cyrilzakka/clinical-trials huggingface dataset:
Thoracic Fluid Content by Bioimpedance-based Starling System

The Starling system is a completely non-invasive hemodynamic monitoring technique. It is able to measure the thoracic fluid content (TFC). The TFC is supposed to reflect the total content of fluid in the thorax. Thus, TFC may include two of the variables that are commonly used for hemodynamic monitoring: the extravascular lung water (EVLW), and the global end-diastolic volume (GEDV). However, whether the TFC actually reflects GEDV and EVLW has not been clearly established. The objective of the study is to establish the determinants of TFC among hemodynamic variables including EVLW and GEDV.

The Starling system is a completely non-invasive hemodynamic monitoring technique. It measures cardiac output through bioreactance. It also measures the mean transthoracic electric impedance (Z0) from which the thoracic fluid content (TFC) can be derived. The TFC is the only other variable that is provided by the system besides cardiac output and that is not inferred from it. The TFC is supposed to reflect the total content of fluid in the thorax and may include two of the variables that are commonly used for hemodynamic monitoring: the extravascular lung water (EVLW), which is the volume of lung edema, and the global end-diastolic volume (GEDV), which is a static index of cardiac preload. Cardiac preload is an important physiological variable; a prerequisite for TFC as a reflect cardiac preload would be that its changes are tightly linked to the changes in well-established markers of cardiac preload, as the GEDV measured by transpulmonary thermodilution, or the central venous pressure (CVP). Nevertheless, this has never been demonstrated. In addition, TFC includes the volume of EVLW, which is the volume of fluid contend in the lungs outside the pulmonary vessels. Nevertheless, the degree to which TFC is influenced by absolute values and changes in EVLW has never been established. The objective of the study is to establish the determinants of TFC among well-known hemodynamic variables including EVLW and GEDV, as well the value of TFC as a marker of cardiac preload and lung water.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 y.o.
* Hospitalization in an ICU
* Monitoring by transpulmonary thermodilution already in place
* Decision by clinicians in charge to perform volume expansion by saline or fluid removal by diuretics infusion and/or ultrafiltration ("Fluid" group)
* Or presence of Acute Respiratory Distress Syndrome according to the Berlin definition ("ARDS" group)

Exclusion Criteria:

* Refusal to join the study
* In "Fluid" group, circulatory failure whose treatment cannot be postponed for ≥5 minutes (time required for the installation of Starling system).
* Impossibility to paste bioreactance electrodes properly in the skin of the thorax.
A Psycho-educational Intervention for Symptom Cluster Management

The purpose of this study is to develop, implement and undertake a preliminary evaluation of a psychoeducational intervention for managing a cancer-related symptom cluster including pain, fatigue and sleep disturbance experienced by Vietnamese cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Are diagnosed with any type of cancer
* Are over 18 years of age
* Have finished the second chemotherapy cycle
* Expected prognosis of at least 12 months
* Karnofsky level of ≥ 60/100.
* Report three symptoms: fatigue, pain and sleep disturbance at severity level of equal or above 3 during the past 7 days.
* Ability to communicate in Vietnamese

Exclusion Criteria:

* Inability to complete questionnaires or participate in the intervention due to literacy level or communication impairment.
* Have been diagnosed with major psychiatric morbidity such as suicidal tendencies or schizophrenia.

Involved in other clinical trials
Exploring Brain Molecular Imaging and Blood Biomarkers in Subjects With Glucocerebrosidase Mutations: Toward a Precision Medicine Approach to Characterize Parkinson's Disease Clinical Trajectories

Glucocerebrosidase (GBA) mutations are the most common risk factor for Parkinson's Disease (PD). GBA-related PD(GBA-PD) exhibits a more malignant phenotype as compared to no-carriers. Still, the mechanisms behind the increased malignancy in GBA-PD are not well understood. The definition of biomarkers able to stratify PD clinical trajectories in PD is therefore crucial to identify effective treatments and support diagnosis.The investigators will examine the role of GBA-mutations in accelerating a-synuclein (a-syn) and synaptic pathologies in PD by combining neuroimaging (positron emission tomography-PET), biochemical and clinical features. This will illuminate the pathophysiology underlying GBA-mutations in PD and identify biomarkers for the malignant PD phenotype. Also, the investigators will combine longitudinal clinical and imaging/biochemical features to define a prognostic algorithm for predicting disease faster progression in GBA-PD and monitoring disease trajectories in unaffected GBA carriers.


Eligibility Criteria:
Inclusion Criteria:

* PD diagnosis according to MDS-PD criteria and for GBA-PD group, presence of heterozygous GBA mutations;
* disease duration 3-7years.

