cyrilzakka/clinical-trials huggingface dataset:
Influence of Propranolol on Conditioned Pain Modulation

An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy controls and pain patients. A number of studies indicate that the autonomic nervous system (ANS) responds to painful stimulation by parasympathetic activity withdrawal and up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether these responses predict individual pain susceptibility or CPM efficacy and whether different pain modalities evoke different physiological stress responses, i.e. do individuals with low pain tolerance exhibit more vigorous ANS responses when subjected to controlled acute pain stimuli, and do high ANS responsiveness to pain coincide with altered psychophysical pain levels/CPM efficacy.

This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of the ANS will yield decreased CPM efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous history of neurologic, musculoskeletal, mental illnesses or a chronic pain condition
* Lack of ability to cooperate
* Current use of medications that may affect the trial, e.g., analgesics, anti-inflammatory drugs
* Consumption of alcohol, caffeine, nicotine or painkillers the morning and until termination of the study on the study day
* Recent history of acute pain affecting the lower limb
* Participation in other pain trials throughout the study period
* Known diagnosis of cardio vascular diseases (low blood pressure, heart conditions)
* Asthma
* Decreased function of liver and kidneys
* Diabetes
The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion

This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion.

A total of 54 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.

Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* 1-level posterior lumbar fusion

Exclusion Criteria:

* mental change
* allergy to local anesthetics
* chronic analgesics user
Optimizing Cerebral Autoregulation During Surgery

The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (MAP) within the limits of cerebral autoregulation during surgery compared with usual care.


Eligibility Criteria:
Inclusion Criteria:

* planned hip or knee surgery (either for fracture or elective) or lung surgery
* age ≥60
* ambulatory at baseline
* expected duration of surgery \> 90 minutes

Exclusion Criteria:

* Planned concurrent surgery
* Allergy to adhesive tape
* Short Blessed Test score \>20
* Clinical diagnosis of dementia
* Opinion of either the anesthesiologist or surgeon that the patient is not appropriate.
Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children

Nuclear magnetic resonance imaging (NMR) is used in pediatric brain tumors for purposes of diagnosis, evaluation of response to treatments, and monitoring of patients in follow-up. Through conventional imaging techniques it remains difficult to differentiate tumor recurrence from pseudo-progression or other iatrogenic changes after radiotherapy or chemotherapy, but it remains a relevant and essential clinical need for patient management.


Eligibility Criteria:
Inclusion Criteria:

* children and/or adolescents (≤18 years) diagnosed with brain tumor.
* children who underwent the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy.

Exclusion Criteria:

* patients \>18 years
Study of Current Practice Which Compare the Rate of Prostate Cancer by Using 2 Kind of Transrectal Biopsies: 3 by IRM-echography Image Fusion and 12 Systematized Guided Echographies.

The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.

The act of current practice evaluated by this research is the act of prostate biopsies : the patient will have to undergo 12 systematized transrectal echography guided biopsies of the prostate and 3 additional biopsies targeted on the suspicious lesion detected with MRI, which are both done in current practice.

* A first operator is not informed of the location of the target. He will perform a series of 12 systematic transrectal ultrasound-guided biopsies of the prostate.
* Immediately after the second operator will perform 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Act added by the research: Using a fusion of MRI - ultrasound images software system (Koelis ®).

Eligibility Criteria:
Inclusion Criteria:

* patient from 45 to 75 years old;
* Serum level of PSA \> 4,0 ng / mL;
* Multiparametric prostate IRM, performed before inclusion and which confirm the diagnosis of suspected target;
* No opposition of the patient notified in the medical record
* patient member in a national insurance scheme.

Exclusion Criteria:

* Previous prostate biopsy;
* suspicious digital rectal examination;
* serum PSA \> 20,0 ng / mL;
* treatment with 5 alpha reductase inhibitor during the last 3 months;
* untreated urinary infection
Scalp Block Decreases Pain and Side Effects

Postoperative analgesia after corrective surgery of paediatric craniosynostosis is crucial in term of short and long-term outcomes. The objective of this observational case- control study was to evaluate the effectiveness of an analgesic technique based on the scalp block versus traditional pharmacological approach.

