cyrilzakka/clinical-trials huggingface dataset:
Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure

A new artificial lung device has been developed that potentially provides added support to mechanical ventilation for severely damaged lungs. The Hattler Respiratory Assist Catheter is designed to provide gas exchange (deliver oxygen and remove carbon dioxide) for a period of up to 7 days, providing more time for the lungs to improve.

Extrapolating from large animal data, the hypothesis is that the Hattler Catheter will be capable of providing 30% to 40% of the basal requirements of carbon dioxide exchange in a manner that is dependable and reproducible.

The Hattler Catheter Respiratory Assist Device consists of a Catheter and a drive console. The catheter consists of a bundle of polypropylene hollow fibers (approximately 1000) in 30cm or 35cm length surrounding a helium filled balloon. The balloon is similar to an Intra-Aortic Balloon, however, it is pulsed at 300 beats per minute, while IABP typically operate at 120 bpm. The hollow fibers are similar to fibers utilized in external oxygenators for cardio-pulmonary bypass. No device exists on the market in which fibers surround a balloon, and no device exists on the market in which the hollow fiber bundle is designed to be inserted into the venous system, i.e., the vena cava. External oxygenators are designed to be used in an extracorporeal circulatory loop.

The Hattler Catheter drive console provides the power to drive the helium filled balloon while removing excess oxygen and carbon dioxide from the venous system via the catheter.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes, 18 years and older
* Have a terminally ill disease process
* On maximum ventilator support
* Intubated and unconscious
* Swan Ganz in place
* Hypoxic
* Unsuitable for organ donation

Exclusion Criteria:

* Circulatory shock (\< 80 mmHg) and unresponsive to drug therapy and volume replacement
* Pregnancy
* Morbid obesity \> 182 kg
* Weight \< 41 kg
* History of bleeding disorders with contraindication to heparin
* Have a disease process with a contraindication to heparin
* Known internal jugular or femoral vein complications or abnormalities
* Known inferior vena cava (IVC) filter in place
Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial

The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. The intervention includes five in-person sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the HSCT experience. The intervention will be tested against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT settings across the United States. P-SCIP will be provided to both Spanish- and English-speaking parents. Participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of HSCT, two, six and twelve months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. The investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.


Eligibility Criteria:
Inclusion Criteria:

* biological or foster parent of children under 19 years of age who are scheduled for HSCT within the next month
* participant is the primary caregiver
* participant must have phone service
* caregiver speaks, reads, and writes English or Spanish (Spanish is for Childrens Hospital Los Angeles and Columbia University only)

Exclusion Criteria:

* pediatric patient has a diagnosis of medulloblastoma or other cancer of the brain
Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens

This is a Phase II, open-label, single-arm, multicentre, study in China assessing the efficacy and safety of T-DXd in participants with HER2-expressing advanced gastric or GEJ adenocarcinoma who have received at least 2 prior regimens including a fluoropyrimidine agent and a platinum agent


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Pathologically documented gastric or GEJ adenocarcinoma
3. Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease
4. ECOG PS 0-1
5. Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status
6. LVEF ≥ 50%

Exclusion Criteria:

1. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART.
2. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids
3. Active primary immunodeficiency, known HIV, active HBV, HCV infection.
4. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
5. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
6. Lung-specific intercurrent clinically significant severe illnesses.
ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis

This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.

Exclusion Criteria:

* Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis.
* Systemic or topical treatments for psoriasis other than emollients. Ongoing bacterial, viral or fungal infections.

History or presence of malignancy.

* Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
A Retrospective Cohort Study on Predicting Delayed Graft Function in Liver Transplant Patients with Hepatocellular Carcinoma: a Nomogram and Machine Learning Approaches.

Background: This study aimed to develop a predictive model for delayed graft function (DGF) in liver transplant patients with hepatocellular carcinoma (HCC) based on preoperative biochemical indicators, using both logistic regression and XGBoost machine learning algorithms.

Methods: A retrospective cohort study was conducted, including 131 liver transplant patients from January 2020 to April 2022. Preoperative biochemical markers and hematological parameters were analyzed. Logistic regression and XGBoost models were constructed to predict DGF, and their performance was evaluated using the area under the ROC curve (AUC). Shapley Additive Explanations (SHAP) analysis was employed to interpret the feature contributions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with liver cancer aged between 18 and 75 years.
2. Patients who have received liver transplantation.
3. Complete preoperative and postoperative medical imaging data, clinical records and pathological test reports are available.

