cyrilzakka/clinical-trials huggingface dataset:
Validation of a Simple Approach to Estimate Alveolar Recruitability in ARDS Patients

This study will test the validity of a new approach to assess alveolar recruitability at the bedside in comparison to direct measurements of lung volume and derecruitment.

Background: Acute respiratory distress syndrome (ARDS) is characterized by a major loss of lung volume due to alveolar flooding, atelectasis and consolidation\[1\]. Positive end-expiratory pressure (PEEP) is applied to recruit non-aerated or poorly aerated lung tissue, and thus may improve gas exchange in patients with ARDS\[2\]. However, PEEP may also be harmful by overdistending the previously open lung tissue. The potential effectiveness and benefit of high PEEP levels depends on the patient's recruitability. Previous techniques for assessing recruitability are usually reserved for clinical research (computed tomography, multiple pressure-volume curves)\[3-4\] or need special equipment. A simple, feasible bedside method to assess the individual needs for PEEP in terms of recruitability seem essential to improve the prognosis of this syndrome. The investigators therefore propose a simplified approach derived from our previous study\[5\] to estimate alveolar recruitability at the bedside.

Objectives: The major aim is to test the hypothesis that this simplified approach is a valid method for assessing alveolar derecruitment at the bedside in comparison to direct measurements of lung volume and derecruitment.

Methods: This physiological study will enroll 30 patients from the three Intensive Care Units at St. Michael's Hospital in two years. All patients will be passively ventilated at two PEEP levels (15 cmH2O and 5 cmH2O) and the plateau pressure will be limited to less than 35 cmH2O. Respiratory mechanics, lung volumes (using the nitrogen washout/washin technique), quasi-static Pressure-Volume curves, lung ultrasound, and arterial blood gases will be assessed at each PEEP level. In patients who already have an esophageal catheter in place, Pes will also be measured.

Data Analysis: The primary endpoint is the correlation and bias between the Vder estimated by our approach and the one measured by the multiple P-V curves technique through paired tests, correlations and Bland and Altman analysis

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 16 years of age
* Moderate-to-severe ARDS as per the Berlin definition (Partial pressure of oxygen (PaO2)/Fraction of inspired oxygen (FiO2) \< 200 mmHg) and within 10 days of onset
* Receiving assist/control mechanical ventilation (volume or pressure) with continuous sedation and an established arterial line

Exclusion Criteria:

* Pneumothorax with fistula or likely to require a chest tube
* Severe hemodynamic instability (\> 30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min)
* PaO2/FiO2 \< 80 mmHg
* Severe or very severe Chronic Obstructive Pulmonary Disease according to the GOLD criteria (stage III: Forced expiratory volume at one second (FEV1) 30-50% predicted; stage IV: FEV1 \< 30% predicted)
* Known or highly suspected elevated intracranial pressure (\> 18 mmHg)
Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS )

Obesity is a major risk factor for obstructive sleep apnea (OSA). However, OSA is still largely under diagnosed in patients with a high cardiovascular risk. In this population the STOP-BANG questionnaire facilitates OSA screening. Moreover, blood bicarbonate concentration is a simple tool to screen for chronic respiratory disease and if elevated, is a marker of cardiometabolic comorbidities in obese patients. A combination of blood bicarbonate concentration and STOP BANG score could provide a cost-effective method of screening for OSA in obese patients. Such screening could enable earlier management and might significantly reduce the costs of treatment and improve the quality of life of patients at 2 years.

OSA is a frequent condition in the general population (3% of women and 10% of men), but remains largely undiagnosed. Obesity is a risk factor for OSA. Sleep apnea is associated with diurnal and nocturnal symptoms (snoring, somnolence, fatigue), and with increased cardiometabolic morbidity and mortality. Currently, continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA and the cost-effectiveness of this treatment has already been demonstrated. Easy-to-use procedures to identify OSA patients earlier and thus to initiate treatment earlier, need to be developed and validated. The STOP-BANG questionnaire has been designed to facilitate the screening of OSA patients. Moreover, a measure of blood bicarbonate concentration is a simple method for screening for chronic respiratory diseases and a marker of cardiometabolic comorbidities. A combination of blood bicarbonate measurement and STOP-BANG score could permit earlier screening and less expensive care of obese patients. The hypothesize is that such OSA screening in the obese population (bicarbonates + STOPBANG) associated with earlier care (with treatment if necessary) could lead to improvement in quality of life of obese patients at 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 80 years
* Obese (BMI ≥ 30kg/m²)
* Referred by GPs to the medical analysis laboratory for usual biological assessment
* Patients with no respiratory follow-up already in place
* Patient affiliated with a social protection plan
* Bicarbonate - Concentration ≥ 27 mmol/L
* STOP-BANG score ≥ 3
* Informed written consent signed by the patient

