cyrilzakka/clinical-trials huggingface dataset:
PCV-VG in Pediatric Laparoscopic Surgery

This Study will aim to compare the effects of Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) mode with volume control ventilation (VCV) and pressure control ventilation (PCV) modes on respiratory mechanics (including the dynamic compliance, PIP, mean airway pressure, driving pressure..etc) and oxygenation in pediatric laparoscopic surgery.

Laparoscopic surgery is superior to open surgery in terms of recovery time, less postoperative pain, less wound complications, shorter hospital stay, and earlier return to work. However, carbon dioxide insufflation causes several intraoperative cardiovascular, renal, and respiratory adverse effects. Regarding respiratory effects, elevated Intra-abdominal pressure and abdominal expansion shifts the diaphragm upwards. Thus, intrathoracic pressure increases, and expansion of the lungs is restricted. This is followed by a significant decrease up to 50% in pulmonary dynamic compliance and an increase in peak and plateau airway pressures. After deflation of pneumoperitoneum both the pulmonary compliance and airway pressures return to the baseline levels. High airway pressures and decreased compliance can be associated with pulmonary barotrauma, which may manifest as immediate pneumothorax. The basal lung regions are compressed during elevated IAP causing atelectasis and uneven ventilation-perfusion relationships, impairing gas exchange. Hence, the choice of ventilation mode is very important, especially in the paediatric population. Volume control ventilation (VCV) and pressure control ventilation (PCV) modes have been used but each has its own drawbacks, with the former risking increase in airway pressure when pulmonary compliance changes which can lead to barotrauma and the latter not guaranteeing the desired tidal volume which leads to hypoventilation that presents with hypercarbia. Pressure Control Ventilation - Volume Guarantee (PCV-VG) is a recent controlled ventilation mode that combines the benefits of both volume control ventilation (VCV) and pressure control ventilation (PCV) by delivering the preset tidal volume with a decelerating flow at the lowest possible peak inspiratory pressure during a preset inspiratory time and at a preset respiratory rate ensuring adequate ventilation .

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II.
* Both sexes.
* Age: 1-8 years old.
* Scheduled for elective abdominal or urologic laparoscopic surgery.
* BMI between the 5th and 95th percentiles.

Exclusion Criteria:

* ASA physical status more than II.
* Pre-existing lung disease.
* Pre-operative chest infection.
* Any thoracic deformities.
* Unsatisfactory pre-operative arterial oxygen saturation or haemoglobin level.
* Patients with cardiac, hepatic, or renal diseases.
* BMI above and below the 95th and 5th percentile respectively.
BEhavioral EConomics for Oral Health iNnovation Pilot Trial

This Phase I randomized pilot trial will assess the efficacy of a fixed incentive payment program and drawing incentive payment program versus a control program to promote early childhood caries (ECC) preventive health behaviors (i.e., toothbrushing performance and dental visit attendance) for young children of predominantly Latino parents/caregivers enrolled in/waitlisted for Early Head Start (EHS) home visit programs.

If both groups are acceptable and feasible, the reward group with toothbrushing outcomes at least 20% better than the other one (and the control) will be chosen for a future Phase II/III trial; if they are similar, the fixed monetary reward will be used because it is simpler to explain, monitor, and implement.

Eligibility Criteria:
Inclusion Criteria for Parent/Caregiver:

* Provide signed and dated informed consent form in English or Spanish.
* Agree to comply with all study procedures and be available for the duration of the study visit.
* Male or female, aged 18 and older.
* Speak, read, and write either English or Spanish.
* Be a parent or caregiver of a child at least 6 months old but less than 3.5 years (42 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the three participating Los Angeles County EHS home visit programs.
* Not be planning to move residence for the next 6 months outside the greater Los Angeles area.
* Own a smartphone with the Google Play or iTunes store and be willing to download the smart powered TB app
* Be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the TB

Exclusion Criteria:

* Known allergic reaction to components of the study product(s).
* Uncooperative or behaviorally unsuited (assessed during a TB prophylaxis at the initial baseline study visit).
* A sibling of a child already enrolled in the study (the family's oldest child in the eligible age range will be the study child).
* Enrolled in foster care.
* Anything else that would place him/her at increased health risk or preclude the individual's full compliance with or completion of the study.
The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence

Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing. SUI affects women of all ages and can result in significant emotional distress. The purpose of this study is to evaluate a non-surgical, investigational treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.

