cyrilzakka/clinical-trials huggingface dataset:
VIT-ARMin Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin

Consideration-of-Concept Trial (stage 1) on robotic therapy of the upper extremity with the ARMin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke, spinal cord injury)

Neurological patients (e.g., after stroke) need long-term neurorehabilitative therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitative training. Investigators aim at developing a unique intensified and patient-tailored robot-aided training strategy of the arm. The exoskeleton robot ARMin will be further developed to adapt software components accordingly. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. It can be intensified by different strategies that will be evaluated alone and in combination. These strategies include:

strength training an error-amplification strategy increased number of repetitions multisensory feedback multiplayer approach

Eligibility Criteria:
Inclusion Criteria:

healthy or CVA or spinal cord injury

* Aged ≥18 years
* No excessive spasticity of the affected arm (modified Ashworth Scale ≤3)
* No serious medical or psychiatric disorder as assessed by their physician
* No orthopaedic, rheumatological, or other disease restricting movements of the paretic arm
* No shoulder subluxation (palpation \<2 fingers)
* No skin ulcerations at the paretic arm
* Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised
* No cybersickness (e.g., nausea when looking at a screen or playing computer games)
* No pacemaker or other implanted electric devices
* Bodyweight \<120 kg
* No serious cognitive defects or aphasia preventing effective use of ARMin

Exclusion Criteria

- Allergy against alcohol or no agreement for skin shaving
Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence

This study is a prospective registry that aims to predict readmissions in patients with heart failure, using -omics, machine learning, patient reported outcomes, clinical data and other high-dimensional data sources.

There is substantial need to better predict outcomes across the spectrum of heart failure (HF) phenotypes in order to provide more efficient care with greater precision. Specifically, no validated methods have been adopted to predict outcomes reflecting transitions in health status across the continuum of HF and changes in cardiac function. A key transition is hospitalization - either readmission or de novo cardiovascular hospital admission. This is a major unmet health care need, to be able to better predict who will require hospital admission.

Novel contributions of biomarkers, -omics, remote patient monitoring, and artificial intelligence (AI). It is anticipated that prediction of readmission and many other outcomes will be further improved by measurement of circulating biomarkers and by incorporating methods from AI including machine learning and probabilistic generative models that can incorporate the lens of how physicians and patients think. Machine learning that incorporates many different types of data, including physician interpretation and a broad array of biomarker/-omics molecular information can lead to significant improvements in predictive accuracy. Novel multimarker strategies coupled with machine learning may enable the ability of physicians to predict a range of outcomes (e.g., transitions in HF health status and LVEF) and refine clinical prediction models. Furthermore, the investigators will collect patient data, including patient reported outcome measures (PROMs), and physiological data (e.g. heart rate, blood pressure, and daily weights data) and integrate these data points into predictive models. The investigators will use the PROMs obtainable using Medly as a predictor of hospitalization, and as an outcome. In this proposal, the investigators will take advantage of recent advances in both deep and high throughput proteomics technologies to perform high-resolution analyses. These novel factors can be integrated into new electronic algorithms to improve HF care in the population.

Eligibility Criteria:
Inclusion Criteria:

* Any patient aged 18 years or older admitted to hospital or seen in the emergency department with heart failure defined clinically
* The diagnosis will be guided by the Framingham criteria for HF and/or BNP. A BNP \>400 will be defined as definite heart failure and BNP 100-400 classified as possible heart failure.
* Provides informed consent

Exclusion Criteria:

* Patients who cannot communicate due to dementia or severe cognitive deficits
* non-Ontario residents
* nursing home residents
* those who are not discharged home but are discharged to a skilled nursing facility (long-term care or chronic institution)
* those who are unable to communicate who do not have a proxy (e.g. spouse or close family member) to facilitate communication with the patient.
Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

TMD treatment, based on state of the art knowledge derived from clinical studies will be applied in patients with tinnitus and TMD. When this approach proves to be useful for the treatment of tinnitus, it offers a new therapeutic option for patients with tinnitus. To understand how TMD treatment works for patients with tinnitus, we will analyse mediating factors, i.e. factors that contribute to the therapeutic effect. To help clinicians in their clinical process we will identify prognostic indicators, i.e. factors that predict a positive or negative outcome of TMD treatment. This can provide a helpful tool in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included when suffering from somatic tinnitus, attributed to TMD, which has been stable for at least 3 months.
* Tinnitus Functional Index score between 25 and 90

