cyrilzakka/clinical-trials huggingface dataset:
Calculated and Graphically Produced Depth of Anesthesia

There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and postoperative complications in the patient undergoing surgery. Having a unnecessary "deep" anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause delirium and increase the mortality rate. Being too "light", on the other hand, can make the patient experience awareness when muscle relaxant is used. This can lead to serious psychological struggles.

Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can be difficult because clinical signs depend on many factors. In addition to clinical evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice. Unfortunately, this method is not always accurate and has a delay.

New devices are now developed to calculate the anesthesia level based on the drugs given. The level is simultaneously presented graphically on screen. The purpose of this study is to investigate and compare clinical parameters within patients undergoing general anesthesia, with and without the use of such devices. Hemodynamic stability, less use of adrenergics, higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate a more precise level of anesthesia, hence, promote patient safety.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* Standard premedication
* General anesthesia, total intravenous anesthesia

Exclusion Criteria:

* Alcoholics
* BMI 35 or higher
* Unable to give consent
Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease

1600 patients with severe, end stage renal disease or post transplant will be randomised 1:1:1 to either standard therapeutic education; or education using a specific app; or the enhanced interactive app using feedback messages.

The total follow up duration is 18 months. Primary endpoint is the cost utility of using app-based therapeutic intervention, secondary endpoints are: compliance with treatment guidelines, app use (professionals and patients), budget impact analysis


Eligibility Criteria:
Inclusion Criteria:

* severe end-stage renal disease Internet, literacy informed consent

Exclusion Criteria:

* did not fill the screening questionnaire
Text Messaging Adherence to Stimulant Medication

The purpose of this study is to determine if an individualized text messaging intervention for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in improving medication adherence and disease management.


Eligibility Criteria:
Inclusion Criteria:

* Male or female children ages 6-17 years
* A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment and supported by a Clinical Global Impression- ADHD (CGI-ADHD) Severity Score of at least 4 (Moderately Ill)
* Has a parent in possession of a cellular phone with text messaging capabilities and is interested in and willing to receive planned text messages
* Has never been treated with stimulant medication, or has begun treatment with stimulant medication within three months of study enrollment.

Exclusion Criteria:

* Any serious, unstable, chronic medical condition, per clinician assessment
* Cardiovascular disease
* Current or past history of seizures
* Treatment with stimulant medication beyond three months prior to enrollment
* Pregnant or nursing females
* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
* Unstable psychiatric illness other than ADHD, including, but not limited to: Autism, Bipolar Disorder, Psychosis, Major Depressive Disorder, Anorexia, Bulimia, Post-Traumatic Stress Disorder and Anxiety Disorders
* History of multiple adverse drug reactions
* Presence of suicidal risk, or homicidality
* Unwilling/unable to comply with study procedures
* Poor command of the English language
Comparison of Two Techniques in Achieving Corneal Graft

The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front of the eye.

When the eye becomes opaque, the eye is not seeing and the only way to restore the visual acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In half the cases the opacification of the cornea is secondary to dysfunction of the endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of regulating the moisture of the corneal thickness and therefore its transparency.

While the total corneal transplantation has long been the only intervention for these diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called endothelial transplant or graft lamellar later. This intervention is now experiencing significant success as it reduces very significantly the incidence of complications found after transplantation of total cornea and the visual recovery period. This type of transplant is still difficult to achieve and the best technique is not yet established.

Indeed, posterior lamellar transplantation of the cornea may be done manually or using an automated device. Manual techniques allow the preparation of grafts extremely thin but are difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may be less efficient in visual recovery.

The aim of this project is to conduct a prospective study in order to compare these two techniques in terms of postoperative visual recovery and the vitality of the graft during the first year. To date, there is no such study.

The department of Ophthalmology in the University Hospital of Rouen is one of the most famous French teams in the field of cornea transplants and receives many patients from different French regions. The recruitment of 40 patients needed to study should be done without great difficulty over a period of 18 months.


