cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain

The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.

Neuropathic pain state is usually refractory to most analgesic regimens and requires polypharmacy for symptomatic relief. Current treatment options for neuropathic pain include both oral and topical medications. Most commonly prescribed oral treatments include antidepressants (eg, amitriptyline, desipramine, and duloxetine), antiepileptics (eg, gabapentin, pregabalin), and opiates such as tramadol and morphine. Current topical treatments include the lidocaine patch and the capsaicin patch. Many patients have inadequate pain relief in spite of these treatment options.

Currently, there are no treatments available for treatment of neuropathy itself other than treating the underlying cause and addressing the symptomatic relief for pain. Current drug therapies for neuropathic pain provide inadequate pain relief and undesirable side effects including sedation and cognitive dysfunction. It is not uncommon to use a combination of agents for the treatment of neuropathic pain to minimize the side effects. Although treating the mild to moderate pain may be relatively easy, it is very challenging for severe neuropathic pain. Although the use of opiates for neuropathic pain is well accepted, it remains controversial because of the potential for abuse and diversion.

Eligibility Criteria:
Inclusion Criteria:

1. individuals with chronic pain of more than 6 months duration
2. pain is determined to be secondary to a documented neuropathy
3. patients who are tolerant of opiates (60 mg of morphine or equivalent for at least one week)
4. male or female patients aged 18-75 yrs and have signed a written informed consent form and privacy statement
5. female patients of child-bearing potential must be using an acceptable form of birth control

Exclusion Criteria:

1. pregnant or lactating women
2. allergy to morphine or its derivatives
3. history of alcohol or substance abuse in the last 3 yrs
4. participation in any other clinical trial in the last 30 days
5. uncontrolled pain
6. patient who is deemed to be medically unstable by principal investigator
7. history of severe lung disease or asthma that is deemed medically significant by principal investigator
rTMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury

The aim of this study is to verify the efficacy of body weight-support treadmill training combined with high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury.

A randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions). Active or sham rTMS will be combined with body weight-support treadmill training to verify the improvement of sensory-motor function in patients with incomplete spinal cord injury. Behavioral assessments will be performed before, after 6 and 12 therapeutic sessions and at the 30-day follow-up after the intervention, though: (i) the WISCI-II Index; (ii) ASIA Impairment Scale (AIS), (iii) ASIA Lower Extremities Motor Scale (LEMS), (iv) Ashworth Modified Scale; (v) the Functional Independence Measure (SCIM-III), (vi) the Short Form Health Survey 36 (SF-36) and (vii) the Patient Global Impression of Change Scale - (PGICS).

Eligibility Criteria:
Inclusion Criteria:

* Presented clinical diagnostic of incomplete thoraco-lumbar spinal cord injury, provided by a neurologist (below the T1 level).
* Duration injury of at least 8 months.
* Presented degree of C or D according to the ASIA Impairment Scale (AIS) scale of the American Spinal Cord Injury Association.
* Patients who are not community walkers.

Exclusion Criteria:

* Pregnant women;
* Pacemaker;
* Historic of seizures;
* Metallic implants in the head;
* Patients with clinical evidence of brain injuries;
* Patients with neurological and / or orthopedic pathologies that have repercussion on a gait and the disadvantages
* Use of neuroleptic medications.
Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses

This project involves evaluation of post operative contrast sensitivity and wavefront aberration results among patients implanted with standard monofocal lenses (Acrysof SN60AT/SN60WF) and the new presbyopic correcting multifocal lens (Acrysof ReSTOR). Higher Order aberrations are visual phenomena such as glare and haloes. They are more prevalent after cataract surgery and can affect night driving.

The Project involves evaluation of contrast sensitivity and higher order aberrations in patients implanted with SN60AT, SN60WF and ReSTOR intraocular lenses. Patients in the department of Ophthalmology will be asked to participate in the study on a routine postoperative visit at least 3 months after cataract surgery. Patients will be asked to sign a consent form prior to participation. Wavefront analysis involves the patient resting their chin in a device similar to a slit lamp; they focus on a distant light and the machine performs the measurements in mesopic and scotopic conditions (light and dark). Contrast sensitivity is a measure of how faded or washed out an image can be before it becomes indistinguishable from a uniform field; it involves the patient identifying patterns on a chart. Wavefront analysis and contrast sensitivity are noninvasive tests that do not employ sedation or anesthesia and does not expose the patient to x-rays or microwaves. The proposed research will not alter usual standard postoperative care and can be done on a routine office visit.

Eligibility Criteria:
Inclusion Criteria: All subject implanted with either SN60AT, SN60WF or ReSTOR intraocular lenses after cataract removal. Subjects include those 18 yrs and over, male and female, all races. Patients will sign an informed consent

Exclusion Criteria: Patients younger than 18 yrs. Patients with other concurrent visually significant ophthalmic disease.
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients

To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+) (objective 80% gain) as main ventilatory support in early stage of critically ill patients in comparison with standard volume-assist control ventilation (ACV).

