cyrilzakka/clinical-trials huggingface dataset:
Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus. All tests and observations will be done at a single visit over the course of approximately 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 6 years
* Signed Informed consent by parent or guardian
* Meet all inclusion criteria.

Exclusion Criteria:

* Children with a history of developmental delay or cognitive deficit
* Children unable to complete the GSE (including visual acuity testing)
Synovitis and Therapy Response in Inflammatory Arthritis With Contrast Enhanced Ultrasound

This study is about using contrast-enhanced ultrasound (CEUS) to assess the degree of synovitis (joint inflammation) in patients with inflammatory arthritis, such as rheumatoid arthritis, and whether it can be used for assessing a treatment response. The investigators hope to learn whether contrast enhanced ultrasounds are better than regular imaging techniques, such as MRI, when used to evaluate the response to disease modifying anti-rheumatic drug (DMARD) therapy in inflammatory arthritis.

Inflammatory arthritis affects approximately 1% of the world population and can lead to significant pain and disability. Although radiographs can identify characteristic patterns of joint space narrowing and erosive changes, these findings are typically late findings and represent irreversible damage. With the development of disease modifying anti-rheumatic drugs (DMARDs), the goal is now to identify the pre-erosive inflammatory features and identify the patients that progress further into severe functional debility if not treated immediately.

MRI with gadolinium enhancement is proven to be very effective in early detection of soft tissue, bone erosions, synovitis, the integrity of ligaments, cartilage and bone marrow edema. However, MRI is expensive, may be impractical for assessing multiple joints and has relatively long examination time. Some patients may have claustrophobia and some may have contraindications to gadolinium administration. The investigators overarching goal is to determine whether the perfusion information provided by novel ultrasound based techniques such as, contrast enhanced ultrasound and superb microvascular imaging, can be used for assessment of treatment response to DMARD therapy for inflammatory arthritis. The recent advances in evaluation of vascularity of the tumors using contrast ultrasound technique can also be applied to rheumatological diseases. It is ideal to develop a sensitive imaging technique that can be routinely available and is relatively cheap. Ultrasound is available and has low cost and can be used for assessment of treatment response to DMARD therapy

Eligibility Criteria:
Inclusion Criteria:

* Patients (≥ 18 years of age) that meet diagnostic criteria for an inflammatory arthritis.
* Clinical suspicion of active synovitis involving at least one target joint.
* Patients competent to sign study specific Informed Consent.
* Patients willing to comply with protocol requirements.
* Intent to treat with disease-modifying anti-rheumatic drugs (DMARDs).

Exclusion Criteria:

* Patients who are pregnant or less than 18 years of age.
* Patients who have a known cardiac shunt or pulmonary hypertension.
* Patients with any known hypersensitivity to perflutren or gadolinium contrast agents or renal insufficiency (GFR \< 30 mL/min).
* Patients who cannot consent for themselves.
Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia

The objective was to observe the satisfaction of local anesthesia during the implantation of the TVT-SECUR for the treatment of stress urinary incontinence, with the use of questionnaires completed by the patients, and to evaluate the short-term efficacy and safety of the sling, with a comparison of the two techniques of implantation: the 'U-Method' and the 'Hammock' technique.

Stress urinary incontinence (SUI) is a common problem, affecting women of all ages. Treatment options for SUI include physiotherapy and surgical interventions, such as retropubic operations and midurethral slings. Conventional retropubic and transobturator tapes are the preferred choice for most surgeons, because of their wide applicability, technical simplicity and clinical efficacy. The retropubic tape has been effective for many years, but exposes the patients to serious complications, such as bladder perforations, principally because of the use of the retropubic space for the fixation of the tape. In an attempt to avoid the retropubic space, the second generation of slings, the transobturator tape, was introduced. However, prolonged postoperative groin pain as well as vascular injuries have been reported.

The last generation of midurethral slings, the tension-free vaginal tape system (TVT-SecurTM, Gynecare, Ethicon, Somerville, NJ, USA), introduced in 2005, attempts to lower the number of complications, by involving only a small vaginal incision and no exit wound. This 8-cm long laser-cut polypropylene mesh can potentially be implanted under local anesthesia, because of a less-invasive technique using minimal vaginal dissection as well as avoidance of retropubic space and obturator fossa. In the case of conventional midurethral slings, even if their implantation under local anesthesia has been studied and proven relatively safe, this practice has not gained popularity.

