cyrilzakka/clinical-trials huggingface dataset:
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT with the EVEBRA device(intervention group) or AFT without the EVEBRA device (control group). AFT will be evaluated in terms of volume, quality of life, aesthetic result, complications and oncological safety.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 23-69
* BMI 18-35 - stable weight, no fluctuations
* Have undergone a total mastectomy at least 3 months prior the study, whether therapeutic or prophylactic, whether unilateral or bilateral, with no resection of the pectoralis muscle
* Agrees to have reconstruction at the time of study involving only autologous fat grafting (AFT)
* Assessed by surgeon to have enough donor fat
* Passes a 20-minutes tolerance test with EVEBRA Device. (Patient will be fitted, instructed on the use, and given the EVEBRA Device to try in the office for 20 minutes. She passes if she tolerates its use, feels comfortable wearing it, and is able to comply with the required wear of the device.)

Exclusion Criteria:

* untreated breast cancer
* history of radiation therapy on the involved breast, even if it was part of a previous breast conservation procedure
* completed chemotherapy course less than 2 months prior (acceptable to still be on aromatase inhibitors)
* except for the biopsy leading to the diagnosis of cancer, had surgery to breast prior to the mastectomy (e.g., multiple biopsies, implant augmentation, mastopexy, fat grating)
* had mastectomy wound healing complications, e.g., seroma, wound breakdown, infection
* mastectomy defect/scar has significant skin excess and deep folds adherent to the chest wall
* has a pacemaker or aneurysm clips
* pregnancy or breastfeeding
* had a cardiac stent placed within the last 2 months
* claustrophobic, as reported by patient
* known current substance abuse, as reported by patient
* history of silicone allergy, as reported by patient
* history of Gadolinium allergy, as reported by patient
* history of lidocaine allergy, as reported by patient
* bleeding diathesis, whether primary or iatrogenic, as reported by patient cigarette smoker and/or Smokeless cigarette smokers, as reported by patient
* medical conditions that preclude breast reconstruction including uncontrolled hypertension or diabetes, renal failure, steroid dependent asthma, and on immuno- suppressant medications, as reported by patient
Far Infrared Irradiation for Managing and Treating Multiple Sclerosis (MS)

Multiple sclerosis (abbreviated MS) is an autoimmune condition in which the immune system attacks the central nervous system (CNS), leading to demyelination. This study will investigate the use of far infrared radiation for MS control, management and treatment.

MS a demyelinating disease, is any disease of the nervous system in which the myelin sheath of neurons is damaged. This impairs the conduction of signals in the affected nerves, causing impairment in sensation, movement, cognition, or other functions depending on which nerves are involved.

MS affects the areas of the brain and spinal cord known as the white matter. White matter cells carry signals between the grey matter areas, where the processing is done, and the rest of the body. More specifically, MS destroys oligodendrocytes which are the cells responsible for creating and maintaining a fatty layer, known as the myelin sheath, which helps the neurons carry electrical signals.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have MS.

Eligibility Criteria:
Inclusion Criteria:

* Patients with MS

Exclusion Criteria:

* None
Prospective Evaluation of Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy (EUS-FNAB) in the Absence of Rapid Onsite Evaluation

\<Background/aims\> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies across EUS programs in Unites States, Europe and other areas of world. The investigators have a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of ROSE, in which the adequacy of specimens will be assessed by a single endosonographer.

\<Methods\> All EUS-FNAB procedures will be performed by an experienced endosonographer and the adequacy of specimens obtained during EUS-FNAB will be also assessed by a same endosonographer. A specimen will be considered adequate if there is an adequate number of representative cells from the lesion. Samples considered to be adequate will be then interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive change, or negative for malignancy. Performance characteristics of EUS-FNAB including sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up of more than 6 months with repeat imagings.


Eligibility Criteria:
Inclusion Criteria:

* Any patients who will undergo EUS-FNA for the diagnostic evaluation of pancreas lesion

Exclusion Criteria:

* Patients who refuse to undergo EUS-FNA
The Effect of Virtual Reality on Anxiety During Vasectomy

The primary purpose of the study is to determine if the use of Virtual Reality (VR) goggles reduces the degree of anxiety patients experience during vasectomy procedures. The eligibility criteria include a.) appropriate age (19-100 years); b.) undergoing elective vasectomy procedure for purpose of desired sterility; c.) acceptance of wearing goggles; d) able to provide informed consent.There will be two groups, Group A will wear VR goggles and Group B will not. Evaluations will be done by survey to include questions regarding the level of anxiety experienced during the procedure, along with satisfaction scores of the experience.

1. The aim of the study is to evaluate the efficacy of virtual reality goggles (VRG) for improving the patient's experience during vasectomy procedure.
2. The secondary aim is to determine if VRG reduces the level of anxiety experienced during vasectomy procedure.

VR is an immersive, multisensory experience in a three-dimensional environment designed to replicate a real world. It has been shown in multiple studies to decrease acute and chronic pain in a variety of clinical settings. The mechanism is due to distraction by activating visual, auditory and proprioceptive senses. One example of this is a report by G. Pooja et. al. where in VR goggles reduced pain and medication use during orthopedic procedures (1). Another study found decrease in pain in medically treated patients (n=50 patients in 2 groups) after a 15 minute VR viewing on pain reduction compared to 2 -D viewing (2).