Several studies on craniosynostosis and the correlated risk factors have been published, the majority of them focusing on the perioperative management of blood losses and avoidance of haemorrhagic shock. Other issues related to anaesthetic management of the surgical correction of craniosynostosis are metabolic and electrolyte disturbances.

Even if craniosynostosis surgery is an invasive procedure, there is a current misconception that it would be associated with minimal pain, despite the extensive exhibition of the skull and periostea dissection. The Literature about the assessment and management of postoperative pain in this particular surgical setting is scarce. Assessment of pain in infants is challenging, and often relies on clinical observation. To date, there are no evaluative and therapeutic parameters globally accredited in this category of patients. The scalp nerve block (SNB) is a regional anaesthetic technique, performed since several years in children undergoing a variety of procedures, from neurosurgery to eye-nose-throat surgery.SNB has been proposed as a complement to the routine craniosynostosis anaesthetic protocol, and should be associated to a reduced need for opioids.

Thirteen patients, aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis were subjected to SNB (Group SB) with Levobupivacaine 0.125% (total dose 2 mg/kg), performed before awakening, in combination with intraoperative intravenous acetaminophen (15 mg/kg if body weight \>10Kg, 7 mg/kg if body weight \< 10 kg). The SNB procedure was performed using the modified Pinosky technique, with levobupivacaine 0,125%(10). A targeted infiltration of 0,75-2ml of local anaesthetic (LA) solution was done at multiple sites with a 23G needle.

This Group of patients were compared with another group of 13 patients, derived from our database, and treated with the traditional pharmacological approach given intraoperatively (intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cranioplasty for the correction of craniosynostosis

Exclusion Criteria:

* allergies to local anesthetics and/or analgesics
* specific drug therapies (pain relievers, sedatives and/or epileptic)
* denied consent to the study; development of postoperative intracranical bleeding and/or gastrointestinal bleeding
* need of nasogastric tube
* development of gastrointestinal infections.
Exenatide for Stress Hyperglycemia

Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients.

It has been shown that perioperative hyperglycemia is an independent risk factor of postoperative mortality and morbidity.

The Leuven et al.'s study suggested that strict glycemic perioperative control using an intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's patients. This study included a majority of cardiac surgery patients. Others studies have suggested that the beneficial effect of insulin-based tight perioperative glycemic control might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain perioperative glycemic stability in most patients.

Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level.

We hypothesize that continuous intravenous infusion of exenatide could improve perioperative glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared to a conventional insulin therapy during the perioperative period of cardiac surgery.

The phase II of the study will assess the safety and the efficacy of a continuous intravenous infusion of exenatide for the management of post operative stress hyperglycemia after planned coronary artery graft bypass (CABG) surgery.

A nested cohort study will concern the 24 first patients included in the study (12 patients/group) to assess the impact of a continuous intravenous infusion of exenatide on post operative glycemic variability after planned CABG surgery.

The aim of the phase III of the study will compare the efficacy of a continuous intravenous infusion of exenatide to the gold standard treatment, i.e the intravenous infusion of short-acting insulin, for the management of post operative stress hyperglycemia after planned CABG surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18.
* Patient consent.
* Non insulin requiring type 2 diabetic patients.
* Non diabetic patients.
* Planned coronary artery bypass graft (CABG) surgery.
* ASA (American Society of Anesthesiologists) score 1, 2, or 3.

Exclusion Criteria:

* Pregnancy and breast feeding.
* Pancreatectomy.
* Acute pancreatitis.
* Chronic pancreatitis.
* Type 1 diabetic patients.
* Insulin requiring type 2 patients.
* HbA1c\>8%
* Ketoacidosis.
* Hyperosmolar coma.
* Preoperative blood glucose level above 300 mg/dl \[21\].
* Insulin or exenatide contraindication.
* History of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min.
* Emergency surgery.
* Planned non CABG cardiac surgery.
Oral and Olfactory Complications of Recovered COVID-19 Patients

This cohort study aims to investigate the long-standing chemosensory disorders and oral manifestation after recovery of the COVID-19 illness. A correlation between the long-standing symptoms and the COVID-19 severity grade will be very important to understand and clarify the aetiology of these symptoms.

