in stroke, but this treatment is not applied in Bangladesh. To overcome this,the investigators have made a protocol for CIMT application with the purpose to study the effects in stroke patients in the Bangladesh situation. Method Beside the CIMT program the investigators also developed a method for getting maximal social interaction in groups of stroke patients. That may help them to exercise on their own with support of their peers. The investigators call that a 'peer group regulated training' and stroke patients got that training in addition to the usual individually focused rehabilitation. This extra training includes the following elements: - Stroke patients perform repetitive tasks in a group together (groups 6-8 persons, max 15). - One of them is assigned as a 'leader', who announces the next task while the therapist is there mainly for helping and correcting patients. - Tasks are fine-tuned to the Bangladesh' situation regarding gender-specific clothing, manipulation of objects and tasks that needs cognitive solutions. - Within the training there are socializing tasks like singing, sharing of experiences, complimenting and encouraging each other. - Patients were asked to perform the tasks by themselves at home as well, and to report about that. This method was applied in two separate groups. The group that is indicated as the control group mainly performed the exercise tasks bilaterally, as in as usual therapy sessions. The experimental group performed the tasks with forced use of the paretic hand, wearing a mitten at the non-paretic hand. The investigators will be compared the performances of the two study groups at the start of the group therapy, at the finish one month later, and at 3, 6, 9 and 12 months afterwards. The hypothesis is that the applied adherence-enhancing behavioral method will have dominant effects, and that the methods: 'bilaterally' versus 'forced use of paretic arm/hand' (CIMT) will show equal improvements in the short and longer term.

NCT ID: NCT04264143 Completed - Clinical trials for Diffuse Intrinsic Pontine Glioma

CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas

Start date: March 10, 2020
Phase: Phase 1
Study type: Interventional

The blood brain barrier (BBB) prevents some drugs from successfully reaching the target source. Convection-Enhanced Delivery (CED) is a method of direct infusion of drugs under controlled pressure to the tumor that may reduce systemic side effects of drugs in the patient. The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor over 9-11 days.

NCT ID: NCT04263974 Completed - Pain Clinical Trials

Effectiveness of an Exercise Program and Education Through a Mobile Application for the Management of Patients With Hand Osteoarthritis and Rheumatoid Arthritis

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Strengthening and stretching exercise programs, and recommendations to protect the affected joint have shown to be effective both clinically and economically in conditions such as hand osteoarthritis and hand rheumatoid arthritis. However, their application format is not up to date. In this sense, problems such as the lack of monitoring by the health professional and the lack of patients motivation may cause poor adherence to the treatment protocol, which is one of the main predictors of treatment efficiency. Therefore, an smartphone application has been developed for the rehabilitation of hand osteoarthritis and rheumatoid arthritis to enhance patients adherence and motivation. The smartphone application includes: a) exercise programs and recommendations based on the most up to date scientific evidence adapted to the pathology; and b) enhancers of patient adherence to treatment (patient diaries and behavioral change strategies).The objective is to develop a cost effective digital solution to optimize the health care offered to these pathologies based on up to date scientific evidence in order to improve the functional ability and the quality of life of these patients, and to reduce the number of consultations to primary and specialized care.

NCT ID: NCT04263714 Completed - Clinical trials for Skeletal Muscle Protein Synthesis

Effect of Exercise on the Human Skeletal Muscle Phosphoproteome

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Generally, resistance exercise increases muscle mass and strength, and fatigue resistance. How resistance exercise achieves these adaptations remains understudied, but what is known is that skeletal muscle translates the physical and biochemical stresses of resistance exercise into morphological and metabolic adaptations. While resistance exercise activates signaling pathways (i.e., proteins) that increase the synthesis of specific proteins to cause adaptations, thousands of proteins are likely involved, and their interactions are complicated. The investigators aim to study these processes.

NCT ID: NCT04263649 Completed - Clinical trials for Peripherally Inserted Central Catheter

Prospective Observational Study of the Power PICC Family of Devices and Accessories

Start date: June 18, 2020
Phase:
Study type: Observational

Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.

NCT ID: NCT04263220 Completed - Clinical trials for Prevention of Diseases of the Musculoskeletal System

Testing the Effectiveness and Safety of a New Prototype of a Passive Industrial Exoskeleton for Back Support

Start date: January 13, 2020
Phase: N/A
Study type: Interventional

This research will provide data on evaluation of the effectiveness and safety of using a passive exoskeleton designed to reduce the negative impact of static and dynamic loads associated with body tilts, lifting and holding weights on the musculoskeletal system of workers. To evaluate a passive industrial exoskeleton for back support, a protocol was developed in which individual production operations will be modeled. This research will recruit 9 valunteers. During a 4-hour laboratory visit, each subject will perform three identical experimental tests: one test without an exoskeleton and two tests using two different modifications of the exoskeleton prototype. To avoid sequence bias, the test order will be randomized (balanced). Two types of labor operations will be simulated. One operation will consist in lifting the load, which is 20% of the volunteer's body weight, from a height of 14 cm to a surface with a height of 70 cm, the frequency of lifting is 1 time in 30 seconds. The second operation is holding a cargo weighing 5 kg in a forced working position (tilt of the body more than 30 °) for 1 minute, after which rest will follow for 1 minute, and then the work will be repeated. Both types of work will be performed for 105 minutes, then a break of 15 minutes, then 105 minutes of work. Heart rate, blood pressure, ECG (Custo) will be monitored. An ergospirometric device (Metamax) will be used to collect muscle activity data (Trust-M, Myoton), inertial sensors (Trust-M) will be used to evaluate the biomechanics of movements. In addition, questionnaires will be filled out for a subjective assessment of the use of exoskeleton prototypes (local discomfort scale, exoskeleton properties assessment questionnaire).

NCT ID: NCT04262713 Completed - Clinical trials for Hip Arthropathy Associated With Other Conditions

Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery

MEIJE
Start date: March 23, 2019
Phase: N/A
Study type: Interventional

A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo ™ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage. This contraindication is based on standardized mechanical tests which may have not taken into account the changes in patient weight that may occur after the intervention. To date, investigators have not been aware of any Meije Duo ™ size 1/2 brakeage in our patients implanted with this type of prosthesis regardless of their weights before 2014. However, it is possible that some of them have had a prostheses failure and consulted another hospital. In the absence of a clinical study on this problem, investigators decided to set up a health care assessment study collecting retrospective and prospective information from our patients.

NCT ID: NCT04262557 Completed - Clinical trials for Sleep Apnea Syndrome, Obstructive

Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

SENSAPNEA
Start date: May 18, 2020
Phase: N/A
Study type: Interventional

Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis. The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.

NCT ID: NCT04262479 Completed - Clinical trials for Latent Autoimmune Diabetes in Adults

Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes

GADinLADA
Start date: March 2, 2020
Phase: Phase 2
Study type: Interventional

This study will evaluate the effects of 3 intra-nodal injections of GAD-alum (Diamyd), together with oral vitamin D supplementation. Safety and feasibility of the treatment will be evaluated and also effects on the immune system and on the preservation of endogenous insulin production.

NCT ID: NCT04262453 Completed - Clinical trials for Upper Aerodigestive Tract Neoplasms

Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract

SAOS-K
Start date: January 21, 2019
Phase:
Study type: Observational

Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract. The patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy)