cyrilzakka/clinical-trials huggingface dataset:
Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients

Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and mortality after lung resection. One-lung ventilation (OLV) is usually required in thoracic surgery. OLV is also an important predictor of postoperative ALI. Recent laboratory findings suggested that tissue hypoxemia and ischemia / reperfusion injury of the collapsed lungs during OLV is the major cause of lung injury. Exhaled Breath Condensate (EBC), which is the exhalate from breath typically collected by cooling device, contains most molecules found in the airway. Metabolomics refers to systematic and scientific study of chemical processes involving metabolites. This study will collect EBC for metabolomic analysis and aim to elucidate the biochemical reactions during one-lung ventilation and pathological mechanisms of acute lung injury following thoracic surgery.

Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and mortality after lung resection. Despite the advancement in both the surgical techniques and the perioperative management, the incidence of postoperative ALI remains remarkable. Risk factors for postoperative lung injury are evident, including preoperative pulmonary function, type of surgical procedure, intraoperative fluid management, one-lung ventilation, and ventilator settings. One-lung ventilation (OLV) is usually required in thoracic surgery. OLV is also an important predictor of postoperative ALI. Recent laboratory findings suggested that tissue hypoxemia and ischemia / reperfusion injury of the collapsed lungs during OLV is the major cause of lung injury. Exhaled Breath Condensate (EBC), which is the exhalate from breath typically collected by cooling device, contains most molecules found in the airway. EBC analysis has potential applications in lung disease, such as severity of airway inflammation in asthmatic patients. Collecting EBC is simple and non-invasive, in contrast to bronchoscopy for lung biopsy or bronchoalveolar lavage. Metabolomics refers to systematic and scientific study of chemical processes involving metabolites. This study will collect EBC from thoracic surgical patients before, during, and after OLV. The investigators will perform metabolomic analysis and aim to elucidate the biochemical reactions during one-lung ventilation and pathological mechanisms of acute lung injury following thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Thoracic surgical patients requiring lung isolation
* Pulmonary resection: lobectomy, segmentectomy
* Esophageal surgery and no pulmonary resection
* Mediastinal surgery and no pulmonary resection

Exclusion Criteria:

* Metabolic disorder
* Metabolic syndrome
* Diabetes
* Pregnancy
Electromagnetic Tracking to Measure Tremor

Deep Brain Stimulation (DBS) is an effective treatment option for individuals with debilitating tremors that do not respond to medical therapy. However, severe tremors, particularly those that develop after central nervous system insult or from multiple sclerosis, can be comprised of several underlying components that represent dysfunction within distinct brain circuits. Some of these dysfunctional brain circuits can be successfully treated with DBS while others respond poorly DBS therapy. For severe tremors, it can be very difficult to discriminate between the underlying components of a patient movement disorder and is exclusively dependent upon clinical expertise. Even with extensive clinical experience, it is difficult to reliably predict the results of DBS therapy for patients suffering from severe, debilitating tremor. In an attempt to gain more knowledge, an electromagnetic tracking system will be used which can precisely measure the position of a patient's upper extremity in space during routine neurologic examination. The goal is to use this tool to quantitatively identify various components of severe tremor, which can be discriminated based on oscillatory frequency and regularity of tremor amplitude. The purpose of this research study is to better understand the nature of complex, severe tremors by carefully measuring movement of the upper extremities with sensors during simple tasks. The goal is to break down complicated tremors into their components and then determine which components will respond to deep brain stimulation.

As a participant in the research study small sensors that are connected to wires will be affixed to points on your hand, wrist, elbow and/or shoulder. These sensors are painless and otherwise noninvasive. They will be used to measure the precise location of the hand and arm in space during the neurologic examination. This exam will test the tremors during short, simple tasks using the hand and arm. This information will be stored along with your name and medical record number for analysis after your testing is complete.

