cyrilzakka/clinical-trials huggingface dataset:
Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.

To examine whether corticosteroid administered epidural space in patients undergoing endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain relief, improves functional disability comparing to placebo

Eligibility Criteria:
Inclusion Criteria:

* Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed

Exclusion Criteria:

* Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid
VR for Burn Dressing Changes at Home

This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.

Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients age 5-17 years (inclusive)
* receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution
* have a dressing that requires daily changes at home for at least one week
* can communicate orally

Exclusion Criteria:

* any wounds that may interfere with study procedures (i.e. face)
* vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
* history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
* minors in foster care
* suspected child abuse
* unable to communicate in English
* families who do not have access to a smartphone (due to the VR-PAT game requirements)
Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma.

Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.


Eligibility Criteria:
Inclusion Criteria:

* systemic sclerosis
* Diffuse Infiltrating Pneumonia

Exclusion Criteria:

* infection
* other lung diseases
* non French native
Repository: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant

This is a repository to store blood and stem cell samples for future research.

Our Hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of GVHD by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Our understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions

Exclusion Criteria:

* Patients \< 18 or \> 70 years old undergoing either autologous transplant or allogeneic transplant
Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK

A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory failure \[acute respiratory distress syndrome (ARDS)\] and death is a global threat. On 11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged Prothrombin time \[PT\] and raised D dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets. The number of patients with infected with COVID- 19 in UK is rapidly rising as with many other European countries. Eventually \>50% of people will have become infected and COVID-19 will remain a public health threat in the long term. It is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly pulmonary embolism (PE), is major problem in COVID patients. In this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment. Determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future. Furthermore, by comparing these data with data from patients without Covid-19, investigators will be able to modify existing protocols and tailor them to the management of COVID -19.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) admitted hospitals with COVID 19 infection (COVID RNA+ +/- radiological change +/- clinical suspicion in absence of RNA)

Exclusion Criteria:

* No exclusions
MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients

The sentinel lymph nodes (SLNs) are the first lymph nodes (LNs) to drain the tumor site and therefore the first LNs to bare metastases. Hence the importance to investigate these LNs for the best treatment strategy. Current-standard-of-care for melanoma patients with a melanoma stage of pT1b or higher, involve a surgical procedure, referred to as SLN biopsy (SLNB). The SLNB procedure involves a combined detection procedure using a radio-active tracer and blue dye followed by surgical dissection and evaluation of the LNs at the histopathology department. Due to the use of radioisotopes, this procedure suffers from several disadvantages such as limited availability, strict rules and regulations, degradation time in patient and radioactive load for user and patient.

To overcome the limitations of a radioactive tracer, a magnetic SLNB was developed which is facilitated by super paramagnetic iron-oxide (SPIO) nanoparticles. This potentially offers numerous benefits making surgery planning more flexible: no exposure to radiation, easy accessibility of the tracer, long shelf life and long half time in the patient. However, the currently available magnetometer for intraoperative detection of SPIO-enhanced LNs is hampered by a relatively low detection depth, biological noise, and effects of surgical equipment. Therefore, surgeons need to switch to plastic or carbon equipment and the system needs to be balanced prior to each measurement, which increases the surgery time.

A new and effective way to localize SPIOs is differential magnetometry (DiffMag). This patented detection principle, developed by MD\&I group at University of Twente (UT), utilizes the nonlinear magnetic response of nanoparticles. An additional advantage of SPIOs is their visibility on MRI, which could provide mapping the SLNs preoperatively. Especially in patients with melanomas on the abdomen or back this would be very useful to see which lymph node stations are connected to the melanoma. In addition, studies have shown that SPIOs are absorbed into lymph nodes in different ways, depending on the presence of metastases. SPIO-enhanced MR lymphography could therefore provide an opportunity for a non-invasive preoperative assessment of nodal status.

In this pilot study the investigators want to evaluate the clinical use of the DiffMag handheld probe. Moreover, the investigators want to map the lymph nodes (metastases) preoperatively using MR lymphography.


Eligibility Criteria:
Inclusion Criteria:

* Patients with melanoma of the upper or lower extremities scheduled for SLNB;
* Willing to \& able to write informed consent from the subject prior to participation;
* Willing to \& capable of following study procedures;
* Is older than 18 years;
* Speaks and understand the Dutch language

Exclusion Criteria:

* Intolerance / hypersensitivity to iron or dextran compounds
* Pregnant or lactating patients;
* Patients having a pacemaker.
* Patients non eligible for MRI investigation (pacemakers or other implantable devices in the chest wall and/or lower body, claustrophobic, etc.)
Comparison of the Effects of Sevoflurane and Desflurane on Endothelial Glycocalyx

The glycocalyx is a dynamic and complex biochemical structure composed of proteoglycans, glycoproteins, and soluble proteins. The glycocalyx interacts with various proteins such as albumin and orosomucoid to form a thick surface layer on the vessel surface that is physiologically active. This is called the endothelial surface layer. This structure is constantly changing with the blood flowing in the vein. The glycocalyx regulates oncotic pressure and also prevents leukocyte and platelet adhesion to the endothelium. Endothelial cell dysfunction is a valuable marker of increased vascular permeability and impaired angiogenesis due to cardiovascular, thoracic, renal, and metabolic diseases.

