cyrilzakka/clinical-trials huggingface dataset:
Descriptive Study of Biological Stress and Perceived Stress at the Center 15

The purpose of this study is to describe biological stress (cortisolemia) and perceived stress in Emergency Call Center Operators and Doctors while processing a center 15 call.

Sample description : qualitative variables be expressed as percentages, numbers and 95% confidence intervals Quantitative variables will be expressed as means, standard deviations or medians, range, interquartile intervals Description of biological stress : it will be described by calculating the difference between the observed peek or peeks of cortisol ans the cortisol level measured at rest (means, standard deviations or medians, range, interquartile intervals) Description of perceived stress : the AVS will be described in terms of means and standard deviation Comparison of the peek-delta/base level of cortisol in the 3 different workstations of the call center operators according to the non parametrical Kruskall Wallis test. Same for the lengthof service of the call operator, the severity of the call and the status of the doctor The AVS score (perceived stress) will be compared to the peek-delta/base level of cortisol (biological stress) thanks to the Spearmann correlation coefficient.

Eligibility Criteria:
Inclusion Criteria:

* medical and paramedical staff from the center 15 (call operators, emergency doctors and general practitioners)
* healthy volunteers having received the specific information letter regarding the sudy and having signed the clarified consent form
* healthy volunteers are affiliated to the french social welfare

Exclusion Criteria:

* chronic alcoholism
* women under oestroprogestative hormonal treatment
* high level athletes
* healthy volunteers under steroids treatment
* healthy volunteers suffering from a mental health related disorder
* fever on the day the sample is taken
* healthy volunteers with endocrine disorders
Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining

To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at any time during an exam, without affecting other testing. This may improve office-flow and spare patients from returning for another exam for additional testing.

Four sites will enroll fifteen subjects each. Individual sites will identify their patients using numbers 1-15. The link to their identity will be stored in their records but will not be forwarded to other investigators. Only the originating site will have the identity log linking the participants to the study records. All patients over age 18 in the patient clinic are eligible for inclusion. Staff members and employees may also participate. Following informed consent, each patient will undergo visual acuity testing, keratometry readings by IOL Master, topography testing by Pentacam, and corneal staining evaluation with fluorescein using the Oxford scoring scale on both eyes. Once all three tests are completed, the Icare tonometer will be used to check the intraocular pressure (IOP) on one eye only. The investigator will be masked as to which eye will undergo applanation. Immediately following the IOP check, corneal staining, topography and keratometry readings will be repeated. The unchecked eye will serve as a control as there may be mild variations in topography or IOL Master even without applanation. Following the repeated testing, the control eye will also undergo applanation to document IOP.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age

Exclusion Criteria:

* Under 18 years of age
Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.

Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with steroid ) and group 2 (hydrodilatation with hyaluronic acid and steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index

Eligibility Criteria:
Inclusion Criteria:

1. age 35-65 years
2. onset of shoulder stiffness since over a month
3. limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion Criteria:

1. ultrasound findings of rotator cuff tears,
2. plain radiography findings of significant glenohumeral joint arthritis,
3. accompanying cervical radiculopathy,
4. systemic inflammatory joint disease,
5. intraarticular injection into the glenohumeral joint within the past 3 months
6. history of surgery on the affected shoulders,
7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids,
8. allergy to corticosteroid or lidocaine.
High-frequency tRNS for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease

The investigators aim to 1) investigate and compare the safety, efficacy and sustainability of hf-tRNS, tACS and sham transcranial current stimulation (tCS) over left inferior parietal lobe (IPL) in mild neurocognitive disorder due to vascular disease (NCD-vascular) patients with sleep disturbances; 2) examine the relationship between the changes in sleep quality, cognitive function and brain morphometry.

Methods: Chinese right-handed mild NCD-AD patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 2-week intervention of either hf-tRNS, tACS, or sham tCS, with 10 participants per arm. Before intervention, structural magnetic resonance imaging (MRI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and blood pressure will be conducted at baseline, 2th week, 6th week and 12th week. Program adherence and adverse effects will be monitored throughout intervention.

