cyrilzakka/clinical-trials huggingface dataset:
Sensory Stimulation to Enhance Hand Function Post Stroke

The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of hand therapy as well as the central nervous system responsiveness in chronic stroke survivors.

Stroke survivors suffer from persistent hand impairment that diminishes their functional abilities and independence, despite multiple courses of rehabilitation. Sensory stimulation can prime central excitability to increase therapy outcome. The investigators developed a new sensory stimulation technique for the hand, using imperceptible vibration applied to the wrist skin. Wearable devices with a vibrating function are low cost and can be easily adopted for rehabilitation purposes to impact a wide range of patients with sensorimotor impairment. Despite the potential for clinical benefits and easy adoption for high impact, knowledge about the long-term efficacy of this new sensory stimulation technique and its underlying mechanism is limited.

The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of 2-week hand therapy as well as the central nervous system responsiveness in chronic stroke survivors. This impact will be assessed in a double-blind stratified randomized controlled trial. The hypothesis is that (a) improvement in hand function will be greater for the experimental group receiving the wrist subthreshold vibrotactile stimulation during therapy compared with the control group who will wear the device with no vibration (placebo). (b) Improvement in hand function is associated with neurophysiologic measures of central nervous system responsiveness. Clinical and neurophysiologic evaluations will be performed before, immediately after, and 2 weeks after a 2 week standardized hand therapy program with the subthreshold vibrotactile stimulation to the wrist vs. sham. The investigators preliminary studies demonstrated an acute effect of the remote subthreshold vibrotactile stimulation on immediately improved clinical sensory and motor function of the hand as well as cortical excitability in healthy young adults and chronic stroke survivors in single-session studies.

The expected outcome is the demonstration that the subthreshold vibrotactile stimulation at the wrist enhances hand function, not only immediately (preliminary studies) but also as a complement to therapy in chronic stroke survivors. This project will also provide preliminary insights regarding plasticity occurring with hand therapy augmented by the subthreshold vibrotactile stimulation. This research will have a positive impact by leading to a portable sensorimotor orthosis worn at the wrist to improve hand function for patients with sensorimotor deficits.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate impairment in upper extremity function

Exclusion Criteria:

* cognitive dysfunction
* stroke\<3 months
* treatment with botulinum toxin in the affected arm within 3 months of start of study
Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.

A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.


Eligibility Criteria:
Inclusion Criteria:

* \>18years of age
* suspected of Interstitial lung Disease
* cryobiopsies performed.

Exclusion Criteria:

* FVC below 50% of predicted
* DLCO below 35%
* Body Mass Index (BMI) above 35
* pulmonary hypertension with a tricuspidal gradient above 40 mmHg
* other cardiac or other comorbidities that would increase the risk of complications
UH3 Phase - Mindfulness-Based Blood Pressure Reduction (MB-BP) : Stage 2a RCT

The primary aim is to identify the impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care on the primary self-regulation target, specifically an assay of self-related processes (Multidimensional Assessment of Interoceptive Awareness) (MAIA) at 6 months, via a randomized controlled trial.

Effects of mindfulness interventions customized for prehypertensive/hypertensive patients are poorly understood. Until methodologically rigorous studies to evaluate customized interventions for hypertension are performed, it will be unknown whether the observed preliminary effects of general mindfulness interventions on blood pressure reduction could be much more effective with a tailored approach. Consequently, this study proposes to conduct a behavioral intervention study to evaluate whether Mindfulness-Based Stress Reduction (MBSR) customized to prehypertensive and hypertensive patients has the potential to provide clinically relevant reductions in blood pressure.

This customized intervention is called Mindfulness-Based Blood Pressure Reduction (MB-BP). The study follows the NIH Stage Model for Behavioral Intervention Development, where targets likely proximally affected by the intervention are identified, that should also have effect on the longer-term outcomes (e.g. blood pressure, mortality). The selected targets, consistent with theoretical frameworks and early evidence how mindfulness interventions could influence mental and physical health outcomes, are measures of self-regulation including (1) attention control (specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness). Based on the degree of target engagement, MB-BP can be further customized to better engage with the targets as needed.

Eligibility Criteria:
Inclusion Criteria:

* Elevated blood pressure or hypertension defined as ≥120 mmHg systolic or ≥80 mmHg diastolic pressure.
* Able to speak, read, and write in English.
* All adults (≥18 years of age), genders and racial/ethnic groups are eligible to be included.

Exclusion Criteria:

Exclusion criteria follow standard guidelines and recommendations:

* current regular mindfulness meditation practice (\>once/week)
* serious medical illness or cognitive condition (e.g., dementia) precluding regular class attendance and/or participation
* current substance abuse, suicidal ideation or eating disorder
* history of bipolar or psychotic disorders or self-injurious behaviors.
An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Acceptable lab testing results
* Allow biopsies

Exclusion Criteria:

* Central nervous system (CNS) tumors
* Uncontrolled or significant cardiovascular diseases
* Active or known autoimmune disease
* Organ transplant

Other protocol defined inclusion/exclusion criteria could apply
Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial

This prospective single-centre randomized controlled trial aims at evaluating the safety and efficacy of hemoadsorption with HA-380® during cardio-pulmonary bypass in 40 patients undergoing complex cardiac surgery.

Cardiopulmonary bypass (CPB) is an extracorporeal circuit used to divert blood from the heart and lungs and take over their functions during cardiac surgery. Cardiac surgery with CPB can induce a major inflammatory response, largely mediated by cytokines. In the most severe cases, this inflammation can lead to vasoplegia, hypotension and potentially end-organ damage.

The investigators hypothesised that the removal of inflammatory mediators (e.g. cytokines) from the blood during CPB could reduce the development of postoperative complications in patients with significant inflammation during cardiac surgery.

Patients undergoing complex cardiac surgery will be enrolled preoperatively and randomised 1:1 to receive either the investigational hemoadsorption treatment plus standard care (intervention group) or standard care alone (control group). Patients allocated to the intervention group will have an HA-380® cartridge (Jafron Biomedical, Guangdong, China) inserted into the CPB during circuit set-up. Hemoadsorption treatment will be performed throughout the duration of the CPB procedure.

For each patient, 4 blood samples will be taken for cytokine measurements (at the start of CPB, at the end of CPB, at ICU admission and 24 hours later). Data on vital signs, organs support, demographics and medical history will be collected in the electronic medical record.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (≥18 years old at study inclusion)
2. Planned for one of the following cardiac surgical procedures: heart transplantation after L-VAD (left ventricular assist device) implantation, OR surgical repair of a type A aortic dissection, OR urgent (within a few days) or emergent (within 24 hours) procedure for acute infectious endocarditis, OR cardiac surgery likely to require \>180 min CPB time as estimated by the surgical team
3. Signed informed consent

Exclusion Criteria:

1. Indication to receive hemoadsorption during CPB for drugs removal
2. Women who are pregnant or breastfeeding (pregnancy test done as standard of care)
3. Previous enrolment into the current study
4. Off-pump procedure
5. Chronic immunosuppression
6. Known allergy to heparin or heparin induced thrombocytopenia
7. Severe thrombopenia (platelets count before surgery \< 20g/L)
8. Patient who does not want to be informed of incidental findings
9. Participation in another study with investigational drug within the 30 days preceding and during the present study
10. Participation in another conflicting research study
Mini Stem Radiostereometric Analysis Study

The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations.

Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.

Eligibility Criteria:
Inclusion Criteria:

* Subject has hip disease that requires a total hip arthroplasty.
* Subject is willing to consent to participation in the study.
* Subject plans to be available for follow-up through study duration.
* Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk.

Exclusion Criteria:

* Subject has insufficient femoral bone stock.
* Subject has had major non-arthroscopic surgery to the study hip.
* Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up.
* Subject has a known sensitivity to materials in the device.
Joint Thoracic Oncology Research Unit of LYon: Lung CancerS DatabaSE (ULYSSE)

Prospective longitudinal cohort associated to blood collection, pathological samples collection, and radiological and pathological imaging collection.