Eligibility Criteria:
Inclusion Criteria:

* men and woman
* 18 years old or more
* Patient having been informed about the study and having signed a non-opposition to the participation

Exclusion Criteria:

* Patient presenting an associated eye pathology previously known and able to limit the visual recovery (age-related macular degeneration, diabetic retinopathy, ...)
* Pregnant women, parturient or breast feeding
* refusal to participate in the study
LAEH Formulation Nasal Spray to Reduce Viral Load

The Covixyl-V LAEH Nasal Spray's safety and efficay is clinically tested for use in subjects with COVID-19 infection.

A randomized, double-blind, multi-center study is conducted to evaluate the efficacy and safety of ethyl lauroyl arginate hydrochloride (LAEH) formulation versus a matching placebo formulation administered as a nasal spray to reduce viral load from nasal area of subjects with coronavirus disease 2019 (COVID-19).

The primary endpoint for this study was the comparison of change in viral load in RT-PCR Test.

Proportion of COVID-19 infection-free subjects between the two treatment arms was followed.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent or, by his or her legal/authorized representatives when the subject is not capable of giving consent, prior to initiation of any study procedures
2. Male or female of ≥18 years and ≤65 years of age (inclusive) at time of enrollment
3. Subjects with laboratory-confirmed diagnosis of COVID-19 at the time of screening (Day -3 to 0) using RT PCR method.
4. Subject with mild COVID-19 symptoms (e.g., fever, cough, sore throat, headache, muscle pain, nasal congestion, rhinorrhea, loss of smell and taste) but who did not have shortness of breath or dyspnea
5. Subjects who did not require hospitalization
6. Subjects with SpO2 levels ≥ 95%
7. Viral load by RT-PCR between 3.3 × 106 copies/mL to 6.6 × 106 copies/mL
8. Female subject who was not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile
9. Female subject of childbearing potential who had negative urine pregnancy test.

Exclusion Criteria:

1. Allergy to LAEH or any of the excipients of the formulation
2. History of allergies or flu within 30 days prior to the day of enrollment
3. Sensitivity to nostril skin or irritation or bleeding history within 30 days prior to the day of enrollment
4. Females who were breast-feeding, lactating, pregnant or intending to become pregnant
5. COVID-19 subjects with moderate, severe or critical illness or requiring intensive care or mechanical ventilation
6. History of severe respiratory disease and requirement for long-term oxygen therapy
7. Had received antibiotic/s, antiviral drug, and hormonal drugs within 30 days prior to the day of enrollment
8. Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
9. Had received or had a plan to receive a SARS-CoV-2 vaccine during the study period
10. Participated in any interventional drug or medical device trials within 30 days prior to the day of enrollment.
An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients

Headache disorders are among the most prevalent medical conditions worldwide. The diagnosis of headache disorders is based on medical history taking. Digital solutions such as natural language processing (NLP) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients. Participants will provide a written description of their headache disorder. The results will hopefully lead to a better understanding of the potential use of NLP in headache disorders.


Eligibility Criteria:
Inclusion Criteria:

* 18 year or older
* Have a headache disorder with at least one headache attack over the last three months
* voluntary participation
* accepted the patient information sheet and gave informed consent
Walking Estimated Limitation Calculated by History - Study 2

The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.

