cyrilzakka/clinical-trials huggingface dataset:
Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery

The evaluation of carotid intima-media thickness (cIMT) has become a possible predictor of the future risk of cardiovascular diseases (CVD). Evidence to date shows that cIMT augmentation is correlated with the extent of atherosclerosis in the coronary arteries and with other risk factors for CVD. More recently, several studies have evaluated the association of cIMT with stroke, to determine whether this measure can also predict future cardiovascular events.

Although the published evidence is scarce and fragmentary, the cIMT retains an increasingly interesting role as a marker of atherosclerotic pathology.

The purpose of the study is to analyze cIMT in patients undergoing thyroidectomy to evaluate a possible correlation between the cIMT variation after the procedure and the cause of the thyroid disease, the levels of thyroid hormones, and the lipid or other markers of atherosclerosis levels.

The primary endpoint will be the variation of the measure of the cIMT before and after surgery.

Secondary endpoints will be:

* major cardiovascular adverse events (death, major stroke, minor stroke, transient ischemic attack) in the short-term period (≤30 days after the procedure);
* major cardiovascular adverse events (death, major stroke, minor stroke, transient ischemic attack) in the long-term period (\>30 days after the procedure);
* the technical success of the procedure;
* the rate of postoperative complications. To date, there are no data that differentiate patients based on the causes of thyroid disease. The results of the present study will allow for correlating the variation of the cIMT to the causes of thyroid disease, the levels of thyroid hormones, and the levels of lipid and other markers of atherosclerosis.

Results from the present study may provide insights into possible areas of quality improvement. It may also influence the economic impact associated with carotid revascularization techniques, in terms of hospital charges and discharges to skilled nursing and rehabilitation facilities.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thyroidectomy according to the American Thyroid Association (ATA), International neural monitoring study group guideline (INMSG), Italian Society of Endocrine Surgery (SIUEC);
* subjects who have read and signed the informed consent;
* subjects who undertake to undergo the instrumental examinations and visits necessary for the study during the follow-up;
* \>18 years of age.

Exclusion Criteria:

* occlusion or stenosis of at least one carotid artery, with plaque \> 30%;
* exposure to ionizing radiation;
* previous neck, carotid (endarterectomy or stenting) and/or thyroid surgery;
* clinical conditions that preclude proper follow-up;
* HIV, dialysis therapy and all clinical conditions with increased cIMT;
* uncontrolled dyslipidemia;
* pregnant and breastfeeding women;
* terminal patients.
Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)

This study evaluates the clinical efficacy and symptom relief of vaginal fractional CO2 laser treatment in post-menopausal women with Overactive Bladder syndrome(OAB). Post-menopausal women with OAB syndrome who receive β3 adrenergic receptors (mirabegron 50mg) treatment, will be randomized in two groups. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (≥ 12 months of amenorrhea or FSH ≥ 40 after hysterectomy with bilateral oophorectomy) who receive β3 adrenergic receptors (mirabegron 50 mg) treatment for OAB
* Overactive bladder syndrome (OAB)

  * ≥ 3 months symptoms of urgency, with or without urinary incontinence, and ≥ 8 micturitions / 24h
  * At least 3 episodes of urgent urination (3rd-4th grade) as recorded in the patient perception intensity of urgency scale (PPiUS) during a 3 day urination calendar , with or without urinary incontinence.

Exclusion Criteria:

* Participants with:

  * Pelvic Organ Prolapse (POP) \> stage II of the pelvic organ prolapse quantitation system (POP-Q)
  * Post void residual volume \> 200 ml (measured by ultrasound)
  * Use of moisturizers or lubricants the last month
  * Use of vaginal estrogen in the last 6 months
  * Use of drugs for urinary incontinence
  * Use of psychotropic drugs
  * Symptomatic urinary tract infection
  * Active genital infection
  * Kidney or liver disease
  * Abnormal cardiac conduction, rate or rythm disorders
  * Diabetic neuropathy
  * Myasthenia gravis
  * History of malignant disease
  * Previous radio-chemo therapy
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis

Palmoplantar pustulosis is a chronic inflammatory skin disease that causes repeated on and off symptoms like erythema (reddening, irritation), vesicle (swelling, cyst), pustules, scale, and crusts in palms and soles. This study evaluates how well risankizumab works compared to placebo (no medicine) to treat palmoplantar pustulosis. Study will assess change in Palmoplantar Pustulosis Area and Severity Index \[PPPASI\].

