cyrilzakka/clinical-trials huggingface dataset:
Stress and Anxiety Affect Residents' Performance

Being an anesthesiologist implies huge dedication and both physical and psychological efforts. None has ever studied the impact of a working day on anxiety, perceived stress levels, physiological data, and executive functions.

During a working day, trainees will have their physiological and psychological data recorded before starting their clinical activity and after them. Electrodermal activity with the eSense device, Executive functions through the TOL-R and all the questionnaires and scales will be sampled at the beginning of the day and at the end of the day the same procedure will be applied again (exclusion for PSS-10 scale, STAY-Y trait anxiety and GAD-7) eSense and TOL-R, are useful tools to understand sympathetic activity and executive functions. The galvanometer it is the gold standard to measure EDA; i.e. electrodermal activity, which is a pure sympathetic index, while Tower of London it is the gold standard to assess planning, monitoring and programming skills, both data are supposed to be heavily involved in an anesthesiologist trainee during the all day.

The aims of the study are to evaluate executive functions at the start and at the end of a working day and to understand theirs relationship with anxiety, perceived stress levels and physiological changes in sympathetic activity.

Eligibility Criteria:
Inclusion Criteria:

* Being an anesthesiologist residents
* Written informed consent obtained

Exclusion Criteria:

* Psychiatric disorders
* Neurological disorders
* Suffering from high blood pressure
Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization

Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE

The incidence of hepatocellular carcinoma (HCC) has increased significantly over the past 30 years.

The majority of HCCs present at an intermediate stage, ineligible for a curative surgical approach and the reference treatment in this situation corresponds to a palliative locoregional treatment of Transarterial chemoembolization (TACE). This treatment modality can be repeated several times and the interval between each session as well as the modalities to evaluate the efficacy of this procedure remain poorly codified. This evaluation is currently based on imaging performed at one month (M1) (MRI and/or CT scan) more or less associated with the study of the variation of the alphafetoprotein level measured before (baseline) and after (M1) the treatment. However, these evaluation tools have many limitations and remain imperfect in predicting response to treatment.

In this context, liquid biopsy, which is experiencing significant growth in oncology, could be a promising tool. It is characterized by the detection of tumor elements in the bloodstream such as circulating tumor DNA (ctDNA). Several studies have successfully demonstrated the diagnostic or prognostic value of ctDNA in patients followed for HCC.

the aim of our study is to evaluate the impact of ctDNA detection in the follow-up of patients treated by TACE.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal, and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared with non-tumor liver parenchyma) at the portal phase or late phase compared with non-tumor parenchyma.
* Histologically diagnosed HCC in the absence of an imaging diagnosis
* Patient with a first TACE (naive) or not, regardless of the number of previous procedures
* Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.
* Treatment decision validated by the digestive oncology staff.
* Patient having read and understood the information letter and signed the informed consent.
* Patient follow-up performed at the Charles Nicolle University Hospital in Rouen.

Exclusion Criteria :

* Other active cancer or hematological malignancy, currently being treated
* Patient not affiliated to the social security system
* Pregnant woman or woman in labour or breastfeeding
* Person deprived of liberty by an administrative or judicial decision
* Person placed under court protection
Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy

RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment.

PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.

OBJECTIVES:

* Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy.

OUTLINE: This is a prospective study.

Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer
* Any disease stage allowed
* Undergoing targeted treatment

Exclusion Criteria:

None
Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 2)

The research is aimed to asses the validity of the communication system improving the quality of life and the degree of sanctification of clinical patients and their caregiver.


Eligibility Criteria:
Inclusion Criteria:

* Escorial revised criteria (Brooks et al., 2000),The diagnosis of ALS requires:

(A) the presence of:

* (A:1) evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiological or neuropathologic examination (A:2) evidence of upper motor neuron (UMN) degeneration by clinical examination, and
* (A:3) progressive spread of symptoms or signs within a region or to other regions, as determined by history or examination, together with: (B) the absence of (B:1) electrophysiological or pathological evidence of other disease processes that might explain the signs of LMN and/or UMN degeneration, and (B:2) neuroimaging evidence of other disease processes that might explain the observed clinical and electrophysiological signs.

  * If they were Taiwanese and used traditional Chinese(Mandarin).
  * If they were older than age 20 years.

Exclusion Criteria:

* If they had been diagnosed with frontotemporal dementia, severe depression, or schizophrenia.
* If they cannot see the communication board after correction.
* If they cannot complete the questionnaire with researchers or family members help.
PSA Versus STN DBS for DT

The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.

