cyrilzakka/clinical-trials huggingface dataset:
SENSIMED Triggerfish in Closed Eyes

This study investigates the effect of eye opening/closure on the quality of IOP (intraocular pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2 24-hour recording sessions, one with the recorded eye open and the other with the eye closed,using an ophthalmic patch.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject without previous ophthalmic medical history (except from indication for glasses)
* Aged ≥18 years, of either sex
* Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Patients with allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Patients not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks
Comparison of Intralipid With SMOF Lipid Following HSCT

The goal of this clinical trial is to have a successful engraftment in after bone transplantation. Acute leukemia patient of both sexes aged 2 to 18 years, who are transplant candidates, participate in this study. Primary hypothesis is Patients receiving SMOF LIPID will have better grafts than patients receiving intralipid. Also, complications after surgery and malnutrition will be less in this group.

Patients will be randomly divided into two groups: the intervention group (TPN based on SMOFLipid) and the control group (TPN based on IntraLipid). At baseline (before HSCT) and after obtaining informed consent and assent, blood samples will be collected to test for biochemical markers, including total cholesterol, TG, LDL, HDL, FBS, Alb, Na, K, Ph, Ca, Mg, CRP, IL-6, BUN, Cr, and CBC. Furthermore, data on nutritional intake (total energy and protein) and appetite status will be gathered. The primary outcomes are neutrophil and platelet engraftment, defined as \&amp;gt;500 for neutrophils and \&amp;gt;20,000 for platelets, respectively. The possibility of oral intake, as well as the achievement of oral + ONS and total oral nutrition alongside TPN duration, will be recorded. On days +15 and +30, biochemical and anthropometric markers will be collected again. Furthermore, clinical outcomes such as acute GVHD, cholestasis, bleeding, infections, hospitalization, and mortality will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to cooperate and complete the informed consent form by the legal guardian of the child;
* Age ≤ 18 years;
* Definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● cell transplantation;
* Eligible for parenteral nutrition support;
* No contraindications for parenteral nutrition;
* No history of allergy to egg or soy protein;
* Absence of severe organ failure or impaired liver function test (bilirubin \&amp;gt; 2.5 mg/dL).

Exclusion Criteria:

* Death of the child earlier than 5 days from the start of the intervention;
* Unwillingness to continue cooperation during study;
* Occurrence of side effects during the study;
* In case of sepsis, hypotension, shock, thrombosis, myocardial infarction, liver dysfunction, the patient will be excluded from the study.
Post-Approval Study of the Tecnis® Toric IOL

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference


Eligibility Criteria:
Inclusion Criteria:

* Minimum 22 years of age
* Bilateral cataracts
* Preoperative keratometric cylinder in both eyes
* Most appropriate toric IOL model choice (ZCT300 or ZCT400)
* Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:

  ≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL
* Clear intraocular media other than cataract in each eye
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
* Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
* Signed informed consent and HIPAA authorization

Exclusion Criteria:

* Irregular corneal astigmatism
* Any corneal pathology/abnormality other than regular corneal astigmatism
* Previous corneal surgery
* Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
* Any pupil abnormalities
* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
* Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
* Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
* Planned monovision correction
* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
Botulinum Toxin Type a Injection to Prevent Keloid Recurrence

The prospective, split-scar, double-blind, randomized controlled study will enroll the patients who are older than 20 years with progressive keloid lesion which is symmetric. Botulinum toxin A will be injected into half of each keloid revision wound immediately after skin closure. The scars will be assessed at 1-year follow-up with Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and the Cutometer.

Continuous variables will be reported as the mean ± standard deviation(SD). Each aspect of the VSS score, POSAS score, and the Cutometer parameters of each scar half between the BTA and control groups will be analyzed longitudinally using the paired t test. The interrater consistency will be evaluated using the Spearman rho. All analyses will be performed with IBM SPSS Version 23.0 (IBM Corp., Redmond, Wash.). A value of p \< 0.05 is considered to indicate statistical significance.

The sample size was calculated based on the results of the investigators' aforementioned study published in 2019. Thirty patients underwent keloid revision and then received radiation therapy based on our treatment protocol. The postoperative Vancouver Scar Scale score was 4.15 ± 1.74. If treatment could improve VSS score by 1, which was considered clinically significant, approximately 26 patients would have been necessary to provide a result with a real significance (using the same SD and considering the standard α error of 0.05 and a power of 0.8). Assuming a 20% non-compliance rate for follow-up evaluation, the sample size was increased to 32 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult (20 years or older)
* Progressive keloid lesion that is bilaterally symmetric, mandibular area, anterior chest or suprapubic area, for example
* At least 4 cm in length
* Repeated or uncontrolled recurrence, and unendurable symptoms with poor response to conservative modalities
* Valid written informed consent provided for surgery and trial inclusion

Exclusion Criteria:

* Allergy to botulinum toxin
* Previous botulinum toxin injection at the lesion within 6 months before enrollment
* Myasthenia gravis
* Focal infection signs
* Pregnant or breastfeeding woman
Noninvasive Mapping Before Surgical Ablation

The purpose of this study is to assess the electrophysiological mechanism of atrial fibrillation by means of a beat-to-beat noninvasive 3D mapping method in patients with concomitant persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.


