cyrilzakka/clinical-trials huggingface dataset:
Motor Cortex as a Research & Therapeutic Target in TMD

The investigators are doing a study to learn about the effects of a type of low-energy non-surgical electrical brain stimulation (HD-tDCS) on chronic pain in people's jaw joints. Disorders in these joints are called temporomandibular joint disorders, or TMD.

Chronic temporomandibular joint disorders (TMD) represent clinical problems in which empirical treatments offer uncertain relief for a large number of patients. Many conventional therapies are ineffectual, leading to persistent treatment failure and/or poor iatrogenic-induced results; which raises the possibility that the cause for their pain endurance may also lie in the brain milieu. Although MRI-based techniques have provided insights into some neuroplastic mechanisms of TMD in humans, many questions regarding its molecular mechanisms in vivo are still unanswered. First, how are endogenous μ-opioid mechanisms in the brain, known to be centrally involved in pain regulation, affected by acute and chronic TMD pain? Second, how can they be directly modulated to provide analgesic effect on pain measures? Finally, what are the neuroplastic effects in the brain after continuous modulation of those molecular mechanisms? The understanding of these processes is crucial to determine the mechanisms engaged in the persistence and, most important, the alleviation of TMD.

Preliminary studies from our center, using positron emission tomography (PET) with \[11C\] carfentanil, a selective radiotracer for mu-opioid receptor (muOR), have demonstrated that there is a decrease in μOR availability (non-displaceable binding potential -BPND) in key pain-related structures in the brains of chronic trigeminal pain patients, which correlated with their clinical pain measures. We propose to demonstrate that acute (masseteric pain challenge) and chronic clinical pain measures in TMD patients are correlated with μ-opioid receptor (µOR) non-displaceable binding potential (BPND) in the thalamus and other pain-related regions.

Eligibility Criteria:
Inclusion Criteria:

* Daily chronic TMD pain and dysfunction for at least one year (Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I Group I: Myofascial pain diagnosis\[15\]) not adequately controlled by previous conventional therapies (TMJ open-surgery naïve) for more than

  1 year
* Self-reported pain score of at least 3 on a 0-10 scale in spite of existing treatment in the two weeks preceding the onset of the study
* Taking stable doses of medications for at least 4 weeks (if taking medications), and willing to limit the introduction of new medications for chronic TMD symptoms during the study

Exclusion Criteria:

* Pain not primarily due to TMD
* History or current evidence of a psychotic disorder (e.g. schizophrenia) or substance abuse by DSM-IV criteria; bipolar or severe major depression
* History of neurological disorder (e.g. epilepsy, stroke, neuropathy, neuropathic pain)
* Any severe clinical condition that in the opinion of the principal investigator interferes with the study
* Pregnant or expecting to become pregnant during the study
Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy

The purpose of this study is to discover how often certain bacteria are found in the rectum at the time of a prostate needle biopsy to diagnose prostate cancer. Certain bacteria are of importance because they can cause serious infection. Antibiotics that urologists commonly use to prevent these bacteria from causing infection are no longer effective. Many physicians around the world are noting increased infections with antibiotic resistant bacteria. Therefore; despite treating patients who are to undergo prostate biopsy with antibiotics, certain patients are being readmitted to the hospital with a serious infection. In order to study the incidence of these particular bacteria, the best method is to culture the bacteria at the time of the biopsy. This involves one rectal culture swab just prior to needle biopsy of the prostate. Once the incidence of these bacteria is known we may take steps to prevent the serious infections that occur as a result of prostate biopsy.


Eligibility Criteria:
Inclusion Criteria:

* adult males
* repeat prostate biopsy

Exclusion Criteria:

* first time prostate biopsy
* minors
Lasertherapy for Vulvodynia

The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.

