cyrilzakka/clinical-trials huggingface dataset:
SPI-guided Analgesia During CEA Under RA

The aim of this randomized prospective trial is to assess the utility of Adequacy of Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain perception intraoperatively, maintainance of hemodynamic stability during anesthesia and its influence on postoperative outcomes, in patients undergoing carotid endarterectomy under cervical plexus block.

Carotid artery stenosis constitutes a major risk factor for ischemic stroke so carotid endarterectomy is performed to protects patients with severe atherosclerotic carotid artery stenosis against stroke.

Surgical Pleth Index (SPI) is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures, where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level; values near 50 or increase in value \> delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia.

A randomized interventional trial to evaluate the effects of SPI-guided rescue analgesia on hemodynamic stability during anesthesia in patients undergoing carotid endarterectomy under cervical plexus block.

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis of stenosis of carotid artery written consent to participate in the study written consent to undergo carotid endarterectomy under regional anaesthesia of cervical plexus using Moore's technique general heath condition I-III of American Society of Anaesthesiology

Exclusion Criteria:

* necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy
* anatomical malformation that make monitoring using SE sensor impossible
* general atherosclerosis and heart rhythm disturbances impairing SPI monitoring
* chronic medication using opioid drugs leading to resistancy to opioids.
* farmacotherapy with anticoagulants
* allergy to local anaesthetics
Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population

To determine that the short duration moderate intensity soleus push-ups will have a better effect on blood glucose level as compared to sustained soleus push-ups.

The soleus muscle is a slow oxidative muscle which possesses molecular machinery necessary for regulating blood borne substrates. It has the ability to increase the local oxidative metabolism for a long period of time without experiencing fatigue. The uniqueness lies in this muscle because of its inability to store glycogen and derives its energy directly from the glucose present in the bloodstream. This in turn helps in lowering the blood sugar by using the excess blood glucose as its primary source of fuel. The soleus muscle also stands out because of its high composition of slow oxidative fibers, around 88% of the fibers are slow twitch fibers, making it the only muscle in human body containing greater proportion of slow twitch fiber.

A specific exercise called soleus push-ups (SPU) can have a huge impact on boosting metabolism and regulating blood glucose level better than the total body muscle exercises, intermittent fasting, weight loss etc. According to the previous study it showed a significant effect on the overall blood chemistry when performed for 270 mins.

So,the purpose of this study will be to find the comparison of acute effects of sustained soleus push-ups with moderate resisted soleus push-ups on blood sugar level. To find whether moderate resisted soleus push-ups will give same or better results in short period of time.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-35 years.
* Gender: both male and female.
* Healthy young adults.
* BMI: healthy weight.

Exclusion Criteria:

* Patient with cardiac issues.
* Any neurological issues.
* Knee injuries.
* Patient with any lower limb injuries.
* DVT and lower amputation.
* Any known diabetic patient.
Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder

Overactive bladder (OAB) affects 12-30% of the world's population. The accompanying urinary urgency, urinary frequency and incontinence can impair the ability to work, interact in social activities and can result in poor social functioning. Multiple treatment modalities are available for overactive bladder. However, each therapy has drawbacks that limit its application in certain patient populations. For example, oral medications have significant side effects and suffer from poor adherence. Botulinum toxin injection into the bladder wall is invasive, requires re-treatment on a regular basis and carries a risk of urinary retention. Current neuromodulatory techniques are invasive and require highly-specialized care. Therefore, a need exists for a non-invasive, well-tolerated and easily administered therapy for OAB. Transcutaneous spinal cord stimulation (TSCS) has been developed and tested in able bodied individuals to initiate locomotor function as well as in the SCI population for lower extremity and upper extremity function. More recently, we have tested this SCI patients to enable lower urinary tract function and decrease detrusor overactivity, resulting in improved continence.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years
2. Known diagnosis of overactive bladder, confirmed by:

   * presence of urinary frequency, urgency
   * frequent small-volume voids on frequency-volume chart
   * high score on ICIQ-OAB, ICIQ-OABQOL, and OAB-q questionnaires

Exclusion Criteria:

1. Younger than 18 years of age
2. Older than 80 years of age
3. Presence of lower urinary tract symptoms suggestive of urinary retention or obstruction
4. Finding of an elevated post-void residual (\>100 ml) on an ultrasonographic bladder scan
5. History of spinal cord injury, spina bifida or other neurological disease affecting the spinal cord
6. Acute or current urinary tract infection
7. History of neuromodulation for overactive bladder (sacral nerve stimulation or peripheral tibial nerve stimulation)
8. Current or planned pregnancy
The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

to detect the effects of RIC on stroke-induced immunodeficiency and inflammation response in acute ischemic stroke patients

Remote ischemic conditioning, consisting of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed its strongest endogenous neuroprotection against brain injury after stroke, of which the immune mechanisms are majorly involved in RIC. At the same time, the inflammation response plays a great role in stroke development, which may expand the infarct area. Stroke-induced immunodeficiency can potentiate stroke-associated pneumonia, which is an important cause of death after strokes. In this study, the investigators will assess the effect of RIC on stroke-induced immunodeficiency and inflammation response in AIS patients.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years old;
* Confirmed diagnosis of acute ischemic stroke(AIS) with onset of symptoms within 48h at recruitment;
* NIHSS score: ≤15;
* Prestroke modified Rankin Scale(mRS) ≤2;
* subject or his or her legally authorized representative was able to provide informed consent.

