cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.

This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated Necrotizing Enterocolitis. The current literature does not allow an objective comparison between these two methods. A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate determination as to the best treatment. The conclusion that only a randomized clinical trial would answer this question has led to this multi-center effort. The relative infrequency of the disease at any one neonatal center has necessitated enrollment of patients at many centers.

Comparison: Premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks (\<1000 gms and 1000 - 1499 gms) for treatment with either laparotomy or primary peritoneal drainage. Daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway. The primary outcome variable is mortality, i.e. death within 90 days of intervention. The main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight less than 1500 grams
* Gestational age 24 -33 weeks
* Diagnosed with necrotizing enterocolitis based on Bell stage II or greater
* Bowel perforation as evidenced by free intraperitoneal air seen on abdominal radiograph, stool, bile, or pus found at paracentesis or clinical evidence of perforation in the joint opinion of the attending surgeon and neonatologist.

Exclusion Criteria:

* Bilateral Grade IV intraventricular hemorrhage
* Previous abdominal surgery
* Evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)
Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in HLH

This study aimed to investigate the efficacy and safety of venetoclax combined with dexamethasone and etoposide as a salvage therapy for hemophagocytic lymphohistiocytosis.

Hemophagocytic lymphohistiocytosis (HLH) is a rare and aggressive disease with high mortality and poor prognosis. The HLH-94 and HLH-04 regimens are most commonly used, but approximately 30% of the patients remain unresponsive. Currently, there is no unified evidence-based salvage treatment. There is no unified salvage regimen. This study plans to enroll 20 patients with refractory and recurrent hemophagocytic lymphohistiocytosis. Subjects will receive venetoclax combined with dexamethasone and etoposide for 8 weeks.The safety was evaluated once a week, and the efficacy was evaluated once every 2 weeks. Overall response rate will be evaluated at 8 weeks. Patients were followed up every 3 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old, expected survival time more than 3 months;
* met HLH-2004 diagnostic criteria；
* ECOG score 0-2；
* ECG QTcF interval: male ≤450ms, female ≤470ms;
* AST and ALT ≤3.0 ULN, TB ≤1.5×ULN；serum creatinine≤1.5×ULN，or CrCL ≥ 50mL/min；INR、APTT、PT ≤1.5×ULN；
* without pregnancy or lactation, and agree to contraception during and for at least 6 months after the study；
* signed informed consent.

Exclusion Criteria:

* patients with malignancies unrelated to HLH, except for fully recovered non-melanoma skin cancer and carcinoma in situ;
* patients participated in other clinical trials within 4 weeks；
* previously treated with Bcl-2 inhibitors；
* unable to take oral medication；
* history of substance abuse or patients with mental illness；
* severe infection；
* cardiovascular disease，NYHA II-IV；
* allergic to venetoclax or etoposide.
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)

The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram.

Exclusion Criteria:

* Patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.
Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning

The goal of this observational study is to test in patients with resectable rectosigmoid cancers. The main question it aims to answer is establishment of a feasibility model for predicting natural orifice specimen extraction surgery (NOSES) based on machine learning.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with colorectal cancer or large adenoma who are suitable for laparoscopic colorectal surgery;
2. Tumor staging ≤ T3 without invasion of surrounding organs;
3. No abdominal seeding or distant organ metastasis;
4. Clear and complete imaging data (CT, pelvic MRI) that can be processed by a computer;
5. Feasible evaluation and determination for obtaining specimens through the rectal channel during preoperative and intraoperative assessments.

Exclusion Criteria:

1. Contraindications for laparoscopic colorectal surgery;
2. Tumor staging is T4, or there are cancer nodules;
3. Presence of metastasis or distant organ metastasis;
4. Incomplete imaging data;
5. Preoperative intestinal obstruction;
6. Tumor or specimen diameter larger than the transverse diameter of the pelvic outlet;
7. Previous rectal radiotherapy;
8. Unsuitable evaluation and determination for obtaining specimens through the rectal channel during preoperative and intraoperative assessments.
Antiretrovirals and Rate of Progression in Carotid Artery Intima-medial Thickness in HIV

It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis. Several cohorts have shown an increased risk of heart disease in people with HIV. The effect of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this study the investigators will assess the effect on carotid IMT of the initiation of antiretroviral combinations that are known to have a minimal effect on lipids and insulin resistance. We will also assess the changes in several inflammation and cardiovascular markers,as well as endothelial activation markers,and how these changes relate to therapy-induced changes in immunologic, virologic and metabolic markers.


