cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Measurement of Pleural Line Sliding as a Surrogate Indicator of Lung Volume Change: A Comparative Study With Ventilator Volume Data

The pleural line is a commonly observed structure in clinical ultrasound, used to evaluate pulmonary pathophysiology such as pulmonary edema, pneumothorax, or pneumonia. During the respiratory cycle, the pleural line undergoes displacement. In the inspiratory phase, the tidal volume increases, leading to an increase in displacement, while in the expiratory phase, the tidal volume decreases, resulting in reduced displacement. Therefore, we hypothesize that this displacement could serve as an indicator of tidal volume changes during respiration.

This study is a retrospective proof of concept study, reviewing cases from January to December 2012, involving 6 to 12 patients who were intubated and on mechanical ventilation with synchronized lung ultrasound recordings. The respiratory parameters and lung ultrasound recordings of the patients were anonymized after being downloaded for subsequent analysis.

For lung ultrasound analysis, we selected ultrasound recordings of the right lower lung apex at the costophrenic angle along the right mid-axillary line. Using the open-source image processing tool ImageJ 1.4, the pleural line corresponding to the right lower lung apex was enhanced and its terminal coordinates extracted. During respiration, the right lower lung apex moves with the breathing cycle, and the pleural line exhibits corresponding motion. The terminal coordinates of the pleural line also shift during respiration, and a plot of this displacement against time is generated to create the pleural line sliding displacement curve.

From the numerical data downloaded from the ventilator, we extracted the tidal volume curve against time during the patient's respiratory cycle. Based on the ventilator's time records, we selected the time segment that corresponded to the pleural line sliding displacement curve. The tidal volume curve and pleural line sliding displacement curve data for the same time period were extracted and synchronized using interpolation.

Linear regression was then performed on the synchronized numerical data of the two curves to obtain the correlation coefficient. Based on the correlation coefficient, the relationship between pleural line sliding displacement and tidal volume can be determined, which further indicates whether pleural line sliding displacement could serve as a surrogate indicator for tidal volume.


Eligibility Criteria:
Inclusion Criteria:

* Patient with endotracheal tube and ventilator use

Exclusion Criteria:

* Age under 18 y/o
Persistence of Immune Response After Vaccination With MCC

Persistence of Immune response after vaccination with MCC


Eligibility Criteria:
Inclusion Criteria:

* healthy adolescents vaccinated with Meningococcal C Conjugate vaccine

Exclusion Criteria:

* ascertained or suspected disease caused by N. meningitidis
* household contact with individuals with proven N. meningitidis serogroup C infection
* significant acute or chronic infections
* any other serious disease
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function

The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease \[ESRD\] with or without hemodialysis) compared to adult participants with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a body mass index (BMI: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening
* Contraceptive use by female participants, male participants and their female partners should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria in the protocol

Participants with normal renal function (Group 1):

-Participant must have an estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute (mL/min)

Participants with renal impairment (Groups 2 to 4):

- The following classifications of renal function are used: Mild renal impairment (eGFR greater than or equal to \[\>=\] 60 to less than \[\<\] 90 mL/min), Moderate renal impairment (eGFR \>= 30 to \<60 mL/min), Severe renal impairment (eGFR \>=15 to \<30 mL/min)

Participants with end-stage renal disease (ESRD) with or without hemodialysis (Group 5):

* Participant must have an eGFR \<15 mL/min if not on hemodialysis
* Participant on hemodialysis treatment must have been on the same hemodialysis regimen for at least 3 months before screening

Exclusion Criteria:

All participants (Groups 1 to 5):

* Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (example, Crohn's disease), with the exception of renal impairment
* Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
* Participant has known allergies, hypersensitivity, or intolerance to JNJ-64041575 or its excipients
* Participants with evidence of an active infection
* Participant is a woman who is pregnant or breastfeeding
Genetics of Mendelian Diseases in Qatar

There are certain categories of diseases which are more prevalent in the Arab world due to increased rates of consanguinity in relatively isolated populations. The goal is to discover these mutations by using next-generation human genetics tools.

