cyrilzakka/clinical-trials huggingface dataset:
Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea.

This clinical trial compares the usual follow-up to a program of telematic control and self-management in a group of patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS), few symptoms and treated with continuous positive airway pressure (CPAP). The objective of the intervention is to achieve a CPAP compliance of ≥4 hours per day in at least 90% of the subjects.

Low CPAP compliance in OSAHS could mean that its possible cardiovascular benefits are not achieved. Telemedicine can be an effective tool to increase CPAP compliance with low cost.

The researchers propose to carry out a randomized study about patients with severe OSAHS and few symptoms, who are expected to have low CPAP compliance.

The main objective is to evaluate if a telematic control and self-management program can increase the compliance with CPAP treatment compared to conventional follow-up, getting at least 90% of patients to use CPAP ≥ 4 hours per day.

Sixty patients from the Pneumology departments of two hospitals, diagnosed with severe OSAHS and with few symptoms (Epworth Sleepiness Scale ≤10) will be randomized to two follow-up groups, telematic and conventional, for 6 months. Patients in the intervention group (telematic monitoring) will collect variables related to symptoms of sleep apnea and side effects of CPAP treatment, using their own smartphone or a tablet provided during the study if they prefer. Other variables as the hours per day of CPAP use, leaks and residual apnea-hypopnea index (AHI) will be transmitted daily and automatically from latest generation CPAP. All information will be processed and each variable will generate alarms and instructions for each patient, allowing the self-management and an early solution of the possible problems related to the treatment. Alarms may also be generated in the database if the professional intervention is necessary.

In addition, before starting CPAP treatment and after six months of treatment, patients will be monitored during a week with a watch-like device. Variables related to circadian rhythm will be collected and analyzed to know the effect of CPAP treatment in both groups (control and intervention groups).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a recent diagnostic of OSAHS with AHI≥ 30 and indication of CPAP.
* Age≥ 18 years
* Few symptoms, so that, without hypersomnolence (Epworth sleepiness scale ≤ 10)
* Absence of clinic suspect or confirmation of other sleep pathology
* With interest in the use of new technologies

Exclusion Criteria:

* Nasal obstruction that prevents the use of CPAP
* Psycho-physical inability to complete questionnaires and carry out the program
* Patients undergoing uvulopalatopharyngoplasty
* Cheyne-Stoke syndrome
* Pregnancy
* Absence of informed consent
* Shift work in the last 3 months and transmeridian trips in the last month.
A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam)

This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby to provide complementary information to the trials CHER and PREDICT on the long term development of (1) HIV-infected children according to age at ARV initiation and (2) HIV exposed but not infected children, all compared with the control group of children uninfected, unexposed to HIV.

Cognitive, motor and sensorial impairments associated to HIV infection have been and remain important concerns in children. The advent of ARV has reduced the frequency and the extent of HIV-related encephalopathys, but literature suggests that more limited impairments remain (CHER and PREDICT trials). These neuro-cognitive disorders might constitute an important public health problem in sub-Saharan Africa where a high percentage of children born to HIV+ women live. Nevertheless,the knowledge on their long-term consequences on children development in this context remains limited. Data on the burden of cognitive, motor and sensorial impairment in resource-limited settings as well as on the interaction with other factors that could also impair children development are scarse.

The Pediacam cohort gives the opportunity to better understand the development of children born to HIV-infected mothers - infected by HIV or not - followed up from birth and living in sub-Saharan Africa.

Eligibility Criteria:
Inclusion Criteria:

* Children included in the Pediacam cohort and age 4 to 7
* Parent or guardian written informed consent obtained

Exclusion Criteria:

-
Treatment of Lateral Elbow Tendinopathy

This study investigates the treatment effect on lateral elbow tendinopathy of strength training in combination with cortico-steroid injection, dry-needling or placebo in a double-blinded randomized controlled trial.

The prevalence of lateral elbow tendinopathy is prevalence of 1-3%, with a peak incidence between 35-50 years of age (Green et al., 2002). The main symptoms are pain over the lateral humeral epicondyle upon palpation and pain full resisted dorsiflexion of the wrist. Ultrasonographic changes include hyper-/hypo-echoic areas and increased doppler signal in the most proximal part of the common extensor tendon. The condition is often self-limiting, however full recovery often takes months to years and recurrence is common. Several different treatment modalities are used in order to increase tendon healing and decrease time to recovery. Deep transverse friction massage showed no significant effect on pain, grip strength or function relative to other physiotherapy modalities (Brosseau et al., 2002). Anti-inflammatory treatment with NSAID's or corticosteroids is typically effective in the short term, however on a longer term there is a poorer outcome than with other treatment strategies including exercise (Coombes et al., 2010). Surgery does not seem to have any beneficial effect (Buchbinder et al., 2011), and there are no conclusive data regarding the use of orthotic devises for the treatment of lateral elbow tendinopathy (Struijs et al., 2002). Eccentric exercise of the extensor muscles has been shown to reduced pain, increase muscle strength, and decrease tendon thickness and time to return to sport (Croisier et al., 2007).

