cyrilzakka/clinical-trials huggingface dataset:
Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children

This study will be conducted to determine the advantages and limitations of sonography compared with chest radiography, in the detection of post procedure iatrogenic pneumothorax in patients underwent to Pectus Excavatum (PE) with Nuss repair.

The Nuss procedure is a minimally invasive technique for the repair of Pectus Excavatum (MIRPE).

Residual pneumothorax (PNX) is reported in more than 50% after Nuss procedure. It is a consequence of the introduction of the scope and bar in the pleural space and is considered a minor complication due to the minimal clinical consequences. It is routine practice to confirm the diagnosis of PNX with a conventional chest X-Ray either in the operating room at the end of thoracic surgery or in the recovery room unit immediately after surgery.However, anterior pneumothorax can occur and chest-X ray could not be able to detected the PNX. Nowadays lung ultrasound (LUS) allows a bedside non-invasive evaluation of the patient(with a sensitivity and specificity of 92 and 99% respectively) without exposure to ionized radiation, can be performed more quickly than chest radiography and therefore can be repeated several times without additional risks. The use of LUS in pediatric age groups is more recent, but is becoming widely utilized both in neonatal and pediatric respiratory diseases.

Bedside sonography for diagnosis of PNX has been well described in emergency and trauma medicine literature and it is resulted to be more sensitive and specific than portable anteroposterior chest radiography. Although there are few studies describing the use of ultrasound for the detection of surgical pneumothorax, none of them studied its use after Nuss Procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients following Nuss procedure for PE repair at Giannina Gaslini Institute

Exclusion Criteria:

* absence of informed consent from parents
* poor quality of the pre-operatory acoustic window
Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients

In this study, the investigators aimed to evaluate to the efficacy of the needle type used in follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.

This study will include:

1. women with less than four follicles on the day of hCG administration
2. women between 20-45 age old
3. The value of progesterone on the day of hCG administration will be under 1.5ng/ml

Eligibility Criteria:
Inclusion Criteria:

1. women between 20-45 years old
2. the number of follicles less than 5 on the day of HCG administration
3. the value of progesteron on the day of hCG administration must be under 1.5ng/ml

Exclusion Criteria:

1. women under 20 years and older than 45 year
2. on the day of hCG administration if the follicle number is more than 5
3. if.the value of progesteron on the day of hCG administration is higher than 1.5ng/ml
A Case Series Comparing T+LRTI to Partial Trapeziectomy for Thumb Osteoarthritis

The purpose of this study was to measure the differences in Health Related Quality of Life (HRQOL) and functional measurements between two groups of patients with Carpometacarpal Osteoarthritis of the thumb.

Two patient groups, who have been diagnosed with Carpometacarpal Osteoarthritis of the thumb were compared to measure the Health Related Quality of life (HRQOL) and functional outcomes following two different surgical procedures. The first procedure is currently the most used procedure is North America, Trapeziectomy with Ligament Reconstruction and Tendon Interposition (T+LRTI); this procedure is compared to Partial Trapeziectomy and Tendon Interposition (PT+TI). HRQOL is measured using three questionnaires: one generic, one condition specific and one to measure utility (costs). Patients received their procedures from the respective surgeons and then came in for regular follow up at 1, 3, 6 and 12 months. At these follow up visits the questionnaires and functional measurements (including grip, key pinch and tip pinch strength), were completed

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced stage (Eaton stages II-IV) Carpometacarpal joint (CMCJ) osteoarthritis (OA of the thumb
* Willingness to undergo surgery for CMCJ OA;
* Over the age of 18;
* Able to provide informed consent; and
* Ability to read and comprehend English to complete the HRQOL questionnaires

Exclusion Criteria:

* 1) Diagnosis of Eaton stage I CMCJ OA of the thumb \[17\]; 2) Under the age of 18; 3) Presence of any concomitant hand pathology (including rheumatoid arthritis, neuropathy and traumatic arthritis); and 4) Previous surgery on the same hand or currently under consideration for other unrelated hand surgery
Diffusion Tensor Imaging of Myelopathy

Myelopathy describes any neurologic deficit related to the spinal cord. Myelopathy is caused by various pathological states of the human spinal cord, including tumors, inflammatory lesions, spinal cord compression and degenerative myelopathy. Clinically, the diagnosis of myelopathy depends on localization of the neurologic finding to the spinal cord, rather than the brain or peripheral nervous system and then to a particular segment of the spinal cord.

