cyrilzakka/clinical-trials huggingface dataset:
Effects of Proprioceptive Sensitivity Stimulation Via the SURA Electrodevice on Kinematics, Kinetics and Spatiotemporal Parameters of Gait.

Recovery of function in people with central nervous system (CNS) injury after stroke is very much like a relearning process that takes advantage of preserved sensorimotor circuits. Relearning can be optimised by providing appropriate proprioceptive (or deep sensory) information to the spinal cord with the aim of maximally engaging the preserved neural circuits. The development of the SURA electrodevice offers this sensitive input mechanism, within the Botton Up therapies. And through research on its use, the impact on the different dimensions related to gait and its components, and the translation to the functional reality of the person, will be evaluated.

Objective: To assess whether the SURA electrodevice improves relevant aspects of dynamic balance in stroke survivors.

Methods:The design is a prospective longitudinal randomised controlled trial with simple masking by the examiner to be carried out at the facilities of the Ricard i Fortuny Social and Health Centre (CSSV RiF). The first phase of the intervention (device-on rest phases) will consist of the activation of the device on the muscle motor points of the medial belly of the gastrocnemius, soleus and peroneus muscles. The motor points are the site of penetration of the motor nerve fibers and the highest concentration of motor plates in the muscle, which when stimulated produce the maximum effective muscle contraction. The second phase (OFF activity-device phase) consists of carrying out the therapy as the patient had been doing normally in the Neurorehabilitation department at the center at a rate of 3 sessions per week on an outpatient basis according to their individualized needs.

The control group will perform the same activity, but without the device activated during the device-on rest phases and adapted to the needs of each participant in their usual sessions without a standardized protocol.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral hemispheric stroke (ischaemic or haemorrhagic) diagnosed by MRI or CT scan, at least 3 months after onset of stroke
* Ability to walk at least 10m (irrespective of the need for assistance)
* Weakness in ankle dorsiflexion of the paretic limb (TFM\>3)
* Ankle ROM \>30° and 0° of foot dorsiflexion in knee extension
* Age between 18 and 85 years
* Mini-Mental State Examination (MMSE) \> 24 score, non-disabling cognitive impairment
* Presence of clonus and hyperresistance to passive joint movement.

Exclusion Criteria:

* Diagnosis of Cognitive, visual or cardiorespiratory disorder (including cardiac pacemaker placement, heart failure and arrhythmia)
* Orthopaedic intervention for IE
* Balance disorders with vestibular features
* Skin diseases
* Botulinum toxin treatment within the last year.
* In addition, subjects who had participated in other studies in the last six months that could interact with the current study will be excluded.
Association Between Renal Resistive Index(RRI) and AKI(Acute Kidney Injury) in Cardiac Surgery Patients With Cardiopulmonary Bypass (CPB)

AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. The conventiional marker for detecting AKI is serum creatinine, however, which has many limits. RRI(Renal Resistive Index) is a non-invasive test measured by ultrasound and could be a useful tool to evaulate renal insult in the early phase. Early detection of renal insult and prevention of progression to AKI can contribute to reduing mortality and morbidity in cardiac surgical patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 19 years and older scheduled for cardiac surgery using CPB

Exclusion Criteria:

* Emergency opeartion, pre-operative shock status requiring vasopressor or inotropics, s/p kidney transplant patients, CKD stage 4 and 5 patients, patients who have renal artery stenosis or history of renal artery stent implantation, patients who have ascites with Child-Pugh classification B or C, In case of CPB weaning failure, In case of poor lung function and PaO2 or PaCO2 cannot be maintained within normal range.
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.


Eligibility Criteria:
Inclusion Criteria:

* Adults, 21-55 years of age.
* Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso.
* Keloids to be excised must have been present for \> 1 year.

Exclusion Criteria:

* Use of tobacco or nicotine-containing products
* Pregnant or lactating
* Post-menopausal or full hysterectomy
Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis

The purpose of this study is to determine if the new ingenol derivative gels are as safe as and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for two consecutive days.

Various concentrations of new ingenol derivatives will be applied to AKs on the forearms. Reactions and safety will be compared to a US registered and marketed ingenol gel to ascertain if the new ingenol is at least as safe and as well tolerated as the registered ingenol.