Loading of human tendon leads to increased tendon collagen synthesis, and interestingly, tendon tissue sampling (biopsies), which causes a minor trauma to the tendon has been shown to increase the level of growth factors locally and stimulate tendon collagen synthesis (Magnusson et al., 2010).

It is hypothesized that both minimal tissue damage and anti-inflammatory treatment could increase tendon healing and decrease time to recovery, when combined with mechanical loading.

Eligibility Criteria:
Inclusion Criteria:

1. Pain around the lateral part of the elbow joint for more than 4 weeks.
2. Pain on palpation of the proximal part of the common extensor tendon.
3. Pain reproduced with resisted dorsiflexion of the wrist.
4. Dash score \> 30.
5. Ultrasonographic appearance consistent with lateral elbow tendinopathy (irregular appearance of the tendon, hypo-/hyper-echoic changes, pathological doppler signal, increased tendon thickness).

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) \> 2 (mild systemic disease).
* Patients with symptoms consistent with differential diagnoses such as:

  * referred pain,
  * radiohumeral synovitis and bursitis,
  * posterior interosseous nerve entrapment (radial tunnel syndrome),
  * osteoarthritis of the elbow, and
  * prior injections or acupuncture around the elbow joint within the last 6 months
CP1110 Sound Processor Feasibility

The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Scene Classifier..

The study will build on the evidence previously collected on behind-the-ear sound processors and noise reduction, with particular focus on the speech perception performance of the CP1110 Sound Processor when compared to the CP1000 Sound Processor.

To assess the primary and secondary speech perception objectives, the study incorporates a within-subject repeated-measures design in which each subject will undergo in-booth speech perception testing with all combinations of hardware and signal processing settings in a sound booth. The average difference scores will indicate the performance difference for each of the paired comparisons.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older
2. Post lingually deafened
3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422)
4. At least 6 months experience with a cochlear implant.
5. At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or Nucleus 7 (CP1000) Sound Processor
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
7. Willingness to participate in and to comply with all requirements of the protocol.
8. Fluent speaker in English as determined by the investigator
9. Willing and able to provide written informed consent

Exclusion Criteria:

1. Additional disabilities that would prevent participation in evaluations.
2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
6. Currently participating, or participated in another interventional clinical study/trial in the past 30 days, or (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.
Impact of the Preventive Emotions Management Questionnaire on the Rates of Isolation and Mechanical Restraint Measures in the Psychiatric Admission Unit

This observational study assesses whether the use of the QPGE has an impact on the rates of isolation and mechanical restraint in adult psychiatric admission units. It is supplemented by a qualitative survey that will collect the experience of caregivers using the QPGE.

The use of isolation and mechanical restraint in psychiatry has deleterious consequences for the patient. Caregivers also testify to their dissatisfaction with using these methods. The Coping Agreement Questionnaire (CAQ) is a form presented to the patient admitted to a psychiatric unit in the United States that has shown a significant effect on the reduction of coercive measures. It has been translated into French under the name Questionnaire Préventif de la Gestion des Emotions (QPGE). In France, the Haute Autorité de Santé has been recommending this type of tool since 2016 in the form of shared prevention plans to better prevent moments of violence.

The main objective is to assess whether the use of a shared prevention plan based on the Preventive Emotions Management Questionnaire (QPGE) can reduce the rates of isolation measures and mechanical restraint in hospitalized people. in a sectoral admission unit receiving patients in care without consent.

Eligibility Criteria:
Inclusion Criteria:

* Have been hospitalized in psychiatric admission unit with an entry date between January 1, 2020 and December 31, 2020
* Be at least 18 years old at the time of hospitalization
* Master the French language in order to have benefited from the QPGE and the satisfaction questionnaire

Exclusion Criteria:

* Being the subject of an isolation and/or restraint measure, decided in another unit before, during the transfer to the study places
* To have objected to the use of data collected during hospitalization following the information in the welcome booklet
Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures

The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.