This was a prospective, clinical study with primary objective to observe the satisfaction of local anesthesia during the implantation of the TVT-SECUR, with the use of questionnaires completed by the patients. The secondary objective was to observe the short-term efficacy and safety of the sling. The final objective was to compare the two techniques of implantation: the 'U-Method' and the 'Hammock' technique.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence
* Acceptance of local anesthesia
Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults

To evaluate the efficacy of the intervention in improving Motivation.

To evaluate the efficacy of the intervention in improving Fatigue, Motivation/Vigor, Focus/Sustained Attention and blood levels of B vitamins and taurine.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female, aged 25-40 years, inclusive, at enrolment.
* Healthy as per site physician/investigator medical assessment based on medical history and physical examination.
* Body mass index (BMI) between 18.5 to 27.5 kg/m².
* Able to understand and provide signed informed consent prior to study enrolment.
* Willing and able to comply with the requirements for participation in this study.
* Day time workers who work ≥ 8 and ≤ 12 hours per day, and ≤ 60 hours per week.

Exclusion Criteria:

* Any significant ongoing or past medical (including celiac disease, obstructive sleep apnea, restless leg syndrome) and/or psychiatric condition, which in the opinion of the site physician/investigator may compromise participant wellbeing/safety, impede participant compliance with study procedures, or ability to complete the study.
* Any clinically significant abnormality detected by the site physician/investigator during physical examination conducted at screening.
* Participants with reported intermediate visual acuity less than 20/25 and without correction.
* Known history of allergy to the ingredients in the investigational products.
* Participants that have taken part in another interventional clinical trial within the last 3 months.
* Current regular smoker (regularity defined ≥2 cigarettes per week).
* Pregnant, lactating, or intending to conceive during the clinical trial.
* Use of chronic over the counter or prescription medicines that may affect cognitive and physical functioning within 30 days or 5 half-lives prior to enrolment e.g., antidepressants, anxiolytics, antihistamines, narcotic analgesics.
* Alcohol consumption above daily recommended alcohol intake for men (2 drinks = 24 g/day) and women (1 drink = 12 g/day) (assessed by self-report; local guidelines)
* Caffeine consumption above recommended caffeine daily consumption, defined as \> 400 mg/day (approximately 4 cups of coffee), and evaluated using the Caffeine Consumption Questionnaire.
* Consumption of energy drinks containing Taurine and/or Vitamin Bs within 21 days prior to enrolment
* Use of vitamin Bs and/or Whey protein and/or amino acid supplements within 30 days of enrolment.
* Presence of sleep disorders (evaluated using the global sleep assessment questionnaire (GSAQ))
* Performing shift work or trans-meridian travel within 10 days of enrolment
Pulmonary Watershed Topographic Map Navigation for Lung Nodule Resection

A method of ICG counterstaining localization under target artery occlusion without cutting，It's a new method of localization of small pulmonary nodules.

1. This technology can replace part of CT puncture-guided positioning, which not only saves CT positioning costs for patients, but also saves time and space resources in CT room;
2. The target artery occlusion technique does not cut off the blood vessels, and the operation is still a wedge resection. Compared with the standard segmentectomy/subsegmentectomy, the steps of cutting off the veins and bronchial tubes are reduced, the operation time is shortened, and the turnover rate is improved.
3. There is less damage to the lung tissue, and the lung function is well preserved. The patients can be discharged in an average of 3 days after the operation, which improves the bed turnover efficiency of the department.

Eligibility Criteria:
Inclusion Criteria:

1. \<1cm CTR≤0.75; \<1.5cm CTR≤0.5; \<2cm CTR≤0.25 Lung nodules
2. The tumor center is located in the peripheral 2/3 area of the lung field
3. Preoperative analysis and planning of watershed by 3D reconstruction
4. Clinically assessed as cT1aN0M0 stage IA1/cT1bN0M0 stage IA2 (eighth edition), clinically resectable

Exclusion Criteria:

1. No surgical video, no postoperative gross specimen and related distance measurement records
2. The incision edge does not exceed the target nodule diameter from the nodule edge
3. The resection range exceeds 50% of the preoperative planning
4. Postoperative pathological staging non-pT1aN0M0 IA1 stage/pT1bN0M0 IA2 stage (eighth edition)
5. Any situation where the investigator feels the need for extended resection
6. Patients with chronic diseases (such as COPD, pulmonary fibrosis, silicosis) that can cause loss of lung function in patients at risk of progression or potential progression
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing moderate procedural sedation in the Emergency Department

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Intoxication
* Cannot give informed consent
* Allergy to any of the three study medications
* ASA physical status score \> 2
* Patients who require deep procedural sedation
Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly

This study aims to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission and mortality of hospitalized elderly.

