cyrilzakka/clinical-trials huggingface dataset:
Predictive Utility of DASIMAR as a Prognostic Biomarker in Acute-on-chronic Liver Failure (ACLF)

Patients with acute on chronic liver failure have a risk of developing multiorgan failure and a high mortality. The current scoring systems defining the outcome of patients with acute decompensation of cirrhosis fail to identify patients that progress to Acute-on-chronic liver failure (ACLF).

The aim of the study is to evaluate if one can identify these patients early on with the proposed biomarkers: dimethylarginines and ischemia modified albumin.

Patients with acute-on-chronic liver failure (ACLF) are at risk of multiorgan failure and high mortality. Recent data suggest that patients with decompensated liver cirrhosis have higher ADMA (asymmetrical dimethylarginine) levels compared to compensated cirrhosis and plasma ADMA levels correlate with severity of liver dysfunction and inflammation. There is also an increase in symmetric dimethylarginine (SDMA), a stereo-isomer of ADMA, which is largely excreted by the kidney. Plasma SDMA levels have been shown to be associated with patients

progressing to renal failure. In a pilot study by our group involving 52 patients with acute decompensation of chronic liver disease, we showed an increase in the summed product of ADMA and SDMA, which we termed dimethylarginine score ('DAS'): This was shown to have a good predictive utility for outcome in this small group of patients (AUROC=0.89).

Furthermore, we and others have shown that albumin of patients with advanced liver disease has widespread abnormalities. The amount of albumin that is found to have reduced metal binding capacity as a consequence of oxidative damage is termed Ischemia Modified Albumin (IMA).

Our data shows that patients with ACLF who die have a significantly increased IMA/serum albumin ratio (IMAR). The summation of these two pathologically relevant biomarkers (DAS+IMAR) we termed DASIMAR and found this score to have a better predictive utility than DAS alone (AUROC:0.91).

Primary objective : To identify the patients early on that progress to ACLF which would facilitate a goal directed therapeutic approach.

Secondary objective : Generation of this dataset will further define and enable prognostication of ACLF. If this study reveals a role for these biomarkers in patients with ACLF, commercial development of simple kits may be possible.

Eligibility Criteria:
Inclusion Criteria:

* All patients with an acute clinical decompensation of presumed cirrhosis (elevated bilirubin \>85 µmol/L, or/and increasing ascites or/and hepatic encephalopathy \< grade 2) related to a clear precipitating event (e.g. infection, bleeding, alcoholic hepatitis, exposure to hepatotoxin)

Exclusion Criteria:

* Admission for reasons other than decompensation of cirrhosis (other co-morbid diseases, especially established cardiovascular or renal disease (U/S).
* Malignancy (extra-hepatic or a hepatocellular carcinoma).
* Patients who have undergone major surgery or have unsolved surgical problems.
* Pregnancy
Intra Articular Botox Injection in Treatment of Osteoarthritis

Compared the short and long term effects sonography guided of intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided

Compared the short and long term effects of sonography guided intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis

Exclusion Criteria:

* coagulopathy Organ failure
An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants

The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.

The primary objective is to determine the burden of RSV disease in outpatient settings among 32 to 35 wGA infants in the USA who did not receive RSV prophylaxis, as measured by rate of RSV-associated outpatient lower respiratory tract illness (LRI) during the infants' first RSV season.

Eligibility Criteria:
Inclusion Criteria:

* Premature at birth (from 32 weeks and 0 days to 35 weeks and 6 days GA)
* Age 6 months or less at the time of screening, and born in May 2009 through January 2010 for Season 1, or May 2010 through February 2011 for Season 2
* Written informed consent and any locally required authorization (eg, HIPAA), obtained from the subject's parent/or guardian prior to performing any protocol-related procedures.

Exclusion Criteria:

* Receipt of any RSV prophylactic agent: at any time prior to study participation
* Participation in studies of investigational RSV prophylaxis or RSV therapeutic agents
* Presence of bronchopulmonary dysplasia,hemodynamically significant congenital heart disease, congenital neuromuscular or congenital airway defects
* Any condition that, in the opinion of the investigator, would limit life expectancy to less than 6 months
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis

The hypothesis of this study is that moderate scoliosis patients have postural and kinematic differences (static and dynamic) compared with healthy volunteers and it is possible to characterize and quantify.

The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis patients compared with healthy volunteers

Subjects participating in the study must wear sensors that will be arrange at the shoulders, spine, pelvis and legs. Subjects will perform under the direction of the investigator, different tasks of a total duration of 45 minutes.

During the period of experimentation, the data collected will be:

* the positions of each one of the sensors in all three planes of space,
* the ground support forces

Eligibility Criteria:
Scoliosis Group - Inclusion Criteria:

* female children patients from 9 to 16 years old,
* patients with idiopathic scoliosis lumbar left and / or right thoracic,
* patients with moderate scoliosis: Cobb angle measured on a radiograph between 10 ° and 25°,
* both parents of patients must be affiliated to social security or similarly regime.