Thoracic blunt trauma, especially when multiple rib fractures are associated, is challenging to manage and causes significant morbidity due to the severe pain implied.

Patients can present with respiratory compromise as their capacity to expand the thorax is limited by pain. As a result, they are at high risk to develop atelectasis and pneumonia.

the key goal of management is adequate analgesia and pulmonary volume expansion Various strategies to treat such pain have been utilized, including regional analgesia (intrapleural, intercostal paravertebral nerve blockade), and neuraxial analgesia (thoracic epidural analgesia (TEA), intrathecal opioids).

The use of neuraxial analgesia in polytrauma is frequently limited by the need for aggressive venous thromboembolic (VTE) prophylaxis, and positioning of the patient for a neuraxial approach may be impossible.

There is a growing interest in exploring treatments that are less invasive than EA and can be performed on patients who have contraindications to neuraxial analgesia. Ultrasound-guided Serratus Anterior Plane (SAP) block is a recent technique, first described by Blanco et al. in 2013, that provides analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. It is a safe, simple to perform block with no significant contraindications or side effects. he described 2 potential spaces, one superficial and another deep to serratus. The SAPB has been used effectively for the management of pain in the context of rib fractures, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome, few studies compared the two approaches, and the difference between them has not yet been studied in patients with multiple rib fractures.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads.

Exclusion Criteria:

* significant head injury and unconsciousness (GCS less than 14)
* Patients with significant pain from other injuries
* pathological obesity (body mass index ≥35)
* history of drug allergy local anesthetics
* local infection at the injection site
* inability to obtain consent from patient or surrogate, and patient refusal
Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

The objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac CT perfusion (CTP) imaging for non-invasive functional assessment of coronary artery disease (CAD). The proposed CTP technique allows concomitant assessment of two imaging-derived cardiac biomarkers including fractional flow reserve (FFR) and myocardial perfusion from a single dynamic imaging sequence, which facilities simultaneous evaluation of the hemodynamics in epicardial coronary arteries and coronary microcirculation in patients with CAD. The CTP results will be compared with invasive coronary angiography / FFR assessment and non-invasive cardiac magnetic resonance imaging (CMR) / radionuclide perfusion assessment.


Eligibility Criteria:
1. Subject Inclusion Criteria

   Patients need to meet all the following inclusion criteria to be enrolled in the study:
   1. Symptomatic and hemodynamically stable
   2. Acute coronary syndrome (ACS) ruled out based on absence of abnormal changes in ECG and cardiac enzymes
   3. Referral for cardiac catheterization based on clinical history and non-invasive imaging test findings. Non-invasive imaging findings include one or more of the following: (i) Evidence of myocardial ischemia from radionuclide myocardial perfusion imaging; (ii) Evidence of myocardial ischemia from CMR myocardial perfusion imaging; (iii) Evidence of ≥ 50% stenosis in the left circumflex artery (LCx), left anterior descending artery (LAD) and/or right coronary artery (RCA) from CCTA.
   4. Ability to undergo stress myocardial perfusion test (absence of contraindications for vasodilator)
   5. Written informed consent
2. Subject Exclusion Criteria

Patients meeting at least one of the following criteria will be excluded from the study:

1. Recent (\< 1 month) ACS
2. CCTA reveals ≥ 50% stenosis in the left main artery
3. Severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
4. Contraindications to stress perfusion imaging, including: i) severe reactive airway disease; ii) high-grade atrioventricular block; iii) allergy to vasodilators; iv) caffeine within 12 hours; v) theophylline use within 48 hours.
5. History of CABG surgery
6. History of malignancy during the past 3 years prior to screening
7. History of alcohol and/or drug abuse within 3 years prior to screening
8. Sign of pregnancy
9. Pregnant or nursing
10. History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents
11. Recent (\< 1 month) use of an investigational drug or device
12. Participation in any other investigational drug or device trial during the conduct of this study
13. Lack of ability or willingness to comply with the protocol requirements or deemed by the Site Investigator to be unfit for the study
Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients

Evaluated Exjade efficacy and safety in patients with aplastic anemia and transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) , in comparison with a group of patients undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) without chelation therapy.

The secondary endpoints that were originally planned for this study were not analyzed as the study ended prematurely.