Eligibility Criteria:
Inclusion Criteria:

* Patient treated for a thoracic cancer in the Lyon University Hospital: non-small cell lung cancer, small cell lung cancer, mesothelioma...
* Diagnosis can be done:

  * By cytology or pathologic assessment
  * Or by multidisciplinary team meeting decision:

    * Irradiation without morpho-metabolic sampling
    * Treatment without sampling based on non-invasive molecular data

Exclusion Criteria:

- Refusal to participate

For optional blood sampling :

* \< 30 kg for blood collection
* No blood sampling schedule for care
Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise and corticosteroid injections in the treatment of lateral epicondylalgia (tennis elbow).

Musculoskeletal conditions account for the third leading cause of health systems expenditure in Australia. Lateral epicondylalgia (tennis elbow) is a painful musculoskeletal condition that is often treated in primary care. Seven out of every 1000 patients seeing their general medical practitioner do so for this condition, though most are not tennis related. On average 10-30% of sufferers take 12 weeks of absenteeism from work and the condition may last 6-48 months.

Two popular treatment options that are commonly prescribed for the management of lateral epicondylalgia are manual therapy/therapeutic exercise and corticosteroid injections. To date there is little evidence that supports manual therapy/therapeutic exercise. This lack of evidence is largely due to the small number of studies of physiotherapy treatments, most of which are of poor quality. The small number of studies of manual therapy contrasts with the larger number of studies of corticosteroid injections, which show that corticosteroid injections are beneficial in the short term (3-6 weeks), but they are associated with significantly greater recurrence rates and offer no advantage in the long term (12 months). The efficacy of a manual therapy and therapeutic exercise programme compared to that of corticosteroid injections is unknown at this stage.

This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise in the treatment of lateral epicondylalgia. The factors associated with success or failure of these common treatment options for lateral epicondylalgia will also be examined. A tangible outcome of this project will be the development of clinical guidelines for the most effective method of treating lateral epicondylalgia.

Eligibility Criteria:
Inclusion Criteria:

* Elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of lateral epicondylalgia
* Diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by gripping activities
* Reduced grip strength and increased sensitivity to manual palpation over the lateral epicondyle
* Reproduction of pain with stretching of the forearm extensor muscles or with specific resisted static contraction of extensor carpi radialis brevis is also usually present.

Exclusion Criteria.

* In the preceding 6 months, had consulted a health care practitioner for neck or arm pain or injury, other than lateral epicondylalgia, which has prevented participation in usual work or recreational activities
* Had treatment with physiotherapy or corticosteroid injections for lateral epicondylalgia in the preceding 6 months
* Upper limb fractures
* Diseases of the bone, muscle and nervous systems that preclude treatment by any of the treatments being evaluated in the project.
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence

A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.

A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent.
* Self-reported stress-type UI symptoms of \>= three months duration
* Diagnosis of stress predominant urinary incontinence based on MESA stress symptom score greater than MESA urge symptom score (percent of total possible urge score).
* UDI-6 score \>/= 25
* Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress Urinary Incontinence using other modalities (i.e. will not wear a pessary, participate in pelvic floor PT or surgery) during the first 8- weeks.

Exclusion Criteria:

* Absence of a vagina.
* Age \<18 years.
* Stage 3-4 pelvic organ prolapse (as determined by POP-Q).
* Diagnosis of any neuromuscular disease.
* Non-ambulatory.
* Currently pregnant or \<12 months post-partum.
* \</= 3 months after failed surgery for stress urinary incontinence.
* Previous pelvic floor muscle training (PFMT) within the last 12 months under a supervised therapeutic plan of care.
* Currently taking, or has taken within the last 2 months, medication to treat urinary incontinence.
* Prior augmentation cystoplasty or artificial sphincter.
* Implanted nerve stimulator for urinary symptoms.
* Participation in another clinical study within 30 days of screening.
* Impaired cognitive function.
* Contraindication to the use of a vaginal probe.
* Unable to understand instructions on the use of the leva® Plus Pelvic Digital Health System.
* Unable to actively recruit the pelvic floor muscles to any degree for attempted volitional contraction.
Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome

Obstructive Sleep Apnea is a common medical condition in children. Diagnosis is based on polysomnography . We conducted an open prospective non randomised clinical trial to assess the efficacy of a new medical device called SUNRISE.