Randomized double blinded sham-controlled clinical study

Main hypothesis:

Laser therapy will be more effective than sham laser therapy in vulvar pain reduction measured by Q-tip test and tampon test

Secondary study hypotheses Laser therapy, in comparison to sham laser therapy

* will lead to more improvement of Sexual Health and HrQoL
* will have similar rates of side effects

Eligibility Criteria:
Inclusion Criteria:

* Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
* multidisciplinary treatment for at least 3 months
* Informed consent

Exclusion Criteria:

* Current genital infection (i.e. candidiasis, herpes )
* Inflammatory vulvar disease/ dermatosis (i.e. lichen sclerosus, lichen planus)
* Neoplastic vulvar disease (e.g. HSIL Vulva, Paget disease)
* Recent vulvar trauma (i.e. bleeding, erosion or ulceration)
* Pudendal neuralgia
* Pregnancy, delivery \<6 months
* Epilepsy or major neurologic or psychiatric morbidity
* Active systemic infection
* Previous treatment with ionizing radiation in the area to be treated
* History of wound healing disorders (i.e. hyperpigmentation, abnormal scarring)
* Fever
* Systemic or local autoimmune disorders
* History of photosensitivity disorder
Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients

At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. However, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. The goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.

With the " multiple N-of-1 trial " study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old and above
* Above knee or below knee amputation (irrespective of etiology and time from amputation)
* Residual limb pain
* Prosthetic with classic fitting
* Fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting ...)
* Recipients or registered with a social security scheme
* Informed consent form signed beforehand

Exclusion Criteria:

* Patient with peripheral neuropathies contraindicating the use of Revofit system
* Pregnant woman, nursing mother or parturiant
* Patient in detention by judicial or administrative decision
* Patient undergoing psychiatric compulsory care
* Patient in a health or social institution for purposes other than research
* Legally protected person
* Patient unable to express their consent
Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

Axillary lymph node status is a vital prognostic factors in breast cancer patients and provides crucial information for making treatment decisions.This projective observational study is planned to identify risk factors for axillary metastases in breast cancer patients with axillary ultrasound and to construct a nomogram to predict the risk of axillary metastases in these patients.

Breast carcinoma is the most common malignancy in women, accounting for 25% of all female cancer cases and 15% of all cancer-related deaths in the world.Lymph node metastasis is a multifactorial event. Among patients with a preoperative axillary ultrasound, almost 40% of patients are pathologically proved to be free from axillary metastasis.The purpose of this study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool to support clinical decision-making.

Eligibility Criteria:
Inclusion Criteria:

* female patients with primary breast cancer
* receiving a successful SLNB or ALND
* pathological diagnosed, without distant metastasis
* a clinically negative axilla

Exclusion Criteria:

* pregnancy
* neoadjuvant therapy
* previous ipsilateral axillary surgery
* inflammatory breast cancer
Mindfulness Training, Mental Fatigue, Endurance Performance and Neurocognitive Functions

Mental fatigue has been suggested that would impair neurocognitive functions and sports performance. On the other hand, mindfulness training (MT) seems to as a promising approach to attenuate mental fatigue and counteract its detrimental effect on cognitive functions and sports performance. The purpose of the present study is to examine the effect of MT on behavioral and neuroelectric indices of inhibitory control, and endurance performance in mentally fatigued athletes.

Accumulating research indicates that mental fatigue induced by prolonged cognitive tasks would impair neurocognitive functions and sports performance. Additionally, recent studies demonstrate that inhibitory control and endurance performance are significantly susceptible to detrimental effects of mental fatigue. On the other hand, mindfulness training (MT) has been widely been used to enhance cognitive functions and sports performance in neurocognitive and sports research, which has been considered a promising approach for attenuating mental fatigue and counteracting the detrimental effect of mental fatigue. However, the effect of MT on inhibitory control, endurance performance, and underlying mechanisms in mentally fatigued athletes remain unclear.

Therefore, the purpose of the present study is to examine the effect of MT on behavioral and neuroelectric indices of inhibitory control, and endurance performance in mentally fatigued athletes.