Eligibility Criteria:
Inclusion Criteria:

* Main diagnosis: aplastic anemia
* Absence of severe and/or uncontrolled comorbidities
* Confirmed iron overload (serum ferritin ≥ 1000 mkg/L)
* Serum creatinine is not higher than the upper limit of normal for the given age
* Absence of severe proteinuria. Protein/Creatinine ratio should be \< 0.5 mg/mg
* Liver enzymes are \< 5 ULN
* Completion of a scheduled cycle of immunosuppressive treatment program, with no severe infectious or generalized hemorrhagic complications
* WHO (ECOG) performance status ≤ 2

Exclusion Criteria:

* No signed informed consent form
* Patient is under 18 years old
* Severe concomitant condition
* Severe infectious and generalized haemorrhagic complication following regular planned cycle of programmed immune suppressive treatment.
* History of increased sensitivity to active substance and any other ingredient of the medicinal product.
* Creatinine clearance (CC) \< 60 ml/min and/or creatinine concentration in blood serum is 2 or more times higher than upper limit of age normal by results of 2 tests at Visits 1 and 2.
* Severe liver disorders (class C by Child-Pugh scale).
* Patients with aplastic anaemia in which chelator treatment will be ineffective due to rapid progression of the disease.
* Significant proteinuria basing on protein creatinine ratio \> 1.0 mg/ml in urine sample from second urination at Visits 1 and 2 (or as an alternative in 2 of 3 urine samples at screening);
* Rare hereditary disorders related to galactose intolerance, severe deficit of lactase or glucose-galactose malabsorption;
* Pregnancy, lactation;
* Level of liver enzymes higher than 5 upper limits of age normal at Visits 1 and 2.
The TI.VA Algorithm: A First-in-Humans Test.

The TI.VA algorithm is a new method to titrate the anesthetic drug concentrations whenever the planned level of anesthesia results to be not appropriate to blunt the patient's reaction to surgical stimulation.

TI.VA is a multiple inputs/multiple outputs algorithm. The control variables are the bispectral index (BIS) and the mean arterial pressure (MAP) combined in a decision-making matrix. The optimal range for the two control variables (BIS: 540-60 and MAP: 65-75 mmHg) identified the Optimal Anesthesia Zone (OAZ) at the center of the matrix. Any time one or both control variables escape from the PAZ, the algorithm proposes an intervention on the hypnotic and/or opioid levels (algorithm outputs).

A First-in-Humans study was designed to capture preliminary data on the safety and performance of the TI.VA algorithm.

The TI.VA algorithm is a new method to titrate the anesthetic drug concentrations whenever the planned level of anesthesia results to be not appropriate to blunt the patient's reaction to surgical stimulation.

TI.VA is a multiple inputs/multiple outputs algorithm. The control variables are the bispectral index (BIS) and the mean arterial pressure (MAP) combined in a decision-making matrix (DMM). The optimal range for the two control variables (BIS: 540-60 and MAP: 65-75 mmHg) identified the Optimal Anesthesia Zone (OAZ) at the center of the matrix. Any time one or both control variables escape from the OAZ, the algorithm quantifies the inadequacy of anesthesia level through a vector connecting the patient's current position on the DMM to the central point identified by the coordinates BIS= 50 and MAP = 75mmHg. Thereafter, the analysis of the vector main components allows the generation of two coefficients that are used to set out a balanced intervention on the hypnotic and opioid levels (algorithm outputs).

A First-in-Humans study was designed to capture preliminary data on the safety and performance of the TI.VA algorithm This is a prospective study involving a single cohort of patients without major comorbidity and candidate for minor superficial surgery. All patients received Propofol and Remifentanil administered by TCI systems as part of Total Intravenous Anaesthesia.

The algorithm was tested during maintenance of anesthesia defined as the period between skin incision and completion of surgical resection. In this step of the procedure, the titration strategy for anesthetic drug concentrations was suggested by TI.VA algorithm.

Data was collected automatically using dedicated software.

Eligibility Criteria:
The inclusion criteria were: :

* age 18-65 years at the time of recruitment.
* candidates for curative surgery for breast cancer.
* American Society of Anaesthesiologists (ASA) status I/II.

The exclusion criteria were:

* ASA status \> II.
* counter-indications for use of the drugs employed in this protocol.
* pregnancy or lactation.
* incapacity to understand the study explanation and sign the informed consent form.

These criteria were selected according to the risk mitigation strategy described in the protocol.
Quality Control Project of Stroke in Liaoning Province

To reduce the incidence of stroke and standard the treatment of stroke in Liaoning Province, the present study should be conducted.


Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke

Exclusion Criteria:

* disagreed patients