Two questionnaires the WELCH and the "walking impairment questionnaire" (WIQ) are submitted to patients referred for vascular investigations for suspêcted peripheral arterial disease (PAD). Comparison of score to hemodynamic parameters (first goal) or maximal walking distance (MWD) on treadmill (secondary goal). Scoring of the WIQ is performed according to references. Scoring of the WELCH has been submitted for copyright protection (involves a series of 4 additions a subtraction and a single multiplication)

Eligibility Criteria:
Inclusion Criteria:

* French Native language
* 18 years old or older
* Signed consent
* Covered by the French social care system

Exclusion Criteria:

* Unable to participate for administrative reasons
* Psychiatric troubles
* Pain at rest or critical limb ischemia
* Unable to walk (ex: wheelchair subjects)

Note: previous inclusion in the protocole is note an exclusion criterion for a new participation.
A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer

There is currently a lack of published HER3 expression prevalence data among non-small cell lung cancer (NSCLC) patients. The estimation of HER3 expression prevalence in this population using archival tissue samples and the assessment of associated patient characteristics in real world (RW) data will ultimately inform clinical strategy and increase awareness among health care providers (HCPs) and the greater medical community to improve patient care.

The purpose of this study is to use archival tissue samples and RW data to generate HER3 expression prevalence data within the NSCLC population and by patient characteristics (e.g., ethnicity, histology, smoking status, age, prior treatment, etc.).

The primary objective of the study will analyze and assess archival tissue specimens and associated RW data to:

* Increase the understanding of HER3 expression in NSCLC among HCPs and the medical community
* Generate evidence to support future clinical strategies in this area

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years in US
* Histologically or cytologically documented advanced or metastatic NSCLC
* At least one sample available and evaluable for HER3 expression

Additional population-specific inclusion criteria:

For Cohort 1:

* Tissue sample collected on or after January 1, 2013

For Cohort 2:

* EGFRm NSCLC previously treated with a 3rd generation EGFR TKI
* 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a 3rd generation TKI (defined as Osimertinib, Aumolertinib \[formerly Almonertinib\])

For Cohort 3:

* ALK+ NSCLC
* 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a TKI

For Cohort 4:

* NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion
* 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment

Exclusion Criteria:

* Prior treatment with an anti-HER3 antibody or topoisomerase I inhibitor (single-agent or combination)
* Prior treatment with an antibody drug conjugate (ADC) that contains a topoisomerase I inhibitor
* Previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease
Clinical Epidemiology of NAFLD in Children and Adolescents

Background: Non-alcoholic fatty liver disease (NAFLD) is rapidly increasing alongside overweight and obesity, not only in adults but also in children and adolescents. It is unknown what impact the development of NAFLD in childhood may have in later life. The importance of early detection and treatment lies in its potential for progression to cirrhosis, liver cancer and liver-related death, as well as its associated extrahepatic comorbidities. Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP) is an effective, non-invasive and safe diagnostic method to estimate the degree of fibrosis and steatosis in the liver, but little is known about its applicability in the paediatric population. Objectives: 1) To assess the prevalence of significant liver fibrosis (LSM≥6,5kPa) using VCTE, and that of non-alcoholic fatty liver disease (≥225dB/m) using CAP in children and adolescents. 2) To determine the optimal cut-off points of the CAP to achieve maximum concordance with the Magnetic Resonance Imaging (MRI) findings in the diagnosis of mild, moderate and severe NAFLD in children and adolescents. Methods: cross-sectional population-based study which will include 2.866 subjects aged ≥9 to ≤16 years. Participants will undergo: anamnesis, physical examination, blood extraction, VCTE, MRI and questionnaires on socio-demographic data, personal and family medical history and lifestyle assessment. Applicability and relevance: the study aims to establish the foundations for the use of VCTE in children and adolescents in order to achieve early diagnosis of NAFLD. Moreover, it will serve to understand in further detail the disease and to identify the risk groups of children and adolescents who may be at risk of developing it. Ultimately, this will help determine to which subgroups of the population we need to target resources for prevention and early detection of this entity, as well as possible intervention for its treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 9 and 16 years.
* Subjects whose parents/legal guardians have signed the informed consent.
* For subjects over 12 years: it will also be necessary to have their own signed informed consent.

Exclusion Criteria:

* Subjects with previously diagnosed liver disease.
* Subjects receiving hepatotoxic drug treatment.
* Subjects with diagnosed eating disorders.
Expressive Writing for COVID-19 Resilience

The purpose of this study is to determine the impact of a 6-week, virtually-delivered expressive writing intervention on resilience in a cohort of individuals currently navigating the COVID-19 pandemic during spring 2020.

