cyrilzakka/clinical-trials huggingface dataset:
Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients

Observational, multicenter, one-arm, non-comparative study. Data will be recorded in a retrospectively manner. The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. The primary objective is describe the antitumor immune response generated in the context of IO (immunotherapy) treatment after cCRT in patients with unresectable NSCLC treated in real world.

The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1\>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically- or cytologically- documented NSCLC who present unresectable stage IIIA-IIIB-IIIC disease, according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology).
* ECOG 0-1.
* PDL1\>1%.
* Age ≥ 18 years at time of study
* Patients without progression after cCRT, that are going to receive IO treatment (Durvalumab) for 12 months as subsequent treatment as per standard clinical practice
* Patient capable of proper therapeutic compliance and accessible for correct follow-up.
* Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines.

Exclusion Criteria:

* Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
* No possibility of venipuncture
* Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
Human Anaplasmosis in Eastern France

Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever, cytopenia and hepatitis.This infection was initially described in United States. In Europe, its epidemiology is not well known. Some isolated cases have been diagnosed in several country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient living in Eastern France, and presenting with compatible clinical symptoms using a new diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our country and the clinical symptoms that are associated with Anaplasmosis.


Eligibility Criteria:
Inclusion Criteria:

* patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite-
* Or
* patient with fever with at least one of following criteria : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities.
* Or
* patient with tick-borne encephalitis, or primary stage Lyme borreliosis

Exclusion Criteria:

* children less that 10 years
* pregnancy
* patients with an other diagnosis that can explain clinical symptoms or biological abnormalities
* antibiotherapy with cyclins during the days before inclusion
Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population

Following labor, epidural or combined spinal-epidural (CSE) catheters are kept in place and deactivated. However, many women opt for procedures such as tubal ligation, which may require epidural anesthesia as a method of pain relief. Our study aims to confirm the ability to predict reactivation of epidural catheter in postpartum females through the electrical epidural stimulation test (EST) which was first described by the PI of this study approximately 20 years ago.

In this study, investigators hope to investigate the ability of the electrical epidural stimulation test (EST) to predict reactivation of epidural catheter in postpartum females. The standard practice for confirming the reactivation of epidural or CSE catheters requires methods such as dosing the local anesthetic. With the EST test this will allow for the anesthesiologist to determine whether or not the epidural can be activated immediately.

Eligibility Criteria:
Inclusion Criteria:

* Females, 18 years and older
* American Society of Anesthesiologists physical status I or II
* Status post natural labor/birth process or C-section
* Has epidural or CSE catheter
* Upcoming procedure requiring epidural/CSE anesthesia for pain management

Exclusion Criteria:

* Contraindication to regional anesthesia
* Allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl
* Use of sedatives or opioids
* Abnormal vertebrae anatomy
* Neurological disorder with lumbar involvement
* Implanted electronic devices
* Did not receive epidural or CSE anesthesia
Evaluation and Treatment of Patients With Epilepsy

This protocol has three purposes: 1) to screen patients with seizures for participation in research studies of NINDS s Clinical Epilepsy Section (CES), 2) to follow the natural course of seizure disorders, and 3) to train CES fellows in evaluating and treating epilepsy. Only standard diagnostic tests and treatments will be used in this study.

Patients of any age with seizures who are referred to CES may participate in this study. At the end of the study, patients may be discharged to the care of their referring physician, offered participation in another NINDS research protocol, or followed for teaching purposes.

Participants will undergo standard diagnostic procedures used to determine the type of their seizures, what part of the brain they are coming from, what is causing them, and whether standard drug treatments can help them. These may include some or all of the following:

* Physical and neurological examination
* Neuropsychological tests tests of learning and memory
* Electroencephalography (EEG) brain wave recording
* Evoked potentials tests of nerve reactions to lights and sounds
* Polysomnography simultaneous recordings of brain waves, breathing and eye movements
* Video-EEG monitoring simultaneous recording of seizures using a video camera and brain waves
* Video-EEG monitoring with extra electrodes to record muscle activity, breathing and eye movements for analyzing sleep patterns
* Imaging studies, such as magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to examine the structure and function of the brain
* Frequent blood tests to measure blood levels of anti-seizure drugs