Magnetic resonance imaging (MRI) plays an essential role in the diagnosis and follow-up of the lesions of the spinal cord using conventional MRI T1- and T2-weighted sequences. Sometimes a studied spinal cord may appear normal on conventional MRI even though patients have symptoms of myelopathy causing a discrepancy between MRI findings and clinical findings.

Diffusion tensor imaging (DTI) is an advanced non-invasive MR imaging technique which assesses the microstructural integrity of nerve fiber tracts.

A number of 70 patient with myelopathy included within the study.

DTI is used primarily for assessing white matter of the brain and spinal cord. DTI can depict alterations to the white matter tract and quantify these changes. Disturbances of diffusion (restriction or increase) may be assessed quantitatively by measurements of apparent diffusion coefficient (ADC). The apparent diffusion coefficient (ADC), is used to measure diffusive strength. Diffusion anisotropy can be assessed quantitatively by using the fractional anisotropy (FA) parameter, which may be also visualized on fractional anisotropy maps. FA is considered as a marker of white matter integrity.

Image acquisition will be conducted on a 1.5-Tesla MR scanner.

The imaging will be done throughout the following sequences:

1. Conventional MRI sequences: sagittal T1W, sagittal and axial T2W sequences.
2. DTI sequence: Single-shot spin-echo echo-planar imaging (EPI) and parallel imaging techniques to achieve motion-free and higher signal-to-noise ratio (SNR) DTI.

Post processing:

The diffusion-tensor imaging data is transferred to an offline workstation utilizing software used for reconstruction of the Diffusion Tensor imaging (DTI) with regions of interest were defined and measured on the ADC and fractional anisotropy (FA) maps. diffusion tensor tractogram will be constructed on the acquired data source.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms of myelopathy

Exclusion Criteria:

* Previous spine surgery
* Spine radiation therapy
* Cerebral palsy
* Contraindication to MR imaging.
Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence

To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.

Urinary incontinence is defined as involuntary loss of urine and is divided into subtypes according to symptoms. These subtypes include SUI, in which urine loss occurs during exertion, physical exercise, coughing or sneezing; urgency urinary incontinence (UUI), in which urine loss is associated with urinary urgency; and mixed urinary incontinence (MUI), which is characterized by the association of stress loss with urgency.

There are non-surgical treatments (e.g., lifestyle modifications, pharmacotherapy, physiotherapy and vaginal pessary) and surgical treatments.

As regards sling use, it was found that mid urethral slings techniques achieved high cure rates in women with SUI and have become the mainstay for surgical treatment of SUI in women over the last 2 decades.

One of the modalities of such procedures is the transobturator mid urethral tape (TOT). It was introduced to minimize the complications of the previous retropubic tapes, which include injury to the bladder, major vessels, and bowel.

In an effort to maintain efficacy while eliminating some of the side effects, a new generation of tapes has been developed, called single incision tapes or mini-slings. They are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings.

Eligibility Criteria:
Inclusion Criteria:

* Women with a medical history of SUI
* mixed urinary incontinence (MUI) in which SUI had to be the dominating symptom
* confirmed by a positive standardized cough test with 300 cm3 water in the bladder

Exclusion Criteria:

* Women will be excluded if they are aged \>60 years
* had previous incontinence or pelvic organ prolapse surgery
* planned or present pregnancy
* residual urine volume\>100 ml
* previous pelvic irradiation
* neurological conditions such as multiple sclerosis
* current treatment with corticoids
* history of genital or abdominal cancer or a pelvic mass.
WAVECREST Post Market Clinical Follow-Up (PMCF) Study

The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.

The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).

Eligibility Criteria:
The criteria for implant are in accordance to the current version of the Instructions for Use:

Inclusion Criteria:

1. Non-valvular paroxysmal, persistent, or permanent atrial fibrillation
2. 18 years of age or older
3. LAA anatomy amenable to treatment by percutaneous techniques
4. Risk factors for potential thrombus formation in the LAA
5. Willing to participate in the required follow-up visits and tests
6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee or Institutional Review Board at the study site

Exclusion Criteria:

1. Known contraindication to percutaneous transseptal intervention
2. Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant
3. Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety
4. Mitral valve stenosis \< 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair
5. Known contraindication and/or allergy to nickel
6. Known active bacterial infection (i.e., sepsis, endocarditis)
7. Any known medical condition or overall health of the subject that could adversely affect procedural safety or potentially prevent the patient from completing all study required visits and tests.
8. Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.
Strength Training and Executive Functions: A Randomized Controlled Trial

A group of 50 age-schooled adolescents was randomized into one intervention and another control group of 25 subjects each. After estimating one maximum repetition for all the participants in a previous session, the intervention group performed a resistance training based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM) whereas the control group performed both stretching and balance exercises. Measures of executive functions ( i.e. a cognitive function associated with academic performance) were taken for all the participants before and after the training. Both independent and paired t-test will serve to check differences between and within groups respectively.

A group of 50 age-schooled adolescents was randomized into one intervention and another control group of 25 subjects each. After estimating one maximum repetition for all the participants in a previous session, the intervention group performed a resistance training based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM) whereas the control group performed both stretching and balance exercises. Measures of executive functions ( i.e. a cognitive function associated with academic performance) were taken for all the participants before and after the training. Both independent and paired t-test will serve to check differences between and within groups respectively. The selected resistance exercise is based on a global muscle involvement.

Eligibility Criteria:
Inclusion Criteria:

* Healthy age-schooled adolescent

Exclusion Criteria:

* Not healthy, injured age-schooled adolescent
Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

Recent research has focused on methods to mitigate scar tissue formation and arthrofibrosis following surgery in hopes that patients may attain maximal range of motion goals, avoid manipulation and secondary surgery (i.e. revision arthroplasty), and improve their function. The synovial fluid milieu has also highlighted the role of local biochemical markers that may be implicated in the development of arthrofibrosis. Losartan is an angiotensin receptor blocker with inhibitory effects on transforming growth factor beta (TGF-b), largely implicated in tissue repair and fibrosis by way of SMAD protein signaling suppression, and has been used in orthopaedic sports medicine to prevent stiffness following hip arthroscopy. To date, this has not commonly been used at NYU Langone in orthopedic surgery. The purpose of this study is to evaluate the efficacy of losartan use pre- and post-operatively on range of motion and the incidence of manipulation under anesthesia following total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
2. Patients ≥18 years of age
3. Patients have been medically cleared and scheduled for surgery
4. Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.

Exclusion Criteria:

1. Any contraindications to Losartan
2. Revision surgery
3. Surgery for fracture, infection, or malignancy
4. Patients with a diagnosis of post-traumatic arthritis
5. Bilateral, simultaneous surgery
6. Patients already taking an ACE-inhibitor or Angiotensin receptor blocker for hypertension
Study Evaluating the Etiology of Intra-Abdominal Infections

The aim of this study is to define the etiology of intra-abdominal infections, to study the role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the need for specific enterococcal antimicrobial coverage.


Eligibility Criteria:
Inclusion Criteria:

* A case will be defined as an intra-abdominal abscess or peritoneal fluid culture that will be positive for enterococcus or an enterococcal bacteriemia in association with an intra-abdominal source of infection.
* A control will be defined as a culture-positive intra-abdominal infection or bacteriemia due to an intraabdominal focus where enterococci have not been isolated.

Exclusion Criteria:

-
Feasibility of a Cognitive Intervention for Youth Post Concussion

The purpose of this study is to evaluate the feasibility and effects of a cognitive intervention for youth following concussion

Concussion, a form of mild traumatic brain injury, is one of the most commonly reported injuries in youth. While most recover quickly, a substantial subset (30-58.5%) report symptoms that persist at one month with a reported 11-14% who continue to report symptoms beyond three months. Currently, there are no evidence-based guidelines for treatment that address occupational (meaningful activity) concerns for youth who are slower to recover post-concussion. It is postulated that a top-down rehabilitation approach with metacognitive strategy training as the core of the intervention might be effective.The Cognitive Orientation to Occupational Performance (CO-OP) Approach is a metacognitive strategy training approach with a growing body of literature supporting it's value in improving participation in meaningful activity and achieving self-selected occupation-based goals for adults with brain injury and youth with moderate to severe brain injury.Given the long-term occupational concerns in youth with persistent post-concussion symptoms, and the lack of evidence based interventions for these youth, it is hypothesized that the CO-OP Approach may facilitate return to meaningful occupation in this population.