A multicenter, prospective, randomized, single-blinded, two-arm longitudinal trial of the safety and effectiveness of the AttenueX Device in reducing incontinence. Subjects randomized to the control arm will have the AttenueX Device inserted at the end of the 3-month control period. For those subjects who are randomized to the treatment group, the AttenueX Device will be inserted into the bladder on Day 0, and replaced every 90 days by a new device for nine months. Subjects randomized into the treatment group will be followed for a minimum of 12 months after receiving the AttenueX Device, while subjects randomized into the control group will be followed for 3 months without the AttenueX Device and a minimum of 12 months after receiving the AttenueX Device.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects ≥ 18 years of age
* Experienced stress urinary incontinence (SUI) for at least 12-months and failed prior non-surgical treatment
* VLPP ≥ 60cm H20
* Stamey Grade ≥ 1
* Free of local skin infection, impassable urethral strictures, trauma or necrosis
* Provide written informed consent

Exclusion Criteria:

* Pregnant or planning pregnancy
* 3 or more urinary tract infections within previous year
* Intrinsic sphincter deficiency
* Incontinence surgery within previous 6-months
* Cystocele ≥ grade 3
* Previous pelvic radiation therapy
* Presence of urethral abnormalities
* Recent urosepsis
* History of interstitial or follicular cystitis
* Uncontrolled diabetes
* Biofeedback within previous 3 months
* Morbid obesity
* Use of anticoagulants other than aspirin
Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study

Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment method. Thus, combining ELAM with PSG will validate ELAM and improve its clinical and research utilization.

The investigators propose to conduct this study to validate ELAM device for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab PSG measures of Sleep-Disordered Breathing (SDB) and sleep architecture in adults with obstructive sleep apnea (OSA) symptoms.

The investigators propose to recruit a total of 40 participants with symptoms of OSA. The overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture will be validated by using PSG analysis as a gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 80 years old. Ideally balanced for sex and age (18 to 80 years old)
* no more than 75% of subjects in one bin of: (male, female)
* no more than 50% of subjects in one age-group (18-29, 30-39, 40-49, 50-59, 60-80)
* Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)
* Without any unstable medical or psychiatric co-morbidities that would be expected to interfere with the study.
* If taking any medication, must be on a stable dose of medication for a month
* Able to read and understand English

Exclusion Criteria:

* Presence of any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol, suicidality, current regular use of psychiatric medications, opiates, or thyroid medications, dementia, current substance abuse, post-traumatic or psychotic disorders, bipolar disorder; any significant neurologic disease, including possible and probable dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma, history of alcohol or substance use disorder within the past 2 years (DSM V criteria);
* If positive airway pressure (PAP) titration study or split night study (diagnostic and PAP titration study combined)
Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine

The purpose of the current study is to evaluate the efficacy of d-cycloserine in augmenting treatment of smoking cessation for individuals with panic attacks. The investigators hypothesize that individuals receiving DCS (versus those receiving placebo) will evidence greater smoking abstinence rates and decreased panic symptoms after receiving a combined CBT-based treatment for smokers with panic attacks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ages 18-65 capable of providing informed consent
* Willing and able to provide informed consent, attend all study visits and comply with the protocol
* Daily smoker for at least one year
* Currently smoke an average of at least 8 cigarettes per day
* Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
* Evidence of panic attack within the past year and endorsement of smoking as an emotion regulation strategy (i.e., score at least a 78 on the SAEQ).

Exclusion Criteria:

* Subjects who do not use smoking as an emotion regulation strategy
* Current diagnosis of a psychotic, eating, developmental or bipolar disorder
* Significant suicide risk as determined by structured interview
* Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
* Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
* Current use of isoniazid or ethionamide compounds
* A history of significant medical condition and/or be deemed as currently unhealthy in the context of a complete physical examination
* Limited mental competency and the inability to give informed, voluntary, written consent to participate
* Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
* Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of anxiety or mood disorder other than general supportive therapy initiated at least 3 months prior to the study
* Use of other tobacco products
* Plans to move outside of the immediate area in the next six months
* Insufficient command of the English language
Evaluation of Optical Genome Mapping in Phi Negative Myeloproliferative Neoplasia in the Detection of Acquired Cytogenetic Abnormalities

Standard cytogenetics (CBA +/- FISH) is of diagnostic and prognostic interest in Ph- MPN. However, its value is limited by the low frequency of detected abnormalities. The development of tools to increase the sensitivity of detection of chromosomal alterations is therefore particularly adapted to these pathologies. Optical genome mapping (OGM) is a high resolution "long read" technique that allows the identification of structural and copy number variations at the whole genome level. Several recent studies suggest that OGM is a future tool for cytogenetic characterization of haematological disorders. Its ability to describe structural abnormalities, including balanced ones, represents a major advantage over currently used technologies. Thus, OGM seems to be the key tool for cytogenetics of haematological malignancies in the coming years, making it possible to replace, under certain conditions, not only karyotype and FISH, but CMA and even RT-MLPA for the search for fusion transcripts, thus filling in the gaps in these techniques while maintaining their advantages.

To define the place of this technology in Ph- MPN, the investigators will perform a OGM analysis on patients with Ph-MPN for whom bone marrow exploration is scheduled. These results will be compared with those of standard cytogenetics (CBA +/- FISH).


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Diagnosis or follow-up of polycythemia vera, essential thrombocythemia or primary or secondary myelofibrosis
* Requires bone marrow cytogenetics at diagnosis or follow-up
* Understanding of the French language
* Information of the patient and collection of no objection
* Person affiliated to a social security regime

Exclusion Criteria:

* Patient with BCR::ABL positive myeloproliferative neoplasia.
* Person with a medical history that may impair the ability to understand the information notice
Diffusion Weighted MRI Accuracy in Cholesteatoma Localization

Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of choice to "second look" surgery). Some people take CT and MRI fusion to improve the localization of cholesteatoma. Many studies have investigated the diagnostic capabilities of MRI but very few have demonstrate their reliability in location diagnosis. The aim of the study was to propose a topographic reading method of the MRI of the middle ear and to evaluate the performances in the localization of the cholesteatoma in order to adapt the surgical management


Eligibility Criteria:
inclusion criteria

* Age: from 1 month and up
* Sex: man / woman
* Patient who had a tympanoplasty in closed technique, for the first surgical time of a cholesteatoma or for residual or recurrent cholesteatoma, performed by the same radiologist (Pr Anne Charpiot) with the following characteristics:

  * Code of the Common Classification of Medical Acts (CCAM)

    * Exeresis of cholesteatoma with tympanoplasty in closed technique and ossiculoplasty (CBFA002)
    * Exeresis of cholesteatoma with tympanoplasty in closed technique (CBFA006)
    * Exeresis of cholesteatoma confined to the tympanic cavity without antro-attic exploration (CBFA005)
    * Tympanoplasty in closed technique with posterior tympanotomy (CBMD001)
    * Secondary tympanoplasty in closed technique (CBMD002)
  * Diagnostic code of the International Classification of Diseases (ICD10)

    * Cholesteatoma of the middle ear (H71)
* Diagnosis of macroscopic and / or pathological cholesteatoma.
* Preoperative diagnosis of cholesteatoma on MRI of the middle ear performed in less than 6 months by the same radiologist (Pr Francis Veillon).
* Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.

Cholesteatoma is a very common disease in the pediatric population, with important functional issues, whose treatment is surgical. That's why our study includes minor subjects.

Criteria of non-inclusion

* Refusal of the patient to participate in the study
* Absence of data concerning the diagnosis and / or localization of cholesteatoma on the operative record
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Pregnancy (woman of childbearing age)
* Breastfeeding
Nutrition in People With a Lower Limb Amputation

The goal of this prospective longitudinal observational cohort study is to determine the nutritional intake, nutritional status, and physical activity level in people who have undergone a major dysvascular lower limb amputation (LLA) at different moments post-LLA (during hospital admission several days post-LLA, and at 5 weeks, 6 months, and 9 months post-LLA). The main questions this study aims to answer are:

* What is the nutritional intake, nutritional status, and physical activity level at different moments post-LLA?
* What is the association between nutritional intake and physical activity level, and nutritional status?
* What is the association between nutritional intake, nutritional status and physical activity level and clinical outcomes (mortality, wound healing, quality of life, physical functioning)?