Exclusion Criteria:

* clear otological or neurological causes of the tinnitus such as Menière's disease, severe depression (diagnosed by a psychologist), progressive middle ear pathology, intracranial pathology
* traumatic cervical spine or temporomandibular injury in the past 6 months
* tumours
* previous surgery in the orofacial area
* in case physical therapy treatment directed to the orofacial area is contra-indicated
* if the patient received TMD treatment in the past 2 months
* drug intake that can affect the outcome measures
Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device

This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device.

This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms.

This project will include three different aims (aim three is a clinical trial) and will be funded by the National Institute of Health (NIH). In aims 1 and 2 the device hardware and device application will be developed and will not be included in this registration as these are not clinical trials. However, aim three is being registered early in the project in order to obtain the Notice of Award (NOA) funding from the NIH. Once the NOA has been obtained the registration will be updated.

Eligibility Criteria:
Inclusion Criteria:

* Participants that are willing and able to come to the clinic for two scheduled visits
* Participants are capable of understanding clinical study procedures
* Participants agree to complete the questionnaires

Exclusion Criteria:

* Participants with implanted medical devices for electrical stimulation (e.g. cardiac pacemaker)
* Those enrolled in a concurrent clinical study
* Those unable to comply with the study protocol due to a disease, psychiatric illness, alcoholism, substance abuse, geographic distance, or other factors that would place the study participant at increased risk or preclude the study participant's full compliance with or completion of the study
The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia

The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.

The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis. The combined surgery includes sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and appliance of llizarov external fixation device. Bone uion rate,average time of healing, Healing index, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria consists of patients with congenital pseudarthrosis of Tibia

Exclusion Criteria:

* Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth.
* Patients with pseudarthrosis of tibia caused by trauma, tumor,infection, etc
* Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
* Parents refused further treatment.
Respiratory Viral Infections in Pediatric Transplantation

A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients will be assembled to determine the incidence of respiratory viral infections diagnosed during an inpatient admission in the first year post-transplant. A sub-cohort of patients that develop a respiratory viral infection within one year of transplantation will be leveraged to investigate factors associated with mortality in the three months after respiratory viral infection.

The purpose of the study is to 1) Determine the incidence of respiratory viral infections diagnosed during the first year post SOT and HSCT; 2a) Determine the all-cause mortality within 3 months of a respiratory viral infection diagnosed during an inpatient admission in the first year post SOT and HSCT; 2b) Determine the proportion of deaths within 3 months of a respiratory viral infection diagnosed during an inpatient admission deemed to be directly attributable to that infection; and 3) To identify factors known at time of onset of the inpatient respiratory viral infection that are associated with all-cause mortality. The study cohort will consist of any SOT or HSCT recipient ≤18 years of age that received their transplant between January 1st, 2010 and June 30th, 2013. Th cohort will determine the incidence of respiratory viral infections diagnosed during an inpatient admission in the first year post-transplant. A sub-cohort of patients that develop a respiratory viral infection within one year of transplantation will be leveraged to investigate factors associated with mortality in the 3 months after respiratory viral infection. Baseline and demographic characteristics will be summarized by standard descriptive summaries. Categorical variables will be summarized by frequencies while continuous variables will be summarized using mean, standard deviation and/or median, twenty-fifth and seventy-fifth percentiles, minimum, and maximum. This is a minimal risk study using data that will be collected retrospectively from medical charts. The only potential risk would be loss of confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age 0 to \<18 years at the time of HSCT or SOT
* Transplantation occurred between January 1st, 2010 and June 30th, 2013.

Exclusion Criteria:

* None
Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata

The investigators hypothesize that Restylane® could serve as a repair matrix which also maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone acetonide for longer periods of time, patients may see a better clinical response for a longer period of time. Quality of life may improve as the number of clinic visits decreases as would the number of IL corticosteroid injections.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ages 18 and greater.
2. Alopecia areata diagnosis in the last two years with extensive scalp involvement, between 74% and 99%, alopecia areata must involve the left and right hemispheres of the scalp.
3. Willing to abstain from use of over the counter products and prescription products, other than study medications, which may promote hair growth.
4. Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation.
5. Subjects are capable of giving informed consent.
6. Willing to adhere to protocol, including scalp examinations and photography.