Eligibility Criteria:
Inclusion Criteria for HIV positive group:

* HIV-1 infection
* Age at least 18 years
* Naïve to antiretroviral therapy
* CD4 cell count \> 400 cells/mm3

For controls: Age at least 18 years, no known HIV infection, and no known medical condition requiring chronic use of prescription medications.

Exclusion Criteria (both groups):

* Diabetes
* Pregnant or breastfeeding
* Women of child bearing age who refuse or are unable to use appropriate methods of contraception during the entire study period.
* Active infectious or inflammatory condition
* In jail or involuntarily incarcerated
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support

The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.

The objective of this study is to collect data on vital signs, oxygen requirements and other data in preterm infants who are breathing stably on non-invasive ventilatory support. The data obtained during this study will be used to compare data obtained in a future study that will add a new medicinal product in combination with non-invasive ventilatory support to accelerate lung development in preterm infants.

The study will enroll approximately 40 patients. Participants will not be receiving any investigational medicinal product or device in this study.

All participants will have vital signs, oxygen requirements and other data collected continuously throughout the study.

This multi-centre trial will be conducted in Germany. The overall time to participate in this study is up to 10 weeks. Participants will be observed until they reach 36 weeks of gestational age or until they are discharged from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* 1. Written, informed consent of both parents or legal guardian(s) obtained (on admission, prior to or after delivery).

  2. Preterm neonates born at or above 27+0 gestational weeks (GW) who are sufficiently stable on nasal continuous positive airway pressure (CPAP). Upper limit 36+0 GW.

  3. Participants' minimum weight at birth must be 800 g. Upper weight limit is 2500 g.

  4. CPAP-positive end-expiratory pressure (PEEP) must be ≥5 cm and ≤ 8 cm H2O. 5. Fraction of oxygen (O2) in ventilator outlet gas flow (FiO2) ≥ 30% to reach saturation goal (SpO2 between 88% and 96%) during the time period from B0 to T0.

Exclusion Criteria:

* 1. FiO2 \> 50% to reach saturation goal (saturation of peripheral oxygen (SpO2) between 88% and 96%) during the time period from 30 minutes after birth (B0) to 45 minutes after birth (T0).

  2. Presence of severe respiratory distress syndrome (RDS) necessitating immediate intubation and surfactant rescue at entry into the study, or having necessitated surfactant rescue prior to entry into the study.

  3. Known life-threatening congenital anomaly or genetic syndrome. 4. Participation in an interventional study in parallel to this observational study.
Direct Laryngoscopy During Cervical Trauma

The aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy

Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive "lactose-free" milk (3.5 g of lactose) two times a day for 21 days. Clinical history, nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days. An external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.

Mortality due to chronic liver disease is among the first five causes of mortality related to digestive tract and liver diseases in patients on productive age. One of the most frequent complications of chronic liver insufficiency is minimal hepatic encephalopathy (MHE), which affects the quality of life and predisposes to the development of clinical hepatic encephalopathy. There are few evidences on the therapeutic alternatives for minimal hepatic encephalopathy. The administration of non-absorbable disaccharides has been proven to ameliorate MHE. Lactose maldigestion may justify the use of lactose in patients with chronic liver disease as a non-absorbable disaccharide for the treatment of MHE.