People requiring an LLA are at high risk for adverse clinical outcomes. Undernutrition and low physical activity level may affect clinical outcomes negatively. However, little is known about the nutritional intake, nutritional status and physical activity level in the LLA population, and their association with clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing or recently (i.e., within the last seven weeks) having undergone a major dysvascular lower limb amputation (i.e., Syme amputation or more proximal level)
* 18 years or older
* Able to collaborate

Exclusion Criteria:

* Requiring re-amputation
* Severe malabsorption disease
Detection of Muscle Quality in Children - Protocol for a Validation Study

The goal of this observational study is to evaluate the validity and reliability of ultrasound echo intensity (EI) as a diagnostic tool for assessing muscle quality in children aged 10-14 years, including normal-weight, obese, and trained young athletes. The main questions it aims to answer are:

Can EI reliably and accurately measure muscle quality in children when validated against gold-standard techniques like DXA and isokinetic dynamometry? What are the age-, sex-, and fitness-specific benchmarks for EI to differentiate between normal and pathological muscle quality?


Eligibility Criteria:
Inclusion Criteria:

• Generally healthy children

Exclusion Criteria:

* Acute illnesses
* Chronic or acute diseases of the endocrine or musculoskeletal systems
* Post-traumatic conditions
Study of CPAP as Intervention After Lung Resection

The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients.

In pulmonary resection surgery complications that lead to significant functional losses of the lung parenchyma and alterations in the ventilatory function may trigger retention of secretions, atelectasis, pneumonia and respiratory failure, which prolong the duration of mechanical ventilation and hospitalisation and contribute to the increase in risk of mortality.

In this study the oxygenation index (OI), Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection.

Similar to Chest Physiotherapy, the preventive application of CPAP in the postoperative period after lung resection in our study also appeared to be a safe technique, which allowed improved oxygenation without increasing air leaks through the thoracic drains.

Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy;
* aged between 40 and 75 years.

Exclusion Criteria:

* Patients who refused to participate in the survey;
* lung resection with incisions other than posterolateral;
* patients who had contraindications to the use of noninvasive ventilation.
The Effect of Late Night Meals on Fasting Glucose in Type 2 Diabetes Patients

High fasting glucose is a very common problem in type 2 diabetic patients. The cause is probably glucose production by the liver, known as the "dawn phenomenon". The investigators hypothesize that a late night meal can lower the fasting glucose level by early morning insulin secretion stimulated by the food. In this study the investigators intend to test the effect of different kinds of late night meals on fasting glucose in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus with HbA1c 6.5-9%, fasting glucose of 126-200 mg/dl and BMI of 27-40.

Exclusion Criteria:

* Patient treated with insulin, GLP-1 analog or weight reduction medications.
* Type 1 diabetes
* Pregnancy
* Renal failure (creatinin \>1.4 for male and 1.3 for female
* Uncontrolled hypertension (\>160/100)
* Abnormal thyroid function test
* Patient treated with steroids or psychiatric medications.
Tranexamic Acid in Gender Mastectomy

The goal of this study is to examine the use of tranexamic acid (TXA) in gender mastectomy surgery, specifically looking at volume loss (blood and transudate) postoperatively.

Anecdotal data from plastic surgeons around the country suggests that tranexamic acid has decreased patient's drain outputs, swelling, and bruising. Based on these anecdotal reports, many University of Wisconsin (UW) surgeons in Plastic and Reconstructive Surgery became interested in its use. It has a very safe profile and is inexpensive; therefore, many UW plastic surgeons have started using it topically prior to closure in many of procedures. Surgeons notice decreased drain output and bruising; and therefore decided to formally study the effects of tranexamic acid to determine whether there was a statistical difference in outcomes with the use of the drug.

For this sub-study, topical TXA will be applied to the surface of surgical sites and the primary outcome will be days to drain removal postoperatively. Secondary outcomes that would be assessed is total drain fluid output in milliliters, hematoma and seroma rates, and need for transfusion for hemoglobin \< 7.0 postoperatively.

The hypothesis is that the use of TXA will result in earlier removal of drains by decreasing total drain fluid output and decreased need for transfusions, thus minimizing the associated complications/risks with drains and transfusions. The overall study is in two-parts, 1) a prospective study with retrospective controls via chart review and 2) a prospective controlled trial in bilateral procedures where participants serve as their own control with one side having tranexamic acid irrigation and the other side having saline irrigation.

This record documents a prospective controlled trial of the use of TXA in gender mastectomy, specifically.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing gender mastectomy
* English speaking

Exclusion Criteria:

* History of thrombotic event (ie deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
* genetic disorder that increases risk of thrombosis
* use of estrogens at time of surgery
* pregnancy