Exclusion Criteria:

* other neurological or systemic diseases;
* presence of mutations in another PD gene;
* impossibility or unwillingness to perform FDG-PET.
Comparing Different Montages of tDCS Combined With Dual-task Training on EEG Microstates

This study investigates whether electroencephalographic (EEG) measures of functional connectivity of the target network are associated with the response to different sets of transcranial direct current stimulation combined with dual-task training in post-stroke patients.

The present study seeks to compare the effects of conventional anodic tDCS (M1) with double-site/dual-site anodic tDCS (M1 + DLPFC) and simulated tDCS on functional connectivity, as assessed by EEG, in patients after staged stroke. chronic. The study is a randomized, double-blind, placebo-controlled, crossover clinical trial. Participants will be submitted to three sessions, each session consisting of a different condition, namely: anodic tDCS - participants who will receive real current over the primary motor area; Dualsite tDCS - participants who will receive real current over the primary motor area and over the dorsolateral prefrontal area (DLPFC) and simulated tDCS - participants who will receive simulated stimulation. Participants will receive 3 tDCS sessions, lasting 20 minutes, associated with a physical therapy protocol based on dual motor and cognitive tasks, on alternate days (3 times a week). On each intervention day, pre and post-intervention assessments will be carried out, the evaluated outcomes will be: functional connectivity (EEG), functional mobility (Timed Up and Go) and executive functions (Trail-making Test A and B, the Clock Drawing Test and Phonemic Verbal Fluency Test). Statistical performance will be performed using SPSS software (Version 20.0) and MATLAB 9.20 with a significance level of p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Post-stroke participants for more than 6 months
* Individuals over 18 years of age;
* Both sexes;
* Patients with mild to moderate degree of injury severity (NIHHS \<17 points)

Exclusion Criteria:

* Patients with other associated pathologies that can influence motor activity (example: traumatic brain injury, brain tumor);
* Habitual use of drugs or alcohol;
* Use of drugs that modulate the activity of the Central Nervous System;
* Gestation;
* Use of metallic / electronic implants and / or cardiac pacemakers;
* Participants unable to communicate verbally;
Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds

The goal of this observational study o is to compare outcomes after either biological or mechanical aortic valve replacement. The main question it aims to answer:

Is survival better after mechanical aortic valve replacement compared to biological aortic valve replacement? Are there less complications and reoperations after mechanical aortic valve replacement compared to biological aortic valve replacement? We perform a retrospective Data Collection of anonymized Austrian health insurance data.

Objectives: In recent years, age recommendations for the utilization of biological prostheses rather than mechanical prostheses for surgical aortic valve replacement (sAVR) have been significantly reduced. This study evaluated survival rates, major adverse cardiac events (MACEs), and reoperation risks following surgical (sM-AVR) and biological (sB-AVR) AVR, with the aim of providing data to inform optimal prosthesis selection for middle-aged patients between 50 and 65 years.

Methods: A population-based cohort study was conducted using data from the Austrian Health System from 2010 to 2020. Patients undergoing isolated sAVR (n=3761) were categorized into sM-AVR (n=1018) and sB-AVR (n=2743) groups. Propensity score matching (PSM) was applied to balance covariates. The primary endpoint was all-cause mortality. The secondary endpoints included MACEs, reoperation, stroke, bleeding, and post-reoperation survival. Outcomes were assessed using Cox regression and Kaplan-Meier analyses.

Eligibility Criteria:
Inclusion Criteria:

* age between 50 and 65 years
* st. p. isolated biological or mechanical aortic valve replacement

Exclusion Criteria:

* transcatheter aortic valve implantation (TAVI; MEL codes DB025, DB026, DB021, or XN010) as index procedure
* age \<50 or \>65 years
* concomitant heart surgery or additional procedures during the index operation
* patients receiving a coronary artery stent (MEL codes DD050 or DD060) within four months before AVR
Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

Pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. The aim of the medicaments is to control behavior and allow safe completion of a dental procedure. Homeopathic remedy is safe and can be effective to control behavior and decrease anxiety in children during dental treatment.

Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety before dental treatment.

2. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for anxious children.

Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will receive homeopathic remedy\\placebo before dental treatment. Anxiety reduction will be measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS), and Houpt behavior scale.

Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment.


Eligibility Criteria:
Inclusion Criteria:

* Dental anxiety
* Needs at least 2 dental treatment appointments

Exclusion Criteria:

* Medically compromised
* Cooperative, needs less than 2 dental treatment appointments
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)

To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial

To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial

Eligibility Criteria:
* ≥18 years of age.
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation.
* De novo liver transplant recipient.
* Written informed consent required.

