cyrilzakka/clinical-trials huggingface dataset:
Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education

Following the proposal to self-monitor by the Freestyle Libre® (FSL) connected object, in diabetic patients in the context of therapeutic education, regarding the appropriation of FSL, what works, for which patients , in what specific contexts and by what mechanisms does it govern? A multicentric observational research will be conducted with mixed method design (follow-up using patient questionnaires) and semi-structured interviews of patients and caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Patients

  * Have type 1 or type 2 diabetes (as included in the education program),
  * Be of legal age (over 18 years old),
  * Do not present legal protection measures due to incapacity (such as guardianship or guardianship).
  * Be able to read and speak French (elementary school level)
  * Be eligible for FSL prescription and authorize the sharing of your data in Libreview®
  * Be affiliated to a social security scheme
  * Have an email address or a phone allowing internet use
* Caregivers

  * Be registered on the roll of his professional order
  * Hold the certificate of 40 hours of training in therapeutic education.
  * Practice therapeutic education on a regular basis

Exclusion Criteria:

* Patients

  * presenting contraindications to the use of Freestyle Libre® (known allergies to adhesive products, coagulation disorders, not treated with insulin therapy or with less than 3 insulin injections per day or continuously, not requiring glycemic monitoring or less than 3 times a day)
  * Patient refusing to follow the education program,
  * Minors, patients under administrative or judicial supervision)
  * Pregnant women,
  * Patients who cannot be contacted in an emergency,
  * Persons in a position to give their consent but with an inability to read / write the French language.
  * Patients who do not have an email address or a phone allowing internet use.
* Caregivers

  * Failure to register with the professional order (except those of the Army Health Service who are exempt)
  * Non-possession of the 40-hour therapeutic education training certificate.
  * Not practicing FSL education
Single Trans-sacral Screw Versus Two Iliosacral Screws

1. To compare Single Trans-sacral screw fixation vs. two Ilio-Sacral screws fixation as regard time for starting weight bearing.
2. To compare between functional outcome using the Majeed Pelvic Score.

Sacroiliac screws (SISs) have been used since Vidal et al introduced them in 1973. Since that, SIS fixation has become a common technology in fixing pelvic posterior ring injuries with important progress in the past 20 years. Currently, SIS fixation represents the only minimally invasive technique to stabilize the posterior pelvic ring. For that reason, it is steadily gaining popularity, becoming one of the most commonly used techniques. The sacrum, serving as the foundation of the spine, transmits the stress between spine and pelvis through sacroiliac joints. Thus, the goal of surgical fixation is the reconstruction of the spino-pelvic-junction to allow early weight-bearing and to facilitate nursing care, particularly for multiple injured patients.

As a result of the deforming forces acting perpendicular to the implant axis, routine ilio-sacral screws fixation may not provide adequate stabilization, especially in certain unstable injuries. Longer trans-sacral screws that traverse the entire upper sacrum and exit the contralateral iliac cortex may improve holding power and also stabilize concomitant contralateral posterior pelvic injuries. These trans-sacral screws are reliably safe to insert using routine intraoperative fluoroscopy, and they provide durable fixation.

Eligibility Criteria:
Inclusion Criteria:

1. Unstable pelvic fractures Tile type B \& C.
2. Sacral Fractures.
3. Recent trauma: less than 1 week from date of trauma.
4. Neurologically free.
5. Injury Severity Score (ISS) \< 18.

Exclusion Criteria:

1. Spino-pelvic dissociation.
2. Comminuted fractures
3. Bilat. Sacral fractures.
4. Sacral insufficiency.
5. Patients with associated comorbidities "eg. uncontrolled diabetes mellitus , chronic renal failure, etc.".
Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

There is accumulating evidence that inappropriate depth of anaesthesia is associated with increased risk of postoperative complications including risk of death. The aim of this study was to identify factors determining the effective end-tidal concentration (EEtC) of desflurane, duration of wash in and wash out phase, and to estimate the risk of perioperative awareness in patients undergoing elective neurosurgical procedure.