Eligibility Criteria:
Inclusion Criteria:

1. Appropriate age range (19-100 years)
2. Undergoing elective vasectomy procedure in the urology clinic
3. Willing to sign consent to participate in the study

Exclusion Criteria:

1. Visually impaired (blind)
2. 18 years of age or younger
3. Subjects under the influence of medications will not be approached regarding study participation.
Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder

Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Patients with a history of any of the following diseases according to the DSM-5 criteria:

  1. Hypersomnolence disorder
  2. Narcolepsy
  3. Breathing-related sleep disorders
  4. Circadian rhythm sleep-wake disorder
  5. Parasomnias
  6. Restless legs syndrome
  7. Substance/medication-induced sleep disorder
* Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy
* Patients with a history of poorly controlled diabetes mellitus (HbA1c \>8%)
* Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (\>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder
* Other protocol defined exclusion criteria could apply
KL₄Surfactant Treatment in Patients With ARDS

Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).

This is a multinational, multicenter, two-part, Phase 2 study that will evaluate the tolerability, safety, and efficacy of KL₄Surfactant in adult ARDS patients when administered by sequential bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung and as a bolus instillation into each lung.

Eligibility Criteria:
Inclusion Criteria:

* Intubated and required mechanical ventilation support
* Met the criteria for ARDS
* Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 200 mmHg and ≥ 60 mmHg within 60 minutes before randomization
* Mean blood pressure was ≥ 60 mmHg immediately before randomization

Exclusion Criteria:

* Had ARDS due solely to a major trauma
* Was currently participating in another clinical trial or received an experimental drug or device within the previous month
* A woman of childbearing age, unless pregnancy was excluded by a negative urine hCG test or if the subject was surgically incapable of childbearing
* Had a previous episode of ARDS that resolved and then recurred during the current hospitalization
* Had a disease that was sufficiently advanced, in the best judgment of the Principal Investigator, to markedly limit life expectancy to \< 6 months
* Was known to have AIDS or symptomatic HIV (CD4 counts \<500). Subjects with asymptomatic HIV were not excluded
* Received chemotherapy or radiation within the previous 90 days
* Received an organ transplant other than corneal transplants
* Received, or was currently receiving, immunosuppression therapy within the last 6 months
* Had severe neurological damage or the presence of a disease that was likely to significantly prevent weaning from the ventilator
* Had a best Glasgow Coma Score (GCS) of ≤ 8 or an intracranial pressure ≥ 20 cm H2O prior to the institution of sedatives or paralysis
Correlation Between Corneal Topographic Patterns and Refractive Status Of The Eye in Sohag City,Egypt

To evaluate corneal topographic pattern \& its correlation with refractive status of the eye .

This study will be established in The Future Center for refractive surgery, Sohag, Egypt.

This study will include 100 eyes of patients aged over 15 years. All patients were subjected to topography imaging.

Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.

The scheimpflug principle describes the optical imaging condition when the plane of an object is not parallel to the film of the camera and has to cut each other in one line or one point of intersection with the advantage to achieve wide depth of focus.

Scheimpflug imaging attains a wide and high depth-of-focus , providing sharp images that include information from an anterior corneal surface through to the posterior crystalline capsule; this depends mainly on media transparency and pupil size .

Eligibility Criteria:
Inclusion Criteria:

* Patients aging more than 15 years old
* All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
* There is no restrictions on the range and regularity of keratometry.

Exclusion Criteria:

* Patients with a history of any trauma to the eye.
* Patients with recent contact lens wear.
* history of ocular surgery .
* Patients with distance corrected visual acuity or abnormal retinoscopy examination (e.g., scissoring reflex).

  5. If there was any error in reading the topographic map. 6. Patients with anemotropic refraction.
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment

This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.


Eligibility Criteria:
Inclusion Criteria:

* History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
* Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
* Post prostatectomy: Detectable or rising PSA level that is \>0.2 ng/mL with a second confirmatory level of \>0.2 ng/mL
* Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
* Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
* Being considered for salvage therapy
* Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
* Previous brachytherapy treatment will have occurred at least 2 years in the past
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
* Androgen deprivation therapy (ADT) in the past 3 months
* History of bilateral orchidectomy
* Inability to tolerate 18F-fluciclovine PET/CT
Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.

For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.

Eligibility Criteria:
Inclusion Criteria:

1. Untreated locally advanced cervical cancer patients with clear pathological diagnosis
2. 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
4. Life expectancy \> 6 months
5. Able to tolerate concurrent chemoradiotherapy assessed by researches
6. No obvious active bleeding;
7. Adequate hematological, renal and hepatic functions:
8. No concomitant malignancies
9. Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;
10. Voluntarily-signed informed consent.