Eligibility Criteria:
Inclusion Criteria:

* concussion diagnosed by a physician;
* presence of at least one post-concussion symptom for three months or more; -experiencing challenges with usual daily activities secondary to post-concussive symptoms;
* able to identify four or more occupation-based goals;
* 12-18 years of age;
* no concurrent serious medical or psychiatric diagnoses.
* has a parent who can support participation and participate in a post intervention interview

Exclusion Criteria:

* non English speaking
Cytokine Persistence as a Marker of Inflammation in the at Risk, Low Socioeconomic Status Pediatric Population

The investigators wish to study the role of persistent markers of inflammation in executive function in young children during critical periods of synaptogenesis (ages 2-3). While the role of markers of inflammation have been validated in the pathogenesis in multiple disorders in the adult population, their study in pediatrics is limited. The investigators therefore propose that demonstration of persistent cytokine inflammatory markers in this preliminary study will allow larger studies to proceed.

Obstructive sleep apnea (OSA) is a common multisystem disorder, affecting up to 10% of the pediatric population. There is scant data about OSA and adenotonsillectomy (AT) outcomes in the very young (ages 1-3). Young children with moderate/severe OSA are often underprivileged, low socioeconomic status (SES) minorities with limited access to care. Further complicating the problem is that African American children may suffer a higher preoperative and post-AT burden of disease, with greater negative consequences to these vulnerable children. Up to 75% of children with OSA continue to have sequelae of the disease post-AT. These include poor school performance, delayed speech, inattention, and long term neurocognitive dysfunction. It has been demonstrated that younger patients (below the age of 3) have larger tonsils and stunted growth on presentation for AT. More telling is that younger children face greater morbidity from the procedure, including respiratory complications, postoperative bleeding, and perioperative anoxic/hypoxic injury as validated by multiple studies. A recent study studied watchful waiting versus early AT in two groups of patients aged 5-9 without severe OSA. The findings indicated that early AT improved respiratory and quality of life indices without corresponding improvement in attention or cognitive function as assessed by neuropsychological testing 7 months post intervention. So it leads to the further question of whether children with severe OSA truly benefit from the procedure at all, and whether there maybe a trend towards harm. In this particular scenario, the investigators are hypothesizing that serum based biomarkers in the form of cytokines are of significant diagnostic benefit in demonstrating ongoing inflammation.

Therefore, the surgical stimulus and consequent stress response in the form of centrally mediated cytokines and inflammatory mediators demands study. These has been well analyzed with adult acute and chronic pain, and have been associated with neurocognitive impairment, but have not been studied as a neurocognitive biomarker in the pediatric population. Children from lower SES, with less stable social environments, or other cultural/linguistic barriers are higher risk and urgently require study.

Eligibility Criteria:
Inclusion Criteria: OSA for adenotonsillectomy -

Exclusion Criteria:

-
Decision Making in Neonatology : a Qualitative Study

This study aimed to describe and understand the decision making process in neonatology in situations of limiting of withdraw life sustaining treatments, by conducting interviews with physicians from one neonatology unit.


Eligibility Criteria:
Inclusion Criteria:

* Physicians in charge of new born babies for whom a decision making regarding limiting or withdrawing treatments is emerging.
* physicians' informed consent to participate to an interview
* parents' informed consent to collect data concerning their new born.

Exclusion Criteria:

- Not fluent French speaker
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy

The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability of nusinersen administered intrathecally to participants with infantile-onset SMA.

This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc..

In August 2016, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Be born (gestational age) between 37 and 42 weeks
* Be medically diagnosed with spinal muscular atrophy (SMA)
* Have Survival Motor Neuron2 (SMN2) Copy number = 2
* Body weight equal to or greater than 3rd percentile for age using appropriate country-specific guidelines
* Be able to follow all study procedures
* Reside within approximately 9 hours ground-travel distance from a participating study center, for the duration of the study

Key Exclusion Criteria:

* Hypoxemia (oxygen \[O2\] saturation awake less than 96% or O2 saturation asleep less than 96%, without ventilation support) during screening evaluation
* Clinically significant abnormalities in hematology or clinical chemistry parameters or Electrocardiogram (ECG), as assessed by the Site Investigator, at the Screening visit that would render the participant unsuitable for participation in the study
* Participant's parent or legal guardian is not willing to meet standard of care guidelines (including vaccinations and respiratory syncytial virus prophylaxis if available), nor provide nutritional and respiratory support throughout the study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.