This study aims to investigate the feasibility, safety and efficacy of hf-tRNS and tACS over left IPL for sleep disturbances and cognitive dysfunction in mild NCD-vascular patients. It wills also test the program adherence, tolerability and adverse effects of this innovative neurotechonology. Information will be helpful for in-depth understanding the relationship of "sleep disturbances-cognition" and guiding the further studies of sleep medicine and neurodegenerative diseases.

Eligibility Criteria:
Inclusion Criteria:

* Chinese, right-handed, aged from 60 to 80 years.
* With at least one cerebrovascular risk factor, e.g., a history of hypertension defined as systolic blood pressure (BP) 140 mm Hg or higher, diastolic BP of 90 mm Hg or higher; or receiving antihypertensive medication.
* Score of Montreal Cognitive Assessment Hong Kong version (HK MoCA) range from 22 to 26 (Lu et al., 2019).
* With preserved functional abilities reflected by a Functional Assessment Questionnaire score of 7 or lower (Hajjar et al., 2020).
* With a medial temporal lobe atrophy (MTA) score \< 2
* No interference with independence in everyday activities.

Exclusion Criteria:

* Previous diagnosis of dementia or stroke;
* Past history of bipolar disorders or psychosis;
* Physically frail affecting attendance to training sessions;
* Already attending regular training, such as cognitive behavioral therapy;
* Taking a psychotropic or other medication known to affect cognition (e.g. anti-dementia medication);
* Significant communicative impairments.
Development Study Using Vaginal Tactile Imager

The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.

Pelvic organ prolapse affects 40-50% of women in US. This study aims to establish a reliable examination procedure, collect data necessary for assessing the performance of Vaginal Tactile Imaging sensors, assess clinical suitability of interface software and correlate elasticity measurements with clinical examination findings for normal versus prolapse conditions of the female pelvis.

Eligibility Criteria:
Inclusion Criteria:

1. no evidence of pelvic organ prolapse and no prior pelvic surgery
2. stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments
3. no evidence of pelvic organ prolapse with prior pelvic surgery (with or without the use of graft material)

Exclusion Criteria:

1. patients with active skin infection, tissue breakdown or ulceration
2. patients with abnormal vaginal anatomy, including vaginal septum, history of vaginal/pelvic radiation, presence of a vaginal tumor or lesion
3. recent pelvic surgery with less than 3-month interval from surgery
Food-based Support for Hospitalized Children and Their Families

The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of government or self-pay insurances will provide benefits. The main questions it aims to answer are:

* Determine the effect of implementing an in-hospital food support intervention for low-income parents on reutilization and family-centered outcomes.
* Among families with baseline food insecurity, determine the effectiveness of a post-discharge food support intervention and as-needed social work referral on reutilization and family-centered outcomes.

Researchers will compare the in-hospital food support intervention and will be rolled out to sequential hospital units. In addition, the post-discharge food support intervention will be compared to standard discharge.

Some participants will:

* Receive in-hospital meal cards or standard care during hospitalization
* Receive post-discharge food support intervention or standard discharge
* Complete a 14-day post discharge follow-up survey


Eligibility Criteria:
Inclusion Criteria:

* All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible

Exclusion Criteria:

* Patients admitted for end-of-life care, patients who will be discharged to a location other than home, patients who live independently, and patients in county custody.
Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients

To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy

Design:

Study will be prospective interventional simple randomized control parallel open label Arms and Interventions Arm 1: Goserelin plus standard chemotherapy Goserelin will be given as a 3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months (26) Arm 2 (control Arm): Standard chemotherapy Patients will take only standard chemotherapy for 3 months Setting: oncology department Beni Suef university hospital Sample size: 80 patients (based on the results from the literature and to ensure a power of 80% and a type I error probability of 5%. we calculate Effect size Primary Outcome Measures

Evaluating ovarian function by: at the start of treatment and after 3 cycles chemotherapy treatment and at end of 6 cycles chemotherapy through:

* FSH level (follicle-stimulating hormone (FSH))
* Estradiol level
* AMH level follow up time time frame 1 year follow up after chemotherapy

Secondary Outcome Measures:

* Overall All Response determined by tumor assessments from radiological tests including one of the following (computed tomography scan, Magnetic resonance imaging Positron-emission tomography or physical examinations according RECIL 2017 criteria.
* Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)

Eligibility Criteria:
Inclusion Criteria:

Female lymphoma patients will be included in the study if they meet the following criteria:

1. Confirmed lymphoma cancer radiological and pathological or by clinical evaluation receiving chemotherapy treatment
2. Normal FSH-level , estradiol level (FSH levels less than 10IU/L at the time of random assignment)
3. Female Age between 17- 40 years
4. Written informed consent

Exclusion criteria:

The patients will be excluded from the study if they have the following criteria:

1. Known hypersensitivity reaction to the investigational compounds or incorporated substances
2. Primary ovarian dysfunction, previous history of amenorrhea \>3 months
3. Age \> 40
4. Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
5. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)
XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.

The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.

The study is a prospective multi-center randomized evaluation of clinical and radiographic outcomes of two commonly used lumbar interbody fusion procedures (XLIF and TLIF) in adult patients with low-grade symptomatic spondylolisthesis. The study seeks to identify differences between the procedures with respect to perioperative variables.

Eligibility Criteria:
Inclusion Criteria:

- Male and female patients who are at least 18 years of age;

- Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at 1 or 2 contiguous lumbar levels between L1 and L5 and are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain;

- Patients who have been unresponsive to at least 6 months of conservative treatments or exhibit progressive neurological symptoms in the face of conservative treatment;

- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.

Exclusion Criteria:

- Patients with lumbar pathologies requiring treatment at more than 2 levels;

- Patients who have had previous lumbar fusion surgery;

- Patients with lytic spondylolisthesis or a defect of the pars interarticularis;

- Patients with radiographic confirmation of Grade IV facet joint disease or degeneration;

- Patients with non-contained or extruded herniated nucleus pulposus
Relationship Between Cardiovascular Disease in Asthma and Eosinophil Subtypes and Biomarkers of Bronchial Remodeling.

To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease.

Recent studies have shown that asthma could be a risk factor for cardiovascular disease, especially in the female and late-onset subgroups. The two entities share several risk factors, such as chronic inflammation and bronchial remodeling. Eosinophilia, characteristic of asthma, has also been described as a predictor of cardiovascular mortality.

The aim of this study is to determine the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease, as well as their relationship with eosinophil subtypes, biomarkers of chronic inflammation and bronchial remodeling.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of asthma
* Signed informed consent

Exclusion Criteria:

* Age under 18 years old
* Age over 99 years old
* Pneumological diseases other than asthma
* Active oncological diseases or with end of treatment \<5 years
* Autoimmune or systemic inflammatory diseases
Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for CAI

The objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI.

The data of 20 patients who underwent surgery after reconstruction of the lateral collateral ligament of the ankle joint and 20 patients who underwent balance rehabilitation training were analyzed to compare the clinical effects of surgical treatment and conservative treatment for chronic ankle instability, in order to better guide the selection of the optimal intervention program for patients with chronic ankle joint.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CAI
* The contralateral ankle joint is healthy

Exclusion Criteria:

* Accompanied by other musculoskeletal injuries
Neck Kinesiotherapy and Massage in Tinnitus Treatment

The primary aim of this study is to investigate the effectiveness of cervical spine kinesiotherapy and massage in tinnitus treatment. Furthermore, we investigate if there is a link between cervical spine range of motion and cervical muscles tension and tinnitus.