All patients with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective neurosurgical procedure under general anaesthesia are studied. In each individual, the manufacturer recommended age-corrected end-tidal concentrations of desflurane is set and achieved initially. Individual effective end-tidal concentration (EEtC) of desflurane is then defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50. Effective analgesia is maintained according to surgical plethysmographic index (SPI) and dose of muscle relaxants according to neuromuscular transmission monitoring (TOF). Comorbidity, regular intake of alcohol and medication, smoking, sex, weight, height, and age are recorded. Postoperative questionnaire is used to reveal the intraoperative awareness.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* elective neurosurgical procedure under general anaesthesia
* Age between 18 and 78
* elective procedures with estimated duration 1 - 3 hours

Exclusion Criteria:

* Glasgow coma scale GCS below 14
* other rhythm than sinus
* pacemaker stimulation
* planned postoperative ventilation
Novel in Vivo Synaptic Imaging in Experienced Meditators

To utilize positron emission tomography (PET) imaging to characterize the distribution of (aka \[11C\]APP311at the Yale PET Center) in cortical and subcortical areas in experienced meditators compared to non-meditating controls.

The investigators will conduct a PET study of the novel SV2A imaging tracer \[11C\]UCB-J in participants, to characterize the distribution of \[11C\]UCB-J in cortical and subcortical areas in experienced meditators compared to non-meditating controls. A total of up to 20 subjects will complete the study. Subjects will undergo one PET scan with \[11C\]UCB-J. Each subject will also undergo one MRI scan for anatomical identification of brain regions.

Eligibility Criteria:
Inclusion Criteria:

* Age 28-70 years
* Voluntary, written, informed consent
* Physically healthy by medical history, physical, ECG and laboratory examinations
* At least 10 years and 5,000 hours of regular meditation practice
* For females, non-lactating, no longer of child-bearing potential or agree to practice effective contraception during the study, as well as a negative serum pregnancy (β-HCG) test at screening, and negative urine pregnancy on PET scanning days.

Exclusion Criteria:

* A history of significant psychiatric, medical (e.g., cardiovascular, renal) or neurological (e.g., cerebrovascular, seizure, traumatic brain injury) illness that is unstable and/or might affect the study objectives.
* Current or history of substance dependence (e.g., alcohol, nicotine, opiates, sedative hypnotics, etc.)
* Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
* Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
* Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.)
* History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
* Medications that effect SV2A binding (e.g., levetiracetam).
Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients.

Can music theraphy during mechanical ventilation in the ICU, decrease the need of pharmacological sedation? Included patients will listen to music selected by a music therapist via headphones two times one hour during two days. Effects on heart rate, blood pressure, respiratory rate and dosing of pharmacological sedation will be observed. 100 patients will be included and radomized equally to earphones with and without music.


Eligibility Criteria:
Inclusion Criteria: In the ICU, entilator treated adults \> 18 years.

-

Exclusion Criteria:

* Children \>18 years.
* Deaf people.
* Children \<18 Years
Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block

Heart rate variability(HRV) and electroencephalography(EEG) has been used widely in anesthetic practice nowadays. One of the most dominant applications is the nociception-analgesia balance. Some evidence support that heart rate variability correlates with perioperative stimulation and postoperative pain score. There are some new evidence support EEG correlated with anesthesia depth and analgesic balance. However, the heterogeneity between the studies and interference factors has limited their usage in clinical practice. On the other hand, peripheral nerve block is broadly used as a routine technique with general anesthesia, but few studies discuss the effect on heart rate variability. Our study focuses on the different HRV and EEG patterns of incision and insufflation during laparoscopic surgery with general anesthesia. Furthermore, we measure the effect of transversus abdominis plane nerve block to heart rate variability during surgery. By this comparison, we can discuss the influences of somatic stimulation, visceral stimulation, and pneumoperitoneum to heart rate variability, and then improve the accuracy of HRV-based nociception-analgesia monitors.


Eligibility Criteria:
Inclusion Criteria:

* ≥20 years of age male or female
* American Society of Anesthesiologists (ASA) physical status classification I or II
* capacity to give informed consent

Exclusion Criteria:

* major cardiovascular and cerebral vascular disease, arrhythmia, respiratory disease, diabetes mellitus with evidence of neuropathy; ASA physical status classification III or greater; a documented or self-reported history of chronic pain; acute or chronic opioid analgesic use; dysautonomia; and intraoperative muscarinic anticholinergic administration during the time of monitoring.
Hepcidin in Anemic Chronic Heart Failure (CHF) Patients

Background: Anemia in chronic heart failure (CHF) is directly linked to increased mortality and reduced exercise capacity. The pathomechanism for the development of anemia in CHF is not well understood. Impairment of iron homeostasis is discussed to be one of the major triggers in anemia of chronic disease. Hepcidin was recently described as the central regulator of iron homeostasis.