The goal of this proposal is to apply PAV+ as routine ventilatory mode in the early stage of critically ill patients, taking advantages of spontaneous breathing and better patient-ventilator interaction.

The standard treatment in patients with acute respiratory failure is mechanical ventilation in control-mode for the first days of acute illness. This procedure is usually associated with patient-ventilator dyssynchrony, higher needs of sedation and/or relaxation, muscle atrophy, etc. PAV + is a new ventilatory mode that applies pressure in proportion to spontaneous patient inspiratory effort allowing better adaptation to changes in internal homeostasis.

Up to now, several reports compare PAV with assisted modes as a feasible alternative only in the weaning phase. However, PAV is able to unload patient effort in different levels, suggesting that high-assistance PAV (about 80%) could be comparable with assist-control modes in terms of respiratory muscles unload.

Whether PAV is as effective as traditional ACV in terms of ventilation muscle unload in the acute phase of illness has not been established and we aim to address this question.

We plan to prospectively enroll patients on mechanical ventilation early at ICU admission, and to ventilate them randomly under ACV (volume-assist control ventilation) or PAV+ (beginning with 80% if possible). We will evaluate length of mechanical ventilation, sedation requirements and respiratory-hemodynamic variables from the very beginning and until attending clinicians decide that patients are ready to be weaned.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Anticipated MV \> 24 hours
* Availability of informed consent from patient or next of kin
* Ventilation parameters measured under PAV+ 80% gain:

PaO2/FiO2 \>100 RPAV \<10 cm H2O/l/s CPAV \> 30 ml/cm H2O WOBTOT \<1.5 J/l VE \<18 l/min

Exclusion Criteria:

* Patients on moribund state or with life-sustaining therapy withholding decision.
* Patients with unstable respiratory/hemodynamic state, PaO2/FiO2 \<100, Dopamine \>15 microg/Kg/min or epinephrine \>0.1 microg/kg/min.
* Pregnancy.
* Air leak.
* Patients needing deep sedation or muscle paralysis
* Patients needing hyperventilation (brain trauma).
* Patients with severe muscle weakness.
* Recruitment maneuvers or prone position.
Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation

Degenerative mitral regurgitation (MR) due to prolapse of the posterior leaflet is the most common dysfunction of the mitral valve (MV) in the Western world and is nowadays treated with a variety of surgical techniques. Quadrangular resection combined with annular plication and annuloplasty, as originally described by Carpentier, has been the standard approach for many years, before sliding/folding plasty and artificial chordae gained larger popularity.However, very few studies have been published on thevery long-term results (up to 20 years) of quadrangular resection and annular plication, often reporting only freedom from reoperation rather than from recurrent MR. This study aims to evaluate the very long-term (20 years) clinical and echocardiographic results of this approach, which was used for many years at the beginning of our mitral repair program.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Affected by mitral valve posterior leaflet prolapse/flail causing severe mitral regurgitation
* Treated with quadrangular resection of the posterior leaflet and annulus plication

Exclusion Criteria:

* Other patients
Superior Mesenteric Artery Dissection

This study investigate CT images of patients with spontaneous isolated superior mesenteric artery dissection (SISMAD). The investigators also further analyze the CT morphological differences between different options, aiming to determine "alarming CT character" during initial conservative treatment.

57 Patients with SISMAD from Oct 2011 to Jan 2018 in investigator's hospital were included in this research. The investigators collected relevant clinical data and further investigated the CTA characters of both true lumen and false lumen. SMA angle, distance between entry site of dissection and SMA root were also measured.

Eligibility Criteria:
Inclusion Criteria:

* SMA dissection

Exclusion Criteria:

* SMA dissection combined with aortic or other visceral arteries
* Trauma related SMA dissection
High-intensity Interval Training in Patients With Spinal Muscular Atrophy

Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy.

Spinal muscular atrophy (SMA) is a neuromuscular disease affecting the motor neurons of the spinal cord that innervate the skeletal muscles, leading to progressive muscle atrophy and weakness. Consequently, many patients end up having to use a wheelchair from an early age.

Besides the impaired motor function, patients with SMA can also experience a variety of symptoms associated with their disease, a sedentary lifestyle and physical inactivity such as lower back and leg pain, obstipation, reduced sleep quality and impacted quality of life.

Training can help alleviate these symptoms in patients with neuromuscular diseases. However, there isn´t any validated way for patients with SMA to train as of today.

Research has shown that high-intensity interval training (HIIT) has been well tolerated among patients with SBMA, a disease resembling SMA with patients tolerating this form for training well.

