cyrilzakka/clinical-trials huggingface dataset:
The Systemic and Brain Oxygen Stauration Change During Bronchoscopy

Bronchofiberoscopy is a widespread invasive intervention in clinical practice with a number of diagnostic and therapeutic indications. The Clinic of Pulmonary Medicine in Debrecen carries out nearly 2000 examinations a year. The intervention is guided by the recommendation of the Vocational College for Pulmonary Medicine in 2005, but it does not contain a clear recommendation on the oxygen therapy used during the intervention. The Hungarian recommendation states that pulsoximetry is mandatory in bronchoscopy, but it does not contain information on the indications and the implementation of oxygen suplementation. The British Thoracic Society Guideline 2013 deals with the issue and makes the following statements:

* patients should be monitored for oxygen saturation under bronchofiberoscopy
* oxygen supplementation during the test is recommended if the patient's desaturation is significant (greater than 4% or less than 90%) and is over 1 minute
* during the bronchoscopy, the occurrence of oxygen saturation decreases depending on the level of initial oxygen saturation, respiratory function, co-morbidity, sedation and the course of intervention.

The aim of our study is to investigate the frequency with which systemic hypoxia occurs during bronchoscopy, what factors may contribute to its development and how the level of cerebral oxygen saturation changes with systemic desaturation (in the case of NIRS, a 20% reduction from baseline is considered significant).

: Consecutive patients admitted to Bronchology Laboratory of Department of Pulmonology, University of Debrecen for flexible bronchoscopy were asked to participate in the study. After explaining the procedure in detail, all patients gave written informed consent.

The indication of flexible bronchoscopy was based in all cases on the results of medical history, physical examination, chest X-ray and/or chest CT scan, lung function tests and laboratory parameters including hemoglobin concentration, hemostasis variables as well as blood gas analysis when necessary.

Bronchoscopy (PENTAX EB-1975K) was performed after an at least 4-hour fasting period. The procedure was performed either in sitting or supine position after a topical administration of lidocaine 2% solution. Routine monitoring consisted of ECG, non-invasive blood pressure measurement, pulse oxymetry (finger probe). As an additional monitoring tool, near infrared monitoring sensor was placed to the forhead of the dominant hemisphere of patients for monitoring cerebral oxygen saturation. INVOS 5100 C cerebral oximeter (Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA) was used for cerebral near infrared spectroscopy measurements.

Eligibility Criteria:
Inclusion Criteria:

inclusion criteria: adult patients (over 18 years) going elective bronchoscopy

Exclusion Criteria:

age under 18 years
C-Brace Prospective Registry

To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.

The purpose of the C-Brace Prospective Registry is to gather prospective baseline and follow-up data to characterize the safety and effectiveness of the C Brace. Patients casted for C-Brace fitting and willing to provide informed consent at participating clinics will be enrolled in the registry. All patients will be followed in accordance with the standard of care for a C-Brace, which will include, at a minimum, baseline evaluation, fitting, patient training/therapy sessions, follow-up at 6 months, 12 months, 24 months and 36 months after the definitive fitting of the C-Brace.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been evaluated and successfully tested with the Trial Tool, and has been casted for a C-Brace.
* Patient is able to communicate, provide feedback, understand and follow instructions during the course of the registry.
* Patient is willing to provide informed consent.

Exclusion Criteria:

* Patient is geographically inaccessible to comply and participate in the registry.
* Patient has not been casted for a C-Brace fitting.
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).


Eligibility Criteria:
Inclusion Criteria:

* Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
* Is scheduled to undergo a unilateral Total Shoulder Arthroplasty.

