cyrilzakka/clinical-trials huggingface dataset:
Spinal Cord Stimulation to Restore Cough

The purpose of this trial is to determine the efficacy of spinal cord stimulation to produce an effective cough in patients with spinal cord injuries.

Patients with cervical and thoracic spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.

The purpose of this trial is to determine if electrical stimulation of the expiratory muscles is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.

In the trial, researchers will study 18 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.

Eligibility Criteria:
Inclusion Criteria:

* Stable spinal cord injury T5 level or higher
* Expiratory muscle weakness

Exclusion Criteria:

* Significant cardiovascular disease
* Active lung disease
* Brain disease
* Scoliosis, chest wall deformity, or marked obesity
Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue

Squamous cell carcinoma (SCC) could be a very aggressive cancer and has a bad prognosis if not detected early and thus is associated with high mortality. The development of simple and reliable biomarkers for the early detection of SCC is one of the solutions to better diagnose, treat these tumors, evaluate and monitor treatments, and hence reduce mortality. In a previous work, the investigators demonstrated the ability of Proton Magnetic resonance spectroscopy (1H-MRS) to non-invasively assess spectroscopic and metabolic profiles of tongue tissue in healthy subjects. In the present work, the investigators challenge the use of in-vivo 1H-MRS as a potential method for non-invasive metabolic monitoring of patients with squamous cell carcinoma of the tongue undergoing therapy. Thus the main objective is to study the spectroscopic and metabolic differences, e.g. including variation in the metabolite TMA-Cho (trimethylamine-choline), of tongue tissue between healthy subjects and in patients with squamous cell carcinoma of the tongue, before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Patients from the maxillofacial surgery department of the Amiens-Picardie University Hospital treated for histologically confirmed squamous cell carcinoma of the tongue
* Patients who have not yet been treated, either surgically or by neoadjuvant treatment
* Patients with a tumor of minimum dimensions of 15 mm in long axis
* Patients without contraindication to MRI
* Patients over 18 years old
* Patients who have provided free and informed written consent
* Patients benefiting from a social security system

Healthy volunteers:

* Subjects without a history of cancer of the upper aerodigestive tract
* Subjects without contraindication to MRI
* Subjects over 18 years old
* Subjects who have provided free and informed written consent
* Subjects benefiting from a social security system

Exclusion Criteria:

* Patients:
* Patients with a lingual tumor measuring less than 15 mm in long axis

Patients and healthy volunteers:

* Patients with other histological types of cancer, or other locations
* Subjects with a contraindication to MRI
* Subjects under 18 years old
* Pregnant or breastfeeding women
* Persons under guardianship, curators, protection of justice or deprived of liberty
Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome

This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study prior to any study procedures.
* Male or female subjects, age between 18-75 years inclusive.
* All women of child bearing potential must have a negative pregnancy test
* Metabolic Syndrome according to the International Diabetes Federation definition:

  * Low plasma HDL-C (Men \< 40 mg/dl ; Women \< 50 mg/dl ).
  * Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
  * And one or more of the following criteria:

    * Triglycerides ≥ 150 mg/d.l
    * Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
    * Fasting plasma glucose≥ 100mg/dl.
    * Previously diagnosed type 2 diabetes.

Exclusion Criteria:

* Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
* Type 1 diabetes.
* HbA1c \> 9.5%.
* Unexplained serum creatine phosphokinase \> 2 x Upper limit of normal.
* History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
* Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.

Other protocol-defined inclusion/exclusion criteria may apply.
MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease

Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. There is a strong possibility that MRI quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. To investigate predictivity of MRI based biomarkers, summary measures of MRCP/MREL from baseline, Year 1 and Year 2, e.g. change rate, maximum, and average will be calculated as predictors for Year 10 clinical outcomes. The same predictors will also be used to model native liver survival in a proportional hazard regression. Findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6-23 years old.
2. Established clinical diagnosis of AIH or PSC.

Exclusion Criteria:

1. History of liver transplantation.
2. Chronic Hepatitis B or untreated hepatitis C virus infection.
3. Pregnancy.
4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).
5. Diagnosis of cystic fibrosis or biliary atresia
6. Diagnosis of cardiac hepatopathy.
7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.
8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).
Tracheostomized COPD Patients and Non Invasive Mechanical Ventilation

The purpose of this study was to determine occurrence of ventilator associated pneumonia (VAP) in tracheostomized patients with COPD discharged in invasive mechanical ventilation (IMV) compared to patients with CPOPD discharged with tracheostomy but in non invasive mechanical ventilation (NIMV).

Acute respiratory failure due to COPD is often treated with invasive mechanical ventilation through endotracheal intubation, followed by placement of a endotracheal canula. However, invasive ventilation is at risk of infective complications and is difficult to manage at home. In particular, invasive mechanical ventilation may be associated with ventilator associated pneumonia (VAP). VAP is usually suspected when the individual develops a new or progressive infiltrate on chest radiograph, leukocytosis, and purulent tracheobronchial secretions. When possible, we tried to put these tracheotomized patients in non invasive mechanical ventilation (NIMV)to avoid VAP. This population was followed for eight consecutive years and compared with patients in invasive home mechanical ventilation (IMV).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD
* Tracheostomy
* Need of domiciliary invasive / non invasive ventilation

Exclusion Criteria:

* Patients with COPD weaned from invasive / non invasive mechanical ventilation
* Lack of tracheostomy
Moving Mindfully for Freezing of Gait

The investigators will conduct an randomized controlled trial (RCT) among people with Parkinson disease (PD) and freezing of gait (FOG) to evaluate the feasibility of a mindfulness intervention compared to a educational program about FOG. FOG is a severe motor disturbance that prevents people from stepping normally and is associated with anxiety, frustration, sedentary behaviors, poorer quality of life, and falls. Mindfulness-Based Stress Reduction (MBSR) is an evidence-based practice that creates a culture to reduce stress and anxiety by increasing conscious awareness and self-compassion. In this study, the investigators will develop a mindfulness-based walking intervention to address both mental health and mobility challenges that constitute FOG.

Conduct pilot randomized clinical trial to evaluate feasibility and acceptability of the standardized Mindfulness Based Walking Therapy (MBWT) program. Using the standardized MBWT protocol devised during earlier aims of this study, the investigators will randomize 24 people with PD+FOG to MBWT or usual care (i.e., medical management and FOG education), examining feasibility elements. The investigators will also conduct follow-up evaluations to monitor burden and continued usage of mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed by a neurologist with idiopathic Parkinson disease;
* age 55 and older;
* a score on the Hoehn \& Yahr (H\&Y) scale between I-IV;
* history of freezing of gait;
* able to provide informed consent;
* experience fear or worry in relation to their freezing of gait;
* able to walk independently with or without an assistive device for at least five minutes; and
* stable medication regimen for one month prior to enrollment.

Exclusion Criteria:

* have evidence of dementia (Montreal Cognitive Assessment (MOCA) \< 18) to ensure understanding of materials;
* are under consideration for deep brain stimulation surgery within the next six months; neurologic condition other than PD;
* inability to cooperate with the protocol;
* language, visual, or hearing barriers to participation; or
* history of orthopedic or other medical problems that limit ability to participate safely in the intervention.
Surgiphor Us in TSA

Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. Surgiphor (sterile Povidone-Iodine) wound irrigation, is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively. The Iodine dissociates from complex and has antimicrobial properties, causing cell death of bacteria, fungi, and viruses through interactions with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane.

This study examines the use of Povidone-Iodine during primary shoulder arthroplasty.

The purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty

Eligibility Criteria:
Inclusion Criteria:

* Adults age \&gt;18 years
* Participants undergoing elective primary total shoulder arthroplasty
* Participants willing to provide written consent

Exclusion Criteria:

* History of prior surgery to the operative shoulder
* Known allergy to povidone iodine, iodine or shellfish
* active clinical infection
* participation in other clinical trials
CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells

This is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection both kidneys.

This study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3) exploratory evidence of clinical effects.

Patients under go 24 hours of preoperative hydration combined with N-actyl cysteine 300 mg IV for prevention of nephrotoxicity. Under general anesthesia 200-300 cc of lipoaspirate is collected into a sterile processing cannister (GID SFV-1, Louisville, CO, USA). The tissue is washed and dissociated with collagenase (Worthington CLS-1, Lakewood, NJ, USA) at a concentration of 200 CDU/ml of total volume for 50 minutes at 39°C. This is followed by inactivation using 40 cc of human serum albumin. SVF cells are separated via centrifugation for 10 minutes at 800 g. The cell pellet is extracted and resuspended in Harmann solution with an aliquot (10 µl) removed for counting and viability assessment of resulting total nucleated cells (YNC) through and image cytometer (ADAM MC, Portsmouth NH, USA).

Femoral artery catheterization is performed permitting advancement of a 100 cc balloon-tip catheter into the renal artery under fluoroscopic control, with position confirmation using 1 cc of OrtoRay® 320 contrast diluted 1:4 with Hartmann solution. SVF cells are then admixed with 200 cc Hartmann solution warmed to 37°C and in fused using a DRE infusion pump (DRE Medical, Louisville, KY, USA) over a 15 minute period with constant agitation. On the 1st pos-operative day creatinine and glomerular filtration rate are checked and the patient is discharged.

Follow-up studies include clinical assessment, chemistries, and renal ultrasound to assess intra-parenchymal renal volume, renal blood flow distribution, and hilar artery vascular resistance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Mesoamerican nephropathy
* Stages 3 and 4
* No other renal disease
* No essential hypertension

Exclusion Criteria:

* Significant abnormalities in laboratory tests that contraindicate surgical procedures.
* Acute pathology or complications of significant chronic pathologies in the 6 months prior to study entry, including, but not limited to:

Medical history of deep vein thrombosis Uncontrolled hypertension Active infection Reduced cardiac ejection fraction Hepatitis B, C or HIV Diabetes treated with insulin or glucose lowering agents Anemia (Hb \<9 g/dL) History of cancer Severe depression (Beck scale) Autoimmune disease
Music Therapy and Hematopoietic Stem Cell Transplant

The purpose of this randomized, controlled study is to determine the effects of pre-transplant music therapy on mood, distress, and physical functioning variables in patients undergoing Hematopoietic Stem Cell Transplant (HSCT).

Primary Endpoint:

Compare the difference in distress via Distress Thermometer for patients who receive music therapy and those who do not.

Secondary Endpoints:

Compare the difference in patient perception of pain, anxiety, and mood via Numeric Rating Scale for patients who receive music therapy and those who do not.

Compare the difference in quality of life via Functional Assessment of Cancer Therapy-General (FACT-G7) for patients who receive music therapy and those who do not.

Compare the difference in the use of total narcotic medications in those who receive music therapy and those who do not (using morphine equivalent doses).

Study Design:

Participants randomized in the experimental group will receive a total of three sessions prior to stem cell infusion day. The first session will occur within 24 hours of admission to the bone marrow transplant (BMT) unit. The second session will occur between 24 - 96 hours after the first session, depending on transplant preparation regimen. The third session will occur on Day -1. For participants in the control group, assessments will be timed to emulate those in the experimental arm.

A decision tree for music therapy interventions will be employed in this study. Participants in the experimental group will be given choices about how to proceed with the session: active or passive, improvisation, re-creative or receptive songs, or receptive (relaxation).

Participants randomized to the standard care group will be asked to rate the same symptoms as those in the experimental group. This will mark the beginning of a 45-minute control condition period during which the participants may fill the 45-minute time-period in whatever ways they choose, however, they will be asked to refrain from listening to recorded music during this time. At the conclusion of 45-minutes, post-condition data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing inpatient allogeneic stem cell transplant
* Must be fluent in English
* Must be able to communicate verbally and have no significant hearing impairment
* Have capacity to provide consent
* All diagnosis, graft source, donor sources will be included.

Exclusion Criteria:

* Patients not meeting the above inclusion criteria
Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor

Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. While tACS applied over the motor cortex at the general applied amplitude (1 mA) and using patch electrodes has been shown to entrain physiological tremor in healthy volunteers, the aim of this study is to test the feasibility of using high-amplitude tACS and to assess the effect of different electrode montages and stimulation sites in entraining physiological tremor. First, 10 subjects (arm 1) will be stimulated with 2 mA current amplitude applied between saline soaked patch square electrodes and comparison will be done between motor cortex stimulation and peripheral cortex stimulation. Then, 10 subjects (arm 2) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes and 5 mA amplitude and comparison will be made between motor cortex and occipital cortex stimulation. Three outcome measurements will be measured during the experiments which are: tremor entrainment, phosphene intensity and phosphene threshold.


Eligibility Criteria:
Inclusion Criteria:

* Above 18
* signed informed written consent

Exclusion Criteria:

* Pregnancy
* History of Epilepsy
* Family history of Epilepsy
Comparison of Gonioscopy With Cirrus and Visante

The aim of this study is to analyze similarities and evaluate interchangeability of Visante and Cirrus OCT (optical coherent tomography)and to compare agreement between gonioscopy and the two systems for evaluation of anterior segment parameters.

All participants underwent routine ophthalmic examination by their physician. Three independent examiners performed gonioscopy using Spaeth Gonioscopic Grading System. Findings were recorded independently along with risk assessment of angle being closed as: high, medium, and low or no risk. Patient information was not available to doctor during gonioscopy. One eye of each patient was imaged using both Visante and Cirrus OCT. Imaging was performed under scotopic and photopic conditions and obtained from horizontal (3:00 and 9:00 o'clock) and vertical (6:00 and 12:00 o'clock) meridians. The same experienced independent examiner performed all Cirrus measurements. Visante was performed by 3 trained technicians using same protocol.

OCT images were exported and masked to be evaluated for presence of open or closed anterior chamber angle. Masked images were presented with no other patient information available to two examiners with glaucoma training working together to score on basis of iridocorneal angle as, closed (0 degree), high possibility (10 degree), medium risk (20 degree), and low or no risk (\> 30 degree).

Eligibility Criteria:
Inclusion Criteria:

• 18 years of age and older with open angle, narrow angle and angle closure

Exclusion Criteria:

• All lasers or intraocular surgery (cataract, glaucoma, retina, cornea)
Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy).

Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological activity and if there are any correlations with the risk of AR.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients
* Age range: 18-70
* Patients taking MMF
* Able to understand and sign an informed consent

Exclusion Criteria:

* Active myelodepression
* Systemic infections or other that may affect MMF absorption
* Pregnancy/breastfeeding
* (History of) cancer
* Drug abuse, psychiatric conditions
* Already enrolled in other clinical trials or participation ended less than one month earlier
* Known sensitivity to polysorbate 80 or MMF
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery

Phase I to evaluate the safety and feasibility of same-day discharge in selected participants undergoing minimally-invasive lung surgery and who receive an enhanced recovery pathway.


Eligibility Criteria:
Inclusion Criteria:

* Signed or verbal informed consent by participant
* Male and female adults, age 18 and above
* Clinical stage I-II lung cancer (suspected, proven, unproven), or secondary pulmonary malignancy
* BMI \< 35
* ECOG 0-1
* Eligible for surgery and lung cancer resection (FEV1 \> 60%, DLCO \> 60%)
* Elective VATS anatomic resection (segmentectomy or lobectomy), or wedge resection
* Capable caregiver for discharge home

Exclusion Criteria:

* Clinical stage III lung cancer
* Surgery requiring pneumonectomy
* Neoadjuvant therapy
* Active pregnancy or breastfeeding
* History of chronic pain syndromes
* History of chronic opioid use
* Concomitant major surgery indicated with current admission to hospital
* Anticipated intraoperative complication including conversion to thoracotomy, major bleeding requiring blood transfusion, extensive adhesiolysis, injury to mediastinal structures, airway injury, nerve injury (phrenic, recurrent)
* Need for epidural or patient-controlled intravenous analgesia
* Need for urinary catheter