Risankizumab is an investigational drug being developed for the treatment of palmoplantar pustulosis. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given study drug and who will receive placebo (no medicine). Participants are randomly put into 1 of 2 groups, called treatment arms to receive risankizumab or placebo in period A. In period B, each group receives both risankizumab and placebo at different time intervals. Around 116 adult participants with palmoplantar pustulosis will be enrolled in approximately 39 sites across Japan.

Participants will receive subcutaneous (SC) injections of risankizumab or placebo at Week 0 and Week 4 (Period A). Beginning Week 16 (Period B), both the groups will receive risankizumab and placebo at different intervals. Total treatment duration is 56 weeks.

There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Stable moderate to severe Palmoplantar Pustulosis (PPP) with a Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score of \>= 12 at the Screening and Baseline Visits.
* Moderate or severe pustules/vesicles on at least one palm or sole (\>= 2 PPPASI severity score) at the Screening and Baseline Visits.
* Experienced inadequate response (or intolerant) to treatment with topical corticosteroids and/or vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate.

Exclusion Criteria:

- History of active skin disease other than PPP which could interfere with the assessment of PPP.
A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer

This study is a multi-centre, prospective observational study. The study plans to enrol 500 patients with localized or locally advanced prostate cancer who are eligible and intended to be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical sites in China. The effectiveness and safety data will be collected at baseline and each visit within 26 weeks after treatment of Zoladex®.

Androgen Deprivation Therapy (ADT) is a standard treatment for locally advanced or metastatic prostate cancer. It is also increasingly used in patients with high-risk localized prostate cancer or in patients with prostate-specific antigen (PSA) relapse after local therapy.

The luteinizing hormone-releasing hormone (LHRH) agonists, such as goserelin acetate(Zoladex®), have provided an effective and reversible means of suppressing androgen level. Zoladex® was originally formulated as a 3.6mg depot injection. Goserelin acetate 10.8-mg depot, given once every 3 months, is pharmacodynamically equivalent to 3 consecutive monthly injections of the goserelin acetate 3.6-mg depot, offers a more convenient and cost-effective dosing regimen for patients.

Goserelin acetate 10.8-mg depot has been available in China since 2012. However, data on the effectiveness and safety of the long-acting depot of Zoladex® (goserelin acetate depot) 10.8mg specifically in a Chinese population is limited. A "real-world" observational study is proposed to establish the effectiveness and safety profile of Zoladex ® 10.8mg in Chinese patients with localized or locally advanced prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent, complete all study assessments and have complete medical record;
2. Male aged 18 years and over;
3. Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;
4. Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);
5. More than 26 weeks' life expectancy;

Exclusion Criteria:

1. Patients who are planned to receive radiation therapy;
2. Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;
3. Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists.
Body Structures Determining Differences in Forearm and Upper Arm Blood Pressures

The first purpose of this study is to see how blood pressures taken at different sites, specifically the forearm, upper arm and heart vessels, are different. The second purpose is to see if body structures such as vessel size and depth, size of the arm, and amount of tissue in the arm influence differences in blood pressures taken at these sites. The third purpose is to develop a mathematical model of the waves generated by the arm arteries (brachial and radial) to predict differences in forearm and upper arm blood pressures. The results of the study may be used to design more accurate non-invasive blood pressure monitors for the forearm site.

Accurate blood pressure (BP) measurement is required to provide appropriate healthcare. Inaccurate BPs may lead to under and/or over-treatment of health conditions and medical diseases such as hypertension. Blood pressure (BP) measurement using automatic, non-invasive oscillometric monitors is common in clinics, physicians'offices and hospital settings. The brachial (upper arm) site is the gold standard for non-invasive BPs. However, in some situations, this site is inaccessible due to injury, surgery, dialysis shunts, intravenous devices, and lymphedema. When the upper arm is difficult to access or the available BP cuffs do not fit an individual's arm, the forearm site is often the preferable alternative. The increased incidence of obesity nationally also contributes to the heightened use of forearm BPs. Questions remain concerning the accuracy of forearm non-invasive BP measurements. Although most researchers report that upper arm and forearm readings are not interchangeable, size of differences vary for individuals and factors influencing differences in readings have not been thoroughly investigated.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* able to speak and write in English