There are certain categories of diseases which are more prevalent in the Arab world due to increased rates of consanguinity in relatively isolated populations. The goal is to discover these mutations by using next-generation human genetics tools. These include high-throughput sequencing and genotyping along with the necessary bioinformatics analyses that will lead to the discovery of the causes of most inherited diseases in the region.The secondary objective will be to build a comprehensive catalogue of genetic variation in the Arab world. This will include all detected mutations, not only the subset that are causing disease (from primary objective), but also known trait-altering mutations as well as general diversity on the DNA level among human populations of this region. This catalogue can become a widely useful resource for many projects down the road, as it relies on anonymizing individual samples and instead displaying data in aggregate as the cohorts of collected samples grow over the years.

The study will include all genetic disorders from all ethnic backgrounds but Mendelian disease for which a gene mutation has already been identified will be excluded.

Evidence of Mendelian Transmission determined by fulfilling one of the following criteria:

Multiple affected family members (at least first degree relative with disease) History of consanguinity Severe disease in newborn in the absence of family history Sydromic disease in single individuals Congenital abnormality affecting major organ system(s) Mendelianized extremes of common disease (eg sever familial diabetes/ obesity/ hypertension)

Eligibility Criteria:
Inclusion Criteria:

* All included individuals must provide informed consent
* All genetic disorders are included
* All ethnic backgrounds are accepted
* Disease must be genetic with no evident environmental cause
* Evidence of Mendelian Transmission determined by fulfilling one of the following criteria:
* Multiple affected family members (at least first degree relative with disease)
* History of consanguinity
* Severe disease in newborn in the absence of family history
* Sydromic disease in single individuals
* Congenital abnormality affecting major organ system(s)
* Mendelianized extremes of common disease (eg sever familial diabetes/ obesity/ hypertension)

Exclusion Criteria:

* Individuals who do no consent to be included
* Mendelian disease for which a gene mutation has already been identified
* Individuals for which a molecular diagnosis has already been established by alternative method
* Disease for which an environmental factor is most likely the cause
* Disease for which late age of onset rule out Mendelian transmission
* Common diseases for which late age of onset rule out Mendelian transmission
TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)

This is a single centre randomised, placebo-controlled phase 2 study in which 96 children age 4 to 16 years with moderate to severe, longstanding allergic eczema will be enrolled.

Following a 4 to 6 week period on standardised treatment (run-in period, to ensure everyone starts with the same treatment approach), participants will be randomised to an active or dummy temperature-controlled laminar airflow (TLA) device, which has been shown to markedly reduce exposure to particles which can cause allergic reactions when being inhaled (inhaled allergens) and other particles which are in the air the investigators breathe in. This has been shown to be an effective treatment of atopic asthma.

The participants will undergo a 12-week treatment period. The device will then be removed and a final follow-up visit occurs at 16 weeks. The total study duration, including the run-in period is up to 22 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 16 years at time of consent
* Persistent moderate to severe eczema despite treatment with topical corticosteroids (TCS) Class II or more and/or topical calcineurin inhibitors (TCI, licenced use only) for at least 3 months.
* Eczema Area and Severity Index (EASI) Score ≥12 at screening and randomisation visit and \>10% body surface involved
* Sensitisation to house dust mite species, confirmed by specific Immunoglobulin E (ImmunoCAP ≥2) and/or Skin Prick Test (SPT ≥5mm)
* Child able to sleep in their own bed and able to use the device for at least 5 out of 7 nights per week
* Written, informed consent of parent/legal guardian and patient assent

Exclusion Criteria:

* very severe atopic dermatitis
* use of systemic immunosuppression (such as cyclosporine, methotrexate, azathioprine, oral steroids) or UV therapy or extracorporal photopheresis within four weeks prior to the screening visit
* received therapeutic monoclonal antibodies (such as Omalizumab or Dupilumab) within six months prior to the screening visit
* Ongoing or planned desensitisation / immunotherapy during the study
* Infections requiring systemic antimicrobial treatment within four weeks prior to the screening visit
* Introduction of special dietary restriction (for eczema treatment) within three months prior to screening visit
* Severe asthma ≥ Step 4 and/or ≥1 course of systemic oral steroids for asthma in the three months prior to screening visit
* Significant underlying chronic medical condition (chronic other skin disease, inflammatory bowel disease, immunodeficiencies, other uncontrolled systemic disease, cancer)
* Planned time away from home (=unable to use TLA) exceeding 2 days/week; unable to use the device at least 5/7 days in the 2-3 weeks prior to end of intervention period.
* Prior research participation is not an exclusion criterion, except if it involved eczema disease modifying agents.
* Participating in current research
Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY

This is a randomized, cross-over study to measure global and clinical impact and level of arousal in subjects suffering from moderate to severe Alzheimer's disease when exposed to emotionally impactful music compared to control intervention.

In partnership with the study partner (a person who spends 10 hours or more a week with the subject and can reliably report on the subject's condition), three tunes will be chosen for the purposes of the study. The tunes chosen will need to be related to a past meaningful, positive experience of the subject, as determined by the subject and the subject's study partner. The pieces will be restricted in duration to between 1.5 and 2 minutes each. A piece will be chosen at random and will be saved on a portable device, and subjects will be asked to listen to the melody using high quality, over-ear headphones. The total exposure time will be 10 minutes each hour over a three-hour period. The melody will be repeated as many times as necessary to complete the 10-minute period. The control intervention will involve listening to nature sounds at the same duration and administration scheme. Functional magnetic resonance imaging will be used to identify how brain networks are modulated via exposure to this music and how they associate with the clinical findings.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Person of any sex/gender aged between 55 and 90
* Stated willingness to comply with all study procedures and availability for the duration of the study
* In the opinion of the investigator, has an informant able and willing to provide accurate information about the participant (may be paid or unpaid caregiver)
* Suffer from moderate to severe Alzheimer's disease as established by the study team using the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria for possible and probable Alzheimer's Disease
* Diagnosis of Alzheimer's disease or other type of dementia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
* Mini Mental State Examination (MMSE) score of 5-20
* Subject is reported by the study partner to be able to listen to a minimum of 10 minutes of music and a sound in an uninterrupted manner.

Exclusion Criteria:

* Suffer from severe hearing impairment as reported by the informant
* Presence of neuropsychiatric symptoms of dementia as determined by clinical observation by the Principal Investigator, including history of agitation and/or combative behavior.
* Individuals who score ≥ 12 seconds on the Timed Up and Go (TUG) Test.
Patterns of Glaucoma in Glaucoma Subspecialty Clinics in Egypt and India in the Year 2018

In this study, we are aiming to identify the patterns of glaucoma observed and treated at Glaucoma Subspecialty Clinics of Kasr Al-Aini Hospital, Cairo University in Cairo, Egypt and corresponding clinics in Sadguru Netra Chikitsalaya Post Graduate Institute of Ophthalmology in Mumbai, Maharashtra, India during the year 2018. We are hoping that this study would provide an update on current statistics available on Indian population as well as provide novel numbers on the prevalence of glaucoma and its patterns in one of the largest tertiary care hospitals in Egypt. These results will then be compared to patterns observed in other epidemiological studies done in other countries.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to glaucoma sub-specialty clinics in the year 2018 in two centres: Kasr Al-Aini Hospital in Cairo and Sadguru Netra Chikitsalaya Postgraduate Institute of Ophthalmology in India

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients with incomplete examination data
Magnesium Sulfate Versus Ipratropuim Bromide in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Treatment with short acting β2 agonists for exacerbations of COPD results in clinical improvement. It has not been established whether combining short acting β2 agonists to other bronchodilators is more effective than β2 agonists alone. The aim of this study is to evaluate the efficacy and safety of combination of SABA and MgSO4 in comparison to SABA and ipratropium bromide (IB) in patients attending the emergency department for AECOPD.

Patients presenting to the emergency department with exacerbation of COPD are randomized to receive nebulised ipratropuim bromide or combined nebulised and an intravenous bolus of magnesium sulfate during 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* 40 years old or over
* have known or suspected COPD based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph
* worsening of dyspnea within 2 weeks,
* partial pressure of arterial carbon dioxide (PaCO2) \>45 mmHg
* respiratory rate \>24/min
* arterial pH \<7.35
* partial pressure of arterial oxygen (PaO2) \<50 mmHg under room air

Exclusion Criteria:

* hypersensitivity to anticholinergics and to magnesium sulfate
* patients that received anticholinergics within 6 hours before ED admission
* systolic arterial pressure \<90 mmHg or need to vasoactive drugs
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)