The glycocalyx is a dynamic and complex biochemical structure composed of proteoglycans, glycoproteins, and soluble proteins. The glycocalyx interacts with various proteins such as albumin and orosomucoid to form a thick surface layer on the vessel surface that is physiologically active. This is called the endothelial surface layer. This structure is constantly changing with the blood flowing in the vein. The glycocalyx regulates oncotic pressure and also prevents leukocyte and platelet adhesion to the endothelium. Endothelial cell dysfunction is a valuable marker of increased vascular permeability and impaired angiogenesis due to cardiovascular, thoracic, renal, and metabolic diseases.

Some medical approaches, including anti-thrombin III, nitric oxide, the TNF-α analog etanercept, and inhalation agents, can repair or prevent deterioration of the endothelial glycocalyx. In a study by Chen et al., it was shown that Sevoflurane has a protective effect on syndecan and heparan sulfate, which are located in the glycocalyx structure, thus reducing leukocyte and platelet adhesion and protecting the vascular endothelium (8).

Kim et al. In a study conducted, it was shown that the protective effect of propofol, an intravenous anesthetic, on the vascular endothelium was greater than that of sevoflurane In our research, no study was found on the effect of another inhalation anesthetic, desflurane, on the vascular glycocalyx structure. In this study, we aimed to investigate and compare the effects of sevoflurane and desflurane on glycocalyx.

Eligibility Criteria:
Inclusion Criteria:

* Be in the 18-65 age rang
* Being in the ASA 1-3 risk group
* patients receiving general anesthesia

Exclusion Criteria:

* refuse to participate in the study
Improving Outcomes After PICU Admission: A Pilot Study

1. Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care;
2. Evaluate the feasibility and acceptability of the study design and procedures;
3. Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU;
4. Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention;
5. To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.

Most children are now expected to make a complete medical recovery following admission to PICU. However, research suggests that some children will go on to develop psychological difficulties, such as problems with emotions, behaviour, and learning. In addition, parents themselves may suffer with emotional difficulties. Although the follow-up of survivors is recommended, there are currently no specific guidelines in place. Intervention in the early stages of recovery could help families pull through without long lasting after-effects.

Eligibility Criteria:
Inclusion Criteria:

* Unplanned emergency admissions to PICU for at least 12 hours
* Parent or primary carer speaks and can read English

Exclusion Criteria:

* Child dies whilst on ward
* Child discharged with a terminal illness
* Child has had multiple PICU admission in the past
* Staff feel it is inappropriate to approach family
* Family live overseas
Female Sexual Function and Back Pain

Back paın is a common hormonal disorder in women that may affect the phases of female sexual function (FSD). We investigated sexual function in patients with back paın A total of 54 women with back paın and 27 age matched voluntary healthy women who served as the as control group were evaluated with a detailed medical and sexual history, including a female sexual function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

A total of 54 women with back paın and 27 age matched voluntary healthy women who served as the as control group were evaluated with a detailed medical and sexual history, including a female sexual function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* 20-45 year old
* Female
* Active sexual life

Exclusion Criteria:

* Younger than 20, older than 45 year old.
* Menopause
Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

Emergence agitation (EA) is common phenomenon in pediatric patients undergoing general anesthesia by inhalation agents. The incidence of EA was reported to range from 18% to 80%. Sevoflurane now is the inhalational anesthetic agent of choice for pediatrics, Different strategies have been suggested to decrease the incidence and severity of EA. No gold standard technique for treating EA after sevoflurane anesthesia is currently available. The main question is can caudal dexmedetomidine be used for this purpose?

The purpose of this prospective comparative randomized clinical study will be to compare the effects of caudal dexmedetomidine on EA in children undergoing lower abdominal operations under general sevoflurane anesthesia. In addition, characteristics of anesthesia recovery and incidence of adverse effects will be compare. A total of (48) children aged 1-5 years old, The American society of Anesthesiologists (ASA) physical status classification system between I-II of both sex who will be enrolled from April 2016 to April 2017 undergoing for lower abdominal surgeries will be included in the study. Patients will be randomized by computer-generated random numbers in a double blinded fashion to get enrolled into 2 equal groups: Group BD patients (n = 24) will be received single dose caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 24) will be received single dose caudal epidural analgesia with bupivacaine only. The dexmedetomidine used for this study will be prepared in a 1 ml syringe wrapped in aluminum foil by an investigator who will not be involved in the anesthesia process and another 1 ml syringe filled with saline will be prepared too.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-5 years old,
* The American society of Anesthesiologists (ASA) physical status classification system between I-II of both sex who will be enrolled from March 2015 to March 2016 undergoing for lower abdominal surgeries, e.g., hernia and perineal surgeries, e.g., undescended testis and hypospadius will be included in the study.