Specifically, the targeted primary outcomes are neurocognitive functions (i.e., reaction time, accuracy and ERPs in Flanker task) and endurance performance (i.e., VO2max \& time to exhaustion); The secondary outcomes are changes in dispositional mindfulness, subjective (i.e., scores in visual analog scale)/objective (i.e., reaction time, accuracy in Stroop task) mental fatigue, motivation in tasks, and changes in mood state (i.e., BRUMS-C).

Eligibility Criteria:
Inclusion Criteria:

1. Regular sports training at least 4 hours weekly
2. Normal or corrected-to-normal vision
3. Right-handed

Exclusion Criteria:

1. Physical limitation or injury in lower limbs before and during the study
2. Diagnosed or self-reported neurological disorders (e.g., epilepsy)
3. Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
4. Major previous experience with mindfulness training
Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS

Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is needed to adapt the use of large volume surfactant of 4-5 ml/kg.

The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on CPAP.

The 5 ml/Kg surfactant is warm to room temperature. Using standard laryngoscope without premedication while the infant is maintained on continuous positive airway pressure (CPAP. The the laryngoscope should be removed after stabilizing the vascular catheter between 2 fingers at the level of lips (weight +6 cm). The surfactant will be administer by boluses of 0.25 -0.5 ml at a time over 20-30 seconds and 10 seconds apart while maintain the vital signs.

The procedure should be stopped if the vital signs deteriorate, CPAP pressure and oxygen requirement might need to adjusted to restore baseline vital signs. If the vital signs remained unstable the catheter should be removed and the infant managed according by positive pressure ventilation (PPV) or intubation by endotracheal tube (ETT).

At the end of the procedure the catheter should be flushed with 0.5 ml of air then catheter should be removed.

FiO2 (fraction of inspired oxygen), oxygen saturation and CPAP pressure will be recorded before during and after the procedure.

Complication like bradycardia (Hear rate below 100 beat per minute) or Apnea (pause of respiration for more than 20 second or less than 20 seconds but associated with bradycardia) All other neonatal outcome will be recorded (IVH \[Intra-ventricular Hemorrhage\], ROP \[Retinopathy of prematurity\], duration of ventilation, duration of hospital stay, infection, duration of oxygen requirement and others.

Eligibility Criteria:
Inclusion Criteria:

-preterm infants less than 35 weeks gestation in 1st day of life with RDS and spontaneously breathing on CPAP and need surfactant administration.

Exclusion Criteria:

* Infants needs of mechanical ventilation
* Congenital anomaly
* Respiratory distress due to non RDS related causes.
* no parental consent
Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems

Trace elements, bioactive secondary metabolites and vitamins are among the most important quality parameters in plants. Yet, very little information is available on their content, bioavailability and health effects of organically grown plant food products. The main objective of the project is to study the impact of different agricultural management practises relevant for organic farming on the ability of cereal and vegetable crops to absorb trace elements from the soil and to synthesise bioactive compounds (secondary metabolites, antioxidant vitamins and phytates) with health promoting effects. Field experiments with a rigidly controlled design will be implemented together with state-of-the-art analytical techniques allowing solid conclusions to be drawn on the variability and optimum levels of bioactive compounds. The multitude of analytical data from plant and soil samples will be analysed by multivariate statistical methods in order to reveal differences between the cultivation systems used. Finally, the relationship between bioavailability of the nutrients studied and the elemental fingerprint of plants will be extracted by the statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-45 years
* BMI 20-30 kg/m2
* Non-vegetarian

Exclusion Criteria:

* Physical activity \> 10 h/week
* Intake of dietary supplements
* Regular use of drugs
* Chronic diseases
* Smoking
* Excessive intake of alcohol
Biomarkers of Mild and Moderate Traumatic Brain Injury

The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age and no more than 80 years of age.
2. Closed injury to the head within 4 hours from symptom onset.
3. Glasgow Coma Scale (GCS) Score of 9-15.
4. Head Computerized Tomography (CT) performed as part of routine care.
5. Subject is willing to undergo the Informed Consent process prior to enrollment.
6. Based upon the Principal Investigator's opinion, subject is an appropriate candidate for the study.