The sensors that are used to measure movements are connected to thin, flexible wires that will be attached with adhesive tape. The motion sensors use a magnet that produces a weak electromagnetic field. This electromagnetic field poses no direct harm, but could potentially interfere with medical devices such as cardiac pacemakers or deep brain stimulators if placed very close to the electromagnetic emitter.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Individuals who have undergone or are scheduled to undergo Deep Brain Stimulation (DBS) placement

Exclusion Criteria:

* Individuals who have not had or are not scheduled for Deep Brain Stimulation (DBS) placement
Direct Discrimination of Quantum States by the Human Eye

Age-related macular degeneration (AMD), is a debilitating eye disease that causes a loss of central vision. The prevalence of AMD increases exponentially with age and causes a significant impact through both medical expenses and the social and economic costs associated with vision loss. AMD is the global leading cause of blindness among people over the age of 60. Detection of this eye disease at early stages coupled with prompt treatment can prevent vision loss; however, modern diagnosis methods are ineffective at diagnosis of AMD before vision loss occurs. While a range of available treatment options has been effective at slowing vision loss due to AMD, no treatment exists which can recover lost vision. The investigators propose to apply tools developed in quantum information science to diagnose AMD before vision has been affected, drastically improving health outcomes for patients with AMD.

There has been tremendous progress in generating and detecting structured light which possesses advantageous propagation characteristics such as quantized orbital angular momentum (OAM), non-diffraction, and self-healing. These special beams have found applications in microscopy, encoding and multiplexing of communications, and manipulation of matter. Here the investigators bring the structured light toolbox to vision sciences for the first time and expand the space of possible stimuli.

A healthy macula possesses azimuthally ordered dichroic fibres that act as a radial polarization filter, enabling a typical person to perceive linearly polarized light through the entoptic phenomena known as Haidinger's brushes. Despite significant interest in the application of this phenomenon to the detection of age-related macular degeneration, no device has currently seen widespread adoption in a clinical environment. This is due to the difficulty in observing Haidinger's brush, the imprecise measurements that this test can extract, and the difficulty in instructing patients during these tests.

Leveraging the quantum-inspired toolbox developed in the field of structured light, the investigators can project polarization-coupled OAM states of light directly on a person's retina. This enables the investigators to create arbitrary entoptic patterns in a person's vision based on the structure and chemical composition of their subjective macula, and the investigators have the opportunity to develop a litany of novel diagnostic tests to characterize and quantify the health of the macula.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are clinically diagnosed with a vision disease affecting their macula
* Older adults who are matched for age.
* Participants who are clinically diagnosed with glaucoma
* Participants who have normal vision.
* One aged-matched control with normal vision will be recruited for each of the diagnosed groups (born in the same year).

Exclusion Criteria:

* Participants with any additional eye diagnosis or condition
The Efficiency of Postoperative Interferon-alpha Treatment in p48 Positive Patients With Hepatocellular Carcinoma

The purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 Positive patients with HCC after curative resection.

BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients with hepatocellular carcinoma (HCC). P48 is a predictive marker for outcome of postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the Efficiency of Postoperative IFN-Alpha Treatment in p48 Positive Patients With HCC.

METHODS: An immunohistochemical study of P48 was performed on specimens that were collected from patients who underwent a curative resection of HCC. These patient with p48 Positive were randomized divided into a treatment group who received postoperative IFN-alpha therapy and a comparison group who not received. Besides the side effect, the overall survival rate and the disease-free survival rate will be observed.

Anticipated RESULTS: IFN alpha treatment improved the overall survival of p48 Positive patients with HCC after curative resection, probably by postponing recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients with p48 Positive who underwent a curative resection of HCC

Exclusion Criteria:

* None
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection

The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants monoinfected with HCV genotype -1 to -6
* HCV RNA ≥1,000 IU/mL at Screening
* Participants who are HCV-treatment naïve or treatment experienced
* Participants in Cohort 1 must have a body weight ≥ 45kg at Day 1

Exclusion Criteria:

* Mixed genotype HCV infections
* Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV
* Evidence of cirrhosis, either compensated or decompensated
* Prior exposure to sofosbuvir and/or NS5A inhibitor

Other protocol defined inclusion/exclusion criteria could apply
Reliability, Validity and Responsiveness of the Upright Motor Control Test in Patients With Stroke

Impaired motor function is common after stroke. Individuals with stroke often exhibit synergic pattern that disturb daily function. It is crucial to identify the movement impairment in the clinical settings. Upright Motor Control Test (UMCT) is one of the tests developed to assess the selective movement control and functional strength in people with central nervous disorders. It can be used to reflect the impairment of motor function and evaluate changes of performance after treatment. Yet is little to know the clinimetrics of the UMCT on clinical utility. To date, only few researches explore that UMCT has some construct and criterion validity.