Healthy Volunteers Group - Inclusion Criteria:

* female children from 9 to 16 years old, matched in age and size with scoliosis patients,
* children with no neuromuscular disease that may have an influence on the required tasks,
* both parents of children must be affiliated to social security or similarly regime,

Exclusion Criteria:

* refusal to consent: from child's in age to consent or from both parents
Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

The investigators will assess Li-induced gray matter volume changes with regard to the endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of Li, which were closely related to the inhibition of apoptotic activity of GSK3beta.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women aged between 19 and 55
* Diagnosis of bipolar I disorder as assessed by the structured clinical interview for DSM-IV (SCID-IV)
* Patients who have not used psychoactive medications for more than 2 weeks
* Individuals who provided written consent for participation

Exclusion Criteria:

* Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
* Women who are pregnant, breastfeeding, or planning pregnancy
* Diagnosis of any Axis I disorder other than bipolar disorder
* Intelligence quotient below 80
* Current or past drug abuse
* Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation

The aim of the project is to experimentally compare the fingers of the hand in terms of measured concentrations of peripheral blood oxygen saturation (SpO2) in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

The finger sensors of pulse oximeters are most often placed on the middle two fingers of the hand. Although there have been many studies looking at the accuracy of different pulse oximeters or comparing fingers in terms of SpO2. There is no study comparing fingers in terms of SpO2 under hypoxic condition with simultaneous randomization of finger probe placement. At the same time, there is no study that compares SpO2 changes between fingers during a step change in blood oxygen saturation. The data obtained could help to improve the reliability of monitoring physiological parameters with pulse oximeters.

Eligibility Criteria:
Inclusion Criteria:

* Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure and blood oxygen saturation

Exclusion Criteria:

* post-traumatic conditions of the upper limbs affecting the perfusion of the fingers or injuries or skin diseases on the fingers.
* pneumothorax or a condition after cardiovascular surgery.
* anemia, bradycardia, hemoglobinopathy or other diseases of the cardiovascular system, pregnancy, diabetes, hypotension or hypertension.
Correlation Study of Family Communication Disorders and Negative Network Use Behavior Among Adolescents

The entry point of this project is the social background of the post-epidemic era, with teenagers and parents as the research object, aims to explore the relationship between family communication disorders and adolescent negative network use behavior in the post-epidemic era. This project intends to investigate whether there are family communication disorders and negative Internet use behaviors among 14-25 year old teenagers by issuing questionnaires (sample size: 140). In order to conclude whether there is some connection between family communication disorder and adolescent negative network use behavior.

This research project takes the "post-epidemic era" as the background entry point, and explores the relationship between teenagers' negative Internet use behavior and family communication by using questionnaires. Through literature review, it is obtained that family communication disorders may be related to adolescents' emotional changes with their parents, limited peer interaction, and changes in the structure of their lives. In order to avoid the negative feelings brought by family communication barriers, adolescents tend to turn to other areas such as virtual networks to compensate and regain happiness, which can easily lead to negative Internet use behaviors if they are not careful. By studying the "loss of compensation" model proposed by Chinese scholar Gao Wenbin, the application of the "loss of compensation" model to family communication disorders and adolescents' negative Internet use behavior is derived. In this context, if we can study the correlation between family communication barriers and adolescents' negative Internet use behaviors, it will be beneficial to ease the parent-child relationship, correct adolescents' negative Internet use behaviors, and promote the healthy growth of adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 14-25 (including 14,25 years old) and their parents;
* Agree to participate in the studies

Exclusion Criteria:

* Persons of interest with a history of prior psychiatric illness, who are suffering from a serious acute illness, are unconscious, emotionally unstable, and unable to communicate normally
Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

Eligible patients who agree to participate will migrate from oral opioids to transdermal patches and be followed for four weeks. Oral morphine will be provided as pain rescue medication. The patients will inform the adverse events and rescue medication consumption. The number of Fentanest® patches will be adjusted every visit aiming to reduce the rescue medication consumption and adverse events to a minimum. The WHO-QOL- bref (quality of life questionary) will be filled before and after the use of Fentanest®. Patients showing benefit are eligible to a 3 weeks compassionate study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged from 18 to 70 years with cancer chronic pain who received in the last 4 weeks at least 40 mg of oral morphine or equianalgesic dose of other opioids. If using adjuvant analgesics, these must be in stable doses in the last 4 weeks.

Exclusion Criteria:

* Life expectancy bellow 4 months;
* Karnofsky score \< 60;
* Hypersensitivity to opioids or patches;
* Acute pain;
* Non cancer pain;
* Increased intracranial pressure;
* Conditions that prevent the patient to understand the study directions and/or give his consent;
* Neuromuscular disorders with increased risk of respiratory depression;
* Impossibility to receive rescue oral morphine; active infections;
* Fever;
* Pregnancy and nursing;
* Uncontrolled diabetes mellitus or arterial hypertension;
* Need of anticoagulation;
* Need to operate machines or vehicles;
* Important skin disorders;
* History of severe allergic reactions;
* BMI ≥ 35;
* Safety exams outrange;
* Participation in another clinical trial within the last 2 months;
* Investigator´s opinion.
REFLECT: Reproductive Education and Fertility Links for Cancer Treatment

The purpose of this study is to evaluate a web-based education tool geared at helping Adolescent and Young Adult (AYA) patients better understand fertility and genetic risks for cancer in future offspring.


Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18-39
* Must have received Cancer care at Moffitt Cancer Center
* Participants must consider having a child in the future or have had children at the time of diagnosis
* Participants must be able to speak and read English
* Participants must have access to a device that can connect to the internet

Exclusion Criteria:

* Any participants who do not meet all Inclusion Criteria
AcuTA: Acupuncture in Test Anxiety

Test anxiety is a well-known phenomenon in general population, but only few scientific advances have been made in order to fully understand and prevent this circumstance.

The number of students which use neuro enhancement to improve their performance and to prevent test anxiety, is increasing. A US-survey estimated that almost 7% of students in US universities have used prescription stimulants against anxiety, and that on some campuses, up to 25% of students had used them in the past year.

Acupuncture might act as an alternate. Several trials could demonstrate, that different forms of acupuncture could relieve symptoms of pre-exam anxiety syndrome significantly and that this therapy was highly safe. In special, the investigation of single point effects in test anxiety could be of general interest. The acupuncture point with the most convincing evidence up to date is Heart 7. Yet, its effectiveness has mainly been chosen in combination with other acupuncture points and not as single remedy in test anxiety. Therefore we establish a trial investigating the immediate needling effects at Heart 7 on the reduction of test anxiety.

Therefore qe implemented a validated stress test, the Trier Social Stress Test TSST, which is known to provoke serious stress responses in healthy subjects. 24 medical students with test anxiety in there history will be randomised to two interventional groups (verum acupuncture and laser acupuncture), being treated and then pass this test. Main outcome is the increase of cortisol in saliva, which is the standardized measure of stress response used in this paradigm.


Eligibility Criteria:
Inclusion Criteria:

* Test Anxiety in the clinical history
* Male medical students 3rd to 5th year
* Compliance
* Age \> 18 years
* Smoking cessation for 24 hours

Exclusion Criteria:

* Severe physical or psychical illness
* Psychiatric record in medical history
* Continuous uptake of antipsychiatric medication, tranquilizers or neuro-enhancers
* Acupuncture treatment within the last 4 weeks
* Hang-over
* Drug consumption
* Smoking (\> 5 cigarettes/ day)
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines

This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe Crow's Feet Lines
* Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any serotype
* Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
* Oral retinoid therapy within 1 year
* Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome

It is observed that replacing meat with protein-rich plant-based food products are associated with lower mortality and obesity prevention. Sources of plant proteins typically undergo several processing and refinement procedures to improve the taste and digestibility of plant-based food products. These procedures alter the chemical composition, which can impact the nutritional quality of the processed food. It is not known what is the impact of processed products on human metabolism and intestinal microbiota. Therefore, the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention

Plant-based diets are known to have beneficial effects on both the environment and human health. Replacing animal protein with plant protein reduces overall mortality risk, and replacing meat with legumes and other sources of plant protein can lower the risk of chronic diseases such as type 2 diabetes and cardiovascular disease. However, the benefits of plant protein products is not evident. In order to make plant protein products more palatable and digestible, plant raw materials may go through several processing and refinement procedures. Typically, during these phases, carbohydrate fractions (e.g. dietary fiber) are removed from the plant material, which results in the loss of micronutrients as well as secondary plant metabolites with potentially health effects (e.g. polyphenolic compounds). Salt and various fats are added to some products, which can reduce the nutritional quality of the product. Subsequently, not all plant-based protein-rich foods are automatically healthy as there may be significant differences in the nutritional quality of the processed products, depending on the food processing utilized. Only little research information is available on the effects of processed plant protein products on human metabolism and intestinal microbiota. Therefore, this cross-over clinical intervention will be conducted with 38 healthy participants to investigate the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate
* 18-65-years olf
* BMI 18.5-27 kg/m2

Exclusion Criteria:

* Chronic disease with continuous medication
* Antibiotic use in the past 6 months
* Active smoker
* Gluten-free or vegan diet
* Pregnancy, lactation
* Abnormal thyroid, liver, or kidney function
* Low hemoglobin
Providing Oxygen During Intubation in the NICU Trial

Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.


Eligibility Criteria:
Inclusion Criteria:

1. Infants ≥28 weeks corrected gestational age
2. Undergoing intubation in the NICU
3. Pre-medication (including paralytic) administered

Exclusion Criteria:

1. Critical Airway or Airway Anomaly
2. Unstable hemodynamics (i.e. active resuscitation)
3. Unable to achieve SpO2 ≥90% prior to intubation attempt
4. Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
5. Unrepaired congenital diagrammatic hernia
6. Tracheal esophageal fistula within 2 weeks of repair
7. Tracheostomy
8. Previous enrollment in the trial
9. Nasal intubation
10. COVID person under investigation (PUI) or COVID positive
11. Cyanotic heart disease
12. Receiving Extracorporeal Membrane Oxygenation support
13. Conjoined twins