cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus

The study will investigate the efficacy of the N-methyl-D-aspartate receptor antagonist ketamine as a first line agent in refractory status epilepticus versus traditional general anesthetic agents used for burst suppression that target the gamma-aminobutyric acid adrenergic receptors.

The traditional treatment for refractory status epilepticus includes diazepam, midazolam, valproic acid, thiopental and propofol. These medications fail to control seizure activity in 20-40% of patients. This is attributed to decrease in activity of gamma-aminobutyric acid receptors along with reciprocal up regulation of N-Methyl-D-aspartate receptors. Glutamate activation of N-methyl-D-aspartate receptors promotes calcium influx and excitotoxicity. Ketamine, an intravenous anesthetic agent which is a non-competitive antagonist of N-methyl-D-aspartate receptors can block the flow of Ca and Na and by combining with phencyclidine binding sites inside the ion channel of N-methyl-D-aspartate receptors, reduce the epileptiform burst discharges and after potential. Therefore, targeting the N-methyl-D-aspartate receptors with ketamine may provide a novel approach to control refractory seizures. Moreover, by blocking glutamate mediated N-methyl-D-aspartate receptor induced neurotoxicity, ketamine may render neuroprotection. Ketamine also provides additional advantage of hemodynamic stability. Currently, ketamine is used as a last resort drug in the treatment of refractory status epilepticus.

The specific aim is to determine whether continuous infusion of ketamine as a first line agent for refractory status epilepticus is effective in controlling seizures.

The central hypothesis of our proposal is that early treatment with ketamine will be much more efficacious in controlling refractory status compared to the traditional treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years of age with a diagnosis of status epilepticus
* Considered for burst suppression therapy after failing 2 or 3 anti-epileptic medications

Exclusion Criteria:

* Post anoxic status epilepticus
* Pregnant women, as confirmed by urine, or blood human chorionic gonadotropin, ultrasound or physical exam
* Prisoners
* Age less than 18 years
* Allergy or sensitivity to the drug in question
Using Open Contest and Neuro-influence Experiment to Develop and Evaluate PrEP Promotion Messages for High Risk Men

The aim of this study is to examine the utility of neuroimaging technique to evaluate pre-exposure prophylaxis (PrEP) promotion messages for men who have sex with men (MSM) at risk of HIV in Baltimore.

This study will examine the utility of neuroimaging technique to evaluate PrEP promotion messages for MSM at risk of HIV in Baltimore. The investigators hypothesize that participants viewing top messages developed via open contests will show higher brain activation in the Medial Prefrontal Cortex (MPFC) regions than those viewing messages developed by a social marketing approach. The investigators further hypothesize brain activation in the MPFC regions is significantly more correlated with PrEP behavioral intention, initiation, and action than self-reported message effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Biological male sex at birth
* Sexually active with men in the past 6 months
* Never taken PrEP
* HIV negative
* Reside in Baltimore City or surrounding counties
* Meet one of the criteria for being an appropriate PrEP candidate (i.e. in a relationship with a partner not known to be HIV-negative; are in a nonmonogamous relationship; have had any condomless anal sex with a casual male partner regardless of status in the prior 6 months; or had a positive sexual transmitted infection (STI) diagnosis within the prior 6 months).

Exclusion Criteria:

- Participated in open contest
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal response to any oral or infusion Disease-Modifying Drugs (DMDs) approved in the United States (US) for RMS in a real-world-setting.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Have diagnosis of RMS, including RRMS and aSPMS, and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI)
* Have time since diagnosis of RMS of at least 12 months
* In the opinion of the investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral or infusion DMD treatment other than cladribine tablets
* Had received their last previous oral DMD for at least 1 month or at least 1 dose of their last previous infusion DMD
* Have decided to initiate treatment with cladribine tablets during routine clinical care
* Meet criteria as per the approved USPI
* Have access to a valid e-mail address

Exclusion Criteria:

* Have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral)
* Transitioning from previous oral DMD solely for administrative reasons such as relocation
* Have comorbid conditions that preclude participation
* Have any clinical condition or medical history noted as contraindication on USPI
* Are currently participating in an interventional clinical trial
* Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period
A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity

In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* between 4 to 8 years of age at the start of the intervention
* overweight or obese (≥85th BMI-for-age percentile)
* have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.)
* not currently participating in a weight loss program and/or taking weight loss medication
* have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions
* caretaker must be able to read, speak and understand English and the child speak English
* have transportation to their child's primary care provider office
* family does not plan to move out of the area before March 2012
Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged over 20 years
* Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator
* Patients has given written informed consent
* Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.)
* Patients has received an ABO compatible donor kidney.
* Complement-dependent Cytotoxic Crossmatch: CDC) result: negative
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney.
* Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil.
* Desensitization
* HLA-identical
* Heart Disease; Heart failure (symptom, EF \<45%)
* Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease
* Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable
* malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma)
* Patient has received a kidney transplant from non-heart beating donor
* Cold ischemic time \> 30hrs
* Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site
* (ANC)\<1,500/mm3, (WBC)\<2,500/ mm3, (PLT)\<100,000/ mm3
* ATG: Anti-thymocyte globulin induction
* Medical condition that could interfere with the study objectives.
* Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment.
* Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment.
* Patient who is judged not to be adequate by the investigator owing to other reasons
* Patient is pregnant or lactating.
* Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)
Suprathreshold Pressure Pain Stimulation in Fibromyalgia

The purpose of this study is to investigate the induced-pain characteristics after suprathreshold pressure stimulation at different intensities in fibromyalgia subjects, compared with healthy volunteers.