The aim of this study is to investigate:(1) if HIIT could be exercise modality in SMA patients (2) and to see what positive effects exercise has for their impaired motor function and related challenges.

The investigators will test the participants at baseline, which will be followed by a 8-week control period. After the control period the participants will be tested again before the intervention period.

During the intervention period the participants will have to train 5 times a week for 10 minutes. After the intervention period, there will be a final test day, where the final results will be compared with those from the baseline.

Eligibility Criteria:
Inclusion Criteria:

* Spinal muscular atrophy
* Age: over 15 years

Exclusion Criteria:

* Competing disorders (as arthritis) or other muscle disorders as well as heart- or lung related issues.
* Current psychiatric treatment
* Unable to use the cycle ergometer due to contractures
Muscle Oxygenation in Stroke Patients

In addition to its many effects, physical movement is known to change both systemic blood circulation and muscle blood flow. In a study examining the effects of motor imagery, which produces effects similar to physical movement, on muscle oxygenation, no change in muscle oxygenation was detected with motor imagery. However, no study has been found examining muscle oxygenation along with motor imagery in stroke patients. However, it has not been investigated whether there is a difference in muscle oxygenation between the affected and less affected extremities after stroke. For this reason, our study was planned to examine the effect of motor imagery on lower extremity muscle oxygenation in stroke patients. In addition, in our study, we will examine whether there is a difference in muscle oxygenation between the affected and less affected extremities in stroke patients under different conditions (rest / physical movement / motor imagery (mental movement)). Since there are insufficient studies in this field in the literature, we think that our study will lead to future studies.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 40-75
* Being diagnosed with stroke
* BMI \<30kg/cm2
* Subcutaneous fat thickness \<12mm
* Mini Mental State Test Score being 24 or above

Exclusion Criteria:

* Having another musculoskeletal, cardiovascular, pulmonary, metabolic or neurological disease that is serious enough to prevent participation in the study
* Having serious vision and hearing problems
* Presence of serious cognitive impairment determined by the physician that would prevent the tests from being performed
* Presence of an open wound or infection in the area to be measured
Role of Oral Glutathione in Skin Whitening

Oral and intravenous glutathione have been used widely to whiten the skin. The investigators tested this hypothesis by giving oral glutathione for 4 weeks to medical students.


Eligibility Criteria:
Inclusion Criteria:

* Healthy medical students

Exclusion Criteria:

* history of skin cancer, especially melanoma
* consumption of any preparations containing glutathione within 1 month of enrollment
* pigmentary disorders or any dermatoses
Assessing Mucociliary Clearance and Airway Liquid Volume in the CF Airway

The objective of this study is to determine the effect of airway surface liquid (ASL) volume on mucociliary clearance in cystic fibrosis (CF). A two-isotope nuclear medicine technique will be utilized. This pilot trial will include the imaging of n=7 CF subjects and n=7 healthy subjects. The trial will include one study visit per subject that will take approximately 3 hours. Hypothesis: The simultaneous imaging of both a "floating" and a "penetrating" radioisotope tag will allow the relative effect of airway surface liquid volume on mucociliary clearance to be determined when evaluated in CF and normal subjects.

Improper function of the mucociliary clearance system in the Cystic Fibrosis (CF) lung is a major factor contributing to the chronic respiratory manifestations of the disease. Normally this host defense mechanism removes inhaled pathogens and toxins from the inner surfaces of the lung. In CF, mutations in the CF gene result in dysfunction of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and bicarbonate. The so called "low volume" hypothesis of CF pathogenesis contends that the liquid lining the airways becomes very thin and viscous due to abnormal absorption of sodium from the airways, which draws water out of the airways, partially or totally defeating mucociliary clearance. The rate at which the mucociliary system clears materials from the lungs can be quantified using a nuclear medicine test called a mucociliary clearance scan. This study pilots a new variation of the mucociliary clearance scan that uses both "floating" and "penetrating" radioisotope tags. The difference in clearance between these tags will provide information on how airway surface liquid volume affects mucociliary clearance. This pilot trial will include the imaging of n=5 CF subjects and n=5 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms (CF subjects only)
* Clinically stable as determined by the investigator (pulmonologist)

Exclusion Criteria:

* Reactive airways disease
* Tobacco smokers
* Positive urine pregnancy test on the day of testing
* FEV1p value of \< 30%
* SaO2 \< 92%, or if they require supplemental oxygen.
* Subjects receiving other radioisotope treatments within the last 2 weeks will be excluded.
* Normal subjects with any history of lung disease will be excluded.
* Women currently breastfeeding an infant.
Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.

The aim of project EMPACOL will be to investigate, while taking into consideration the clinical factors known and well described in the literature, among the non-clinical factors, in particular, patient-healthcare personnel (HCP) relationship, a link between HCP's empathy perceived by the patient, and the results of the curative treatment of non-metastatic colorectal cancer, throughout the patient's care.

EMPACOL will be a multicenter prospective longitudinal study. Over a 2-year period, in two French areas covered by a cancer register, 8 centers will include patients with non-metastatic CRC, uncomplicated at diagnosis Based on the curative treatment strategy, patients will be divided into three groups: group 1 (surgery alone), group 2 (surgery and adjuvant chemotherapy), group 3 (neo-adjuvant therapy, surgery and adjuvant chemotherapy).

The relationship between HCP's empathy, perceived by the patient, after 2 years of inclusion, and the quality of life (QoL) at one year after the end of treatment will be investigated. QoL will be investigated using the QLQ C-30 questionnaire. Finally, a link between PHC perception and oncological outcomes will be sought.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 to 75 years, French-speaking, affiliated to a social security system, having received informed information and not having expressed an unfavorable opinion to participate; carriers of non-metastatic and uncomplicated CRC (without occlusion/ perforation/bleeding), requiring elective therapeutic management. The included patients have a cognitive state capable of understanding and completing the questionnaires (autonomous completion).

Exclusion Criteria:

Patients who were minors or older than 80 years, residing in a department outside Calvados or Manche, presenting a CRC other than adenocarcinoma and all metastatic forms or requiring emergency surgery (perforation, hemorrhage, occlusion), exclusive endoscopic treatment, or a missed-CRC discovered after surgery for non-oncological indications.

Patients with another neoplastic disease under treatment and/or evolving, patients with a history of inflammatory bowel disease (Crohn's disease, ulcerative colitis) and/or hereditary disease predisposing to CRC (Lynch syndrome, familial polyposis) or with severe cognitive impairment preventing proper comprehension of the questionnaires. Pregnant women will be excluded.
Effect of Balint Group on Burnout and Self-efficacy of Nurse Leaders in China: A Randomised Controlled Trial

Background: Burnout is common among nurses and is related to negative outcomes of medical care. This study aimed to explore the effectiveness of Balint group activities in burnout reduction among nurse leaders in a Chinese hospital.

Methods: This was a randomised controlled trial with a pre- and post-test. A total of 80 nurse leaders were randomly assigned to either a Balint group (n=40) or a non-Balint group (n=40). Participants in the Balint group completed Balint training for a period of three months. Participants in both groups completed the Maslach Burnout Inventory-Human Services Survey (MBI) and the General Self-Efficacy Scale (GSES) at the beginning and end of the study（three months later ）. Balint group members also completed the Group Climate Questionnaire-Short Format the end of the study（three months later ）.


Eligibility Criteria:
Inclusion Criteria:

1. nurse leaders in clinical departments
2. voluntary participation

Exclusion Criteria:

a. previous participation in Balint groups
Sclerotherapy and Bone Marrow Injection In Aneurysmal Bone Cyst

Aneurysmal bone cysts (ABCs) are benign, locally destructive growing bone tumors, which were first described in 1942 by Jaffé and Lichtenstein (1). They are most often diagnosed in childhood and early adulthood. The literature reports that ABCs comprise 1-6% of all primary benign bone tumors (2). Most cases of ABCs (75-90%) are reported for patients younger than 20 years, with a slightly higher incidence for females (3). Most common localizations are the pelvis, the metaphysis of long bones and the spine, but ABCs can also affect any other localization(2). ABCs that are associated with a preexisting osseous lesion are defined as secondary ABCs. They represent approximately 30% of all ABCs (2). Secondary ABCs can occur, e.g., in cases of a giant cell tumor, chondroblastoma or telangiectatic osteosarcoma

The clinical symptoms of an ABC are usually accidently discovered or may consist of pain and swelling in the affected region and pathological fractures ( complete and incomplete ) can be observed occasionally. In conventional radiography a relatively well-defined osteolytic, expansile lesion with possible blowout of the periosteum and a soap-bubble appearance can be found (4). MRI scanning shows cystic formations with typical fluid-fluid levels due to blood sedimentation (7). Because of the possible rapid growth with local destruction, the literature describes cases of ABCs that mimic malignant bone tumors

Eligibility Criteria:
Inclusion Criteria:

* All Patients above age of 1 year.
* The affected area was all bones except skull, ribs, and other non-orthopedic specialties.
* Primary or recurrent ABC
* Incomplete Fractured affected bones as greenstick fracture.
* Healed Pathological fracture without any surgical intervention

Exclusion Criteria:

* ABC. In skull, ribs, and other non-orthopedic specialties.
* Age less than 1 year
* Suspected malignancy or other bone cysts
* Complete fractured bones and healed pathological fracture with surgical intervention.