Main hypothesis: Plasma hepcidin levels are altered in anemic CHF patients compared to non anemic controls and might be a main contributing factor of anemia in CHF.

Iron regulator-hypothesis High levels of cytokines in CHF patients cause up-regulation of hepcidin, which in turn leads to low iron uptake causing anemia. In this case venous hepcidin and hemoglobin concentrations should both correlate with cytokine levels.

Erythropoietin regulator-hypothesis Dysregulation of the erythropoietin system results in anemia, which represses hepcidin. This leads to a negative correlation between hemoglobin and hepcidin in plasma.

Methods: 100 consecutive patients diagnosed with systolic CHF will be prospectively included in the study. Iron status will be assessed and hepcidin, erythropoietin as well as interleukin-1, interleukin-6 and soluble TNF alpha receptor levels will be measured by ELISA.

Patients will be followed up for one year and mortality, rehospitalization and worsening of CHF will be documented.


Eligibility Criteria:
Inclusion Criteria:

1. Systolic left ventricular dysfunction (LVEF\<45%)
2. Signed informed consent

Exclusion Criteria:

1. Women of child bearing potential
2. Pregnancy
3. Non cardiac illness limiting life expectancy to \<1 year
4. Renal disease of non-cardiac reason
5. Malignancy
6. Chronic inflammatory disease
7. Acute infection
8. Erythropoietin therapy or iron substitution within the last 6 months
The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation

There has been no study yet on the effect of stingless bee honey (Kelulut honey) produced by Melipolini sp. in diabetic wound healing in Malaysia. Kelulut honey, apart from possessing similar pro-healing properties with other honey, is also found to have a better antioxidant capacity, anti-inflammatory, and free radical scavenging activity than Tualang honey. These effects are due to the much higher content of phenolic and flavonoid substances in Kelulut honey, the key bioactive factors promoting wound healing and preventing oxidative stress-related injury. Australian researchers have also recently discovered a novel source of the rare disaccharide trehalose in stingless bee's honey, which is highly anti-diabetic and antioxidating. This study aims to investigate the efficacy of honey against gel dressing for wound bed preparation among diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Aged between 18-70 years old
* Patient with full thickness cavity wound
* Controlled diabetes mellitus (defined as: fasting blood glucose (FBG) \< 10 mmol/L upon selection)

Exclusion Criteria:

* Severely contaminated wound/infected
* Patient with history of allergy to honey or stingless bee product
* Patients who are immunocompromised or on chronic steroid use ( defined as use of steroid for more than 2 weeks)
* Pregnancy
* End stage renal failure (ESRF) patient
Strategy Training for Individuals With Unilateral Neglect

It is common for individuals after stroke to have a cognitive perceptual impairment called unilateral spatial neglect (neglect). Individuals with neglect have difficulty paying attention to one side of their body or one side of the environment and therefore experience difficulty performing daily activities. There are a lack of effective treatments for neglect and new interventions are needed to help reduce disability for these individuals. Metacognitive strategy training (strategy training) is an intervention that has the potential to reduce neglect-related disability and improve individuals' awareness of their neglect. This study seeks to examine the effects of strategy training on self-awareness, disability, and neglect.

Unilateral spatial neglect (neglect) post stroke is characterized by a lack of attention to one side of the body or one side of the environment. Individuals with neglect experience significant disability and are often unaware of their neglect symptoms which can make it even more difficult to treat. There are a lack of effective treatments for neglect and new interventions are needed to help reduce disability for these individuals. Metacognitive strategy training (strategy training) is an intervention that has the potential to reduce neglect-related disability and improve individuals' awareness of their neglect. Strategy training teaches individuals to develop personalized goals, self-assess their performance of daily activities, and develop and evaluate strategies designed to overcome barriers and improve their performance of daily activities. While strategy training shows promise for individuals with neglect, no studies have tailored the intervention for this group of individuals or examined the effects of strategy training for individuals with neglect. This study examines whether strategy training facilitates reductions in disability and neglect and improves self-awareness after acute stroke.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of stroke
* admission to inpatient rehabilitation facility
* ≥18 years old
* presence of neglect as determined by score of \<18 on the Virtual Reality Lateralized Attention Test (VRLAT) or score below established cutoff for neglect on one of the six subtests of the Behavioral Inattention Test (BIT)