The aim of our study is to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic liver disease of whichever etiology
* Minimal hepatic encephalopathy
* Lactose maldigestion

Exclusion Criteria:

* Patients with clinical manifestations of hepatic encephalopathy
* Recent use of antibiotics or psychotropic drugs
* Recent use of alcohol abuse
* Gastrointestinal bleeding
* Others neurological disorders that affect the psychometric test
* Chronic renal failure
* Congestive heart failure
* Chronic Obstructive Pulmonary Disease
* Severe symptoms of lactose intolerance
Addressing Unintentional Leakage When Using Nasal CPAP - Study B

Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Higher levels of CPAP are associated with higher leak. In the present study, a sequential approach to control excessive unintentional leak will be tested. In study A, the reduction of therapeutic CPAP level will be tested. In study B, oronasal CPAP will be compared to nasal CPAP with a chinstrap.

Study B will consist of a controlled crossover trial to compare unintentional leak during the use of an oronasal mask versus a nasal mask with a chinstrap, among subjects who remain with excessive leak at the end of study A. The order of interventions will be randomized. One of the groups will initially use an oronasal mask for 10 days. A washout period of 7 days under nasal CPAP will follow. After washout, subjects will continue using a nasal mask and will be asked to use a chinstrap for another 10 days. In the other group, the order of interventions will be the opposite.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate and severe obstructive sleep apnea;
* Use of CPAP with a nasal mask;
* 95th percentile of unintentional leak from the last 7 days above 24 l/min, or at least 4 sudden drops of leak over one night of nasal CPAP
* Persistence of excessive leak at the end of Study A.

Exclusion Criteria:

* Patients who experience unintentional leakage from the mask/accessories.
* Diagnostic polysomnography examination with a predominance of central apnea;
* Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD;
* Previous surgery for obstructive sleep apnea;
* Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points).
A Novel Intervention for Training Auditory Attention in Adolescents With Autism Spectrum Disorder

Background: Previous research has shown that individuals with ASD often have difficulties coping with auditory stimuli in the environment. These difficulties can be extremely debilitating, lead to anxiety and disruptive behaviors, and interfere with the ability to process and understand speech.

Research Design: In previous research, the investigators have identified a brain marker associated with poor auditory attention that can provide a direct readout of auditory processing issues. The investigators will develop and test a cognitive/behavioral intervention (a tablet-based game app) that is highly engaging and accessible to a wide range of individuals with ASD. The intervention is designed to train adolescents with ASD to adapt and attend to auditory cues.

Objectives: To evaluate whether the intervention leads to improvement in auditory attention as assessed by behavior changes over the course of training; to investigate the impact of the intervention on behavioral assessment of problems hearing speech in noisy environments, neural processing of sounds, and changes in parent report on responses to sounds that impact that daily lives of the participants; and finally- to determine which adolescents with ASD benefit the most and least from interventions such as this one.

We hypothesize that we can elicit changes in the neural processing of sounds for adolescents with ASD via training in the form of the tablet-based game we are developing. If we are successful, this could lead to other interventions for persons with ASD in the hopes of improving the auditory difficulties they face.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent children and young adults, both males and females;
* Between the ages of 13:0 and 20:11 years of age
* Speak or hear English at home at least 50% of the time
* Meet criteria for a confirmed diagnosis of Autism Spectrum Disorder.

Exclusion Criteria:

* Nonverbal mental age below 18 months
* Insufficient manual dexterity that would prevent working with a tablet or phone-based app
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy

Cerebral palsy is the leading cause of motor disability in children. Children with little or no walking (GMFCS III, IV and V) represent 43% of children with cerebral palsy, the majority of whom present pelvic and spinal deformities in the frontal and sagittal planes. However, sagittal pelvic spinal statics have been little studied, especially in the sitting position, which is the functional position of these children.

Moreover, there are currently no recommendations on how to perform follow-up radiographs of the spine in children who do not walk much.

A better understanding of pelvic and sagittal spinal statics would help prevent deformities and their complications.

Standardizing the method of performing pelvic-spinal radiographs in the sitting position will make monitoring of spinal statics more reliable.