Exclusion Criteria:

1. Primary non-hepatocellular carcinoma
2. Recipients were younger than 18 years and older than 75 years
3. Due to incomplete or missing clinical data, this dataset did not meet the criteria for inclusion in the statistical analysis.
4. Serious complications associated with liver transplantation, such as acute transplant rejection or transplant liver failure, occur within 7 days after surgery.
5. Re-surgery within 7 days after surgery due to liver transplant-related complications or other surgical procedures, such as transplant site infection or other major surgery.
Hypotension Prediction Index in Living Donor Liver Transplantation

The Hypotension Prediction Index via the Edwards Hemosphere advanced monitoring system is monitored in living donor liver transplantation recipients. The Hypotension Prediction Index is analyzed to verify the performance in predicting hypotensive events.

Hypotensive events during surgery and anesthesia occur frequently and are associated with complications such as myocardial infarction, acute kidney injury, and increase in mortality. Therefore predicting and preventing hypotension can lead to better outcomes.

The Hypotension Prediction Index is monitored with the Edwards Hemosphere advanced monitoring system in living donor liver transplantation recipients via the radial artery. The monitor is blinded so that the anesthesiologist cannot see the index, and the anesthesiologist manages the blood pressure according to the institution's anesthetic protocol for liver transplantation. After the surgery is done, the Hypotension Prediction Index is analyzed to see how well the index predicted actual hypotension that occured during the liver transplantation surgery. Receiver operating characteristic curves are drawn to show the performance of the Hypotension Prediction Index in liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for living donor liver transplantation aged 20 years and older
* Patients who understand the trial and have given informed consent

Exclusion Criteria:

* Patients with arrhythmia or pacemaker
Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.

The Sleep Apnea Self-Management Program (SASMP) was evaluated by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group attended 4 weekly educational sessions of approximately two hours each. A trained leader facilitated the program from a scripted manual. Key topics covered in this program included: (1) management of OSA symptoms, CPAP side effects, and weight loss; (2) maintaining social contacts and family relationships; and (3) dealing with symptoms of depression and worries about the future.

The primary aim of this study was to examine the effect of the SASMP, compared to Usual Care, on CPAP adherence. It is hypothesized that SASMP participants will have higher levels of CPAP adherence compared to those in the Usual Care group.

A second aim of the study was to examine the effect of the SASMP, compared to Usual Care, on proposed mediating variables derived from social cognitive theory (perceived self-efficacy, outcome expectations). It is hypothesized that SASMP participants would have higher levels of self-efficacy and outcome expectations compared to the Usual Care group.

And the third aim of the study was to measure the short- and long-term effects of the SASMP, compared to Usual Care, on health outcomes (e.g., OSA symptoms and OSA-specific HRQOL). It is hypothesized that improvements in OSA symptoms and OSA-specific HRQOL will be seen both initially and as maintained 6 months and 1 year after the start of the SASMP.

Eligibility Criteria:
Inclusion criteria were:

1. Diagnosis of OSA
2. Prescription for CPAP treatment by a sleep physician
3. Being CPAP naïve (ie, no previous use of CPAP).

Exclusion criteria were:

1. Residence in a geographical area outside of San Diego County
2. Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
3. Significant documented substance/chemical abuse
To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery

This is a study to investigate the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery . This will include enrolment of 400 patient undergoing open heart surgery .


Eligibility Criteria:
Inclusion Criteria:

* adults male and female , aged 45 years old and above
* undergoing open heart surgery that requires hospital stays of more than 5 days

Exclusion Criteria:

* previous diagnosis and treatment of OSA or any sleep related breathing disorder.
* unwilling or physically unavailable for polysomnography before surgery.
* Patient undergoing MAZE procedure .
* Patient with severe COPD
Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer

Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.

Goal:

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with esophageal cancer
* Patients receiving a radiotherapy dose \> 40 Gy

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria
Gastric Ultrasound of Diabetic and Non-Diabetic Patients Following Preoperative Fasting Instructions

This study evaluates the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures.

Any surgical procedure carries an inherent risk of pulmonary aspiration. Food or liquid from the stomach might be forced back up the throat from where it could enter the lungs (aspiration) resulting in serious complications prolonging the hospital stay or in extreme circumstances death.

The risk of this is slightly higher in diabetics when compared to non-diabetics as the emptying of contents from the stomach is slightly delayed. This is why people going for surgery are asked not to eat for a specific time before their surgery. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.

This study aims to evaluate the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures. The investigators also aim to find an association between the type and duration of diabetes mellitus with residual gastric volume. Episodes of intra-operative regurgitation, vomiting or aspiration will also be documented.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective surgery aged 18 to 85 years
* American Society of Anesthesia physical status classification I to III
* Body mass index \< 40 kg/ cm2.

Exclusion Criteria:

* Pregnancy (currently or within the past 3 months)
* Previous surgery of the upper gastrointestinal tract
* Achalasia
MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood

Childhood obesity condition has increased 10 times in the last 40 years, representing one of the most important public health challenges of our century.