Objectives: To evaluate patients with epilepsy

Study Population: adults and children with epilepsy

Design: In this protocol we will use standard clinical studies, including neurologic examination, antiepileptic drug levels, clinical neurophysiology (EEG, EMG, evoked potentials, simultaneous Video-EEG monitoring, polysomnography), computed tomography, structural functional, and spectroscopic magnetic resonance imaging, and other studies, such as FDG-PET (performed by nuclear medicine as a clinical procedure) and neuropsychological testing, to evaluate patients referred for uncontrolled or suspected seizures. Tests will be performed in patients when clinically indicated. The protocol will be used to screen patients for inclusion in other protocols, follow the natural history of seizure disorders, and train fellows in the evaluation and treatment of epilepsy. Both inpatients and outpatients will be studied. Standard clinical evaluation and drug treatment of epilepsy is performed under this protocol.

Outcome Measures: clinical characteristics of epilepsy

Eligibility Criteria:
* INCLUSION CRITERIA:

All patients older than 2 years referred to the Clinical Epilepsy Section will be included. DPA assignment for adults without consent capacity is required at the time of enrollment.

EXCLUSION CRITERIA:

None.
Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease

The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving haemodialysis for ESRD
* Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months

Exclusion Criteria:

* Pregnant or lactating women
* Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
* Patients who are HIV+
* Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months
How Important Are Hematological Parameters in the Prognosis of Severe Covid-19 Patients?

It is aimed to reveal the treatment and prognostic values by evaluating the differences in hematological parameters and indices, especially in dead Covid-19 cases.

Material Method: It is planned to retrospectively examine the hemogram parameters of 125 male, 44 female and 169 critical Covid-19 patients hospitalized between 01.03.2020 and 31.12.2021. Subjects were divided into 2 groups as deceased (77) and living (92) patients according to demographic data such as age and gender.

Statistical evaluation: All analyzes were SPSS 25.0, Kolmogorov Smirnov test was used to determine distribution, median and interquartile range (Tukey's Hinges Percentile) were used to summarize variables. The differences between the Independent-Samples Mann Whitney U Test and the data of the patient groups and the optimal cut-off values, sensitivity and specificity values will be determined by ROC analysis. It will be considered statistically significant when the p value is below 0.05 (with the two-tailed test)

The aim of this study is to examine the effectiveness of routine laboratory complete blood count parameters and rates as diagnostic and prognostic criteria in severe COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18
2. Critical patients taken to intensive care
3. The length of stay in the ICU is more than 24 hours

Exclusion Criteria:

1) Patients under 18 years of age (2) Patients with hematological malignancies (3) The length of stay in the ICU is less than 24 hours.
Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease

The primary objective is to investigate in patients suffering from intermittent claudication due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of HMR1766 to placebo, and calibrating such effect versus cilostazol.


Eligibility Criteria:
Inclusion Criteria:

* Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis etiology (symptoms present for 6 months or longer and not significantly changed within the past 3 months)
* Initial claudication distance of 30 to 250 meters at screening constant workload treadmill test
* Confirmation of underlying Peripheral Arterial Disease (PAD) at screening
* Confirmation of symptom stability at randomization based on constant workload treadmill test performance
* The patient must have optimal cardiovascular risk prevention and appropriate management of PAD, including clopidogrel at the dose of 75mg per day, during the study period

Exclusion Criteria:

* Patient participated in investigational clinical trials in the last month prior to screening
* Pregnant or breast-feeding woman or woman without documented double birth control measures for at least 3 months prior to randomization
* Symptoms of PAD before the age of 40 years
* Recent initiations or discontinuation of treatment by vasoactive agents (e.g., pentoxifylline, berprost sodium, papverine, isoxsuprine, nylidrin, cyclandelate, and niacin derivatives). Patients treated by cilostazol within 3 months prior to screening will also be excluded
* Recent lower-extremity surgical or endovascular arterial reconstructions or sympathectomy, or recent deep venous thrombosis
* Recent occurrence of at least one of the following: acute myocardial infarction, unstable angina, coronary artery bypass graft, percutaenous coronary intervention, transient ischemic attack or stroke

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers

Importance:

Patient reported outcome and experience measures (PROM and PREM) constitute a cornerstone of the collective efforts to improve and personalize healthcare systems. The EORTC quality of life (QOL) group developed instruments evaluating general and disease specific oncology QOL questionnaires, and the quality of information received. Implementation of PREM and relevant PROM is essential for equity, better resources utility, accessibility and patient centered treatment.

