cyrilzakka/clinical-trials huggingface dataset:
Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing

The study first aim is to investigate the relationship between different patterns of electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to optimize spinal cord stimulation parameters . The second aim of the study is to investigate the role of the spinal cord in some aspects of cognitive-sensory-motor processing, specifically the presence of top-down attentional effects on the sensory analysis of an external stimulus at the spinal cord level.

The study will be performed on patients that will be implanted with a spinal epidural electrode because of chronic intractable pain. From these electrodes, spinal cord evoked potentials (SCEPs) will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 70
* Candidates for spinal cord stimulation
* Epidural electrode at the the level of the cervical or thoracic spine.

Exclusion Criteria:

* Generalized sensory deficit interfering with the recording of spinal cord evoked potentials
Vibrational Spectroscopy for Endometrial Cancer Diagnosis

The purpose of this study is to investigate the ability of vibrational spectroscopic techniques, Raman spectroscopy and Attenuated Total Reflection - Fourier Transform Infrared spectroscopy (ATR-FTIR), to accurately differentiate endometrial tissue, lymph nodes and blood samples with womb cancer or endometrial hyperplasia from healthy controls.

Womb cancer is the sixth most common cancer in women, with rising incidence worldwide. Current diagnostic strategies are time consuming, invasive and have limited accuracy, furthermore there is no population-wide screening. Treatment depends on patients' health, type of disease and spread at the time of diagnosis. Most women will be offered surgery, however the role of lymph node dissection in early stage disease remains controversial.

There is therefore a need for an objective, accurate test, able to detect pre-cancer and cancer early and able to identify metastatic node involvement, so that lymph node excision is performed only when necessary.

Attenuated Total Reflection - Fourier Transform Infrared (ATR-FTIR) spectroscopy and Raman spectroscopy are non-invasive, objective techniques that use the interaction of light within tissues to gain detailed information about the chemical composition of biological samples. These methods have shown tremendous potential for improving diagnosis and treatment of cancer.

This study aims to use Vibrational Spectroscopy to examine blood plasma and serum, endometrial biopsies via Pipelle device and pelvic/para-aortic lymph nodes for the presence of endometrial pre-cancer and cancer changes. The analyses will be performed on fresh (wet) as well as dried samples.

The ultimate goal is to develop a point-of-care test and an intra-operative tool for endometrial cancer screening and diagnosis. Such a test could speed up endometrial cancer diagnosis, reduce treatment delays and individualise patients care.

Eligibility Criteria:
Inclusion Criteria:

1. Endometrial cancer group:

   * Established histopathological diagnosis of cancer of the endometrium (any stage and subtype)
   * Patients must be eligible for primary staging surgery (any route, e.g. laparoscopy and laparotomy)
2. Endometrial hyperplasia group:

   * Established histopathological diagnosis of endometrial hyperplasia (with or without atypia)
   * Treatment with hysterectomy deemed necessary
3. Control group

   * Healthy with benign disease, non-malignancy
   * Undergoing hysterectomy (any route, e.g. laparoscopy and laparotomy)

Exclusion Criteria:

* Patient's refusal / inability to consent
* Synchronous gynaecological cancer (ovary, cervix, fallopian tubes)
* Previous pelvic radiotherapy
* Previous hysterectomy
* Undiagnosed vaginal bleeding
* Previous endometrial ablation
Breathing and Attention Training for Chronic Low Back Pain

The purpose of this research study is to see if breathing and attention training (BAT) treatments improve pain symptoms and well-being in people who have chronic low back pain (cLBP). For this breathing intervention, you will be randomly assigned to either standard or focused BAT. The standard BAT includes instructions on deep breathing and relaxation. The focused BAT is similar to the standard BAT in most ways but includes extra instructions to help you focus and alter your breathing patterns.

The primary objective of the proposed pilot randomized controlled trial (RCT) is to examine the safety, feasibility, and acceptability of a 5-day breathing and attention training (BAT) in a sample of 30 adults with cLBP. The secondary objective is to explore preliminary clinical efficacy and potential mechanisms of the breathing interventions (focused-BAT and standard-BAT), by examining changes in clinical pain outcomes and potential pain-related psychological, physiological, and behavioral mediating variables. Both interventions will be delivered via an audio recording in order to standardize the interventions across participants and to enhance treatment fidelity. Results from this study will inform the successful design and implementation of a larger RCT and provide preliminary evidence regarding the potential efficacy of this breathing intervention for people with cLBP.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain consistent with recommendations of the NIH task force on cLBP (i.e., participants with cLBP of at least moderate impact that has persisted on more days than not over the past 3 months)
* Age 18-65

Exclusion Criteria:

* Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia).
* Asthma, breathing problems, or a respiratory disorder (e.g., chronic obstructive pulmonary disease).
* Daily use of opioids. We will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. Other medications being used will be recorded and controlled in statistical analyses as needed.
* Uncontrolled hypertension (i.e. SBP/DBP of \> 150/95), orthostatic hypotension, cardiovascular or peripheral arterial disease. These exclusions are in place primarily for safety reasons, however, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals.
* Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, vasovagal syncope) or evidence of previous brain injury, including stroke and traumatic brain injury.
* Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation.
* Current substance use disorder or history of hospitalization for treatment of substance use disorder.
* Pregnant
* Any significant comorbidities that, in the opinion of the investigators, could interfere with the study or lead to deleterious effects for the patient.
iScreen Study: Best Methods for Social Screening in Pediatric Caregivers