Eligibility Criteria:
Inclusion Criteria:

* legal age (18-90a)
* life expectancy \> 2 years
* patients suffering from persistent and long standing atrial fibrillation
* scheduled for concomitant surgical ablation
* possibility to follow-up
* given informed consent

Exclusion Criteria:

* vulnerable patient groups
* pregnancy
* any previous surgical ablation
* acute surgical indications
* any physical condition that leads to a life expectancy of less than two years
* any contraindication to the treatments necessary for the trial's conduction as e.g.

  * known allergic reaction to contrast agent
  * known allergic reaction to antiarrhythmic drugs
  * claustrophobia or anxiety in small spaces
  * severe renal impairment
  * unmanageable hyperthyroidism
* participation in any other clinical trial that either excludes enrolment or may be a confounding factor to results
* voluntary retention
Blood Glucose Control With A Software-Algorithm In Intensive Care Unit (ICU) Patients

Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Recently, large randomized controlled trials have demonstrated that tight glycaemic control (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence intensive insulin therapy is currently finding its way into the critical care practice.

In the meantime numerous insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented. Recent reviews comparing different types of protocols describe widely ranging practice and difficulties in achieving TGC despite extensive efforts of the intensive care unit (ICU) staff. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. The primary objective of the current study is to investigate the performance (efficacy) of a control algorithm for glycaemic control in ICU patients for the whole length of ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 18 years of age
* Stay in the ICU expected to be \> 120 h
* Blood glucose \> 110 mg/dl or patient on insulin treatment

Exclusion Criteria:

* Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
* Known or suspected allergy to insulin
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
* Moribund patients likely to die within 24 hours
First Line Metastatic Breast Cancer Treatment (ESMERALDA)

The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities.

It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 ans
* Patient with metastatic mammary adenocarcinoma
* Hormone receptors ER and PR positive or negative for HER 2 negative

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* Previous treatment with eribulin or bevacizumab
* Presence of symptomatic brain metastases or meningeal
Comparative Bioavailability Study of Codeine Sulfate

The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to codeine sulfate or any comparable or similar product.
Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging

Tomorrowlabs has developed a revolutionary cosmeceutical formulation to rejuvenate aging skin. Tomorrowlabs is conducting this research to study whether this cosmeceutical can reduce the visible signs of cutaneous aging.

It is proposed to study a cosmeceutical formulation designed to reduce the visible signs of cutaneous aging. It is expected that daily application of the formulation may minimize wrinkles and fine lines of the face.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who desire to improve their appearance by reducing the visible signs of cutaneous aging in the face

Exclusion Criteria:

* Subjects who have undergone facial plastic surgery or aesthetic dermatology treatments to the face (such as fillers and neuromodulators) in the past 6 months
* Subjects with a history of collagen vascular disease, cutis laxa, connective tissue disease, psoriasis, or lupus.
* Subjects diagnosed with scleroderma.
* Subjects with a body mass index (BMI) \> 30.
* Subjects taking steroid therapy.
A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration

The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the sealed radiation source is placed temporarily over the retinal lesion by means of a handheld medical device.

Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of \< 12 total disc areas (21.24 mm2), and a GLD ≤5.4 mm
* Subjects must be age 50 or older

Exclusion Criteria:

* Subjects with prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic anti-angiogenic or intravitreal anti-angiogenic agents in study eye. (Note: This includes subjects with no known history, but with photographic evidence of prior therapy)
* Subjects who underwent previous radiation therapy to the eye, head or neck
* Subjects that have been previously diagnosed or have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)

The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of typical GERD
* partial responder to a stable standard clinical symptoms control dose of PPI therapy
* body mass index ≤ 32 kg/m2

Exclusion Criteria:

* exclusively atypical symptoms of GERD
* symptoms that have been shown not to be associated with GERD
* erosive oesophagitis
* treated with a dose of PPI greater than the dose indicated for clinical symptom control of GERD
* hiatus hernia \> 3 cm
* current diagnosis of co-existing psychiatric disease
* known clinical significant allergy or known hypersensitivity to drugs
* is pregnant or breast-feeding
* has received sodium valproate or topiramate within 30 days of Screening
* has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom

Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect instillation.

Patients on Xalatan/Xalacom who have consumed more than one bottle per month within a year according to consumption data drawn from the Clalit Health Services database, will use the Xal-Ease device for a year. The device is expected to reduce consumption of bottles and result in saving money for both patients and medical care providers.


Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma or hypertension treated with Xalatan/Xalacom who have consumed more than one bottle per month within a year prior to initiation of the study.

Exclusion Criteria:

* Patients younger than 18 years,
* Patients with severe manual disabilities,
* Patients with impaired cognition and mentality.
Application of New Magnetic Resonance UTE Technique in Hip Joint Lesions

Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more accurate basis for clinical evaluation and treatment.

Osteoporosis is a systemic bone metabolism-related disease characterized by decreased bone mass per unit volume, increased bone fragility, decreased bone density, thinning of the bone cortex and changes in bone microstructure. It often occurs in the lumbar spine and hip joint. Femoral neck fracture is a common complication of hip osteoporosis, which seriously affects people's quality of life. UTE technology can clearly image and quantify human cortical bone and cancellous bone, and advanced UTE technology such as STAIR-UTE and UTE-MT have made some progress in the field of osteoporosis. The purpose of this study was to explore UTE technology for imaging and quantitative study of cortical bone, cancellous bone and cartilage of hip joint, and to find more accurate imaging methods for clinical evaluation of hip osteoporosis and other diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with past or suspected osteoporosis and bone loss;
2. Patients with previous femoral neck fracture;
3. Patients with avascular necrosis of femoral head;
4. Hip osteoarthritis patients.

Exclusion Criteria:

1. Patients with metal implants in corresponding parts;
2. Claustrophobic.
Discharged with Indwelling Chest Tube and Valve

This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be screened prior to discharging from the hospital and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained the subject will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped. The subject will be followed until they have their chest tube removed.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Male and Female
* Consultation with a thoracic surgeon
* Discharge from the hospital with a chest tube and valve in place
* Subject is able to understand the study procedures and provide informed consent.

Exclusion Criteria:

* Pregnancy
* Allergy to Keflex and Clindamycin
* Special consideration should be taken in enrolling subjects with preexisting conditions that can be exacerbated by antibiotic use but are allowed at the discretion of the treating physician.
Prevalence, Clinical Features, and Prognosis of Coronary Artery Embolism with Concomitant Atrial Fibrillation

The goal of this observational study is to learn about the Prevalence, Clinical Features, and Prognosis of Coronary Artery Embolism With Concomitant Atrial Fibrillation. The main question it aims to answer is:

What is the proportion of coronary artery embolism with concomitant atrial fibrillation among all myocardial infarctions and myocardial infarctions with concomitant atrial fibrillation? What are the clinical characteristics of coronary artery embolism with concomitant atrial fibrillation? What is the prognosis of coronary artery embolism with concomitant atrial fibrillation? All participants will receive routine diagnosis and treatment, and baseline demographic data, clinical examination laboratory results, and follow-up data will be collected for analysis.

The study is designed as an observational study without involving experimental drugs or device interventions, only collecting data from routine medical practice.

Importance: Atrial fibrillation (AF) and acute myocardial infarction (AMI) share common risk factors and interact pathophysiologically. Coronary embolism (CE) is a critical mechanism of AMI in AF patients, yet its clinical features and prognosis remain understudied.

Objective: To investigate the incidence, clinical characteristics, and prognosis of CE in patients with AF.

Design, Setting, and Participants: A single-center retrospective case-control study was conducted at the Affiliated First Hospital of Ningbo University, China. Patients diagnosed with AMI who underwent coronary angiography (CAG) between January 1, 2014, and December 31, 2023, were included. CE was diagnosed using the Shibata criteria. Participants were categorized into three groups: AF-related CE, non-CE AF with AMI, and AMI without AF.

Main Outcomes and Measures: Baseline characteristics, clinical features, coronary involvement, treatment strategies, and outcomes (all-cause mortality, cardiac-death mortality, major adverse cardiovascular and cerebrovascular events \[MACCE\], recurrent embolism, and major bleeding) were compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Acute myocardial infarction
* Selective coronary angiography has been performed.

Exclusion Criteria:

* Clinical diagnosis of Iatrogenic coronary artery embolism
* Clinical diagnosis of Coronary artery dilation
* Clinical diagnosis of Coronary in-stent thrombosis and embolism
* Clinical diagnosis of Coronary slow flow syndrome
* Clinical diagnosis of Coronary artery dissection
* Clinical diagnosis of Coronary artery spasm
* Pathological examination showed that the embolus contained atherosclerotic plaque
* Endovascular imaging examinations, including intravascular ultrasound (IVUS) and optical coherence tomography (OCT), indicate the presence of plaque rupture, erosion, or ulceration in the culprit vessel.
* Clinical diagnosis of Previous myocardial infarction
* Previous coronary stent implantation or coronary artery bypass surgery.