Exclusion Criteria:

1. Concomitant other malignancies;
2. Patients with metastatic or recurrent disease;
3. Patients received any form of treatment before enrollment;
4. Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;
5. Impaired hematological, renal or hepatic functions:

   1. Hemoglobin \< 9.0 g/dl
   2. Neutrophils \< 2000 cells/μl; Leukocytes \< 4 × 109/L
   3. Platelets \> 100 × 109/L
   4. Serum ALT/AST \> 2.5×UNL
   5. Serum Total bilirubin \> 1.5× UNL

   g. Serum urea nitrogen (BUN) \> 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) \> 1.5 × upper normal limit (UNL)
6. Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
7. Patients with uncontrolled mental diseases;
8. Pregnant or lactating woman;
9. Participating in other clinical trials;
10. Anyone considered not suitable for enrollment by principal investigator;
Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients

Introduction: Nearly 1% of the population is currently treated with long-term corticosteroid therapy. When corticosteroids are introduced, patient information concerning the adverse effects and the modalities of prevention by the lifestyle changes is usually proposed. However, studies have shown an imperfect acquisition of this information about treatment and prevention of adverse effects, as well as a difficult implementation on diet and physical activity advices. In this study, the investigators aimed to evaluate the difficulties encountered by patients with dietary advice in the context of long-term corticosteroids use in order to optimize care, drug adherence and the quality of life of patients.

Methods: the investigators will recruite adult patients from general medicine and rheumatology practice and treated by long-term corticosteroids (≥ 3 months, ≥ 5mg/day). the investigators will perform a qualitative analysis in a semi-directed interview.

Prospective Qualitative Study Carried out among patients followed in rheumatology and in general medical practice.

For each voluntary patient, a semi-directed interview was carried out in a consultation room after obtaining his agreement.

The same investigator used a single guide and conducted all the interviews based on open-ended questions.

At the end of the interviews, the entire recorded audio data was converted in written form before being analysed thematically.

Data were analysed using a Fisher's exact test for categorical variables (presented as frequencies and percentages), and using a non-parametric Mann-Whitney test for continuous variables (presented as the median and interquartile range, IQR).

Eligibility Criteria:
Inclusion Criteria:

* adult patients taking corticosteroids at an average dose ≥ 5 mg/day of equivalent prednisone over a period ≥ 3 months.

Exclusion Criteria:

* major memory impairment or language barrier.
The Influence of Hormonal Changes During Pregnancy on Corneal Biomechanics in Humans

The intraocular pressure in the human bulbus requires that the "wall" of the eye shows a certain (bio)mechanical strength. The human cornea represents the anterior portion of this wall. Since several years, there is a growing interest in the ophthalmological community for identifying factors modulating the biomechanical stability of the human cornea. Reasons are twofold: advances in keratoconus research and the increasing numbers of refractive laser surgery procedures with (correspondingly) increasing numbers of complications due to non-respecting the limits of corneal biomechanics.

There is evidence that oestrogen, but also thyroïd hormone changes have a major impact on corneal biomechanics. A number of recent observational studies have reported on keratoconus and refractive laser surgery patients with decompensating biomechanics during pregnancy.

Both hormones also show physiological changes during pregnancy and little is known about the impact of these physiological changes on the human cornea.

The aim of this study is to establish baseline values for physiological changes in the human cornea during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Pregnancy confirmed by echography
* Before gestation week 14

Exclusion Criteria:

* Pre-existing corneal disease
* Previous eye surgery
* Inability to understand the nature of the study
* Patient with legal guardian
Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease

The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate Alzheimer's Disease
* Male or female 55 years or older
* Living with caregiver
* Read, understand and speak English

Exclusion Criteria:

* Need to drive during the study
* Treatment with acetylcholinesterase inhibitors or NMDA antagonist, such as Aricept or Namenda, within 2 weeks of check-up and during the study
* Frequent Smoker
* Frequent Consumer of Caffeine
Use of GM-CSF Supplemented IVF Medium in Patients With Recurrent Implantation Failure

The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with GM-CSF, a growth factor working on stem cells, may improve the embryo implantation in patients experiencing recurrent implantation failure in IVF cycles.

In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. In particular there are a group of patients, in young reproductive age, experiencing recurrent implantation failure, nevertheless the good embryos produced and transferred. Recently, it has been showed that culture medium supplemented with GM-CSF, may improve the embryo outcomes in IVF. In this trial the investigators will test the potential benefits of this culture medium on embryos of patients experiencing recurrent implantation failure. 100 women with recurrent implantation failure, at least three failed previous IVF attempts with at least 8 good embryos transferred no more than 40 years old will be selected. These patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. After the oocyte retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with the GM-CSF supplemented culture medium (EmbryoGen, Origio, Denmark), or in normal culture in micro drop of 30microliters under oil until the day of transfer (day three or 8 cells sage embryos). A maximum of three embryos will be transferred. The pregnancy rate the implantation rate will be the outcomes considered

Eligibility Criteria:
Inclusion Criteria:

* woman age 40 years old or less,
* 3 or more consecutive previous failed IVF cycles with a total of at least 8 good embryos replaced in uterus

Exclusion Criteria:

* chromosomal defects in the couple,
* metabolic diseases (diabetes, etc),
* other genetic diseases (thalassemia, cystic fibrosis, etc.)