Exclusion Criteria:

* Subject is a multi-organ transplant recipient.
* Subject is antibodies blood group (ABO) liver incompatible.
* Subject has severe systemic infection.
* Subject is Human Immunodeficiency Virus (HIV) positive.
* Subject has acute/fulminant liver failure.
* Subject is pregnant.
Hand Perfusion and Pulse Oximetry Performance

The purpose of this study is to compare oxygen saturation measurement readings from manufactured pulse oximetry devices to the oxygen saturation measurements of arterial blood samples drawn at the same time of measurements.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women of all races and ethnic backgrounds recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities.
* Equal number of male and female participants to address potential sex differences in physiology.
* We will intentionally recruit subjects with dark skin because of the issues surrounding accuracy of pulse oximetry and skin tone.
* Non-smokers
* BMIs between 18-30 kg·m-2.
* Female subjects will be non-pregnant.
* Free of cardiopulmonary diseases or other conditions and/or taking medications that might affect pulse oximeter-based estimates of arterial saturation.
* All inclusion and exclusion criteria are at the discretion of the Principal Investigator.
* At least 8 of the subjects will have Fitzpatrick Skin Type of IV to VI.

Exclusion Criteria:

• Children under the age of 18 will not be studied. We will exclude children less than 18 years of age because they are unable to give consent, and because these studies are non-therapeutic.
Tau PET in Imaging and Cognition: Healthy Adults From 55-90

The investigators aim to use the new PET radioligand, 18F-MK-6240, to detect tau pathology in cognitive healthy and mild cognitive impairment (MCI) elders. The investigators will then examine the interactions between differential tau burden and performance on cognitive tasks, functional magnetic resonance imaging (fMRI) neural activation patterns, and other cognitive and behavioral measures. By investigating these relationships, the investigators hope to understand the cognitive and behavioral outcomes of tau deposition found in specific brain regions in cognitively normal/mildly cognitively impaired adults. Furthermore, the study aims to examine how the presence of tau may contribute to the risk of subsequent cognitive decline, neurodegeneration, and dementia.

Many cognitively healthy older adults have, upon post mortem evaluations, been found to have varying amounts of neurofibrillary tangles (tau) and beta-amyloid plaque deposits, which are the hallmark brain pathologies known to be associated with Alzheimer's disease and various other dementias. While some with these pathologies may not clinically express cognitive decline or dementia in their lifetime, human post-mortem studies suggest that increasing neurofibrillary tangle density correlates with neurodegeneration and cognitive impairment.

Imaging tauopathy in-vivo provides an opportunity to examine neurocognitive correlates of differential levels of tauopathy in the brain, allowing to further qualify pre-clinical states of cognitive impairment. The investigators aim to investigate possible protective mechanisms, such as cognitive reserve, that may modulate the relationship between tauopathy and cognitive decline.

Eligibility Criteria:
Inclusion Criteria:

* Aged 55-90
* Previously received an amyloid PET scan
* Residing near Columbia University Medical Center
* Must be willing and able to participate

Exclusion Criteria:

* Have a contraindication to PET (e.g, metallic implants, pacemaker, claustrophobia, or cannot lie flat for one hour)
* Pregnancy
* Lactating Women
* Current, past, or anticipated exposure to radiation
* Significant active physical illness
Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery

Interscalene brachial plexus block is known as the gold standard for analgesia after shoulder surgery, but limits the use of ipsilateral phrenic nerve paralysis. Recently, interest in potential diaphragm-sparing alternative blocks has increased for patients undergoing shoulder surgery.Two of these blocks are upper trunk block (UTB) and costoclavicular brachial plexus (CCBPB) block. This randomized controlled trial will compare ultrasound-guided UTB and CCBPB in patients undergoing arthroscopic shoulder surgery.

The main outcome is pain intensity score at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rating scale (NRS) from 0 to 10. The investigators research hypothesis is that UTB and CCBPB will result in equivalent postoperative analgesia at 30 minutes in the PACU.