Obstructive Sleep apnea affects 4 percent of children. The standard device for the diagnosis and follow up is the polysomnography (PSG). However acess for this technique is difficult and expensive in certain institutions . Moreover, not all centers are qualified to receive the pediatric population. Thus expert consensus is present on the need for the development of a less expensive and easily accessible device to ensure the equality in medical care.

Recently an innovative medical device utilising the artificial intelligence technology is used to diagnose OSA in adults by recording the mandibular movement. Martinot et al were the first to use this device in children and noted a correlation between the mandibular movements and polysomnography measurements.

A multidisciplinary approach is used in the treatment of OSA. Indeed, the treatment is based on continous positive pressure and non invasive ventilation. To better evaluate the treatment, the sensor can be an alternative allowing to analyze the mandibular movements without moving at home.

We conducted an open prospective non randomised clinical trial to assess the efficacy of a new medical device called "SUNRISE" in the diagnosis and monitoring of OSA.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-18 years inclusive.
* With a diagnosis of severe OSA diagnosed at PSG, defined by an apnoea-hypopnoea index ≥ 10/ hours or an apnoea index ≥ 5/ hours, and associated or not with alveolar hypoventilation.
* Ventilated with noninvaisve ventilation or continuous positive airway pressure during sleep.
* With a nasal or nostril interface.
* Followed in one of the 2 participating centres: the Grenoble-Alpes University Hospital or the Trousseau Hospital in Paris.

Exclusion Criteria:

* Patients with centrally-induced sleep apnoea syndrome.
* Patients at the end of life or for whom limitation of active therapies has been established.
* Patients ventilated with a naso-oral interface.
Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements

The purpose of this research is to evaluate and create a new clinical prediction model for CCHD screening that combines non-invasive measurements of oxygenation and perfusion.

This study will create and test an enhanced critical congenital heart defect (CCHD) screen that combines non-invasive measurements of oxygenation and perfusion in two ways. The first will use current equipment without automated interpretation and the second will require additional software/device but will automate the interpretation. To work towards development of those two algorithms in this stage of the study, the study team will download oxygen saturation (SpO2) and perfusion index (PIx) measurements from newborns with and without congenital heart disease (CHD) and apply statistical tests to the data afterwards to identify parameters to include in the newly developed screening algorithms. The overall objective is to create an automated screening algorithm to improve acyanotic CCHD detection, preventing morbidity and mortality associated with diagnoses missed by SpO2 screening. The central hypothesis is that the addition of non-invasive perfusion measurements to SpO2 will be superior to SpO2-alone screening for detection of acyanotic CCHD. The data collected during this study will be used to develop the two algorithms and the algorithms will be compared to the standard of care using statistical tests on the data after the fact (k-fold validation). The newly developed algorithms will not be tested in-situ on patients during this study.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 22 days
* and either: a) asymptomatic newborn undergoing SpO2 screening for CCHD, or 2b) newborn prenatally or postnatally diagnosed/suspected with CHD.

Exclusion Criteria:

* For Controls: Echocardiogram completed prior to enrollment as the newborn would then no longer be considered "asymptomatic undergoing SpO2 screening for CCHD"
* For Newborns with confirmed/suspected CHD: a) Patent ductus arteriosus and/or atrial septal defect/patent foramen ovale without other defects, b) Corrective cardiac surgical or catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.
Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Eligibility Criteria:
Inclusion Criteria:

* Adults of age 18 or older

Exclusion Criteria:

* Subjects with wounds or surgical incisions at the site of sensor placement