Exclusion Criteria:

1. Participating in another clinical study that may affect the results of either study.
2. Time of injury cannot be determined.
3. Head CT not done as part of clinical emergency care.
4. Primary diagnosis of ischemic or hemorrhagic infarct.
5. Not available for 35 day follow-up visit.
6. Venipuncture not feasible.
7. Blood donation within 1 week of screening.
8. The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
AIR OPTIX® COLORS Registration Trial

The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.

This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
* Normal eyes and not using any ocular medications.
* Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
* Manifest cylinder less than or equal to 0.75 diopter.
* Best spectacle corrected visual acuity greater than or equal to 20/25.
* Have current prescription glasses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment infection, inflammation, or abnormality.
* Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
* Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of refractive surgery or irregular cornea.
* History of pathologically dry eye.
* Corneal vascularization greater than 1 millimeter of penetration.
* History of herpetic keratitis.
* Eye injury within 12 weeks immediately prior to enrollment in this trial.
* Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.
* Other protocol-defined exclusion criteria may apply.
18F-FDG Tomography and Labeled Leukocyte Scintigraphy

The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy in patients with a malignant otitis externa.

The management of malignant otitis externa (MEO) is a major issue in patients who are often polypathological and fragile. Appropriate antibiotic therapy must be started quickly after the diagnosis is made and followed for a period of at least 6 weeks. Imaging plays a major role in assessing the extent of the infection and especially healing, after 6 weeks of antibiotic therapy. The persistence of an infection at the end of the treatment, observed in imaging, will allow a change of antibiotic line. This study consists in studying in a population affected by an OEM, the performance of PET/CT with 18F-FDG compared to scintigraphy with labeled leukocytes. The usefulness of the latter in the follow-up of the pathology after antibiotic therapy has already been proven in the literature. The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy.

Eligibility Criteria:
Inclusion Criteria:

* patients with malignant otitis externa who received a 18F-FDG positron emission tomography and a labelled leukocyte scintigraphy

Exclusion Criteria:

* patients who refuse to have their imaging data used
High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy

The primary endpoint of this study is to determine what percentage of patients receiving high-dose Cyclophosphamide may experience a halt in the worsening of their disease or experience improvement of their disease and for how long the benefit may last.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a common and under-recognized peripheral neuropathy that is thought to be immune-mediated. Randomized, placebo controlled clinical trials in CIDP demonstrate benefit from treatment with corticosteroids, plasmapheresis, and IV Ig. However, not all patients respond to these therapies. IV cyclophosphamide, cyclosporine, interferons, total lymphoid irradiation, and mycophenolate mofetil have been proposed as appropriate therapies for refractory patients.

Patients with CIDP often respond to immune-modulating treatment. However, the high rate of relapse and treatment-related side effects result in poor long-term outcomes for many patients. CIDP is assumed to be an autoimmune disease, but the pathogenesis is poorly understood. T cell infiltrates are predominantly CD8, suggesting a T cell mediated process. There is not, however, restricted T cell receptor Vbeta utilization seen in sural nerve biopsies. Immunoglobulin and complement deposits noted on the myelin sheaths support an antibody-mediated process. Antibodies to the P0 myelin protein are seen in a minority of patients. High-dose cyclophosphamide is believed to eradicate both B and T lymphocytes. This therapy does not damage hematopoietic stem cells, which allows for rapid white cell recovery without stem cell rescue.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CIDP according to the American Academy of Neurology clinical and electrophysiologic criteria
* Age \>18 but \< 75 years
* Modified Rankin Scale score of \>3 after two standard treatment regimens
* Patient must have a left ventricular ejection fraction of \>45%
* Serum Creatinine \<3mg/dL
* Willingness to participate in a clinical trial

Exclusion Criteria:

* Patients who are preterminal or moribund
* Patients with active malignancies
* Patients with chromosomal abnormalities or peripheral blood counts suggestive of myelodysplastic syndrome
* Patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection
* Pregnant women and breast-feeding women