Objectives:

The investigators describe the EORTC INFO 25 translation process followed by investigation of subpopulation where action is most needed. The investigators investigate which QOL questionnaire better reflects clinical parameters among head and neck cancer (HNC) patients.

Design:

A prospective cohort. Setting Tertiary, referral, head and neck dedicated surgical service.

Participants:

Consecutive head and neck cancer adult patients, surgically treated, recruited between January to December 2022.

Exposures:

The investigators prospectively analyzed the new EORTC INFO 25 Hebrew questionnaire together with previously established Arabic translated version and the general (QLQ-C30) and specific (QLQ - H\&N43) oncology QOL questionnaires.

Main Outcomes and Measures:

Analyzing the quality of information provided and desired in diverse HNC subgroup of patients.

Analyzing which of PROM questionnaire better reflects HNC patients' disease and treatment parameters, which in turn, may predict poorer QOL.

Results:

The investigators recruited 60 patients, consisting of equal female: male ratio, of which 16.66% were native Arabic speaking. Validated INFO 25 scores (median 62.6±17.5) were not associated with patients' age, sex, education status, disease, and treatment parameters. Yet, the Arabic spoken sub-population had significantly lower scores (p\<0.001).

In contrast to QLQ-C30, clinical imperative associations were demonstrated between QLQ - H\&N43 and patients' disease stage (P\<0.001), admission days (p\<0.0001), free flap reconstruction (P\<0.001) and adjuvant radiotherapy (P\<0.001).

Conclusions and relevance:

The final version of the native EORTC INFO25 translation was approved by the EORTC. The investigators demonstrate lower INFO25 scores among the Arabic speaking population, suggesting frail equity and accessibility. In order to improve patients' centered treatment and resource utilization, the investigators reveal a strong association between disease severity and treatment aggressiveness and poor quality of life on specific, HNC oriented, EORTC QLQ - H\&N43 questionnaire that was not validated on EORTC QLQ-C30, which can be omitted.


Eligibility Criteria:
Main inclusion Criteria:

* Adult patients (≥18 years)
* Head and Neck cancer patients surgically treated

Main exclusion Criteria:

\* Illiterate
The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women

Violence against women is a major public health threat that carries significant consequences for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual assault (SA) are more likely than non-abused women to seek certain forms of health services, such as for sexually transmitted infections, chronic pain and illnesses, depression and/or pregnancy-related concerns. As a result, the health sector is an ideal setting to identify and support survivors. The U.S. Institute of Medicine has identified the health care system, including the public health infrastructure, as key for identification of and support for survivors of violence, as well as for violence prevention. While some evidence-based models exist, no current national consensus has been reached on scalable best practices in screening and brief counseling for IPV/SA.

This multi-level intervention includes integrating into the clinic setting IPV/SA screening, universal education, trauma informed counseling, warm referrals (e.g. provider/staff contact advocacy program with survivor) to local IPV/SA advocacy agencies, and access to the evidence-based myPlan safety decision aid app. The evaluation, using a cluster randomized trial design, will measure longitudinal outcomes (over 6 months) of patient self-efficacy, health and safety outcomes, as well as participant and provider perceptions of the intervention and clinic level changes in primary and reproductive health clinics in four states (Arizona, Massachusetts, Pennsylvania and West Virginia) to achieve the following aims:

Aim 1. Evaluate the effectiveness of an evidence-based screening, universal education and trauma-informed counseling with tailored safety action plan and referrals to partner IPV/SA programs compared to standard practice, on survivor health and safety outcomes over a cumulative period of six months.

Aim 2. Examine longitudinal changes in clinic-level screening, universal education, trauma informed counseling, safety action plans and referrals to on-site and/or partner IPV/SA programs and improved standards for documentation through the electronic health record (EHR) and continuous quality measurement and reporting.