Exclusion Criteria:

* Boston Diagnostic Aphasia Examination (BDAE) Severity Scale score of 0 (severe global aphasia)
* diagnosis of dementia indicated in medical record
* diagnosis of active major depressive disorder/bipolar/psychotic disorder indicated in medical record
* anticipated length of stay \<10 days
Effect of One-time Versus Three-times of Umbilical Cord Milking on Neonatal Hemoglobin in Late Preterm

To compare the neonatal hemoglobin (Hb) in late preterm between one-time versus three-times of umbilical cord milking (UCM)

This was a double-blind randomized controlled trial that performed between May 2021 to March 2022 at the Obstetrics and Gynecology Department of Queen Savang Vadhana Memorial Hospital. Late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times UCM. The primary outcome was neonatal Hb level at 48-72 hour after birth.

Eligibility Criteria:
Inclusion Criteria:

* Late preterm pregnant women (34-36+6 week's gestation)

Exclusion Criteria:

* placenta accrete
* placenta percreta
* placenta previa
* placental abruption
* congenital anomaly
* hydrops fetalis
Exercise as Cardio Protective Modulates in Diabetic Patients

* Physical exercise for 6 months produced significant improvement in adiponectin, hs-CRP, and nitric oxide (NO) and was significantly correlated with adiposity markers, lipid profile and glycemic control factors in both obese and non-obese diabetic patients.
* Patients with good physical activity reported a significant decrease in BMI, CHD risk scores, reduced hs-CRP, an increase in the levels of adiponectin and nitric oxide.
* In patients with type 2 diabetes mellitus, adiposity markers, lipid profile, hs-CRP, and adiponectin were significantly improved following moderate exercise interventions

To elucidate the potential role of exercise as anti-adiposity and anti-cardio protective modulates, we thought to investigate the effect of supervised aerobic training of moderate intensity on adiposity markers, nitric oxide level, plasma adiponectin, hs-CRP, and its association with CHD risk score in obese and non-obese patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes for more than 5 years.
* Patients who were diagnosed according to the criteria of the American diabetes association.
* Not receiving any drugs affecting the data obtained
* had Normal daily diets
* Not participating in any other exercise programs
* Without any musculoskeletal disorders affecting an exercise program

Exclusion Criteria:

* Exclusion criteria included anemia, overt complications of diabetes like nephropathy, neuropathy, retinopathy, obvious ischemic heart disease (angina, myocardial infarction, and lead electrocardiogram abnormalities), HCV, HBV, chronic liver and kidney diseases, hypothyroidism, and drugs (diuretics; oral contraceptives).
Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19

Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 25 to 70 years old.
* Type 2 diabetes.
* In Metformin or sulfonylureas

Exclusion Criteria:

* Treatment with other antidiabetics
* Osteopososis or gastrointestinal disease
* Smoking
* Long term steroid treatment
* Weight change more than 3 kg within the last 3 months.
* Overweight or intestinal surgery
Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.

This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.


Eligibility Criteria:
Inclusion Criteria:

* 18\~65 years old.
* Subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions.
* Subject can fully understand and voluntarily sign informed consent forms.

Exclusion Criteria:

* Subject with a history of allergic diseases.
* Subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past.
* Subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion.
* Subject transfused with washed RBC.
* Received allo-HSCT transplantation before.
* Subject with heart failure.
* Subject suffered from sequelae of cardiovascular or cerebrovascular diseases.
* Pregnant or nursing women.
* Inability to understand or to follow study procedures.
Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma

To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma


Eligibility Criteria:
Inclusion Criteria:

1. solitary papillary thyroid carcinoma confirmed by fine-needle aspiration or core-needle biopsy;
2. largest diameter ≤10 mm;
3. no evidence of extrathyroidal extension( no signs of unsmooth thyroid capsule or involvement of the perithyroidal tissue) on ultrasound;
4. no evidence of cervical lymph node metastasis on US or neck CT;
5. no distant metastasis on chest CT;
6. no history of neck irradiation.

Exclusion Criteria:

* (1)aggressive subtype of papillary thyroid microcarcinoma confirmed by biopsy(1); (2)multiple tumors; (3) incomplete data or lost follow-up