Eligibility Criteria:
Inclusion Criteria:

1. American Association of Anesthesiologists (ASA) physical status I - III
2. BMI 20 to 35 kg / m2
3. Patients scheduled for elective arthroscopic shoulder surgery

Exclusion Criteria:

1. Patients who refuse to participate in the study,
2. Pre-existing (obstructive or restrictive) lung disease,
3. Coagulopathy,
4. Sepsis,
5. Hepatic or renal insufficiency,
6. Pregnancy
7. Allergy to local anesthetic drugs,
8. Chronic pain condition requiring opioid intake at home,
9. Surgery in the neck or infraclavicular region
10. BMI above 40.
11. History of psychiatric diseases needing treatment.
12. Failure of nerve block performed in the preoperative block room
13. Substance abuse history
Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay

The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1) infected individuals that have viral loads across the dynamic range of the Aptima HIV-1 assay. The plasma samples will be tested in a method comparison study to support the approval of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of the method comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by comparing the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc., Branchburg, New Jersey) in plasma samples that have viral loads across the dynamic range of the Aptima HIV-1 assay.


Eligibility Criteria:
Inclusion Criteria

* The subject has documented HIV infection
* The subject is at least 15 years of age at the time of enrollment
* For ART subjects, subject has documented HIV-1 RNA levels above the lower limit of quantitation of an FDA-approved assay in a sample collected in the past 90 days.
* The subject (and/or legally authorized representative, if allowed) is willing and able to provide written informed consent before providing a specimen (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board \[IRB\]-approved waiver for parental consent for minors).

Exclusion Criteria

* A potential subject will be ineligible for the study if the subject, clinician, or medical record reports any of the following:
* Subject's HIV disease stage and/or current ART status is unknown.
* It is unknown if current or previous ART was changed or stopped due to therapy failure.
* For non-ART subjects, subject was previously on ART in the past 30 days
* Subject already participated in this study and subject's previous sample(s) was provided and not withdrawn (ie, subject has an evaluable sample in the study)
* Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study
* Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study
Evaluation of Intestinal Permeability in Cirrhotic Patients Before and After Treatment With Non-selective Beta Blocker (Propranolol)

This study seeks to investigate whether non-selective beta blocker treatment decreases intestinal permeability in cirrhotic patients by altering the expression of genes encoding intercellular junction proteins.

There is evidence that the non-selective beta-blocker (NSBB) propranolol reduces intestinal permeability and decreases bacterial translocation in cirrhotic patients, independent of hemodynamic effects on portal pressure. The mechanism by which this decrease in intestinal permeability and bacterial translocation occurs has not been established. Among the proposed mechanisms are: modification of splanchnic hemodynamics, increased gastrointestinal motility, and immunological properties of nonselective beta blockade. It is not known, however, if beta-blocker treatment decreases intestinal permeability by altering the expression of genes encoding intercellular junction proteins. This study seeks to investigate this question to improve understanding of the mechanism by which beta-blockers work in primary and secondary prophylaxis of variceal hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Diagnosis of cirrhosis of any etiology or severity as established by the treating physician (biopsy, biochemical, imaging)
* High risk gastroesophageal varices, that is those with medium/large varices or any size varices with red wale signs
* Scheduled appointment for endoscopic ligation as previously ordered by the treating physician
* Signed informed consent
* Ability to keep return appointments

Exclusion Criteria:

* Beta blocker treatment within 1 month prior to study period
* Antibiotic treatment during or within 1 month prior to study period
* Prebiotic or probiotic treatment during or within 1 month before study period
* Current immunosuppressive treatment
* Patients with active infectious process
* Patients with portal thrombosis
* Patients with hepatocellular carcinoma
* Patients with intestinal surgical shunts
* Patients with chronic diarrhea or documented celiac disease
* Patients with chronic renal failure (KDOQI: ≤ 3)
* Patients with allergy or absolute contraindication for the use of nonselective beta blockers (asthma, significant heart block, systolic BP \<90 mm Hg, basal HR \<55, refractory ascites)
Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves

The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection.

There are many treatment options available for restoring primary anterior teeth. A clinician's decision to opt for any specific treatment option is based on multiple factors such as the clinician's liking of a specific material or method, esthetic demands by parents, the child's behavior, and moisture and hemorrhage control. Out of many treatment options, preformed zirconia crowns for primary teeth have been available for over a decade. There is insufficient research that compares the success of anterior pediatric zirconia crowns with and without retentive grooves.

Eligibility Criteria:
Inclusion Criteria:

* Healthy 2 to 6-year-old children.
* Those having opposed anterior teeth.
* No history of systemic illness or dental developmental anomalies
* Minimal of two surfaces of caries in the upper anterior teeth.
* Patient with Early Childhood Caries.
* Patients treated under General Anesthesia.
* English, Spanish, and Arabic speaking patients

Exclusion Criteria:

* Teeth nearing exfoliation.
* The presence of a single surface caries, not involving the proximal surfaces.
* Teeth that have been subjected to trauma.
* Bruxism.
* Special health needs.
* Presence of teeth wear on the opposing teeth, or absence of opposing teeth.