This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating dystonic tremor. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Three months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 7 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with dystonic tremor based on the MDS 2018 consensus
* Duration of DT symptoms: ≥3 years of motor symptoms
* If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent
* Good compliance and written informed consent

Exclusion Criteria:

* Any intracranial abnormalities that would prevent DBS surgery
* Any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
* Severe cognitive impairment, MOCA score \<24
* Any current substance or alcohol abuse according to DSM-V criteria
* Any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints
* Any terminal illness with a life expectancy of \<1 year
Effectiveness of Smoking Cessation Advice Combined With Spirometric Results in Adult Smokers (ESPITAP)

The purpose of this study is to evaluate the effectiveness of the spirometric results information advice about the smoking habit the investigators designed an intervention trial in primary care.

Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction and abandonment than just smoking cessation advice.

Expected results: In adult smokers, a detailed discussion of the results yielded by spirometry tests together with brief smoking cessation advice on the part of the primary care practitioner can facilitate tobacco reduction and abandonment.

Main objective: To evaluate the effectiveness of smoking cessation advice combined with a detailed discussion of the spirometric results with the primary care practitioner on the smoking habit in adult smokers.

Methodology:

Design: Intervention study using a randomised control group. Setting: 12 primary care centres of two health areas. Participants: 600 smokers, aged 35 to 70 years, seeking medical advice from their primary care practitioner (GP) for any given reason (selection visit), excluding those patients with Chronic Obstructive Pulmonary Disease (COPD).

Measurements and interventions: In the selection visit, all participants will be required to undergo a series of tests that will include spirometry, tobacco dependence test, a test to measure the motivation to stop smoking and a structured questionnaire on sociodemographic data, smoking habit, respiratory symptomatology, etc. Based on the spirometric results, patients presenting airflow limitation will be excluded.

Randomisation will be performed using a computer programme. Randomisation will be carried out by the Coordinating Centre.

All other patients will be scheduled for another visit with their primary care practitioner one month later. In this visit (visit 1) and depending on the randomisation into 2 groups, one group will be given brief but structured smoking cessation advice together with a detailed and structured discussion of the spirometric results while the second group will also be given the same brief smoking cessation advice but without discussing the spirometric results. Both groups will be scheduled for a visit at 6 months (visit 2), and at 1 year (visit 3). During visit 2, the patient will be asked about his or her smoking habit. One month before visit 3, patients will be required to undergo again the series of tests performed prior to visit 1. In visit 3, all those patients who claim to have stopped smoking will be required to take a carbon monoxide test.

Eligibility Criteria:
Inclusion Criteria:

* Adult smoker subjects aged between 35 and 70 years

Exclusion Criteria:

* Previous antecedents of any respiratory disease
* Suffering of any chronic or terminal disorder
* Counterindication to undertake spirometry or that may hinder the performance of the spirometry test
Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.

Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-70 years old
* ECOG performance status 0-1
* Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
* Adequate organ function

Exclusion Criteria:

* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* Previous serious cardiac disease
GB001 in Adult Subjects With Moderate to Severe Asthma

A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria

* A diagnosis of asthma by a physician at least 12 months before Screening Visit.
* Treated with medium or high dose inhaled corticosteroid (ICS) plus additional controller for at least 12 months prior to Screening Visit. Subjects must maintain a stable ICS dose regimen during the 4 weeks prior to the Screening Visit.
* Forced Expiratory Volume in 1 second (FEV1) of ≤ 85% of predicted normal
* Demonstrated reversibility of at least 12% in FEV1
* Evidence of uncontrolled asthma
* Eosinophilic asthma
* No changes in ICS dose and compliant with standard of care asthma therapy during run-in period.

Exclusion Criteria

* Current smokers (any substance)
* Serious co-morbidities
* Fridericia's correction QT factor (QTcF) ≥450 msec (male) or ≥470 msec (female)
* Use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to Screening Visit
* Regular use of systemic corticosteroids or immunosuppressive treatments or monoclonal antibodies for asthma
* Pregnant or breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply.
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis

This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant \[ASCT\]) and have persistent cardiac dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Confirmed diagnosis of systemic AL amyloidosis
3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic response
4. Cardiac involvement
5. NT-proBNP ≥650

Exclusion Criteria:

1. Non-AL amyloidosis
2. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma
3. NT-proBNP \>5000
4. Received Plasma cell directed chemotherapy within 6 months
5. Received autologous stem cell transplant (ASCT) within 12 months
Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.

This study is being conducted to compare the impact of somnolence (sleepiness) on cognition (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after a meal) and in the fasted state (before a meal) in patients with moderate to severe spasticity.