The study is planned with power of 80%. A total of 118 adult patients with subjective tinnitus are divided into two groups: Kinesiotherapy group (n=59) and Waiting list group (n=59).Kinesiotherapy group receives a complex set of cervical spine exercises and neck massage for consecutive 10 working days (entire treatment takes two weeks). Each visit lasts around 30 minutes. Patients from kinesiotherapy group will fill the outcome measures on the following time points: (a) Time point 0 - baseline (b) Time point 1- Two weeks after the baseline

(c) Time point 2- Four weeks after the baseline. Individuals from waiting list group are enrolled on a waiting list and do not receive any treatment. They undergo assessment at three time points corresponding to Kinesiotherapy group i.e Time point 0, Time point 1 and Time point 2.

.

Eligibility Criteria:
Inclusion Criteria:

-Adult patients with subjective tinnitus experienced in the ears or in the head (temporary and constant tinnitus) with and without sensorineural hearing loss.

Exclusion Criteria:

* Other tinnitus treatment in last 6 months,
* Objective tinnitus,
* External and middle ear pathology,
* Acute infections, conditions with fever
* Bleedings or risk of bleeding
* Severe respiratory and circulatory insufficiency
* vasculitis, thrombophlebitis,
* Pregnancy
* Acute arthritis and periarticular soft tissues inflammation in the cervical region,
* Severe pains in different locations,
* Advanced osteoporosis
* Uniformed services.
* Cervical spine instability, cervical disc herniation, cervical radiculopathy.
* Status post cervical spine surgery.
* Status post lumbar puncture, status post computed tomography with contrast.
* Lack of cooperation between the patient and the therapist, cognitive impairment.
* Atherosclerosis, vertebrobasilar insufficiency.
Sonazoid in Myocardial Perfusion Imaging

Currently, Sonazoid is mainly used for imaging liver lesions by assessing perfusion characteristics. However, the ultrasound technology is the same as for cardiac imaging and the stability of the microbubbles will potentially aid the detection of myocardial perfusion defects. This study will look at the feasibility of using sonozoid in this way.

Ultrasound contrast agents are gas-filled microbubbles that enhance the visualisation of cardiac structures, function and blood flow. Myocardial contrast echocardiography enables us to visualise myocardial perfusion and provides incremental information for diagnosis of coronary artery disease (CAD) and prognosis beyond wall motion assessment .

Using ultrasound at low acoustic power (low/intermediate MI) causes the microbubbles to oscillate resulting in giving off non-linear signals which are different from tissues which gives off linear signals.

The first contrast agents were used in 1968. Since then the technology has been refined and now the microbubbles are more stable and consist of an inert gas encapsulated in a lipid or albumin shell. These microbubbles remain intact in the systemic circulation because of their small size can transit through the pulmonary circulation.

The indication for myocardial perfusion imaging is when vasodilator stress like Dipyridamole is performed. Vasodilators do not readily induce wall motion abnormalities but cause perfusion defects to occur which allows detection of CAD. Myocardial perfusion imaging is also indicated during treadmill or dobutamine stress when suspicion of CAD is high as it is more sensitive than wall motion for the detection of CAD.

Myocardial perfusion imaging looks at a uniformity of contrast appearance in the myocardium, following a continuous microbubble infusion. If there is decreased perfusion, the appearance of contrast will be delayed and the opacification will not be uniform.

The advantage of Sonazoid over the other frequently used contrast agents (Sonovue, Luminity, Optison) is that the microbubbles are more robust, allowing for a higher MI setting to be used during scanning. The higher MI setting enhances higher intensity bubble signal with improved spatial and temporal resolution which improves image quality and diagnostic accuracy.

This study is not looking for diagnosis in patients, which will be done according to standard of care. It is to evaluate whether it is possible to assess myocardial perfusion using the contrast agent Sonazoid.

Eligibility Criteria:
Inclusion Criteria:

* Positive and normal Clinical SE
* Able to provide informed consent

Exclusion Criteria:

* Unable / unwilling to give informed consent
* Allergy to Perfluorobutane
* Egg allergy
* Patients with right to left arteriovenous cardiac or pulmonary shunt
* Unstable heart disease
* Serious pulmonary disease
* Pregnancy or lactation Women of child bearing potential (defined as not chemically or surgically sterilised or post menopausal)