Eligibility Criteria:
Inclusion Criteria:

* Seeking healthcare at one of 14 partner clinics
* Ability to complete a survey on a device (computer/tablet/smartphone in English or Spanish)
* Access to safe device (as defined above) if doing surveys online
* Has a safe email address or safe phone number
* Is not acutely ill

Exclusion Criteria:

* Male
* Not seeking healthcare at one of 9 partner clinics
* Younger than 18 years of age
* Older than 59 years of age
* Cannot read/speak English or Spanish
* No access to safe device if doing surveys online
* Does not have a safe email address or safe phone number
* Acutely ill
[BrainConnexion] - Neurodevice Phase I Trial

This study aims to evaluate the safety of a wireless implantable neurodevice microsystem in tetraplegic patients, as well as the efficacy of the electrodes for long-term recording of neural activities and the successful control of an external device.

The goal of this study is to develop a miniaturized wireless implantable neurodevice microsystem that records and transmits signals from the motor cortex of tetraplegic patients, bypassing the damaged nervous tissue, to control an external assistive device that restores some form of independence to patients in terms of communication or mobility.

Eligibility Criteria:
Inclusion Criteria:

1. 21 years old and older
2. Tetraparesis
3. Written informed consent obtained from the patient or legal representative (in the event where the patient is unable to provide consent) prior to entry into the study in accordance with local EC/IRB regulations and/or other application regulations for surrogate consent.
4. Able to perform the pre-operation Brain Computer Interface training as judged by the research team.

Exclusion Criteria:

1. Significant medical co-morbidities e.g. cardiac disease
2. Bleeding disorders
3. Any contraindication to surgery
4. Other concomitant intracranial pathologies
5. History of seizures or epilepsy disorder
6. Complications of coagulopathy
7. Surgically unfit
8. Significant psychological issues e.g. Depression
9. Poor psychological support
10. Pregnancy
11. No means of communication
12. Any disease, in the opinion of the Investigator, that is unstable or which could jeopardise the safety of the patient

If applicable, psychological assessment may be performed prior to selection as the implantation process will be a long a stressful event, requiring a significant degree of patient cooperation and resilience.
Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial

Physical activity exerts a variety of long-term health benefits in older adults.This randomised controlled trial investigates the effect of a 12-week physical exercise program on the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging. Follow-up lasts for 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. be above 65 years of age,
2. voluntariness
3. capacity to consent,
4. having passed medical entry exam by the Department of Sports Medicine,

4) regular mental capacity, 5) written informed consent

Exclusion Criteria:

1. untreated clotting disorders,
2. musculoskeletal diseases significantly reducing mobility,
3. severe bacterial or viral infections,
4. severe respiratory diseases (Gold IV),
5. acute pulmonary embolism,
6. instable angina pectoris or severe heart failure (NYHA III or IV),
7. severe vascular disease of the extremities or the brain,
8. severe pulmonary-cardiac dysfunction,
9. acute myocardial infarction or early phase of rehabilitation,
10. critical aortal stenosis,
11. severe hypertrophic and obstructive cardiomyopathy,
12. untreated malignant arrhythmias,
13. untreated severe hypertonia,
14. severe pulmonary hypertonia,
15. symptomatic cardiac malformations,
16. cardiac-block grade II or III,
17. left bundle branch block,
18. complex ventricular arrhythmias,
19. Cognitive impairment
Gene Mutations in Non-Small Cell Lung Cancer Cells

To compare the frequency of individual genetic abnormality between tumor cells and blood specimens.

Samples will be collected before the systemic therapy. After initiation of therapy, samples will be collected at end of the 1st month, at the end of the 2nd month at the end of 3rd months and once every three months thereafter concurrently with the tumor assessment such as time of performing CT scans. In selected consented patients, peripheral blood samples will be collected every week for the first month.

Disease status will be assessed every 2\~3 months and at the end of treatment according to RECIST criteria. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. Progression-free survival, overall survival and response rate will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic or cytological confirmation of NSCLC.
* Patients must understand and provide written informed consent prior to initiation of any study-specific procedures.
* Have a life expectancy 3 months.
* Have malignant pleural/pericardial effusion or metastatic non-small cell lung cancer.
* Have measurable or evaluable disease.
* ≥20 years.
* Candidate for systemic treatment such as EGFR-TKI or chemotherapy.

Exclusion Criteria:

* Prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.