Eligibility Criteria:
Inclusion Criteria:

* Must be male or female and at least 18 years of age.
* Female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
* Ability to provide informed consent

Exclusion Criteria:

* location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma
* undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
* use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
* use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of Visit 2
* Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to visit 2
* use of systemic retinoids
* those who are currently participating in any other clinical trial
* females who are pregnant or are breastfeeding
* those known or suspected of not being able to comply with the requirements of the protocol or provide consent
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

Exclusion Criteria:

* Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
Group Motivational Intervention in Overweight/Obese Patients.

The overall goal of IMOAP study is to assess whether the efficacy of the healthcare professionals' usual practices, together with a motivational group intervention (delivered by a nurse trained by an expert psychologist), is more effective than an isolated traditional intervention on weight loss and its maintenance in overweight and obese patients. Furthermore, the study will evaluate whether this result has a positive impact on quality of life, changes in eating habits, and a reduction in the associated cardiovascular risk factors and overall cardiovascular risk.

The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study in two geographically separated groups, one of which would receive the group motivational intervention, and the other one would receive the usual follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Overweight (BMI\>25) and obese (BMI\>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
2. Aged between 30 and 70 years
3. Agreement to participate in the study

Exclusion Criteria:

1. Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
2. Patients with secondary obesity (hypothyroidism, Cushing's disease, etc)
3. Patients with severe sensorial disorders capable of interfering with the motivational intervention (severe, uncorrected deafness, severe visual deficit, etc).
4. Patients with serious psychiatric disorders
Ataxia GAA-FGF14 - Descriptive Genetic and Clinical Study

Cerebellar ataxias of late onset are of undetermined etiology in many cases. A new cause of late-onset cerebellar ataxia was discovered in January 2023 corresponding to an expansion of GAA triplets in intron 1 of the FGF14 gene.

However, this cerebellar ataxia is still poorly known and requires further investigations to know its clinical phenotype and its evolution in order to propose a diagnosis and a genetic counseling adapted to patients and families. The objective of our study will be to describe the clinical and genotypic phenotype of patients with GAA-FGF14

The objective of our study will be to describe the clinical and genotypic phenotype of patients with GAA-FGF14. We wish to describe the precise clinical phenotype by detailing each patient's clinical examination, medical history, treatment history, frequency and symptomatology of episodes, MRI radiological data, otho-rihno-laryngeal examination data etc . We would also like to describe the precise genotype for each patient, specifying the number of GAA expansions and its characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of cerebellar ataxia of type GAA-FGF14

Exclusion Criteria:

* patients not wishing to be followed
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only

The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle System. This study will follow subjects for a period of up to 10 years post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for total ankle arthroplasty
* Patient is skeletally mature
* Patient is mentally capable of completing follow-up forms
* Patient will be available for follow-up out to 10 years
* Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator
* Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

* Patient with excessive bone loss at the ankle joint site
* Patient with severe osteoporosis
* Patient with complete talar avascular necrosis
* Patient with Active Osteomyelitis
* Patient with Infection at the ankle site or infection at distant sites that could migrate to the ankle
* Patient with Sepsis
* Patient with Vascular deficiency in the involved limb
* Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)
* Patient with Neuropathic joints
* Patient with Neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing
* Patient with Poor soft tissue coverage around the ankle
* Patient with Charcot arthropathy
* Previous ankle arthrodesis with excision of the malleoli
* Excessive loads as caused by activity or patient weight - per investigator discretion
* Skeletally immature patients (patient is less than 21 years if age at time of surgery)
* Patient with dementia
* Patient with known metal allergies
* Patient who is pregnant
OCT in Borderline Coronary Artery Lesions

To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis.

It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT.

Exclusion Criteria:

* Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions.
Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia

This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb. We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. The locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Intraoperative pain is assessed using NOL index monitoring, ALGISCORE and Numerical Scale, and second point study is the midazolam and propofol requirement.

Introduction: Intraoperative pain assessment is difficult and based on indirect parameters of sympathetic-parasympathetic system stimulation. Recently, the Nociception Level index (NOL™) providing a value from combination of multiple physiological parameters to measure pain has been developed to enable intraoperative pain monitoring during general anesthesia. While this monitoring has also been used postoperatively in awake patients, data are scarce to assess pain under locoregional anesthesia. This study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb.