Exclusion Criteria:

* Acute disease or recently diagnosed chronic disease (\< 2 months)
* Hospitalization for respiratory, metabolic or cardiovascular event (\< 2 months)
* Renal insufficiency stage 4 or 5, or autoimmune disease, or viral hepatitis, or cirrhosis
* Cited persons in Sections L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a person who is the subject of a judicial or administrative legal protection)
* Patients already included in an interventional study (end of the study \< 1 month)
Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating children who have relapsed or refractory neuroblastoma.

OBJECTIVES:

* Determine the response rate to rebeccamycin analogue in children with relapsed or refractory neuroblastoma.
* Determine the toxicity of this drug in these patients.
* Identify and establish in vitro biologic correlates of clinical responses and toxicity of this drug in these patients.

OUTLINE: Patients receive rebeccamycin analogue IV over 1 hour once on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: This study will accrue up to 30 patients within 1.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven relapsed or refractory neuroblastoma
* Measurable disease

PATIENT CHARACTERISTICS:

Age:

* Children

Performance status:

* ECOG 0-2

Life expectancy:

* At least 2 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin less than 1.5 mg/dL
* SGOT and SGPT less than 2.5 times upper limit of normal (ULN)
* Adequate liver function unless due to disease

Renal:

* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance at least 60 mL/min
* Adequate renal function unless due to disease

Other:

* No other serious concurrent illness
* No active uncontrolled infection
* Not pregnant
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Recovered from prior immunotherapy
* Prior autologous bone marrow transplantation allowed
* No concurrent immunotherapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy and recovered
* No other concurrent systemic chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Recovered from prior radiotherapy

Surgery:

* Not specified
Core Stabilization Training in Child and Adolescent Underwater Rugby Athletes

Demographic information of children aged 9-17 who volunteer to participate in the study and who play underwater rugby will be recorded, and all participants; respiratory function will be assessed with a portable spirometer (Cosmed Poni FX) device, respiratory muscle strength will be assessed with a portable (micro RPM brand) electronic mouth pressure measurement device, and quality of life will be assessed with the KIDSCREEN scale. Core muscle endurance will be assessed with trunk flexion, trunk extension, lateral plank tests and flat plank test developed by McGill.

Respiratory muscle strength will be measured according to ATS/ERS criteria using a portable electronic mouth pressure measurement device (micro RPM brand). Respiratory function test will be performed using a portable spirometer (Cosmed Pony FX) to assess respiratory function. Capillary blood oxygen saturation of children will be recorded according to pulse oximetry results. Blood pressure will be measured with a cuff of appropriate size after a 5-minute rest according to age, gender and height percentile.

The experimental group will receive core stabilization training in addition to the training process. This training; Exercise training will be provided for 6 weeks, 3 days a week, 2 sets of 10 repetitions for the first two weeks, 2 sets of 15 repetitions for the second two weeks, and 3 sets of 12 repetitions for the third two weeks (Rahmat, et al., 2014). MIP/MEP values will be evaluated once a week. The control group will be monitored during the training and no training program will be given. The exercise program will be applied at the end of the project by being included in the follow-up list. The children will be taken to the second evaluation 6 weeks after the first evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Doing underwater rugby.
* No mental problems.
* Able to cooperate.

Exclusion Criteria:

* Diagnosed with respiratory system disease.
* Kyphoscoliosis and/or advanced postural alignment problems that will affect respiratory function.
* Any orthopedic and neurological problems.
Smartphone Addiction and Physical Activity

This study aimed to determine the effect of smartphone addiction on physical activity level in healthy individuals. A total of 300 (134 female) healthy university students were included in this study. The mean age of the subjects was 21.36 ± 2.33 year.

This study aimed to determine the effect of smartphone addiction on physical activity level in healthy individuals. A total of 300 (134 female) healthy university students were included in this study. The mean age of the subjects was 21.36 ± 2.33 year. The universe of the study consisted of volunteer students (Coaching Education, Physical Education and Sports Teaching, Sports Management, Recreation Departments) at the Faculty of Sport Sciences. Participants' demographic information was obtained and their physical activity levels were questioned with International Physical Activity Questionnaires (IPAQ) and smartphone addictions with the Smartphone Addiction Scale- Short Verison (SAS-SV).