Exclusion Criteria:

* Individuals with non-intact skin where the BP cuffs would be placed
* Individuals with injury or surgery to the arm within the last month
* Individuals with lymphedema in the limb selected for measurements
* Individuals with arteriovenous fistulas
* Individuals with differences \> 5 mm Hg between right and left arm oscillometric systolic BP measurements
* Individuals with documented valvular disease
* Individuals with atrial fibrillation or atrial flutter (as recommended by BP device manufacturers due to device inaccuracy)
* Individuals with an International Normalized Ratio (INR) \> 1.7
* Individuals with intravenous catheters in both arms
* Individuals who require immediate cardiac surgery or unanticipated emergency treatment or who are unstable during the procedure
Systolic Ankle arteriaL Pressure and Transcutaneous oximetrY During a TURTLE Test in Athletes

Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects

Patients suspected of PES and healthy controls after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of thigh flexion in the standing position.

Eligibility Criteria:
Inclusion Criteria:

- Age over 18 years Insurance company affiliation Symptoms consistent with iliac kinking (patients) or absence of symptoms (controls)

Exclusion Criteria:

* Refuse to participate Exclusion period from another protocole Non affiliation to the French healthcare system
Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and downhill walking by means of videofluoroscopy.

Total arthroplasty of the knee (TKA) aims to relieve patient pain and improve functionality of the joint. To maintain sufficient range of motion, but also not overload the surrounding soft tissue structures, reproduction of tibio-femoral kinematics of the healthy knee is thought to be beneficial. In previous studies, it has been shown that the medial condyle, described by the centre of the medial condylar sphere, does not move anterioposteriorly during progressing joint flexion, whereas the lateral condyle has been observed to translate in a posterior direction producing tibial internal rotation with flexion (Freeman and Pinskerova 2003, Pinskerova, Johal et al. 2004, Freeman and Pinskerova 2005). The GMK Sphere prosthesis is specifically designed to mimic the healthy kinematics with providing a medial pivot.

The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Fixed Bearing. The study includes the simultaneous assessment of the 3D kinematics of the TKA by means of an automated moving fluoroscope and subsequent 2D/3D registration based on CAD models of the TKA, whole leg kinematics by means of skin markers and ground reaction forces during level walking, stair descent and downhill walking a 10° inclined slope. Precisely, the aim is to assess tibio-femoral kinematics in 8-10 TKA subjects implanted one or more years previously with the GMK Sphere prosthesis. In addition, 8-10 conventional GMK PS Fixed Bearing TKA subjects, as well as 8-10 GMK UC Mobile Bearing TKA subjects will be measured to provide a comparison against the GMK Sphere prosthesis kinematics.

Eligibility Criteria:
Inclusion Criteria:

* Female or male
* Age: 40 to 100 years
* Unilateral TKA
* ≥ 1 years postoperatively
* BMI ≤ 33
* Good outcome, WOMAC between 0 to 28 (0-14 (Excellent), 15-28 (Good)) No pain subjects, VAS ≤ 2
* Good health condition, adequate for test procedure

Exclusion Criteria:

* Other actual significant problem on lower extremities
* Any other arthroplasty at the lower extremities
* Subject incapable to understand and sign informed consent
* Pregnancy at time of testing
* Incapable of performing the motion tasks
* Misaligned TKA (≥ ± 3° from mechanical axis)
CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment

This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors combined with CD19 positive feeder T cells treatment for CD19+ acute lymphoblastic leukemia patients in remission .

Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell( CAR-T) and CD19-positive T cells.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65
2. Voluntary informed consent is given
3. Expected survival ≥12 weeks
4. Relieve CD19+ acute leukemia
5. Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin \<2.0 mg/dl (3)Creatinine \< 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time \< 2 times of ULN (5)Arterial oxygen saturation\> 92%
6. Karnofsky score ≥ 60 ;
7. No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;

Exclusion Criteria:

1. Uncontrolled active infections
2. Active hepatitis B or hepatitis C infection
3. HIV infection
4. History of myocardio infarction in the past 6 months, or history of severe arrhythmia
5. Congenital immunodeficiency
6. Pregnant or lactating women
7. History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
8. Previous treatment with any gene therapy products
Xeomin® and Gait Related Mobility After Stroke

The aim of the present pilot study is to evaluate the association between change in gait related mobility in ambulatory male and female adult hemiparetic patients before and 4-6-weeks after Xeomin® injection into the upper limb, using two standardized tests of physical function in outpatient rehabilitation that are widely used; the 10-meter walk test and the timed 'up and go' test (TUG).