Hospitalized elderly people show malnutrition, physical inactivity, and pronounced systemic inflammation which may be exacerbated the catabolic state and promote drastic muscle wasting during the hospitalization and, thus increasing the length of stay, morbidity, and mortality. Therefore, the aim of this study is to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission, and mortality of hospitalized elderly.

Eligibility Criteria:
Inclusion Criteria:

* both sex;
* 65 years and older;
* hospital stay less than 48 hours;

Exclusion Criteria:

* cancer in the last 5 years;
* delirium;
* cognitive deficit that impossibility the patient to read and sign the informed consent form;
* neurological disease;
* neurodegenerative muscular disease;
* impossibility to receive the intervention.
Developement of Questionnaire to Evaluate a Regularity of Lifestyle in Type 2 Diabetic Patients

In order to manage of type 2 diabetic patients with irregular lifestyle, developement of an appropriate questionnaire to evaluate a regularity of lifestyle is necessary.

We have a plan to perform the seven day's records and the questionnaires which is necessary to type 2 diabetic patients for the initial step. Next, we will revise a questionnaire with professional advices for several times. Finally we will test a reliability with a final version as form of multisite based study and will confirm a questionnaire for a regularity of lifestyle in type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients

Exclusion Criteria:

* Type 1 diabetic patients, gestational DM patients
The Immersive Experience of Virtual Reality During Chemotherapy in Patients With Early Breast and Gynecological Cancers: the Patient's Dream Study

"Patient's dream" study is a two-arm randomized controlled trial that will be conducted at Regina Elena National Cancer Institute, IRCCS (Rome), from April 2019 to January 2020. Before starting the first course of chemotherapy, patients will be randomly divided to receive the VRE (VRE arm) as "distraction therapy", or to entertain themselves with conventional means such as listening to music, watching a mobile program, reading newspapers, books, magazines or also doing nothing, according to the patient's preferences and for the entire duration of administration of the first CT cycle (control arm). A clinical team composed of three oncologists, three psychologists, one nurse and one expert VR operator will support the patients involved in the study.

The primary aims were the assessment of psychological distress, anxiety and quality of life between the two study arms. Secondary endpoints were the perceived time during the first course of CT and the acute and late toxicity.

The study will conduct in accordance with the ethical standards as laid down in the Declaration of Helsinki and its later amendments and within the protocol approved by the Central Ethics Committee (Trial registration number: RS 1105/18). A written informed consent will obtain from all participants included in the study.


Eligibility Criteria:
Inclusion Criteria

* diagnosis of breast or ovarian cancer confirmed histologically, from I to III stage;
* surgery as first therapeutic approach (in case of ovarian cancer, patients with minimal residual disease after surgery will be also included)
* first cycle of adjuvant CT, with or without a biological treatment according to the specific cancer (regimens including anthracyclines/taxanes, anthracyclines/cyclophosphamide, carboplatinum/taxane combined or not with trastuzumab for breast cancer, carboplatin/paclitaxel combined or not with bevacizumab for ovarian cancer);
* aged ≥ 18 years;
* performance status (ECOG) 0-2;
* life expectancy \> 12 months;
* ability to understand and sign the informed consent.

Exclusion Criteria:

* presenting prior history of seizures;
* disorders of the mood;
* previous history of alcohol and/or drug addiction;
* disorder of vision and eyes;
* history of psychiatric pathologies.
Clinical, Functional and Musculoskeletal Differences Between Adult Patients With Hemophilia and Their Healthy Peers

Background. Hemophilia is characterized by the development of a progressive, degenerative, intra-articular lesion (hemophilic arthropathy). This arthropathy presents with chronic pain, limited range of motion, axial changes, and periarticular muscle atrophy.

Goal. To analyze the clonic, functional and musculoskeletal differences between adult patients with hemophilic arthropathy of the knee and ankle and their healthy peers.

Study design. Cases and controls study patients. 21 patients with hemophilia A and B and 21 subjects without joint damage.

Variables and measuring instruments: pressure pain threshold (pressure algometer); joint status (Hemophilia Joint Health Score scale); and strength (dynamometry) and muscle activation (surface electromyography).

Expected results. Observe the differences between patients with knee and ankle arthropathy and their healthy peers in muscle strength and activation.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B.
* Over 18 years
* With medical diagnosis of knee arthropathy
* With clinical evaluation by Hemophilia Joint Health Score
* In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
* Healthy subjects must meet knee joint health criteria; over 18 years; and no previous knee or ankle injuries in the 6 months prior to evaluation.

