cyrilzakka/clinical-trials huggingface dataset:
Noninvasive Ultrasound Assessment of Detrusor Dysfunction

The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.

The purpose of this study is to evaluate the effectiveness of quantitative ultrasound bladder vibrometry (QUBV) as a noninvasive tool for detrusor overactivity assessment and for benign prostatic hyperplasia (BPH) treatment selection. Participants in this study will have a QUBV ultrasound performed at the same time as a urodynamic study that had been ordered as part of their regular clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Aim1:

Age \>18 scheduled to undergo UDS for their clinical care for one of the included diagnoses.

-Aim2: Inclusions: Age \>45 scheduled to undergo selective photovaporization of the prostate.

Exclusion Criteria:

* Aim1:Obesity (BMI \>35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as for uterine or colorectal cancer), prior bladder surgery (including prostate resection), and pregnant or breast-feeding women.
* Aim2:Obesity (BMI \>35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as colorectal cancer).
CREATE - Children Reading With Electronic Assistance To Educate

This pilot randomized controlled trial (RCT) will test the methodology for a full RCT of assistive technologies for children/young people with low vision/blindness. The investigators will recruit 40 students age 10-18 years in India and the UK, who will be randomised into two groups. Apple iPads will be the active intervention; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage and accessibility of the device and trial feasibility measures. Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, the investigators will carry out semistructured interviews with the participants and their teachers, and attempt to evaluate cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* age 10-18 years
* low vision, defined as "best corrected visual acuity (BCVA) for distance between - less than 6/18 (0.48 logMAR) and 3/60 (1.30 logMAR) in the better eye" (WHO) ability to read printed material
* no previous or current use of a tablet computer for educational purposes We will include students who have access to a tablet computer already, but only use it for recreational purposes. We will also include students who use a laptop. We will also include students who use or have previously used optical low-vision aids such as magnifiers, telescopes and CCTV systems.

Exclusion Criteria:

* current or previous use of a tablet computer for educational purposes
Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery

The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient with ASA score 1-3
* Body mass index \< 30 kg/m\^2
* Patient is schelduled for major abdominal surgery (laparotomy without risk of haemorrhage whose duration is assumed to be greater than 120 min)
* The patient passes from home, directly to the hospital, without schelduled hospitalization in another department

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* The patient has a contra-indication for treatment necessary for the study
* ASA score \> 3
* body mass index \> 30 kg/m\^2
* Expected surgical time of \< 120 minutes
* Surgery with risk of hemorrhage
* Surgery via celioscopy
* The surgery require perineal access, thus rendering any blinding impossible
* Hepatic surgery
* Contra indication for intermittent venous compression
TReatment of Pulmonary Hypertension Group II Study

The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life.

This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR\>3 wood units.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
* Male or female, ≥ 18 years of age at the time of screening
* Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
* Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
* Patient with a current diagnosis of NYHA functional class II/III
* Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150μmol/l

Exclusion Criteria:

* Pregnant women or women planning a pregnancy within 12 months of study enrolment
* Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
* Patient with life expectancy of less than a year
* Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
* Patient with pulmonary artery anatomy that precludes treatment
* Patient with moderate to severe pulmonary artery stenosis
* Patient with any pulmonary artery aneurysm
* Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
* Patient experiencing a current episode of acute decompensated heart failure
* Patient who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrolment. Patient who has implantable Cardiomems device, neurostimulators or drug infusion devices, regardless of implant date.
Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicaments in Retreatment Cases

Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra canal Medicamentson Postoperative flare -up following two-Visit Endodontic Retreatment cases

1. Each patient will be anesthetized with the same solution, 40 mg articaine hydrochloride + 0.006 mg/mL epinephrine hydrochloride (Ultracaine DS; Aventis Pharma, Istanbul, Turkey).
2. The standard procedure for each group at the first appointment included rubber dam isolation,removing of previous coronal restorations, and root canal filling materials. The removal of previous root canal fillings will be performed with one of these: Gates Glidden drills, hand files, heated pluggers, and Ni-Ti rotary instruments.
3. After the removal of previous root canal fillings, the working lengths were determined by apex locator and periapical radiographs 1 mm from the apexes.
4. Chemo-mechanical preparation of root canals will be made with the master apical files ranged from #25 to #70 depending on the initial diameter or preparation of the root canals.

   Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation was made by saline, and the root canals were dried with paper points.
5. In the 1st group the root canals will be medicated with a calcium hydroxide paste for 7 days.(calcium hydroxide injectable paste Metapex , 2.2g paste in a 1 syringe).

   In the 2nd group the root canals will be medicated with a calcium hydroxidechlorhexidine paste for 7 days. The paste consists of 1.2 g Ca(OH)2 powder per 1 mL 0.2% chlorhexidine in water. The teeth in both groups will be closed with a sterile dry cotton pellet and a minimum of 3 mm of temporary restorative material.
6. In the next appointment, the tooth was reopened, the intra-canal paste will be removed and a patency file (size 08 Flexofile; Dentsply-Maillefer) was pushed through the foramen.