Exclusion Criteria:

1. Allergy or intolerance to Restylane® or hyaluronate preparations
2. Allergy or intolerance to triamcinolone acetonide, 10 mg/cc.
3. Underlying disease that might be adversely affected by Restylane® or triamcinolone (ex. patients with bleeding disorders).
4. Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV).
5. Pregnant or lactating female.
6. Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks.
7. Systemic administration of corticosteroid or other systemic treatment (i.e. prednisone) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks.
8. Clinical evidence of secondary skin infection (i.e., folliculitis).
9. Other inflammatory or infectious skin disease that might interfere with evaluations during the study.
10. Investigational medications within the past 30 days.
11. Patients with susceptibility to keloid formation.
12. Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies
13. Patients with allergies to gram positive bacterial proteins
14. Unable to give consent.
HDV Screening Study

This is a territory-wide cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC.

Chronic hepatitis B virus (HBV) infection remains endemic in Hong Kong with an estimated prevalence of 6.2% in the recent Population Health Survey 2020-2022.1 The estimated prevalence of chronic HBV infection among individuals living with HIV is 8%.2 Yet, no data are available concerning the disease burden of hepatitis delta virus (HDV) among individuals living with HIV/HBV coinfection.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with HIV infection, i.e. anti-HIV or HIV RNA positive; AND
2. Individuals with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart; AND
3. Aged 18 years old or above.
4. Written or verbal consent obtained

Exclusion Criteria:

1. Refusal to consent
2. Age \< 18 years
10-week Leucine Supplementation in Cerebral Palsy

The purpose of this study is to assess the effects of 10-weeks leucine supplementation on muscle growth, metabolism, body composition, inflammation and wellbeing in adolescents and young adults with CP.

Cerebral palsy (CP) is caused by damage to the developing brain and descending pathways, leading to altered patterns of growth and development. Those with CP may encounter early symptoms of paresis and spasticity, leading to progressive secondary musculoskeletal complications, including increased muscle atrophy and abnormal growth of contractile and non-contractile tissue. This causes significant weakness of the muscle and compromises daily motor function, leading to substantial declines in activities of daily living and independence. As such, interventions aimed at increasing muscle mass or preventing muscle atrophy for those with CP must be established. It is well established that dietary protein ingestion stimulates protein synthesis and inhibits proteolytic pathways, resulting in a positive protein balance and net muscle mass gain. In particular, leucine (a branched chain amino acid; BCAA), has been used to facilitate protein synthesis and muscle growth. Leucine also has anti-inflammatory roles, some of which are central in origin and have been shown to effect mood and features of wellbeing. However, there has been no investigation of the effects of leucine supplementation on any of these parameters in CP. Therefore, the purpose of this study is to assess the effects of 10-weeks leucine supplementation on muscle growth, metabolism, body composition, inflammation and wellbeing in adolescents and young adults with CP.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of spastic cerebral palsy
* Aged 12-22 years

Exclusion Criteria:

* Orthopaedic surgery of the upper-limbs in the past 12 months
* Botulinum toxin type A injections in the past 6 months
* Serial casting in the past 6 months
* Insufficient cognitive understanding to comply with the assessment procedures and intervention
* Liver and/or kidney dysfunction
MRI Screening of Placenta Adhesion Abnormalities

Placenta Adhesion Abnormalities (PAA) are the consequence of an excessive invasion of the placenta within the myometrium. PAA are related to severe maternal pregnancy outcomes, especially in case of incidental discovery during delivery that increase the risk of intraoperative massive bleeding, hysterectomy and even maternal death. Ultrasound is the standard modality for diagnosing PAA, but Magnetic Resonance Imaging (MRI) has been increasingly performed in the case of inconclusive sonographic findings. However, standard morphological MRI sequences appear as insufficient to improve the sensitivity and specificity values for detecting PAA, while quantitative MRI may be more efficient.