Method: 50 consecutive patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia were included. Exclusion criteria were emergencies, request for general anesthesia, and patients under 18 years of age. All patients were informed and consented to the technique of locoregional anesthesia and pain monitoring without change of practice. After premedication with oral hydroxyzine, locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Monitoring began as soon as the venous infusion was started, and parameters were recorded at the time of locoregional anesthesia, tourniquet inflation, surgical incision, skin closure and dressing.

Pain is also assessed using the ALGISCORE by the nurse and the numerical scale (0 to 5) and satisfaction score at the end of the procedure. The need to administer midazolam or propofol at the anesthetist's discretion is noted, as is the effectiveness of locoregional anesthesia (conversion to general anesthesia). Data were analyzed using Friedman and Mann-Whitney tests.

Eligibility Criteria:
Inclusion Criteria:

scheduled upper limb orthopedic surgery under regional anesthesia

Exclusion Criteria:

Patient less than 18 years old emergency surgery patient refusal of regional anesthesia chronic neurocognitive disease
Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy

Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.


Eligibility Criteria:
Inclusion Criteria:

* Type2 diabetes patients
* Age \<30yrs-70yrs\>
* Overt proteinuria (Urinary protein creatinine ratio \> 200mg/g 2 times or more during past 6 Mo)
* Scr \< 2.5 mg/dL
* HbA1C \< 7.5
* Systolic blood pressure \> 160 mmHg without antihypertensive drugs or \> 140 with antihypertensive drug
* No history of previous cardiovascular event (Stroke, Myocardial infarction, unstable angina, hospitalization, surgical correction PVD or PVD with claudication)
* No hospitalization within 1 yr except for elective surgery

Exclusion Criteria:

* Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)
* Non adherence to protocol
* Intolerable to ACEI or ARB during run-in
* Abnormal liver function test at the run-in period
* Rapid declining renal function (SCr increase \> 40%) during run-in
* Hyperkalemia (serum K \> 5.5 mEq/L at randomization)
* Malignancy detected o
* SBP lower than 110 mmHg (at randomization)
Assessment of S-ICD Eligibility With 12-Lead ECG

The primary objective of this study is to develop an approach to determine eligibility for subcutaneous ICD by analyzing routine clinical 12-lead electrocardiogram.


Eligibility Criteria:
Inclusion Criteria:

* medical condition, predisposing patient to life-threatening ventricular arrhythmias, eligible for currently approved ICD indications for primary or secondary prevention of sudden cardiac death

Exclusion Criteria:

* Acute medical condition (e.g. acute myocardial infarction, severe trauma, post-surgery, admitted to ICU)
* End stage organ failure
* Pregnancy
* Patient, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent
Transesophageal Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia on the Cardiac Function

Dexmedetomidine is a selective alpha-2 adrenergic agonist that can be considered as an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular effect through activation of receptors in central and peripheral nervous system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial short-term increase in blood pressure followed by long-lasting decrease in BP and HR. There were several reports about these hemodynamic changes of dexmedetomidine, but not the evaluation of direct effects on cardiac function. The purpose of this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant on cardiac function by using the transesophageal echocardiography.


Eligibility Criteria:
Inclusion Criteria:

1. Above 20 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. general anesthesia

Exclusion Criteria:

1. severe functional liver or kidney disease
2. diagnosed HF ( NYHA class \>3)
3. arrhythmia or received treatment with antiarrythmic drug .
4. severe bradycardia (HR \< 45 bpm) and AV block
5. pathologic esophageal lesion (esophageal stricture or varix )
6. pregnancy
Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD). This is a pilot investigation in which all participants will receive the active treatment.

Alcohol use disorder (AUD) is a major public health concern, affecting over 16 million Americans. Peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. TheraNova has developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of AUD. In this study, we will conduct a cross-over, home-use study in participants with AUD. Participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the Empower device. We will evaluate endpoints for safety and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Is male or female ≥ 21 year of age at Visit 1
* Has a current diagnosis of alcohol use disorder per DSM-5 by clinician assessment
* Endorses Criterion 4 in DSM-5
* Has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use
* Has a breath alcohol concentration of 0.00% at enrollment
* Is able to provide informed consent
* Is able to understand spoken and written English
* Is capable and willing to follow all study-related procedures

Exclusion Criteria:

* Has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage
* Requires acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
* Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
* Has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the Empower Neuromodulation System
* Will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet.
* Is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* Has used an investigational drug/device therapy within the past 4 weeks
* Is deemed unsuitable for enrollment in the study by the PI