Exclusion Criteria:

* Is undergoing a revision surgery.
* Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone.
* History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
* Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
* Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator.
* Has been administered immediate-release bupivacaine HCl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery.
* Has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer).
* Has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years.
* Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection.
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy).
* Has a body mass index (BMI) \>40 kg/m2.
Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity

Head and neck squamous cell carcinoma (HNSCC) are malignant tumors originating from the epithelial mucosa of the upper aerodigestive tract. The oral cavity is the most frequent location of HNSCC (oral squamous cell carcinoma: OSCC). Tobacco use and alcohol consumption are the greatest risk factors. The Hauts de France region has one of the highest incidence rates of OSCC. The overall survival of patients with OSCC remains low, with a 5-year overall survival rate of around 60%. In addition to the oncological prognosis, OSCCs and their treatment have a significant impact on the quality of life of patients. An early diagnosis of OSCC is recommended, but it remains difficult. It can be for example challenging to diagnose OSCC in a context of oral premalignant lesions. Identifying objective biomarkers of malignancy would be an advantage and would allow better progress in the field of precision medicine and surgery for these tumors.

The investigators propose to establish the diagnostic use of an optimized DNA methylation profile detected in the saliva of OSCC patients by comparing these epigenetic marks before and after tumor resection.

The investigators will construct a consolidated signature of 4 genes whose DNA is subject to methylation and gene expression is restricted to cancer cells, by crossing TCGA analysis with single-cell analysis (single-cell RNA sequencing).

The investigators propose to analyse DNA methylation of the corresponding genes in the saliva of n=30 OSCC patients recruited for primary surgical resection in the Department of Maxillofacial Surgery vs controls. In addition, the investigators will examine the methylation profiles before / after complete excisional surgery of OSCC. This pilot study will aim to validate the analysis of DNA methylation markers in saliva of OSCC, with the aim of improving the diagnostic precision of OSCC and, secondly, to compare these markers before and after treatment by primary surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient group:
* Patients from the maxillofacial surgery department treated for a histologically confirmed squamous cell carcinoma of the oral cavity
* Patients whose first-line treatment decision at the multidisciplinary meeting in the service of Maxillofacial Surgery is surgery
* Patients who have not yet been treated surgically or by neoadjuvant treatment
* Patients over 18 years old
* Patients who have provided free and informed consent in writing
* Patients benefiting from a social security scheme

Control group:

* Patients in the maxillofacial surgery department not covered for head and neck cancer
* Patients over 18 years old
* Patients who have provided free and informed consent in writing
* Patients benefiting from a social security scheme
* Control group homogeneous with the patient group according to age, sex, tobacco and alcohol consumption

Exclusion Criteria:

* Patients with other types of cancer
* Patients under the age of 18
* Pregnant or breastfeeding women
* Patients under guardianship, curators, legal protection or deprived of liberty
Mild Therapeutic Hypothermia During Severe Sepsis

Objectives: to evaluate the feasibility, the safety and the effects on physiological parameters of mild therapeutic hypothermia during septic shock.

Design: a randomized, controlled, pilot physiological study. Setting: a 15-beds university-affiliated intensive care unit of a teaching Hospital.

Patients: twenty ventilated and sedated adults patients with septic shock Intervention: Mild therapeutic hypothermia between 32 and 34°C during 36 consecutive hours using an external water cooling blanket.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18-yrs,
* sedation and mechanical ventilation for at least 48-hrs,
* the diagnosis of septic shock according to standard guidelines.

Exclusion Criteria:

* bradycardia \< 50 bpm, or any severe ventricular rhythm disturbances,
* pregnancy,
* need for emergent surgery or any other complementary exam involving patient transport within the sixth hours following inclusion,
* decision to withdraw or withhold life support,
* predictable death within six hours.
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery

The aim of this study is to examine the effects of altitude (high altitude versus low altitude) on incidence and severity of postural puncture headache (PDPH) following spinal anaesthesia for caesarean delivery. The investigators hypothesized that the risk of PDPH would be higher in highlander parturients than in lowlander parturients.

This will be a prospective cohort study conducted in two different altitudes in Nepal. The high-altitude site is in Jumla, approximately 2514 m above the sea level, and a low altitude city is Dharan, located at 350 m from sea level.