Eligibility Criteria:
Inclusion Criteria:

* IRB approved ICF must be signed and dated by patient or patient's legal representative
* Male or Female 18 years of age or older
* Clinical diagnosis of established spasticity (at least 3 months) secondary to multiple sclerosis, stroke, or spinal cord injury
* Currently on stable dose of up to 36mg of Zanaflex
* Must be able to swallow tablets or capsules whole

Exclusion Criteria:

* Patients with dementia, aphasia, or other deficits in cognition
* Unwilling or unable to complete cognition test or daily diary
* Known sensitivity to Zanaflex
* Taking Zanaflex on an as needed ("prn") basis
* Currently being treated with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine)
* Currently on any other muscle relaxant or any drugs having muscle relaxant properties (including baclofen, dantrolene, diazepam and other benzodiazepines, tranquilizers, narcotic analgesics, high dose neuroleptics, chlormezanone, meprobamate, methocarbamol, orphenadrine, carisoprodol, gabapentin and clonidine
* Taking any over-the-counter or prescription sleep aids within 30 days prior to screening
* Use of illegal drugs or legal drugs for recreational purposes or excessive use of alcohol
* Patients suffering from disabling, symptomatic hypotension (i.e., syncope)
* Patients having any systemic disease such as renal insufficiency, clinically relevant elevations in hepatic transaminase, severe, uncontrolled systemic hypertension
* Any clinically significant illnesses, within four weeks of screening
* Patients with known sleep disorders
* Patients who participated in a clinical trial within thiry days prior to screening
* Women of childbearing potential who are pregnant, have a positive serum pregnancy test, lactating, or do not or will not take adequate contraceptive precautions for the duration of trial
Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing RIRS

This study will include patients aged between 18 and 70 who will undergo retrograde intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 40 patients in each group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the level of pain felt by patients in the postoperative period.

The level of pain of the patients in both groups will be evaluated by using visual analog score (VAS) and verbal rating score (VRS) in the postoperative 0 min (the moment patients gets consciousness after he/she wakes up from general anesthesia), 10th min, 30th min, 60th min and 120th min.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18-70 years old
* Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone

Exclusion Criteria:

* Patients with uncontrolled diabetes mellitus and diabetic nephropathy
* Patients with blood pressure \> 140/80 mmHg despite regular use of antihypertensive agent(s)
* Patients with chronic kidney failure who need dialysis
* Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
* Patients who have had pyelonephritis 3 months or much earlier
* Patients younger than 18 years or older than 70 years
* Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
* Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
* Patients using any kind of medication that can affect his/her perception of pain
Post Lumbar Radiofrequency Neurotomy Imaging

MRI imaging post radio frequency ablation procedure for facet arthritis

This study is an imaging study. Following a radio frequency ablation procedure for facet arthritis low back pain the patient can join the imaging study.

During the study the patient undergo contrast enhanced MRI imaging of the lumbar spine Once the imaging is done the patient finishes the study

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and females, legally able and willing to participate in the study
2. Able and willing to complete the research questionnaires and communicate with the investigator and research team
3. Patients who are scheduled to have bilateral or unilateral treatment by radiofrequency neurotomy for chronic lumbar pain.

Exclusion Criteria:

1. Pregnant or breastfeeding patient
2. Patients younger than 18
3. Patients unable to understand and complete the research questionnaires in English
4. Patient with any contraindication for MRI contrast agents - Patients with known intolerance or allergies to the MRI contrast agent (e.g., Gadovist) including advanced kidney disease
5. Patients with a pacemaker, implanted defibrillator or internal pacing wires.
6. Patient with mechanical heart valve
7. Patient with an aneurysm clip
8. Patient with eye surgery or injury involving a metallic object
9. Patient with ear surgery or implanted device to the ear
10. Patient with any implanted electrical, metallic or magnetic device such as implanted neurostimulator, implanted drug infusion pump or bone growth stimulator
11. Patient with any kind of prosthesis (Eye, Ear, Penile, limb), or any other metal in your body from surgery or injury
12. Patient with vascular clamp, filter, coil or stent
13. Pregnant or breast-feeding patient
14. Patient with anemia, liver disease or history of MRI contrast reaction
15. Patient with any known kidney disease, prior kidney surgery or on dialysis
16. Patient with hypertension or diabetes that requires medication
17. Patient with any metal in or on their body (example: shrapnel, BB's, Tattoos, permanent makeup)
18. Patients who are claustrophobic or known adverse psychological reactions with previous MRI
Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Eligibility Criteria:
Inclusion Criteria:

* Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
* Open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria:

* Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
* Prior ALT
* Prior SLT within 90 days of screening visit