The goal is to better understand the social needs of a population seeking care in a large, urban children's hospital emergency department with a large Medicaid population. Consenting English and Spanish-speaking adult caregivers will be randomized to social screening via a face -to-face interview with a trained bilingual researcher or via a self-completed tablet-based survey. We hypothesize that there will be no difference in disclosure rates between the two screening formats for items other than highly sensitive items. For highly sensitive items we hypothesize disclosure rates will be higher for the self-completed tablet-based survey.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver must by age 18 years or older accompanying a child less than 18 years old
* Primary language English or Spanish
* Familiar with the child's household environment

Exclusion Criteria:

-
Early Abdominal Wall Prosthesis Infections: Epidemiology, Risk Factors and Factors Linked to Recovery

Abdominal wall prosthesis infections are among the complications most feared by digestive surgeons. Indeed, this complication is associated with high morbidity and is difficult to manage (antibiotic therapy? surgical revision?). Much data is missing in the literature because there are many types of prosthesis, implemented in patients with very varied conditions and the treatment is not strictly speaking codified.

The investigators wish to carry out a retrospective study on approximately 500 patients and research the main characteristics of the different infections (which microorganism? which site? what time of appearance), the factors linked to the appearance of these infections and above all how to optimize their management. charge.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject operated on at the HUS in the department of Pr. Rohr between January 1, 2017 and July 26, 2023
* Operation of an incisional hernia cure with installation of an abdominal wall prosthesis
* Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed his opposition to the reuse of his data for scientific research purposes.
PAXIL CR Bioequivalence Study

This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.


Eligibility Criteria:
Key Inclusion:

Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.

Key Exclusion:

Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; \>14 drinks/week for men or \>7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.
A Culturally Specific End-of-life Communication Skills Training

The goal of this clinical trial is to evaluate the effectiveness of culturally specific end-of-life communication skills training (CST) among Chinese oncology nurses.

The main question it aims to answer is: What is the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses? Participants will receive an 8-week communication skills training. Researchers will compare the intervention group and the wait-list group to see if skills, self-efficacy, and outcome expectancy beliefs will be improved.

Objectives: The study aims to evaluate the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses.

Design and participants: It is designed as a single-blind, pre-post randomized controlled trial (RCT). Registered nurses who work with advanced cancer patients in hospital settings will be recruited. The participants will be randomly assigned to either the intervention group (IG) or the control group (CG). The IG will receive the end-of-life CST between the two measurement points, and the CG will be a waitlist group and receive the training after the end of data collection.

Data analysis: Demographic information about the participants will be summarised in descriptive statistics. Independent t-tests and chi-square tests are used to investigate the comparability of groups in terms of the demographics generated by randomization. The primary and secondary outcome variables will be examined using covariate-adjusted linear mixed models. This approach enables the consideration of missing data. For non-repeated continuous measurements, ordinary linear regression and logistic models will be adopted. The intention-to-treat (ITT) analysis and post hoc analyses of contaminated data will be performed.

Expected results: Nurses' skills, self-efficacy, and outcome expectancy beliefs will improve after the CST.

Eligibility Criteria:
Inclusion Criteria:

* Registered nurses who work with advanced cancer patients in hospital settings
* Consent to participate in the study

Exclusion Criteria:

* Nurses working temporarily in the two hospitals as scholars or trainees from other hospitals
* Specialized nurses in palliative care
Effect of Downhill-uphill Walking Exercises on Functional Level and Muscle Strength in Patients With Knee Arthroplasty.

This study is planned for investigating effect of downhill-uphill walking exercises on functional level and muscle strength in patients with knee arthroplasty. Patients who have had primary knee arthroplasty and has gone 3 months after surgery will be included in this study. The patients will be divided into two groups by randomization. Totally, 22 patients will be included in this study. Every patients will have same standart post-operative rehabilitation programme. In addition,group 1 will have downhill walking exercises with %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope. Assessments will be made before and after treatment.

This study is planned for investigating effect of downhill-uphill walking exercises on functional level and muscle strength in patients with knee arthroplasty. Patients who have had primary knee arthroplasty and has gone 3 months after surgery will be included in this study. The patients will be divided into two groups by randomization. Totally, 22 patients will be included in this study. Every patients will have same standart post-operative rehabilitation programme. Assessments will be made before and after treatment. Rehabilitation programme after knee arthroplasty has included muscle strength and endurance, balance and proprioceptive sensation, increasing functional level and providing independence in daily life activities.For this purpose, a standard physiotherapy program will be implemented in accordance with the goals and objectives stated for all patients. In addition,group 1 will have downhill walking exercises with %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope. It takes 30 minutes for one session.