Eligibility Criteria:
Inclusion Criteria:

* Child or adolescent aged 4 to 17 years
* Child or adolescent with cerebral palsy GMFCS III, IV or V
* Child or adolescent whose parents, or the child if possible, have given free, informed and written consent
* Child or adolescent affiliated or beneficiary of a health insurance plan

Exclusion Criteria:

* Child or adolescent with history of spinal surgery
* Child or adolescent with parents unable to give consent
* Child or adolescent participating in a therapeutic research study (RIPH 1 or drug study)
* Child or adolescent in an exclusion period determined by another study
* Child or adolescent under court protection, guardianship or curatorship
* Pregnant, parturient or breastfeeding patient
I USE LR in the ED

To study the difference in mortality and major adverse kidney events during and after treatment in the emergency department with intravenous fluids per standard of care at 30 days before and after the system-wide implementation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) receiving a minimum of 1000ml of intravenous fluids starting in the emergency department per standard of care

Exclusion Criteria:

* Patients aged ≤17 years
* Previously enrolled patients with \>1 ED admission within the 30-day follow-up period
A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults

Heavy alcohol use among young adults is a significant public health problem. Advances in technology may offer an innovative solution. This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting heart rate, and sleep via biosensors and electronic diary methods.

Proposed is a study to conduct the first controlled test of a feedback intervention targeting heart rate variability, resting heart rate, and sleep for heavy-drinking young adults (N=60; ages 18-25) and will leverage the capabilities of a consumer-marketed PPG sensor/mobile app. This study will evaluate the feasibility, acceptability, and preliminary efficacy of this intervention for promoting improvements in drinking, sleep, and health.

Eligibility Criteria:
Inclusion Criteria:

* 18-25 years of age
* Report ≥ 4 heavy drinking occasions in the past 28 days
* Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm
* English Speaking
* Have a personal smartphone

Exclusion Criteria:

* Sleep Disorder History
* Night/ Rotating work shift
* Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation
* Clinically severe AUD in past 12 months
* Currently enrolled in alcohol or sleep treatment
* Current, severe psychiatric illness
* Current DSM-V substance use disorder
* Positive urine drug screen for a substance other than marijuana
Ex Vivo Exploratory Analysis in Healthy Full-term Infants

* Exploratory analyses of the immune response in a ex vivo culture system
* Characterization of the composition of maternal milk and infant urine


Eligibility Criteria:
Inclusion Criteria

* Infant or infant-mother pair in good health
* Infant or infant-mother pair is from smoke-free home
* Infant is a singleton, full term
* birth weight was \> 2490 g
* Between 0 and 17 days of age at enrollment
* Human milk fed infants must have been exclusively human milk-fed since birth; formula fed infants must have received Similac Advance or Similac Sensitive since birth
* Parents confirm their intention not to administer vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D), solid foods or juices to their infant from enrollment throughout the study

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history, including gestational diabetes that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant has been treated with antibiotics
* Participation in another study -
Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP)

Breath samples from patients with Ventilator Acquired Pneumonia (VAP) will be analyzed to identify Volatile Organic Compounds (VOC) that have been specifically associated with VAP in previous animal models.

Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System in the early detection of VOC's associated with VAP.

On clinical suspicion of VAP, breath samples will be collected from the expiratory limb of the patient's ventilator tubing circuit. A sterile Tedlar collection bag will be used to connect to the sample port and collect the breath sample. The expiratory limb sample port will be utilized to ensure maintenance of the integrity of the ventilator circuitry. The breath samples will be analyzed via the ZNose breath analysis system.

Immediately following collection of breath samples, bronchoalveolar lavage fluid (BALF) will be collected and subjected to bacteriology testing for confirmation of VAP-positive and VAP-negative patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 48 hours of ventilation with suspected VAP infection. Suspicion of VAP infection based on clinical evaluation criteria:

  1. Three or more positive out of the following:

     1. Tympanic temperature \> 38 °C or \< 35.5 °C
     2. Blood leukocytosis (10,000/µl)
     3. More than ten leukocytes in Gram stain of tracheal aspirate (in high-flow field)
     4. Positive culture of tracheal aspirate
  2. New, persistent, or progressive infiltrate on chest radiograph

Exclusion Criteria:

Patients with pre-existing structural lung disease (COPD, asthma, lung cancer, etc.), thrombocytopenia (\< 40,000/µL) and other coagulation abnormalities.