The investigators will screen the eligible participant admitted to the in-patient obstetric unit. The investigator will also record patient baseline characteristics, preoperative anxiety, antenatal depression, presence of chronic pain conditions or preexisting headache. Spinal anaesthesia will be administered in the sitting position at the L3-L4 or L4-L5 interspace using a 25-G pencil point spinal needle (Pencan® 25-gauge).

The diagnosis of post-dural puncture headache will be based on the international headache society ICDH-3 criteria

Eligibility Criteria:
Inclusion Criteria:

* Parturient, aged more than or equal to 18 years
* American society of Anesthesiologist 2 and 3
* Scheduled for elective and non-elective (category 2 \& 3) caesarean delivery with spinal anesthesia
* Native to their resident altitude i.e., those born, raised, and have continuously lived at the same altitude, at least for the past 1 year.

Exclusion Criteria:

* Hypertensive disorder
* Cerebrovascular disease
* Mental disorder (schizophrenia and other psychotic disorders)
* Known fetal anomalies
* Contraindication to spinal anaesthesia.
* Those requiring general anaesthesia for delivery due to failed spinal anesthesia
* Major post-delivery complications (severe haemorrhage, sepsis, or ICU admission)
* Those who migrate from their resident altitude (either low to high or vice versa) within 7 days post-delivery will also be excluded.
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Provide written, informed consent to participate in the study and follow the study procedures
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Measurable disease per RECIST 1.1 criteria
* Histologically or cytologically documented inoperable, locally advanced or metastatic urothelial cell carcinoma (also termed TCC)
* Fresh biopsy or archival tissue
* No prior systemic chemotherapy or investigational agent for inoperable locally advanced or mUC
* Ineligible for cisplatin

Key Exclusion Criteria:

* Patients who have an active, known or suspected autoimmune disease
* Patients must not have received prior IL-2 therapy
* Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte associated protein 4 (anti CTLA-4) antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Patients with hypertension must be on a stable antihypertensive regimen for the 14 days prior to Cycle 1 Day 1

Additional protocol-defined inclusion/exclusion criteria applied
High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)

Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Data on the original coronavirus -SARS pneumonia suggested that high dose (\>160ppm) inhaled Nitric Oxide could have beneficial effects also on COVID-19, due to the genomic similarities between these two coronaviruses (1-3). This study will test whether high dose inhaled nitric oxide is safe and can reverse virus burden and respiratory failure in patients on mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed infection with COVID-19 positive RT-PCR tracheal aspirate prior to treatment
2. Use of mechanical ventilation with or without ECMO
3. Male or female ages \> 18 years
4. \< 14 days from symptom initiation to study enrolment and \< 7 days from intubation to study enrolment

Exclusion Criteria:

1. Patients on other interventional clinical trials
2. Subjects diagnosed with congestive or unstable heart disease including heart failure, left ventricular dysfunction (LVEF \< 40 %) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
3. Subjects diagnosed with immunodeficiency
4. Hematology: patients with clinically significant anemia e.g. Hemoglobin \< 100 and thrombocytopenia e.g. Platelets \< 75
5. Subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding
6. Hepatic Function: Patients with abnormal liver function defined as any two of the following ALT \>3x ULN, AST \>3x ULN, Total bilirubin \< 1.5 X ULN
7. Patient receiving drugs that have a contraindication with NO e.g. use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening as relevant to the proposed study population
8. Pregnancy
9. Subjects with a known hypersensitivity to methylene blue, subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency
10. Known or suspected thalassemia, sickle cell disease, or other conditions associated with poor oxygen carrying capacity
Chairless Chair Exoskeleton. Work-physiological-biomechanical Analysis of the Lower Extremities

Standing work is associated with increased risks of venous and musculoskeletal disorders; particularly low back pain is commonly reported in prolonged standing work. In manufacturing work, workstations often do not allow standing aids due to insufficient functional and spatial conditions. In 2014, the car manufacturer Audi introduced the lower leg exoskeleton developed by Noonee to their employees working in the factories. This exoskeleton, the 'Chairless Chair' has the advantage that standing work can be performed while technically sitting on this device. The exoskeleton offers the potential for reduced awkward body postures, but it is unclear which physiological and biomechanical loads are influenced and how. This proposal provides a study design evaluating the 'Chairless Chair' in a laboratory setting, by testing its effectiveness in terms of physiological and biomechanical parameters. It is suggested to compare different assembly tasks while wearing the exoskeleton, compared with not wearing the exoskeleton. The 'Chairless Chair' is developed in one size only, which is why we propose to include participants of different body height, which will enable us to investigate whether body height influences the effectiveness of wearing the device.