Therefore, this study aims to 1) establish the inter-rater reliability to administer the UMCT. 2) explore the correlation between the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) and UMCT. 3). investigate whether the UMCT is able to predict the walking ability in patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* First-ever, unilateral cerebral stroke within one month
* Being able to maintain standing for more than 10 seconds

Exclusion Criteria:

* Could not follow commands
* Deformity or fracture of lower limb
* Less than 20 years old
The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
* Patients between the age of 18 and 80 at the time of consent
* Listed for total knee replacement surgery.
* Patients who are willing and able to give informed written consent

Exclusion Criteria:

* Progressive local or systemic infection
* Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
* Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
* Patient whose BMI exceeds 40
* Any case not described in the inclusion criteria
Ischemic Postconditioning in Cardiac Surgery

Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.

Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients \> 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included.

The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing elective surgery of the ascending aorta or the aortic valve

-

Exclusion Criteria:

* Coronary artery disease requiring bypass surgery
* Tricuspid valve surgery
* Mitral valve surgery
* Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure)
* Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed)
* Patients with autoimmune diseases
* "Redo" operations
* Active endocarditis (ongoing antibiotic therapy)
* On the discretion of the operating surgeon or anaesthesiologist
Tourette Discrimination (TD) Stigma Scale

The goal of this qualitative study is to understand the challenges of stigmatization and discrimination in children and young adults with Chronic Tic Disorders (CTD), including Tourette Syndrome. Measuring and understanding how stigma affects those with CTD will help inform future work.

This study will utilize a phased approach, where (1) Narrative and thematic content data will be obtained through in-depth qualitative interviews of CTD stakeholders. (2) Based on these results, a novel scale will be developed through the Delphi Method with CTD stakeholders. (3) Preliminary analyses of the scale's psychometric properties.

Eligibility Criteria:
Inclusion Criteria:

CTD Cohort

1. Physician-confirmed diagnosis of CTD based on the Diagnostic and Statistical Manual for Mental Disorders-Fifth Edition (DSM-V) criteria
2. 8-30 years old.

Parent/caregivers, supporters, medical providers, advocate cohort (s)

1. Involved in the care of a child, youth or young adult with CTD
2. The known person with CTD has had tics for more than a year at the time of screening

Exclusion Criteria:

CTD Cohort

Exclusion criteria:

1. Non-English speaking
2. Diagnosis of intellectual disability
3. Diagnosis of psychosis
4. Any other condition that, in the Principle Investigator's opinion, would limit the participant's (or parent's) ability to understand study measures.

Parent/caregivers, supporters, medical providers, advocate cohort (s)

1) The known person with CTD has an intellectual disability or diagnosis of psychosis
FilmArray® and Management of Ventilator Associated Pneumonia in COVID-19 ARDS

Ventilator Associated Pneumonia (VAPs) are a very common side effect in intensive care units. They are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%.

VAPs complicate about 40-50% of COVID-19 acute respiratory distress syndrome (ARDS) and the mortality would be twice higher.

Thus, in this context of the COVID-19 pandemic, this represents a considerable rate of patients.

Unfortunately, the risk factors for VAPs are poorly understood and the bacterial ecology varies around the world. Also, facing a high prevalence of multi-resistant bacteria in this population, the choice of probabilistic antibiotic therapy is complex and represents a considerable impact for care.

New microbiological rapid diagnostic techniques have appeared in recent years, among them the FilmArray® seems to present interesting diagnostic performances with the ability to detects resistance to antibiotics.

This technique has been studied in acute community pneumonia but has not been validated in VAP and even less during the COVID-19 period.

Investigators decide to conduct this study to investigate if the early identification of the pathogens and their mechanism of resistance using FilmArray® would improve the relevance of the antibiotic treatment.