Exercise intensity was measured before treatment; will be determined using the Karvonen formula depending on the heart rate. Walking intensity during exercise; 55% of the maximum heart rate will be determined at the beginning of the treatment and 85% towards the end of the treatment. Walking exercise on the treadmill will be performed in conjunction with a qualified physiotherapist in this area for 4 weeks(3 session in 1 week).

Within the scope of the assessments, patients' pain levels will be determined using the Numeric Pain Scale (NAS). For the knee joint, the normal range of motion will be determined by universal goniometer. For the determination of functional level, Iowa functional activity scale, Iowa ambulatory speed scale and Hospital For Special Surgery (HSS) knee scoring, 10-meter walking speed, Timed Up and Go (TUG) test, SF-12(12-Item Short Form Survey) quality of life scale will be used. Hand dynamometer will be used to evaluate muscle strength.These assessments will be made before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative diagnosis have to be knee osteoarthritis.
* Patients with primary knee arthroplasty after 3 months surgery.

Exclusion Criteria:

* BMI \>40 kg/m2
* Having orthopedic or neurologic disorders which cause walking disorders.
* Revision total knee arthroplasty
Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients in a Vegetative State

Progress in resuscitation has increased the chances of survival after anoxic or traumatic brain injury. More and more patients with severe cerebral damages are resuscitated but upon awakening from coma, some patients remain in a state which cannot be qualified as conscious and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative state). This condition can be transitory and evolve towards recovery, or remain chronic and lasting for years.

To improve the diagnosis of patients with disorders of consciousness, recent advances in brain imaging have led to the development of new methods of detecting awareness. In the absence of overt behavioral responses from these patients, imaging-based diagnostic methods have been first used to assess whether some cerebral areas were preserved in UWS patients and showed an activation of the primary sensory cortices in some UWS patients, whether it occurs at the auditory, visual or somatosensory level. Unavoidable technical and ethical issues are raised for clinicians before responding to such requests:

1. Is it technically possible to generalize neuroimaging protocols to all healthcare institutions?
2. Is it ethically acceptable to propose neuroimaging protocols without an accurate estimation of their psychological impact on families and caregivers?

The present study aims to understand and anticipate the technical and ethical issues related to an evaluation of consciousness with functional neuroimaging. How the evaluation of awareness in a patient affects the caregivers and family members will be investigated. By using qualitative research hopes and expectations will be clarified through the experiences of families, clinicians and nurses faced to this situation.

Will be included in this research professional caregivers and persons closely related to UWS patients:

* Family members or close circle visiting the patients on a regular basis
* Referring clinicians
* Nurses in charge of the patients' care

This prospective study uses qualitative, interview-based, research. Two key-moments are explored in succession to examine the impact of a neuroimaging evaluation of consciousness in institutionalized UWS patients:

* interviews of professional caregivers and families about their hopes concerning the evaluation of consciousness of UWS patients,
* interviews of professional caregivers and families about the impact of evaluating consciousness on their beliefs


Eligibility Criteria:
Inclusion Criteria:

* adult family members, clinicians, nurses (aged \>18 years) closely related to UWS patients
* patients diagnosed as being in an UWS

Exclusion Criteria:

* patients in a minimally conscious state, in a locked-in-syndrome of akinetic mutism
* refusal of family members, clinicians or nurses to participate to the study
* family members considered by clinicians not to be capable of passing the interviews
* subjects aged \< 18 years
* non french speaking subjects
Addressing Dementia Via Agitation-Centered Evaluation

This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
* Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.

Exclusion Criteria:

* Patient has dementia predominantly of non-Alzheimer's type.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.
Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder

Deep TMS to the left dorsolateral prefrontal cortex intervention to reduce craving and recurrent opioid use among patients with opioid use disorder who are abstinent for at least one week.

The participants will undergo baseline assessments, including rating scales and urine opioid metabolite tests. The participants will receive one of two treatments: High-frequency (10Hz, 3000 pulses per session) dTMS using a double cone coil targeting the left dorsolateral prefrontal cortex or sham stimulation. Each treatment will be preceded by a short-guided imagery (2-3 min) design to activate the relevant brain circuitry (provocation of symptoms may increase the response rate to deep TMS as was evident in the treatment of PTSD, cigarette smoking, and OCD). dTMS sessions will be conducted 10 times per week for 2 weeks, for 20 sessions. 8 weeks of patient follow-up, including clinical visits at weeks 0, 2, and 8. During this phase, subjective and objective measures of opioid use (self-report and analysis of urine samples for opioid metabolite) will be collected. Following the completion of the main part by the individual, an "open-label" treatment using the same parameters of the experiment will be offered (regardless of the treatment group).

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 65
* Clinical diagnosis of opioid use disorder

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Mental retardation, bipolar disorder, any psychotic disorder
* Neurological diseases such as epilepsy, ischemic stroke, multiple sclerosis
* History of head trauma that resulted in loss of consciousness for ≥5 minutes and retrograde amnesia for ≥30 minutes (self-reported history)
* Any history of seizures other than febrile childhood seizures (self-reported history)
* Clinically significant hearing impairment
* Having any prosthesis, such as an implant and pacemaker.
* Illiteracy