This is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer
* ≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node
* metastasis一group lymph node region will be classified as one metastatic lesion）
* Tissue biopsy prior to treatment
* ECOG performance score 0-1

Exclusion Criteria:

* EGFR mutation or ALK positive.
* Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia.
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
* Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).
A Brief Cognitive Task Intervention for NHS Staff Affected by COVID-19 Trauma (GAINS-2 Study)

Frontline healthcare staff are frequently exposed to traumatic events at work (e.g., witnessing patients die), amplified by the COVID-19 pandemic. A significant proportion experience intrusive memories of these events that pop suddenly into mind: they can disrupt functioning and can contribute to post-traumatic stress disorder. Previous research has shown that a brief behavioural intervention can reduce the number of intrusive memories after a traumatic event. In this study we will test the effect of a digital imagery-competing task, a digital music-listening task and treatment as usual (TAU) for National Health Service (NHS) staff with intrusive memories of work-related traumatic events from the pandemic. We test the effect on the number of intrusive memories (primary outcome), and other clinical symptoms (PTSD, anxiety, depression, and insomnia), in addition to work functioning, general functioning and quality of life (secondary outcomes). Intervention feasibility, acceptability and implementation will also be explored (additional outcomes). We will recruit approximately 150 NHS staff (via the Intensive Care Society, social media and direct advertising by NHS Trusts) with intrusive memories of traumatic events experienced during the COVID-19 pandemic.

The study is funded by the Wellcome Trust (223016/Z/21/Z).

A statistical analysis plan will be prepared prior to the first interim analysis using Bayesian analyses for statistical inference.

Regular monitoring will be performed by P1vital Products to verify that the study is conducted, and data are generated, documented and reported in compliance with the protocol, GCP and the applicable regulatory requirements. Quality assurance representatives from the Sponsor may carry out an audit of the study in compliance with regulatory guidelines and relevant standard operating procedures.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above.
* Able to read, write and speak in English.
* Worked in a clinical role with COVID-19 patients in the NHS during the COVID-19 pandemic.
* Experienced at least one traumatic event related to their clinical work during the COVID- 9 pandemic meeting criterion A of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for Post-Traumatic Stress Disorder (PTSD): "exposure to actual or threatened death, serious injury, or sexual violence" by "directly experiencing the traumatic event(s)" or "witnessing, in person, the event(s) as it occurred to others".
* Experience intrusive memories of the traumatic event(s).
* Experienced at least three intrusive memories in the week prior to screening.
* Have internet access.
* Willing and able to provide informed consent and complete study procedures
* Willing and able to be contacted by the research team during the study period.
* Have not taken part in a previous study of this intervention from this research team

Exclusion Criteria:

• Have fewer than three intrusive memories during the run-in week.
The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings

The aim of the study is to identify the prevalence of malnutrition and sarcopenia in patients admitted in Swiss rehabilitation centers. Furthermore, the aim is to investigate the changes of selected malnutrition and sarcopenia parameters over the length of the rehabilitation stay.

The project aims to investigate the prevalence of malnutrition and sarcopenia in the rehabilitation setting. A cross-sectional national multicenter study will be conducted in five rehabilitation centers in Switzerland, including 80 - 130 participants per center for the primary objective (prevalence study). Patients will be screened for malnutrition and sarcopenia with established screening tools and if an elevated risk is observed, diagnosis will be confirmed and severity investigated according to international guidelines. Furthermore, the evolution of selected malnutrition and sarcopenia parameters over the rehabilitation stay should be assessed.

Eligibility Criteria:
Inclusion Criteria:

Patients treated in the following groups of rehabilitations will be included:

* Geriatric rehabilitation
* Pulmonal rehabilitation
* Cardiovascular rehabilitation
* Neurological rehabilitation
* Musculoskeletal rehabilitation
* Internistic rehabilitation and oncological rehabilitation

Exclusion criteria:

* Inability to give informed consent
* Inability to follow study procedures (e.g., due to delirium or language barriers)
* Expected life expectancy \< 3 months and/or palliative care
* Isolation for example due to Covid-19 infection or tuberculosis
* Severe dehydration/ volume overload
* Medical conditions that prevent conducting a Bioelectrical Impedance Analysis (BIA) measurement (e.g. non-removable plasters or bandages at feet or hands) or defibrillator