This prospective cohort study aims to investigate the long-standing chemosensory disorders and oral manifestation after recovery of the COVID-19 illness. A correlation between the long-standing symptoms and the COVID-19 severity grade will be very important to understand and clarify the aetiology of these symptoms.

Study objectives:

1. To describe the frequency and severity of oral signs and chemosensory disorders that persist after the recovery of COVID-19 and to examine whether "taste disorders" can be discriminated into an- or hypogeusia and an- or hyposmia.
2. To report any correlation between the severity grade of COVID-19 and the resulting standing symptoms.
3. To describe the oral microbiome after infection with COVID-19 and to describe possible changes in comparison to normal healthy individuals.

Clinical and -if indicated- radiological examination to assess the long-term oral and chemosensory impairment and complaints of COVID-19 patients after their recovery shall be performed in an interdisciplinary setting of Maxillofacial Surgery, ENT and Medical Microbiology.

The study subjects will be divided into three groups according to the severity grade of illness: non-hospitalized, hospitalized, and intensive care patients. All adult COVID-19 recovery patients (exceeding the age of 18) will be included in the study. The time between illness and study recruitment shall be at least 3 months. Exclusion criteria are psychiatric or neurological diseases, previous trauma, surgery or radiotherapy in the oral or nasal cavities, pre-existing taste or smell dysfunctions or chronic rhinosinusitis.

The study variables include age, sex, co-morbidities, possible causes of exclusion from the study. The oral health assessment will be performed by examination of: periodontal status, assessment of oral lesions, a radiological examination by using panoramic x-ray if clinically indicated, photo documentation, objective evaluation of the olfactory and gustatory functions with psychophysical tests. The gustatory and olfactory function will be tested by using the combined Burghart Screening 12 test containing smelling sticks and taste strips (Fa. MediSense, Groningen, Netherlands). Evaluation of taste and smell is performed by offering the sticks/strips and demand a forced multiple choice.

Eligibility Criteria:
Inclusion Criteria:

* All adult COVID-19 recovery patients (exceeding the age of 18) will be included in the study. The time between illness and study recruitment shall be at least 3 months.

Exclusion Criteria:

* Exclusion criteria are psychiatric or neurological diseases, previous trauma, surgery or radiotherapy in the oral or nasal cavities, pre-existing taste or smell dysfunctions or chronic rhinosinusitis.
The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates

Patients with panel reactive antibodies have many difficulties to find a crossmatch-negative kidney for transplantation and are at the risk of post transplantation rejection more than other transplanted patients. We evaluated the effect of simvastatin on PRA and post transplant outcome of these sensitized patients. We also performed a descriptive study.

The presence of panel reactive antibodies (PRAs) in the sera of renal transplant candidates is associated with hyperacute or delayed humoral immune responses against the graft after transplantation .

In addition, these sensitized patients wait for a long time to find a cross-match negative kidney for renal transplantation . As a result, some modalities have been used for desensitization including plasmapheresis and intravenous immunoglobulin (IVIG) in combination with immunosuppressive drugs .

However, recently, the use of statins such as simvastatin, pravastatin and etc. has been proposed to be safer and more effective for desensitization .

Eligibility Criteria:
Inclusion Criteria:

1. patients with ESRD on hemodialysis or peritoneal dialysis
2. On the waiting list for renal transplant
3. PRA more than 25%

Exclusion Criteria:

1. Pregnant women
2. Patients who need ongoing blood products
3. Patients taking other therapies to decrease PRA
4. Patients listed for multi-organ transplant other than kidney
5. Patients with liver failure
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients

The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the end of the flu season

Influenza is a major cause of morbidity in the US. Patients with monoclonal gammopathies are known to have increased risk of developing influenza. Furthermore, several of the medications (such as proteasome inhibitors), commonly used to treat these tumors, are known to further increase the risk of these tumors. Seasonal influenza vaccination has been shown to reduce influenza related morbidity and is approved for routine prophylaxis in US. In 2009, Fluzone® high- dose vaccine was FDA approved in 2009 for adults aged 65 and older based on the data regarding higher rates of seroprotection (defined as hemagglutination antibody inhibition (HAI) titer of 40 or higher).