Exclusion Criteria:

* uncontrolled hypertension (defined as systolic blood pressure ≥200 mmHg);
* participation in another device or drug trial simultaneously;
* any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated unilateral arm ischemic preconditioning;
* peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion);
* Women who have a positive pregnancy test;
* History of malignancies;
* Using remote ischemic conditioning within the preceding 1 week;
* known infection at admission;
* a history of infection or the use of antibiotics, immunosuppressants, or steroids within the preceding 3 months.
* Other conditions are not suitable for this trial (evaluated by researchers)
Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study

The aim of the study is to examine the effect of RIPC on physiological parameters in non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique bio-date base for further analysis of molecular and genetic mechanisms responsible for observed results.

The potential effect of RIPC on AF inducibility and/or prothrombotic activity might be implemented as additional treatment component to reduce AF burden and minimize thromboembolic risk.

Interim Analysis will be done after 73 patients.


Eligibility Criteria:
Inclusion Criteria:

* planned invasive Atrial Fibrillation ablation

Exclusion Criteria:

* AF in ECG at Admission
* history of AF ablation
* age \<18
* pregnancy
* neoplastic disorders
* acute or systemic inflammation, autoimmune diseases
* documented atrial flutter
Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care

This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.

The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* The patient, her person-of-trust, must have given his/her consent and signed the consent form / inclusion decision made by the investigator when a person-of-trust is absent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is able to fluently read and speak French
* Blood loss \> 500ml and sulprostone treatment is insufficient at 20 minutes
* Duration of pregnancy \> 32 weeks of amenorrhea
* Uterine atony

Exclusion Criteria:

* The patient is participating in another study except for the followin studies: ElastoMAP, ElastoDéclench, Papillo PMA, GrossPath, LXRs, DGPostPartum
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient cannot read French
* The patient was transferred to another center not among the centers participating in this study
* The patient has a contraindication for a treatment used in this study (Sulprostone), or an incompatible treatment combination
* The patient has a contraindication for third level techniques
* The patient has at least one of the following conditions: chorioamnionitis, cervical cancer, uterine rupture, anatomical abnormality preventing the introduction of the device, purulent infection of the vagina, cervix or uterus.
Relative Drug Exposures Of Two Formulations of PF-02341066

The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over, single-dose study employing administration of two PF-02341066 formulations in the fasted state to healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram(ECG) and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory Follicle-stimulating hormone(FSH) test results at Screening.
Stem Cells and Tibial Fractures

The aim of this trial is to determine the safety and tolerability of expanded autologous progeny of an adult CD34+ (haemopoietic) stem cell subset when infused directly into the tibial artery of patients with recent tibial fracture. The trial will also seek to determine clinical improvement or deterioration by measurement of clinical parameters such as, length of time to union of the fracture, changes in bone mineral density, improvements in pain scores (VAS), functional ability (TUGT) and IPAQ scores.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed closed tibial fracture on one limb only
* Normal blood count
* Normal coagulation screen
* Life expectancy of at least 12 months
* Ability to give written informed consent

Exclusion Criteria:

* Patients with additional lower limb injuries
* Patients with abnormal lower limb vasculature
* Pregnant or lactating women
* Unexplained abnormal baseline laboratory results
* Males and females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study
* Subjects who test positive for HTLV, HIV, hepatitis B or hepatitis C, have a chronic inflammatory disease, autoimmune disease or are on chronic immunosuppressive medications
* History of alcohol or drug abuse within 3 months of screening
* Subjects with evidence (clinical, laboratory, or imaging) of cancer or cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma)
* Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period
* Patients unable to give written informed consent
Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients.

The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.

For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.

The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients.

The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. Stratum was constructed based on age and randomization scheme was performed separately within each stratum. Block randomization was done to ensure balance of the age groups.

For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.

For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.