Exclusion Criteria:

* Patients with neurological or cognitive disorders that prevent the understanding of physical tests
* Not having signed the informed consent document
Prevalence of Erythropoiesis Stimulating Agents Hyporesponsiveness in Dialysis Patients in Assiut University Hospital

* The prevalence of erthropoietin stimulating agents hyporesponsiveness in hemodialysis patients in Assiut university hospital
* Assessment of cardiovascular diseases risk in patients with erythropoiesis stimulating agents hyporesponsiveness in hemodialysis patients in Assiut university hospital

Anemia is common in patients with chronic kidney disease. The routine use of erthropoietin in anemia control has reduced morbidity and mortality rates in patients with chronic kidney disease. Despite an increase in the use and average dose of recombinant human epoetin over the last 15 years, a substantial percentage of patients still don't achieve hemoglobin targets recommend by international guidelines. The definition of recombinant human epoetin resistance has been introduced to identify those patients in whom the target hemoglobin level is not attained despite a greater than usual dose of erthropoietin stimulating agent. In recent years, increasing attention has been paid to the relationship between dialysis, increased inflammatory stimulus, malnutrition, and erythropoiesis stimulating agents response. Erythropoiesis stimulating agents hyporesponsiveness was defined by the erythropoietin resistance index, which was the erythropoietin dose per week divided by body weight and Hemoglobin level . The resistance to erythropoiesis stimulating agents is directly related with incident comorbidity in patients on hemodialysis and it can be interpreted as a useful marker of early mortality. Patients with higher erythropoietin resistance index values had a higher all cause mortality rate and cardiovascular mortality rate. Erythropoietin resistance index was related with left ventricular mass index, left ventricle systolic function and cardiovascular events in patients with hemodialysis. By monitoring of erthropoietin resistance index, early identification of the epoetin resistance may be useful to predict the cardiovascular risk in hemodialysis patients

Eligibility Criteria:
Inclusion Criteria:

* age more than 18
* End stage renal disease patients undergoing regular hemodialysis in Assiut University Hospital - Hemodialysis unit for duration at least 3 months

Exclusion Criteria:

* acute infectious disease within one month
* active liver disease or cancer
* recent blood transfusion or surgical intervention
* active bleeding or hemorrhage
Cortisol and Food Insecurity

This study will use a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 50% men). These participants will then, in counterbalanced order, be exposed to a gold-standard laboratory stressor and a control condition, one month apart. Moderation analyses will test whether cortisol reactivity to the stressor acts as a modulator of the relationship between high levels of food insecurity and increased hyperpalatable food intake.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* English-speaking

Exclusion Criteria:

* Recent (\<1 year) diagnosis of major psychiatric disorders including any mood disorder, schizophrenia, or PTSD
* Recent (\<1 year) diagnosis of eating disorder
* Recent (\<1 year) diagnosis of metabolic or endocrine disorder or steroid or hormonal contraceptive use
* Pregnancy
* Allergy to any of the foods in the food buffet
* Participation in strict dieting or caloric restriction
Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery

Intraoperative hemodynamic optimization decreases postoperative complications and length of stay in high risk patient. Therefore, continuous monitoring of cardiac output (Qc) is recommended to guide fluid management. Thoracic bio-reactance is a recent technique that allows cardiac output non-invasive monitoring. However, additional clinical validation studies in humans are required to better define the typologies of patients for whom this monitoring could be proposed routinely. Lung surgery is defined as an intermediate or high risk surgery regarding postoperative cardiac complications. However, surgical patients rarely benefit from continuous monitoring of cardiac output, the available methods being considered too invasive or insufficiently reliable in daily practice. Thoracic bio-reactance (Non Invasive Cardiac Output Monitor (NICOM) Starling SV) has not been studied in this subgroup of clinically relevant patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Scheduled in Louis Pradel hospital operating theater (Lyon University Hospital) for elective Lung surgery (lobectomy, bilobectomy or pneumonectomy); by thoracotomy and / or thoracoscopy.
* Having stated their non opposition to be part of this protocol

Exclusion Criteria:

* Pregnant women ;
* unemancipated minors;
* Persons unable to express their consent;
* Patients with contraindications to the placement of an oesophageal Doppler probe
* Patients with suspicion of pathology or oesogastric lesion (dysphagia, diverticulum, stenosis ...)
* Patients known for stage 2 or higher oesophageal varices
* Patients with a history of significant mediastinal irradiation, or bariatric surgery.
* Patients who have been treated in a therapeutic trial within 30 days of enrollment or who wish to participate in an ongoing study that may interfere with this study.
* Persons benefiting from legal protection measures;
* Patients unable to understand study objectives or refusing to comply with postoperative instructions