Fibromyalgia syndrome is a chronic painful, non-inflammatory rheumatic disease with a high negative impact on the quality of life, and is characterized by widespread pain, fatigue and generalised hyperalgesia on examination, symptoms that can be the consequence of central sensitization.

Despite several methods have successfully addressed this increased responsiveness of nociceptive neurons in the central nervous system, there is a lack of consensus about how to systematically perform them and those that are more appropriated for different syndromes. Therefore, investigating appropriate simple methods to assess clinical manifestations of central sensitization is relevant in the assessment of fibromyalgia.

The present study aims to investigate the pain response after suprathreshols pressure stimulation in fibromyalgia subjects compared with healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Fullfilled the American Collegue of Rheumathology criteria for fibromyalgia.
* Understanding of spoken and written Spanish.

Exclusion Criteria:

* Diagnosed psychiatric pathology.
* Rheumatic pathology not medically controlled.
Modified SALT Score for Alopecia Areata

Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, mSALT score and dermoscopy.


Eligibility Criteria:
Inclusion Criteria:

* localized scalp AA ( 2 patches and ≤50% scalp involvement , duration more than 6 months) • patients who did not receive any medication for at least 2 months before starting the study and those who agreed to join the study and signed written consent.

Exclusion Criteria:

* • pregnant, and lactating females

  * Alopecia totalis or universalis or ophiasis or cicatritial alopecia
  * Usage of systemic treatment of alopecia areata 2 months prior to the study.
  * Any scalp lesion within the treated area
  * Bleeding diathesis, severe anemia or platelet disorders
  * Medical conditions such as autoimmune diseases.
Positive Airway Pressure Versus Breathing Exercises With Load Inspiratory in Patients Undergoing Bariatric Surgery

Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory function and lung function, leading to reduction in lung volume and capacity. Such dysfunctions are worsen after bariatric surgery to be associated with factors inherent to this procedure. The objective of this study was to evaluate and compare the effects of the application of bilevel positive airway pressure and exercises with inspiratory pressure with linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle strength, respiratory muscle strength and prevalence of pulmonary complications after bariatric surgery.

This is a clinical trial, randomized, blinded, in which 60 volunteers, after evaluation preoperatively, consisting of: cirtometry to measure thoracoabdominal mobility, spirometry for measures of lung function, nasal inspiratory pressure to inspiratory muscle strength and endurance incremental test for evaluation of respiratory muscle strength, were randomized and allocated into three groups, with 20 volunteers each. The interventions were performed in the immediate postoperative period and the first day after surgery. The first group, called the control group received care by Conventional Respiratory Physiotherapy (CRP), consisting of breathing exercises, incentive spirometer and ambulation. The second group, called Positive Pressure Group received two-level positive airway pressure for one hour, addition of CRP. The third group, called Load Inspiratory Group held exercises with inspiratory pressure with linear load, linked also to the CRP. Treatments were applied twice in the immediate postoperative period and shortly after returning to the ward and after 4 hours of the initial treatment and three times a day on the first day after surgery. On discharge, the second day after surgery, the volunteers performed chest x-ray and underwent the same evaluations performed preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Submitted to Roux-en-Y type gastric bypass by laparotomy
* Normal preoperative pulmonary function and chest x-ray

Exclusion Criteria:

* Hemodynamic instability
* Hospital Stay longer than three days
* Presence of postoperative complications
* Smoking
* Respiratory chronic diseases
Safe Zone in Trigger Point Injection

The goal of this observational study is to define the safe distance that will reduce the risk of pneumothorax through ultrasonographic imaging measurements in both sitting and prone positions to ensure patient safety during these procedures. The main question\[s\] it aims to answer \[is/are\]:

The mean distance between the skin and pleura in sitting position during the inhalation and exhalation The mean distance between the skin and pleura in prone position during the inhalation and exhalation

Myofascial pain syndrome is characterized by pain and tenderness at specific points known as trigger points. Tension and spasm occur in the muscles, making it one of the most common causes of musculoskeletal pain. Various treatment options, such as TENS, dry needling, and trigger point injections, are available for the management of myofascial pain syndrome. Trigger point injection is one of the evidence based treatment methods that can provide both temporary and long-term relief.