Tidal volume and oxygen saturation are recorded during study period.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients scheduled for elective surgery under general anesthesia
* BMI \< 30
* ASA class 1 or 2

Exclusion Criteria:

* with difficult airway
* preexisting pulmonary disease
* upper respiratory tract infection
* intestinal obstruction
* with risk of pulmonary aspiration
* history of stoke or moyamoya disease
Imaging Airway Liquid Absorption in Cystic Fibrosis

The investigators are developing a new nuclear medicine imaging technique for measuring liquid absorption in the airways that can be applied to screen new medications being developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the small molecule radiopharmaceutical Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) will indicate changes in liquid absorption in the airways and demonstrate whether new CF medications will be effective. In this study the investigators will further develop this technique through testing involving pediatric CF patients and healthy control subjects.

The investigators have recently developed a novel aerosol-based imaging technique to detect changes in liquid absorption in the airways - a central pathophysiological process known to be important in cystic fibrosis (CF) lung disease. This technique may provide a measure of disease severity and indication of therapeutic correction in advance of currently available outcome measures. It involves the simultaneous delivery of two radiopharmaceuticals by inhalation: one an absorbable small-molecule (Indium-111 labeled diethylenetriaminepentaacetic acid; In-DTPA) and the other a non-absorbable particle (Technetium 99m labeled sulfur colloid; Tc-SC). The overarching hypothesis is that In-DTPA absorption provides a quantifiable, non-invasive measurement of airway liquid absorption that (a) is sensitive to CF genotype, (b) uniquely identifies basic disease phenotype and predicts disease severity, and (c) is modulated by therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy control arm:

  * subjects 18 years old or older without a diagnosis of lung disease.
* Pediatric CF arm:

  * subjects 6-14 years with a diagnosis of cystic fibrosis as determined by sweat test or genotype
  * subjects who are clinically stable as determined by the pediatrician co-investigator
  * subjects must have a previously demonstrated ability to perform reproducible pulmonary function testing based on previous clinical visits.
* Females in all groups who are of child-bearing potential will need to have a negative urine pregnancy test.

Exclusion Criteria:

* Adult healthy control arm:

  * FEV1%p \< 80% of predicted
  * nursing mother
  * positive urine pregnancy test or unwilling to test
  * cigarette smoker (regular smoking within 6 months of study).
* Pediatric CF arm:

  * FEV1%p \< 40% of predicted
  * nursing mother
  * positive urine pregnancy test for females of childbearing potential
  * unable or unwilling to comply with test procedure
  * cigarette smoker (regular smoking within 6 months of study).
  * Subjects unable to lie recumbent without moving for the 80 minute imaging period will be excluded.
Pilot Study Evaluating Functional and Wellness Outcomes of the Shepherd CAN DO MS Program

The study evaluates the efficacy of the CAN DO Program for improving health, wellness, and quality of life in people with MS, and compares outcomes between people with MS who participate in the CAN DO Program to a control group of people with MS who do not participate in the CAN DO Program. The study also evaluates the impact of the CAN DO Program on support partners.

Can Do MS Programs offer evidence-based, comprehensive, and personalized educational and experiential opportunities aimed at empowering and enabling a person with MS to live a healthy life beyond their MS. The signature program of Can Do MS is the four-day CAN DO® Program (CAN DO). Preliminary outcomes suggest that participation in CAN DO leads to significant improvements in self-efficacy and various aspects of health status.1 The majority of 129 participants who participated in one of the three CAN DO Programs showed improvements in self-efficacy at one month (n=98), 3 months (n=84), and 6 months after the program (n=82; all p\<0.001). Participants also showed significant improvements to varying degrees in subscales of the SF-36, including Physical Functioning (p=0.01), Role Physical, General Health, Vitality and Mental Health. These improvements were maintained to varying extents at one and 3 months post-program.

These important outcomes have not yet been compared to those in people with MS who receive traditional care but do not participate in this comprehensive educational opportunity. Furthermore, the impact on physical activity, participation, and quality of life has not been measured or compared to those who do not participate in CAN DO. Finally, recognizing the tremendous burden that can be placed on the support partner living and supporting a person with MS, education for support partners is another critical element of CAN DO. However, the impact on the support partner of empowering an individual with MS to adopt healthy behaviors also has not been assessed.

This project will allow Shepherd Center and Can Do MS to gather long-term health, wellness, and quality of life outcomes in people with MS and their support partners, as well as pilot data evaluating this study design for future larger scale clinical trials. Demonstrating the efficacy of this program will provide evidence that will impact the lives of people with MS and their families, specifically, their ability to live healthy lives independent of their MS.

Eligibility Criteria:
Inclusion Criteria:

* CAN DO Program group: have MS and participated in the May 2019 Shepherd CAN DO Program
* CG-iCMS: Have MS

Exclusion Criteria:

* CAN DO Program group: Active members of the Shepherd Center MS Wellness Program, or who have previously been a participant in any CAN DO MS Programs.
* CG-iCMS: Cannot participate in any of the CAN DO MS Programs at any time prior to the study