Eligibility Criteria:
Inclusion Criteria:

* to be 18-35 old years

Exclusion Criteria:

* not to be sports science students
Effects of Aerobic Exercise on Basic Metabolic Panel Perceived Exertion and Exercise Adherence in Elderly

Participants were randomly assigned to two groups prior to their second visit:

the High intensity interval training group A (HIIT) and Low intensity interval training group B (LIIT).

The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined.

Group A will receive a program of high intensity interval training program Group B will receive a program of Low intensity interval training program


Eligibility Criteria:
Inclusion Criteria:

* could stand and walk for 30m without becoming out of breath.
* could walk safely without the aid of another person.
* body mass index (BMI) ≥ 30 kg/m2

Exclusion Criteria:

* uncontrolled preexisting health conditions such as:
* uncontrolled hypertension
* uncontrolled diabetes
* uncontrolled heart disease
Which Physical Activity Influences Achilles Tendon Blood Flow the Most?

Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as to the most solid warming-up of the AT. Therefore, knowledge about activities which increase blood flow in the AT could be useful in the development of a solid warming-up programme for the AT. The aim of this investigation was to define the influence of different kinds of physical activity on the vascularisation of the AT in a healthy asymptomatic population. Subjects performed five activities in randomized order: running, static stretch, dynamic stretch, cycling and rope skipping. The vascularisation of the AT of the dominant limb was measured with the non-invasive oxygen-to-see (O2C) device. Blood flow was measured before, immediately after, five and ten minutes after activity to investigate the duration of the vascular response to activity.


Eligibility Criteria:
Inclusion Criteria:

* no history of Achilles tendon complaints
* healthy and active adolescents

Exclusion Criteria:

* history of Achilles tendon pain or current complaints
* not healthy or not active population
* children
Efficacy of Re-challenge With Immune-Checkpoints Inhibitors in Advanced Non-Small-Cell Lung Cancer Patients: a Retrospective Observational Study

This is a multicentre, retrospective, national observational study aiming to describe clinical outcomes of advanced NSCLC patients that performed an ICP re-challenge during their history of disease. The objective of this study is to evaluate the ICP re-challenge efficacy.

Immune checkpoint inhibitors (ICP), including nivolumab, pembrolizumab and atezolizumab, are currently approved by EMA (European Medicines Agency) and ANSM (National Agency for the Safety of Medicines and Health Products) for the treatment of advanced Non-Small-Cell Lung Cancer (NSCLC) in first or second line with different strategies according to the expression of PD-L1. Moreover, durvalumab recently entered the treatment strategy for locally advanced disease in PD-L1 expressing (\>1%) patients. Median progression-free survival (PFS) for patients with advanced NSCLC is approximately 3 to 4 months with this kind of drugs and chemotherapy is currently the reference treatment after progression. However, the scientific community is now evaluating the re-challenge strategy. Notably, in patients with metastatic melanoma, different trials have shown the efficacy and the good safety of re-challenge with ipilimumab or a combination of nivolumab and ipilimumab after an initial period of disease control with ipilimumab.

To date, no studies have reported the clinical benefit of ICP re-challenge in patients with advanced NSCLC. The effectiveness and tolerance of the re-challenge strategy with the same or another ICP remains therefore a major issue.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NSCLC
* Advanced disease (stage III-IV) according to the TNM 7th /8th edition classification at the beginning of first ICP
* Patients must have received at least two lines of ICP during their history of disease
* Patients with EGFR mutation and/or ALK translocation must have received all specific target agents regularly reimbursed (during the reporting period) prior to the first PCI

Exclusion Criteria:

• Opposition form signed by the living patient or opposition clearly indicated in the deceased patient's medical records
Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)

Generally, patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Regular physical activity improves emotional well-being, increases immunological response, improves wound healing, lessens fatigue and improves general functionality and quality of life.

This study will determine effectiveness of the 12-week exercise intervention program, determine if physically active patients differ in quality of life, depression and fatigue during the course of the study, and determine if the change in physical activity levels is related to changes in immune responses.

The general hypothesis of this research is that patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Increasing and sustaining physical activity of these patients will improve their emotional well-beings, increase their immunological response, improve wound healing, lessen fatigue and improve their general functionality and quality of life.

The purposes of this study are to: (1) determine the effectiveness of the 12-week exercise intervention program in increasing physical activity in head and neck cancer patients; (2) determine if physically active patients differ in quality of life, depression and fatigue during the course of the study; and (3) determine if the change in physical activity levels is related to changes in the immune responses in human.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 19 years of age or above (Nebraska legal age).
2. Patients diagnosed with HNC who are seen at the University of Nebraska Medical Center.
3. Patients who have undergone chemotherapy, radiation and/or surgery for their cancer.
4. Patients who have completed their cancer treatment at least 3 months prior.
5. Patients who have consented to participate in this study with approval by their physicians.
6. Patients who have no significant mental impairment.