Trigger point injections can be performed under ultrasound guidance or by blind technique. Although trigger point injection is generally be considered a safe procedure when performed by a skilled practitioner, complications may occur. These complications include pain during and after the procedure, nerve injury, bleeding, infection, and serious complications such as pneumothorax. Pneumothorax may occur when trigger point injections are administered into the chest wall muscles, particularly the trapezius, rhomboid major, or rhomboid minor muscles. Among these muscles, the rhomboid major is very thin, and the thickness of the skin, subcutaneous fat layer, and other soft tissues surrounding it varies between individuals. Since nerves, vascular structures, and the pleura are present in the deeper parts of these muscles, determining the appropriate injection depth is crucial.

In clinical practice, trigger point injections are administered by clinicians in both prone and sitting positions. To the best of our knowledge there is no studies thatinvestigates the determination of a safe distance through measurements in both the sitting and prone positions. In this study we aim to calculate the safe distance using ultrasound that will reduce the risk of pneumothorax through ultrasonographic imaging measurements in both sitting and prone positions during inhalation and exhalation to ensure patient safety during these procedures.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with Myofascial Pain Syndrome
* patients scheduled for trigger point injections due to Myofascial Pain Syndrome.

Exclusion Criteria:

* under 18 years of age,
* additional diseases other than Myofascial Pain Syndrome,
* the presence of active infection in the interscapular area where ultrasound imaging and measurements will be performed,
* lesions that disrupt skin integrity or affect subcutaneous and muscle structures such as anomalies or masses that could impair imaging quality
* individuals with known lung diseases
* not consent to participate in the study."
Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study

Approximately 150,000 children present each year to emergency departments (EDs) in the US with concussion and many more are treated by primary care physician, or outpatient specialists.

Concussion is defined as a traumatically induced transient disturbance of brain function and involves a complex pathophysiological process. There is a variety of symptoms related to concussion, and the diagnosis of concussion requires the use of symptom-checklist. Since there is a various degree of the severity of those symptoms, the diagnosis is a subjective one and lacks sensitivity.

One major problem is that approximately one-third of the children with concussion experience ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as persistent post-concussion symptoms. A recent study that investigated the validity a 12-point PPCS risk score revealed that it had modest validity (0.71). Moreover, one of the greatest concerns is the child's schedule return to activity.

Since the basic mechanism for concussion is acceleration/ deceleration movement of axons, it is likely to be expressed in desynchronization of delta wave activity between anterior hemispheres as seen in pathological problems related to attention and/ or working memory).

The aim of this proof-of-concept study is to find-out whether interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres can identify acute concussion in children. If the investigators find that IHDD can accurately diagnose acute concussion, a second objective will be to examine whether this index can be a useful tool in the follow up of patients with persistent post-concussion symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Study group will include children aged 11-18 years with diagnosis of acute concussion based on the RPSQ. (Eisenberg et al., 2013; Harmon et al., 2013)
* Controls will be healthy children who will be admitted to the ED due to an isolated limb injury such as laceration, contusion or fracture and are not painful. Nonverbal or non-cooperative children will be excluded from the study.

Exclusion Criteria:

* Nonverbal or non-cooperative children.
* Lack of inform consent.
Non-invasive Evaluation of Portal Pressure by MRI

The objective of this research is to study the correlation between the portosystemic pressure gradient and azygos blood flow measured by MRI.

All patients will benefit from:

* Pressure gradient measurement portosystemic
* MRI measurement of azygos flow, aortic, portals, spleen and lower cellar
* Liver biopsy
* Laboratory tests

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of chronic liver disease
* Indication to perform a liver biopsy transjugular
* Patient able to consent

Exclusion Criteria:

* contraindication to MRI:
* Holders of a pacemaker or a defibrillator, an implanted material activated by electrical, magnetic or mechanical
* Holders of hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants
* claustrophobic
* Severe hepatic encephalopathy
* Inability to MRI in the week surrounding the first jugular
Role of Psychological Factors and Acceptability of New Technology in Engaging Seniors in Physical Activity

This study will be a non-interventional study intended to identify psychological antecedents of the acceptability of WeWard application among people aged 55 years and older, , and its impacts on engagement in physical activity. Participants will be included in the study on a voluntary basis and healthy volunteers will be registered on the national volunteer database. This study will include people aged over 55 from senior citizens associations, from patients coming for frailty consultations at the Cimiez University Hospital Centre, and from any senior living in France. Regarding the recruitment, application users will receive a request to participate in a scientific study. If the request is accepted, participants will fill in the non-opposition form via the application and will complete, with their smartphone, a series of psychometric questionnaires (e.g. level of physical activity, personality, motivation, perceived physical competence, new technologies acceptability, etc.). Participants will then use the mobile application for a period of 12 weeks during which time, physical activity data provided from participants smartphone will be gathered such as the number of steps or gait speed. Psychometric questionnaires comprising each time one item (i.e. ecological momentary assessment) will be administered to participants randomly, in order to assess their evolution. After the 12 weeks of using the mobile application, older people will answer to the same series of psychometric questionnaires administered at the beginning of the study. Finally,lparticipants who will drop out the trial during this study will be contacted in order to clarify the reasons for their withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* signed non opposition
* \> or = 55 years old

Exclusion Criteria:

-