In this study, the investigators will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies irrespective of age versus a standard of care control group. Primary endpoint is composite of documented influenza infection rate and disease progression (as defined by International Myeloma Working Group criteria) at the end of the flu season. Based on the background data, the investigators expect a higher rate of success in the experimental arm. As such, the investigators power for success rates of 90% and 70% in the experimental and control arms, respectively.

The investigators will also analyze several secondary endpoints including rates of influenza related morbidity, the analysis of humoral and cellular immune response to these vaccines and the rate of disease control (defined as lack of disease progression by standard international myeloma working group criteria).

Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent form.
* Age ≥18 years at the time of signing the informed consent form.
* Diagnosis of any monoclonal gammopathy: Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic / active multiple myeloma, asymptomatic / active Waldenstrӧm Macroglobulinemia (WM).

Exclusion Criteria:

* Any serious egg allergy or prior serious adverse reaction to an influenza vaccine.
* Use of any other influenza vaccine for the 2015 to 2016 flu season.
* Women who are pregnant or plan to become pregnant in the study period.
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age 18 years or above
* Chronic kidney disease (CKD) with anemia
* Patients on dialysis receiving short-acting epoetin (EPO)
* Serum ferritin level \>/=100 ng/ml or transferrin saturation (TSAT) \>/=20%

Exclusion Criteria:

* Patients unwilling to give informed consent
* Uncontrolled hypertension
* Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
* Relevant acute or chronic bleeding history
* Hemolysis
* Hemoglobinopathies
* Pure red cell aplasia
Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery

Bone flaps after craniotomy are typically fixed with suture material, mini plates and others devices. In some cases, fixation with suture material is not secure as it may result in shifting of the bone flap with its dislocation. We will test the safety and efficacy of SKULL GRIP a new device for fixation of the bone flap during cranial procedure comparing to traditional suture materials.

At the end of the operation to start the fixation of cranial bone flaps, at least three Skull Grip titanium clamps will be positioned equidistant to one another along the craniotomy opening. The lower parts (complete circle) will be inserted between the dura and the cranium. The linear parts of the superior semicircle have to be in line with the craniotomy borders to allow the lodging of the bone flap. The different heights of the device are finalized to suit it for the different thickness of the cranial vault. The same procedure will be performed with all remaining Skull Grip titanium clamps.The bone flap will be then placed in its original position. By using a forceps, a simple and easy clockwise rotation of the superior semicircle will allow to block the SKULL GRIP clamp in place. For simple removal if necessary of the Skull Grip titanium clamps, even if bone ossification of the craniotomy edges has already occurred, it will be necessary just to lift up the superior semicircle of the Skull Grip by a forceps and to cut by a cutting forceps the pin between the two circle. Then, craniotomy could be completed in a standard way.

Eligibility Criteria:
Inclusion Criteria:

1. Major patient (aged ≥ 18 years)
2. Patient scheduled for craniotomy for a benign tumor
3. Patient informed and have signed informed consent

Exclusion Criteria:

1. Patient not affiliated with a social security scheme (or beneficiary entitled)
2. Patient with a known allergy to titanium
3. Patient non-compliant or whose follow-up to 3 months is impossible
4. Patient with against-indication scanner
5. Pregnant or lactating
Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99

An expanded access trial of belimumab for named patients who participated in LBRA99.

An expanded access trial of belimumab for named patients with Rheumatoid Arthritis (RA) who have experienced continued benefit under HGS Protocol LBRA99.

Eligibility Criteria:
Inclusion Criteria:

1. Have in the clinical judgment of the investigator, experienced significant clinical benefit while on belimumab treatment in the HGS Protocol LBRA99.
2. Over the course of the study and for 60 days after the last dose of study agent, any woman with an intact uterus who is not post-menopausal must agree to practice a medically accepted method of contraception.
3. Over the course of the study and for 60 days after the last dose of study agent, all men must agree to practice a medically accepted method of contraception.
4. Have the ability to understand the requirements of this study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the required study visits.

Exclusion Criteria:

1. Had not been previously treated with belimumab in LBRA99 or were discontinued from treatment prior to HGS' decision to terminate LBRA99.
2. Had clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to RA (ie, cardiovascular, pulmonary, anemia, gastrointestinal, hepatic, renal, neurological, cancer or infectious diseases) that could, in the opinion of the principal investigator, put the patient at undue risk.
3. Are a pregnant female or nursing mother.