Exclusion Criteria:

* mental retardation, developmental delay, known allergy to any of the study drugs, congenital anomalies of spine, neurological or psychiatric illness that may be associated with improper communication, any signs of local infection in the sacrum region, any kind of cardiac conduction disorder, bleeding disorders, any previous cardiovascular disease and parental refusal.
Educational Follow-up in COPD Patients After Pulmonary Rehabilitation.

After pulmonary rehabilitation, the challenge is to maintain the benefits reached during the program and increase physical activity.

As exercise training, education is the corner stone of pulmonary rehabilitation. Education allows to support behavioral changes in daily life.

Recommendations about modalities for maintaining physical activity are still clear, however for educational follow up recommendations need to be clarified.

After a pulmonary rehabilitation program, there is no defined plan for educational follow up nor location to perform education session.

The aim of this study is to evaluate the proportion of patients who succeed to establish and maintain the objectives they defined during the pulmonary rehabilitation program, one year after this program.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients COPD patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation unit of CH des Pays de Morlaix or CHU Brest

Exclusion Criteria:

* inability to answer to the questionnaire
* refusal to participate.
* inability to perform the pulmonary rehabilitation program.
Management of Drooling in Children With Cerebral Palsy in France

The study is a transversal, observational, descriptive survey of the practices and opinions of health professionals carried out nationally across France that aims to characterize children with cerebral palsy and pathological drooling and to describe care pathways, assessment and treatment of drooling.


Eligibility Criteria:
Inclusion Criteria:

* health professional known to assess and/or treat drooling
* health professional known to assess and/or treat children with Cerebral Palsy
* health professional exercising in France

Exclusion Criteria:

* health professional with an inactive e-mail address
Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening

This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.

Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian Women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS-reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness measured through incremental ratios and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* HPV positive
* Age 25 - 60 years
* Private mobile phone

Exclusion Criteria:

* Pregnant on day of enrolment
* Menstruating on day of enrolment
* Hysterectomy
* Diagnosed with cervical pre-cancer within past 12 months
* Diagnosed with cervical cancer
* Invalid mobile phone number
* Unreachable when trying to convey HPV positive result
An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy

The purpose of this study is to evaluate the effectiveness and safety of the novel compound RWJ-333369 in reducing the frequency of seizures in patients with epilepsy.

333369EPY2006 is the open-label extension study that follows the double-blind study 333369EPY2003. In an open label study such as 333369EPY2006, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY2003, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of study 333369EPY2003 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369). RWJ-333369 is a new chemical compound with anticonvulsant activity that is currently under investigation as a treatment for epilepsy. Patients electing to enter the open-label extension phase will be supplied with both open-label carisbamate (RWJ-333369) and blinded study medication for the transition phase. During this transition phase (approximately 3 weeks in length), the patient's dose of double-blind study drug will be gradually reduced and stopped and treatment with open-label RWJ-333369 will be started. Throughout the remainder of the open label extension phase, investigators will be allowed to make further adjustments of the dosage and schedule of carisbamate, including independent adjustment of the morning and evening doses, but a dosage of 1,200 mg/day may not be exceeded and increases in dosage must be in increments of no more than 200 mg/day. After 12 months of participation in the open-label extension study, patients who, in the judgment of the investigator, continue to benefit from treatment with RWJ-333369 may continue to receive the drug with follow up clinic visits every 3 months until RWJ 333369 is available by prescription or the program is terminated by the sponsor. RWJ-333369 (100, 300, 800, or 1,600 milligrams per day) administered orally in 2 equally divided doses for up to 16 weeks of double-blind treatment followed by the option to continue RWJ-333369 treatment in an open-label study for at least 1 year, then until drug is available or production ceases.

Eligibility Criteria:
Inclusion Criteria:

* Patients must complete Visit 8 (Day 112) of the double-blind treatment phase of Study EPY-2003 to be eligible for entry into the open-label treatment phase of Study EPY-2006.

Exclusion Criteria:

* Patients who have seizures that cannot be quantitated accurately
* Patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
* Patients with a history of drug or alcohol abuse within the past 2 years
* Patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
* and patients who are pregnant or nursing.