Exclusion Criteria:

1. Patients who are on enteral feeding.
2. Patients who are not able to walk or whose surgeons report that walking is not advisable.
3. Patients diagnosed with Lymphoma, Thyroid cancer or Melanoma.
4. Patients who are on antidepressant medications.
5. Patients who are unwilling to return to the clinic at the end of the study - after 12 weeks of intervention.
6. Patients participating in another research study involving a therapeutic intervention.
7. Patients with chronic medical and orthopedic conditions that would preclude physical activity (e.g., congestive heart failure, recent knee or hip replacements).
8. Patients who are at 18 months or more after the start of cancer treatment.
PErsonalized TReatment for Endometrial Carcinoma

The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare:

* Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas.
* Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup.
* Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.

Endometrial carcinomas can be classified into four molecular subgroups, i.e. mismatch repair deficient (MMR-D), p53 abnormal (p53 abn), polymerase-ϵ (POLE) ultramutated, and "no specific molecular profile" (NSMP). Molecular subgroups can be considered to be distinct diseases as they are associated with different clinicopathologic characteristics, prognoses and, possibly, responses to adjuvant therapy. Molecular classification of endometrial carcinoma is recommended to be implemented in routine clinical practice to improve prognostication and triage to adjuvant therapy. The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial, led by the Finnish Gynecologic Oncology Group (FINGOG), is a multicenter prospective clinical trial for women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. The efficacy of chemotherapy vs. chemoradiotherapy is compared in p53 abn subtype and nonendometrioid carcinomas, and vaginal brachytherapy vs. whole pelvic radiotherapy in MMR-D and NSMP molecular subgroups. Patients who consent to follow-up within the trial but not to randomization are treated as recommended in multidisciplinary meetings and enrolled for follow-up only (comprehensive cohort study design). The primary outcome is the 5-year cumulative incidence of disease recurrence. Secondary outcomes are vaginal, pelvic, and distant recurrence rates, 5-year recurrence-free and overall survival, adverse events, and patient-reported symptoms and quality of life. The findings of the trial may eventually help decrease under- and overtreatment and, consequently, improve patient outcome and decrease treatment-associated adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 100 years
* WHO performance status 0 to 2
* Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma

Exclusion Criteria:

* Age \<18 years or \>100 years
* WHO performance status \>2
* Uterine sarcoma
* A history of malignancy within 5 years
* Previous pelvic radiotherapy
* An interval of \>30 days between surgery and start of chemotherapy or \>8 weeks between surgery and start of radiotherapy (longer intervals may be permitted with investigator´s approval)
The Effectiveness of Car Seat Checks at Routine Pediatric Visits

The purpose of this research is to evaluate the effectiveness of checking car seats during pediatric well-child visits on the use and properness of use of car seats for children 0-8 years. We are following up with families when they return for the next pediatric check up to see if they are appropriately using car seats for their children.

The purpose of this investigation is to evaluate the effectiveness of a car seat inspection at the time of a pediatric visit on the proper use of car seats 4-6 months later.

Motor vehicle-related injury is the leading cause of death of children. Proper restraint in a motor vehicle reduces the risk of fatality in a crash by approximately 70%. However, multiple studies have found approximately 85% of car seats are misused. Urban poor and minority populations have been found to have higher child passenger death rates, and may have lower car seat usage rates than the rest of the population. Child passenger safety (CPS) technicians trained by the National Highway Traffic Safety Administration (NHTSA) and certified by the American Automobile Association (AAA) capably check proper car seat usage in "check up" events, and operate recently established "fitting stations." However, we are not aware of an attempt to provide the CPS technical services to families attending a routine checkup with their medical provider.

This project will involve implementing and evaluating a program providing car seat checks at the time of routine pediatric visits at the Friend Family Health Center (FFHC). To determine if the car seat checks improve proper car seat use, children who receive the intervention will have their car seat use reassessed at the time of a scheduled return visit to their medical provider. The frequency of routinely scheduled health maintenance visits is greatest for the youngest children. Opportunities to collect follow up car seat use data therefore will be greatest for the youngest children. This evaluation will focus on 0 year olds. While we will also assess the older children and booster seat use, the sample size calculation for this study was determined for these younger children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-8 years
* Child's family has a vehicle

Exclusion Criteria:

* Children over 8 years of age
* Child's family does not have a vehicle