The aim of this project is to evaluate the contribution of a rapid diagnostic technique to the management of Ventilator Associated Pneumonia during COVID-19 acute respiratory distress syndrome before an interventional study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yers
* COVID-19 acute respiratory distress syndrome hospitalization
* affected Ventilator Associated Pneumonia
* having multiplex PCR analysis FilmArray®

Exclusion Criteria : Patient opposition to participate to the study
Application of Vibration Wave Therapy to the Children Suffering From Cerebral Palsy and Tongue Spastic Dysarthria

Vibration therapy is the widely used in many neurological disorders for different type of problems. Recently, it is being used by researchers for the betterment of motor disorders and muscle movements of the cerebral palsy patients and significant results are obtained. Investigators are conducting this research to explore that whether this therapy can have some effect on the Spastic Tongue Dysarthria of the Cerebral Palsy patients.

This study is going to be conducted in collaboration with Shahbaz Khalid Ranjha , Speech Language Pathologist, Family Health Hospital Islamabad who is the main person for the idea of the study and National University of Science \& Technology. This study is funded by Higher Education Commission of Pakistan. Recruitment and Intervention Work will be carried out in Family Health Hospital. Special device is being designed for transmission of Vibration waves in Lab of the university. The device is capable to transmit vibration waves to the patient. Urdu language phonological and articulation test(TAAPU) will be used for assessment as it is specially designed for Urdu language population which will be the main focus. Investigators have defined speech parameters for analysis which will be collected before application of intervention, after 3 months and then at the end of the study. Parents assessment will be collected and noted through out the intervention.

Eligibility Criteria:
Inclusion Criteria:

* children having dysarthria due to cerebral Palsy
* Dysarthria due to damage in motor speech area/ broca area.
* Children having type Spastic Dysarthria

Exclusion Criteria:

Children diagnosed with following are excluded from our study

* Any speech disorders
* hearing impairments
* cleft palate
* tongue tie.
Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm

The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.


Eligibility Criteria:
Inclusion Criteria:

* patients with a confirmed diagnosis of bilateral benign essential blepharospasm, and having symptoms of such for at least 6 months prior to the baseline visit
* naïve patients to botulinum toxin type A treatment, or patients who had received a single treatment of botulinum toxin type A, or those who had demonstrated a satisfactory response, in the investigator's opinion, to the last 2 injections of botulinum toxin type A with a minimum of 12 weeks since the last injection and where a further injection at full dosage was now indicated
* patients with a minimum score of 8 on the BDS

Exclusion Criteria:

* patients with either neuroleptic-induced blepharospasm, isolated levator dysfunction or apraxia
* previous surgical, chemical and thermal myectomy or neurectomy
* any condition where intramuscular injection is contraindicated
* ophthalmolgical infection
* myasthenia gravis or other disorders of the neuromuscular junction
* prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission, or medication where the dose or choice of medication has not been constant for the last 30 days
ABA-101 in Participants With Progressive Multiple Sclerosis

This study will test the safety and effects of ABA-101 when given as a single dose to participants with progressive multiple sclerosis.

It is the first study of this treatment in humans. After safety is demonstrated with a low dose of ABA-101, a higher dose will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Is ≥18 years old at signing of consent.
* Has a diagnosis of MS per the 2017 revised McDonald criteria.
* Has documented evidence of progression of disability independent of MS relapse activity (clinical or radiographic).
* Expresses the HLA that matches the TCR restriction.
* Presence of a radiographic biomarker of CNS inflammation as identified by MRI.
* Meets Expanded Disability Status Scale (EDSS) criteria.
* Meets the nine-hole peg test (9HPT) criteria.

Exclusion Criteria:

* Presents with clinical or radiographic evidence of relapse within 24 months prior to or at Screening.
* Is considered by the Investigator to be immunocompromised.
* Current treatment with disease-modifying therapies (DMTs).
Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections

In this cross-sectional study the investigators will examine two populations: young adults with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on \> 2 insulin injections per day. The sample size for this observational study will be up to 125 patients. The investigators will issue a Common Sensing GoCap bluetooth-enabled pen cap that fits on the end of Solostar Lantus and Apidra insulin pens; this pen cap registers the position of the insulin pen plunger and automatically sends confirmation of dose delivery to a smartphone app.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes or insulin-requiring Type 2 diabetes
* \> 2 insulin injections
* Age 18-35 or older than 65 years
* Use of glargine insulin as basal insulin
* Stable insulin doses for past 3 months

Exclusion Criteria:

* Previous tape/adhesive allergies with CGM sensors
* Visual or cognitive impairment with inability to self-administer insulin