For this pilot study, the investigators hypothesize that there will be durational improvements in gait related mobility on the instrumented TUG and 10-meter walk tests 4-6-weeks post upper extremity Xeomin® injection. Physical function will be quantified as time to complete the instrumented TUG.

A one-group pretest-post-test experimental design will be used. Participants will be tested on the primary and secondary outcome measures before upper extremity injection with Xeomin® and 4 to 6 weeks thereafter. Additionally, participants will be contacted for an end of study visit via telephone approximately 12-weeks post Xeomin® injection to obtain information regarding any adverse events and gain insight into the therapeutic duration of the Xeomin®. The proposed duration of the study is 2 years to allow adequate time for screening, recruitment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemiparesis and spasticity secondary to stroke with upper and lower limb spasticity and unilateral motor and/or sensory deficit
* No prior surgery to the lower limb
* Able to walk at least 10 meters without physical assistance from another person and without an assistive device
* Toe- ground clearance during swing phase without assistive device or orthoses
* No treatment with botulinum toxin within the past 4 months

Exclusion Criteria:

* Passive range of motion at either the ankle, knee, or elbow joint less than 30 degrees
* Participants with uncorrected hearing impairment
* Weight bearing restrictions due to concurrent orthopedic injuries that would make ambulating with or without an assistive device unsafe
* Speech language expression deficit (e.g., aphasia)
* Absence of proprioception upon neurologic examination
* Presence of fixed contractures in the upper or lower extremities not correctable to neutral
* Other confounding neurological diagnoses or active acute illness (cancer, Parkinson's disease, multiple sclerosis)
Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.

Trauma and soft injuries of the wrist, hand and fingers have a high incidence, and large social and healthcare costs are generated, mainly due to productivity loss. Therapeutic exercises must be part of the treatment and in the last 10 years the scientific literature highlights the need for the inclusion of the sensorimotor system in both surgical and rehabilitative approaches. Current methods as leaflets or videos lacks of adherence control, evolution control and knowledge of how the patient do the exercises which compromise the expected results. Touch-screens of Tablet devices have showed a large potential to cover these needs and for the retraining of sensorimotor system. ReHand is a Tablet digital tool (Android and iOS) to prescribe and monitor exercise programs based on sensorimotor approach and developed under the guidelines of various healthcare professionals (hand surgeons, physiotherapists, rehabilitators and occupational therapists) to implement home exercise programs and monitor patients. Subjects are selected by emergency, hand surgery, rehabilitation and physiotherapy services of six hospitals from Andalusian Public Health Service through consecutive sampling. Concretely, patients over 18 years of age with trauma and soft injuries of the wrist, hand and fingers, no more than 10 days after surgery or removal of immobilization. Experimental group will receive access to ReHand app to perform a monitored home exercises program. Control group will receive the conventional method employed: a home exercise program in paper with recommendations. Clinical variables will be assessed at baseline before group allocation, 4 weeks, 3 months and 6 months. At the end of the study, cost-utility variables will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Patients with trauma or soft tissue injuries of the wrist, hand and fingers. Dupuytren, carpal tunnel syndrome, rizarthrosis, distal radius fracture, carpal fracture or metacarpal fracture.

Exclusion Criteria:

* Neurological pathology that affects the upper limb.
* Non-cooperative.
* Psychiatric illness.
Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke

The purpose of this study is to evaluate whether pharyngeal electrical stimulation in addition to standard care can enhance swallowing recovery in severely dysphagic stroke patients post extubation compared to sham treatment plus standard care.


Eligibility Criteria:
Inclusion Criteria:

- severe dysphagia post extubation due to acute stroke

Exclusion Criteria:

* preexisting dysphagia
* comorbidities that can possibly cause dysphagia
* psychiatric comorbidities
* pacemaker or other implanted electronic devices