The main objective of this study is to characterize the diagnostic performance of quantitative MRI parameters (mainly Apparent Diffusion Coefficient, T2 and T2\*) reflecting placental perfusion and/or oxygenation at high field, without injection of gadolinium-based agent, for the detection of PAA in women with ongoing pregnancy between 30 and 38 weeks of gestation with risk factors for PPA.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant participant between 30 and 38 weeks of gestation,
* Age ≥18 years old,
* Participant who completed the preliminary medical examination,
* Participant who has received full information about the organization of the research and has signed her informed consent.
* Participant planning to give birth at CHRU of Nancy
* Participant presenting risk factors for PAA : low-lying or covering placenta or in front of the uterine scar.

Exclusion Criteria:

* Multiple pregnancy,
* Participant presenting at least one contraindication or restriction to performing an MRI as described in the protocol, in accordance with the current recommendations,
* Participant unable to understand or follow study procedure,
* Person referred to in Articles L. 1121-6 to L. 1121-8, L1122-2 and L. 1122-1-2 of the Public Health Code.
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis

Inflammatory markers have been analyzed in several diseases of unknown etiology, in the expectation of increasing therapeutic perspectives. This possibility arises from the different levels of tissue injury with low-grade chronic inflammation that have been observed in studies in which the markers were not evaluated traditionally, and today have influenced clinical management.

The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS before and after aerobic and combined exercise training.

Inflammatory markers have not been evaluated in adolescent idiopathic scoliosis (AIS), but this deformity potentially involves various musculoskeletal structures permanently, which justifies the analysis. A low-grade chronic inflammation may be related to the lower capacity in exercise performance observed in this population, which must be stimulated to perform standardized physical activity.

Eligibility Criteria:
Inclusion Criteria:

* thoracic curvature ≥ 45 degrees
* indication for surgical treatment of spinal deformity
* absence of pulmonary, cardiac, articular or neurological disorder, atopic dermatitis and previous or current allergy
* agree part in the research with a assent statement and the person responsible with the consent form and informed

Exclusion Criteria:

* acknowledged chronic liver or kidney inflammatory disease
* use of corticosteroids, acetylsalicylic acid or other nonhormonal anti-inflammatory clinical or laboratorial evidence of infection
* severe obesity
Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury

Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury and concerns up to 30% of severely brain-injured patients.

PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more pain, more cardiovascular distress, more infections and prolonged rehabilitation and mechanical ventilation; additionally it could lead to a worse outcome.

Classical music was shown to reduce autonomic nervous system imbalance in healthy people and in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured patients presenting with PSH, as well.

Our study aims at demonstrating that early musical intervention, started with the weaning of sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic hyperactivity in traumatic brain-injured patients.


Eligibility Criteria:
Inclusion Criteria:

* Severe traumatic brain injury (either initial Glasgow Coma Scale \< 8 or intracranial pressure \> 20mmHg for more than 20 min)
* National health service coverage
* Informed consent signed by next of kin

Exclusion Criteria:

* Non-traumatic brain injury
* Conditions interfering with measures: bilateral fixed pupils, temporal bone fracture including acoustic channel, eye trauma, previous eye surgery, otorrhagia, hypoacusis,
* Preexisting autonomic nervous system imbalance: severe diabetes, arrhythmias, pace maker, implantable defibrillator, cardiac transplantation
* Respiratory rate \< 9/min
* Patient subject to guardianship or wardship
* Pregnant or breastfeeding woman
* Current participation in another biomedical research protocol
Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

The primary objective of this study is to evaluate the safety and efficacy of intravenous (IV) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with COVID 19.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Signs and symptoms suggestive of COVID-19 infection
* Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection ≤7 days before randomization
* Currently hospitalized or in an emergency department with planned hospitalization
* Peripheral capillary oxygen saturation (SpO2) \<93% on room air at Screening

Exclusion Criteria:

* Simultaneous participation in any other clinical study incompatible with this one
* Treatment with an antibody immunotherapy within 4 weeks of Screening
* Requirement for mechanical ventilation or ECMO at Screening
* Hypotension at Screening
* Severe liver injury defined as AST or ALT ≥5x the upper limit of normal
* Severe kidney failure defined as an estimated glomerular filtration rate (eGFR) \<30 mL/min
* Pregnancy or breastfeeding
* \> 120 hours between admission and signing consent