The overweight and obesity in children are conditions associated with several determinants, mostly related to dietary habits, physical activity, and environmental behavior.

To counteract childhood obesity, several prevention programs have been promoted, however evidence concerning their efficacy was contrasting, especially among the younger population and in the long term.

Moreover, due to the wide variety of interventions administered it is not clear which specific strategy (or combinations of strategies) was the most effective.

The LIVELY study aims 1) to assess the prevalence and the factors associated to childhood overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood obesity by involving families and recognizing the role of schools as an environment for raising awareness on healthy and sustainable dietary patterns and lifestyle.

LIVELY is a study with a one group pre-test - post-test design (without control). The study will be conducted in the primary schools of the Istituto Luigi Cadorna in Milano (Lombardy Region, Northern Italy). The study population will involve children (6-11 years) belonging to different socioeconomic status and ethnic groups, attending classes of the school whose teachers will accept to participate.

The educational interventions will consist in:

Eligibility Criteria:
Inclusion Criteria:

* children 6-11 years
* children whose parents will provide written consent to participate.

Exclusion Criteria:

* Children who do not have inclusion criteria.
Fecal and Oral Microbiota Between Pancreatic Cancer and Benign/Low-grade Malignant Tumor Patients

Significant gaps exist in understanding the gastrointestinal microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze these microbiota characteristics and explore their potential use in distinguishing malignant pancreatic lesions.

In the past decade, microbiome research has rapidly progressed, revealing the critical roles of fecal and oral microbiota in maintaining internal homeostasis. Studies employing 16S rRNA and metagenomics have highlighted dysbiosis of the fecal and oral microbiota as closely linked to PCA development and progression. However, significant gaps exist in understanding the fecal and oral microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze fecal and oral microbiota characteristics, and to establish classifiers to discriminate PCA from NPCA, providing a reference for early clinical identification of malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a pancreatic tumor detected via imaging with no prior treatment before sample collection
* Patients volunteer to provide oral and fecal samples

Exclusion Criteria:

* Current or previous diagnoses of (a) other malignancies, (b) infectious diseases, (c) oral or gastrointestinal disorders (d) psychiatric or neurodegenerative disorders
* Specific medical procedures or interventions within defined periods, including (a) antibiotic, hormone therapy, or immunosuppressant within the past three months, (b) gastrointestinal reconstructive surgery within the past three months, (c) frequent use of cathartics, antidiarrheals, or therapeutic doses of probiotics within the past month, (d) oral or gastrointestinal examinations within the past three days
Changes of the Peripapillary Retinal Nerve Fiber Layer After Filtration Surgery in Glaucoma Patients

At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma.

The aim of this prospective observational case study is to determine changes of the peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence tomography in patients with glaucoma after surgical reduction of intraocular pressure.

Baseline and postoperative measurement of the peripapillary retinal nerve fiber layer (RNFL) thickness will be performed using the following spectral domain optical coherence tomography (OCT): Cirrus™ HD-OCT (Carl Zeiss Meditec) and Spectralis® Heidelberg-Engineering.

The main outcome measures will be changes in overall and quadrant RNFL thickness with respect to reduction in intraocular pressure (IOP), correlation between RNFL thickness and alteration in visual field and predictive factors of postoperative IOP-reduction and changes of RNFL thickness.

Eligibility Criteria:
Inclusion Criteria:

* primary or secondary open angle glaucoma
* target intraocular pressure under medical treatment was not reached
* progression of visual loss
* best corrected visual acuity of 20/100 or more
* spherical equivalent refraction of -8.0 to +4.0 D
* perimetry: less than 20% false positive answers

Exclusion Criteria:

* primary or secondary angle closure glaucoma
* congenital glaucoma
* normal tension glaucoma
* neovascular glaucoma
Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

Bone density was found to be impaired among lage babies and infants of diabetic mothers as found in small group studies. The assumption is that large weight decreases fetal movements and causes decreased bone mineralization.The aim of the study is to compare 2 study groups - of large infants and infants of diabetic mothers to each other and to controls.


Eligibility Criteria:
Inclusion Criteria:

* Term infants of birth weight 4 kg and above, and
* Infants of diabetic mothers.

Exclusion Criteria:

* Preterms,
* Major congenital malformations,
* Sick babies.
AI Noise Reduction in Phonak Hearing Aids

The purpose of this study is to determine if artificial intelligence- based noise reduction can offer objective improvement in hearing and speech perception for hearing impaired patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hearing impairment not using hearing aids
* Individuals with hearing impairment currently using hearing aids
* Cochlear implant patients with a single-sided implant (using a hearing aid in the opposite ear)