Each participant was exposed to all experimental conditions, which were the following:

* Standing without the exoskeleton
* Sitting with the exoskeleton

For both experimental conditions, the working height was adjusted to the individual to become optimal. The working distance to the simulated assembly tasks was also adjusted to the individual to become optimal. Both the working height and distance were based on textual guidelines provided in DIN EN ISO 14738:2009-07.

Each work cycle consisted of assembling and disassembling the following three tasks:

* Screwing
* Clip fitting
* Cable mounting

In addition, we investigated suboptimal working heights and distances. The results of these suboptimal conditions will not be reported in the results on this website, but in a separate publication.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 18 and 40 years old;
* Gender: male;
* Voluntary informed consent (oral and written) is obligatory for study participation.

Exclusion Criteria:

* Age: \<18 and \>40 years old;
* Gender: female;
* People under the influence of intoxicants, analgesics, or muscle relaxants;
* Alcohol abuse;
* People with cardiovascular diseases;
* People with a heart pacemaker;
* People with a disability who, due to their restriction at a workplace of this kind, will not be able to participate;
* People with Diabetes Mellitus;
* People with severe muscle contractions of the lower extremities, back or arms;
* People with acute ailments or pain;
* People who are unable to complete the examination program due to language or cognitive obstacles;
* Depending on the degree of severity, people with diseases of the veins and joints of the lower extremities, spine, muscle disorders, symptomatic neurological-psychiatric diseases, acute pain syndromes, maladies or other current diseases.
Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life

The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes.

Questions remain about patients' perception and acceptance on this automatisation of the management of their glycemic variability.

Thus this study is built to evaluate the impact of the activation of the closed-loop on quality of life and burden of their diabetes in patients with type 1 diabetes under CSII.

This cohort study will follow patients with type 1 diabetes undergoing under continuous subcutaneous insulin infusion (CSII) with Continuous Glucose Monitoring (GCM). After inclusion visit, there's a 20 days' period to assess their quality of life and perception of the burden of their diabetes and confirm their eligibility to the closer-loop. During this 20 days' period, patients should complete all the self-questionnaires.

Then, during the 2d visit, the closed-loop will be activated by the diabetologist for a 6 months follow-up including six visits with 3 phone contacts (at week 1, week 2 and week 6) then 2 direct visits at 3 months and 6 months.

The 3 phone contacts are mainly planned, as recommended in French guidelines, to ensure the good use of the device and to detect or prevent any unexpected events.

The 2 visits at 3 and 6 months, are planned to assess the glycemic variability using Continuous Glucose Monitoring data and to collect perception of the patients via the 2 main criteria self questionnaires (Quality of life and burden to be filled-in by patients at 3 and 6 months) and all perception dimensions by all the self questionnaires.

Main results will provide data on the evolution of quality of life and burden of diabetes by comparison between scores at 6 months and baseline, and evolution of glycemic variability.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patients undergoing a CSII therapy for at least 6 months and using Tandem t:slim X2 for at least 4 weeks.
* Patient using CGM for 6 months including Dexcon G6 for at least 4 weeks.
* Eligible patient (according to French Society recommendations) for activation of the closed loop
* Informed Patient accepting the computer processing of their medical data.
* Patient correctly completing the 2 main self questionnaires
* Patient with HbA1c below 11%

Exclusion Criteria:

* Pregnancy or Lactation during the study
* Patient with a diabetic retinopathy not controlled by laser
* Patient suffering from a disease or undertaking a treatment altering glucose metabolism