Master apical file will be checked again and then master cones will be placed and radiographed. Obturation will be done using lateral compaction technique with AD seal resin sealer using spreader for placement of auxiliary cones.

Eligibility Criteria:
Inclusion Criteria:

1. Patients' needs retreatment.
2. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
3. Age range is between 20 and 50 years.
4. Patients who can understand the categorical tool (points)for measurement
5. Patients able to sign informed consent.

Exclusion Criteria:

1. Complicating systemic disease
2. Having severe pain and/or acute apical abscesses
3. Being under 18 years of age
4. Using antibiotics or corticosteroids
Hernia Repair Using the Totally ExtraPeritoneal (TEP) Laparoscopic Approach Without Curare and Without Orotracheal Intubation.

Laparoscopic treatment of inguinal hernia with the totally extraperitoneal approach (TEP) is indicated for simple and bilateral inguinal hernias. It consists of placing a large prosthesis in the posterior position by direct access to the extra-peritoneal space. This prosthesis is interposed between the defective wall and the peritoneum. Unlike the transperitoneal laparoscopic method, the strictly extraperitoneal approach reduces complications related to contact with the intestinal loops and preserves the peritoneal layer intact.

TEP approach is traditionally performed under general anesthesia with curare and orotracheal intubation.

In the study, we would like to assess this intervention without curare and without standard orotracheal intubation but with a laryngeal mask airway to permit ventilation.

Laparoscopic TEP hernia repair is traditionally performed under general anesthesia with curare and orotracheal intubation. Indeed, according to the French SFAR Recommendations (2018) regarding to curarization and decurarization in anesthesia, it is recommended to administer a curare to facilitate intubation of the trachea. Moreover, the SFAR in these same recommendations specifies that it is probably not recommended to systematically administer curare to facilitate the fitting of a supraglottic airway device (otherwise called a laryngeal mask airway).

The idea of this study is to perform this intervention without curare and without standard orotracheal intubation but with a laryngeal mask airway to permit ventilation. This ventilation technique has already been commonly used by the site for several years. The recent global shortage of curares has led them to increasingly resort to this method during this phase of the global pandemic.

In addition, limiting the patients exposure to curares avoids possible anaphylactic reactions. According to the SFAR, the incidence of anaphylactic reactions to curares varies by country. It was estimated at 184.0 \[139.3 - 229.7\] in France, 250.9 \[189.8 - 312.9\] for women and 105.5 \[79.7 - 132.0\] for men.

The main hypothesis of the study is that the repair of inguinal hernia using the totally extraperitoneal laparoscopic approach (TEP) is feasible without curares and without orotracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 or over
2. BMI below 30
3. Non-recurrent unilateral hernia
4. Operating time estimated at less than 60 minutes at the surgeon's discretion
5. Patients eligible to an ambulatory surgical setting at the discretion of the surgeon and the anesthetist
6. Patient informed of the study and agreed to take part.

Exclusion Criteria:

1. Patient under legal protection measures
2. Impossibility of using a laryngeal mask airway
3. Pregnant or breastfeeding woman
Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.

With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To offer an satisfied surgery process for patients, a proper sedation is necessary. So in this study, we want to investigate the influence of two different sedative drugs on outcomes of patients received hip replacement surgery .


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older and undergoing hip fracture repair

Exclusion Criteria:

* Patients with severe cognitive impairment (MMSE score, \<15)
* Preoperative delirium as determined by Confusion Assessment Method
* Contraindications to local anesthesia
* Prior hip surgery
* Mental or language barriers that would preclude data collection
* Severe congestive heart failure (NewYork Heart Association class IV)
* Severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV)
Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma

This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible.
* Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma
* L-MTP-PE is deemed to be of potential benefit by the treating investigator
* Willing and able to understand and sign informed consent and assent as appropriate
* Life expectancy \> 6 weeks
* Adequate organ function as follows:
* Adequate bone marrow function defined as:

  * absolute neutrophil count (ANC) ≥ 750/mm\^3
  * platelet count ≥ 30,000/ mm\^3
  * hemoglobin ≥ 8 g/dl
* Adequate renal function defined as:

  * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m\^2 OR
  * Serum creatinine ≤ 2x the upper limit of normal based on age/gender
* Adequate liver function defined as:

  * Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease
  * AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases
* Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant

Exclusion Criteria:

* Use of chronic steroids of other immunosuppressive agents
* Pregnant or breast feeding
Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

This study occurs during five visits that are already scheduled as part of "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688). If participants have dystonia associated with Parkinson's disease, the investigators will consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale) to assess the severity of dystonia.

To measure the effects of DBS on dystonia, the investigators will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline. This will allow them to contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)
* Diagnosis of Parkinson's disease with and without dystonia

Exclusion Criteria:

* Not enrolled in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)
Evaluation of Advanced Practice Nurse's Management of Patients with Chronic Myeloid Leukemia

Chronic Myeloid Leukemia (CML) affects 820 people per year in France (2018), half of them are older than 60 years old.

Tyrosine Kinase Inhibitors (TKI) are new kind of targeted therapy whose efficiency allow for a high rate of complete molecular response, leading to a disruption of treatment under certain conditions.

Optimizing CML treatment is a major concern, particularly for adverse events management, treatment compliance and therapeutic response. Multiple studies demonstrated that grade ≤ II adverse events are most likely to be under reported by patients and clinicians. Although these adverse events are mostly reported by clinical examination, needing minimal treatment. These toxicities could alter daily and domestic living activities, potentially impacting treatment compliance and therapeutic response. Therefore, early detection of these adverse events is a major challenge for the prognosis and care of CML.

The Advanced Practice Nurse (APN), a new health care professional, acquired the skills needed to independently follow, manage and care the patients with medical approvals.

At international level, many studies, in oncology and in others domains, have been done to demonstrate the added value of the APN, particularly in improving patient's quality of life, management, care of drug-induced adverse events and treatment compliance.

In France, because of the recentness of the profession, only few studies were have been conducted. The goal of this study is to demonstrate the benefit of APN in clinical follow-up, quality of life, treatment compliance, and therapeutic response of CML patients. These effects could be managed thanks to early detection and management of ≤ grade II adverse events during consultation, in partnership with the patients, and in collaborative working.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* CML patient in chronic phase, eligible for oral therapy.
* Newly diagnosed CML and/or initiating oral therapy :

  * Patient changing treatment for non-response or loss of therapeutic response or toxicities, on the condition that these toxicities are resolved or grade I maximum at the time of inclusion.
  * Newly start of oral therapy.
* Patient eligible to a follow-up by an advanced practice nurse.
* Patient capable to understand french and complete a questionnaire.

Exclusion Criteria:

* Patient that had a follow-up \> 3 months by an advanced practice nurse for CML before inclusion.
* Patient changing treatment for toxicities, if these toxicities are still \> grade I at inclusion.
* Patient enrolled in another interventional research protocol for CML.
* Pregnant women.
* Patient under legal protection, deprived of liberty or unable to be included in a research protocol.
Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery

The goal of this clinical trial is to see if pantoprazole (a proton pump inhibitor used for acid reflux/heart burn) can reduce nausea and vomiting after gynecologic surgery in women between the ages of 18 and 79.

Researchers will compare a placebo to the active medication.

Participants will be asked to take three pills around their surgery, two taken before and one taken the night after.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective gynecological surgery by either an open abdominal or minimally invasive approach (to include both endoscopic and vaginal). Procedure must be performed under general anesthesia.

Exclusion Criteria:

* Pregnant,
* Patients with gastrointestinal disease requiring ongoing medical management.
* Prior gastrointestinal surgery with the exception of diagnostic procedures, appendectomy and cholecystectomy.
* Patients with a history of H2 receptor blocker use, proton pump inhibitor use or other GERD specific therapy within 30 days of surgery.
* Any patient identified by their surgical care team as having a history of PONV warranting additional perioperative prophylaxis.
* Known r suspected malignancy
* Lactose intolerance
Persistent Organic Pollutants and Mechanical Discharge: Limiting the Impact of Bariatric Surgery Through Personalized Adapted Physical Activity

For the most severe cases of obesity, recourse to bariatric surgery is the ultimate solution. Although highly beneficial to individual health, this massive loss of body mass could also have negative effects on metabolism and neuromuscular function. Unfortunately, these effects have been relatively little studied in the scientific literature, and are poorly taken into account in patient follow-up when bariatric surgery has been recommended. One of the adverse effects of bariatric surgery is the release into the bloodstream of Persistent Organic Pollutants (POPs) which, are not only persistent, but also bioaccumulative, toxic and mobile. The major problem is that these circulating POPs are linked to a number of adverse side effects, including reproductive disorders, neurobehavioral alterations, metabolic disorders, gut microbiota alterations inflammatory changes and physiological alterations. POP neurotoxicity could also affect psychomotor abilities and neuromuscular function. In addition, the mechanical unloading (i.e., reduced mechanical stress on muscles) induced by loss of body mass, an effect targeted by bariatric surgery and largely beneficial to the health of individuals, could also alter neuromuscular function and potentially alter muscle architecture and contractile properties. Unfortunately, no data are currently available in the scientific literature to confirm or refute these hypotheses. Physical activity-based intervention strategies may be usefull to counteract the effects of mechanical unloading and the release of POPs as suggested in scientific literature. However it is also possible to question which exercise modality should be preferred. Our hypothesis is that eccentric muscle strengthening would better preserve muscle mass and neuromuscular function while limiting the risks associated with POPs release, compared with an aerobic and a control group.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (18-55 years)
* Patient scheduled for bariatric surgery
* Patient practicing a leisure-time physical activity \< 8 hours of moderate intensity per week or \< 4 hours of high intensity per week
* Presence of effective contraception (hormonal or mechanical)

Exclusion Criteria:

* Patient already involved in another experimental study
* Pregnant (urine pregnancy test) or breast-feeding women
* Patient in a particular situation deemed incompatible with the study by the investigator
* Patients from outside the Alpes-Maritimes and Var departments
* Patient having received antibiotic treatment during the 3 months preceding the first stool collection
* Presence of a contraindication to adapted physical activity
* Presence of a contraindication to neurostimulation