The purpose of this study is to determine the impact of a 6-week, virtually-delivered expressive writing intervention on resilience in a cohort of individuals currently navigating the COVID-19 pandemic during spring 2020.

Eligible subjects will be adults who are able to read and write in English and are cognitively able to provide informed consent. Potential subjects will be recruited through the Duke Health \& Well-Being email lists. The entirely virtual 6-week expressive writing intervention will be delivered via Zoom, REDCap, and email, and subjects will complete measures at baseline, 6 weeks, and 10 weeks (1 month post-intervention). Each week of the intervention will invite participants to complete a series of expressive writing assignments designed to support emotional expression and cultivate resilience, and the assignments will take approximately 60-90 minutes each week to complete.

The primary outcome is the 25-item Connor-Davidson Resilience Scale (CD-RISC). Other measures will include a basic demographics survey, questions about COVID-19 impact, post-writing surveys collected after the writing assignments, the 10-item Perceived Stress Scale (PSS), the Center for Epidemiologic Studies Depression Scale-Revised, and the 21-item Post -Traumatic Growth Inventory (PTGI). Participants will also have the option to share the content of their writing assignments with the research team if they choose.

The risks of participation in this study are minimal and include the risk of mild sadness after the writing assignments and the risk of loss of confidentiality.

Eligibility Criteria:
Inclusion Criteria:

Potential subjects will be considered eligible if they feel they have been personally impacted by circumstances surrounding COVID-19. Other eligibility criteria include:

* Able to speak, read, write, and understand English
* Cognitively able to provide consent
* Ability to participate in a 6-week intervention delivered via Zoom, REDCap, and email
Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability

Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.

According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence cardiorespiratory function.

In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.

Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted.

This is a randomized control trial. The experimental group (EG) will perform the diaphragmatic fatigue protocol using a specific inspiratory endurance test, in which volunteers, one-on-one, and in a single session, will breathe against submaximal inspiratory loads equivalent to 60% of their Maximum Inspiratory Pressure (MIP) through a threshold valve device. The participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts.

The activation group (AG) will perform the protocol of 2 sets of 30 repetitions at 40% of their MIP, one-on-one, and in a single session, using a threshold valve device.

The control group will do a seat and wait.

The interventions will be supervised by a physiotherapist. The primary outcomes will be

Respiratory muscle strength will be assessed using a respiratory pressure meter or manometer designed, and with ultrasound image measuring the cross sectional area of the diaphragm at 8-9th rib level and speed of contraction with a deep and fast inspiratory manoeuver. This will be done immediately before intervention and immediately after intervention

Heart rate variability (HRV) will be assessed using a heart rate sensor Polar H10.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-45 years.
* Non-smoker.
* Engaged in sports activity at least 3 times a week for a minimum of one year.

Exclusion Criteria:

* Having a medical condition that impedes engaging in physical activity.
* Individuals with compromised cognitive capacities.
* Subjects with any chronic disease (cardiorespiratory, neurological, metabolic, oncological, etc.).
* Subjects with tympanic perforation or middle-inner ear pathology.
* Subjects who have undergone lower limb surgery within the past 12 months.
* Subjects experiencing an active episode of lower limb pain.
A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ED-SCLC) to evaluate the efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

Aged 18-75 years

Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC)

Ongoing clinical benefit (partial response \[PR\], or complete response \[CR\] per RECIST version 1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin, plus etoposide)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Subjects must have adequate bone marrow, renal and hepatic function

Exclusion Criteria:

Subjects with Central Nervous System (CNS) metastases

Subjects receiving consolidative chest radiation after last dose of first-line chemotherapy.

Subjects with pleural effusions that cannot be controlled with appropriate interventions.

All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline