cyrilzakka/clinical-trials huggingface dataset:
CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)

The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing treatment on OCTA and to correlate OCTA findings with SD-OCT findings.


Eligibility Criteria:
Inclusion Criteria:

* Naïve patients
* Type 1 or type 2 Choroidal NeoVascularization (CNV)
* Age ≥ 55 years
* Presence of subfoveal CNV secondary to Age-related Macular Degeneration (AMD)
* At the time of inclusion, multimodal imaging should reveal exudative features
* Exudative AMD diagnosis established between 1 and 7 days before inclusion
* Monitored monthly
* Loading phase then bimonthly retreatment.
* Signed Informed Consent.
* Patient covered by the French Health Insurance

Exclusion Criteria:

* Polypoidal choroidal vasculopathy
* Type 3 neovascularization
* Choroidal neovascularization attributable to causes other than AMD
* Macular hematoma
* Pigment epithelial detachment higher than 150µm
* Fibrosis \> 50% lesion on fundus color photography, fibroglial scar
* Media opacity annoying acquisition
* Retinal vascular occlusion
* Diabetic retinopathy
* Adult-onset foveomacular vitelliform dystrophy and other pattern dystrophies,
* Refractive error \>-6D
* Active intraocular inflammation in the study eye
* Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
* Patient taking part in an interventional study at the time of enrolment.
* Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
* Pregnant and lactating women
* Stroke and/or myocardial infarction 3 months before inclusion
The Role of Midkine in Diagnosis of Thyroid Cancer

1. Evaluation of the role of serum midkine in differentiating malignant from benign thyroid nodule
2. studying the level of serum midkine in relation to different thyroid cancer stages


Eligibility Criteria:
Inclusion Criteria:

patient with thyroid nodule

Exclusion Criteria:

1. Other known organ tumour
2. Chemothyrapy
3. Radiothyrapy c. Sample Size Calculation
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery

This phase IV trial compares methadone versus hydromorphone given in the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecal) for postoperative pain relief in patients with gynecologic cancer undergo surgery. Methadone binds to opioid receptors in the central nervous system and is a long-acting opioid pain medication. Intrathecal hydromorphone works by changing the way the brain and nervous system respond to pain and is similar to an epidural. This trial may help researchers determine if methadone works as well as intrathecal hydromorphone for pain relief after surgery in patients with gynecologic cancer.

PRIMARY OBJECTIVE:

I. To determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive methadone intravenously (IV) during induction of general anesthesia for standard of care (SOC) surgery.

ARM II: Patients receive hydromorphone intrathecally (IT) prior to induction of general anesthesia for SOC surgery.

After completion of study intervention, patients are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery with a laparotomy for gynecologic malignancy
* Planned inpatient admission greater than 24 hours

Exclusion Criteria:

* Chronic pain requiring greater than 20 morphine milligram equivalents of opioid medications as an outpatient
* Prolonged corrected QT interval (QTc) \> 500ms
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 milliliters per minute (mL/min)
* Documented cirrhosis
* Preoperative platelets (PLT) \< 100
* Preoperative international normalized ratio (INR) \> 1.1
* Inappropriate cessation of anticoagulation medications prior to surgery
* Intolerance to hydromorphone or methadone
* Contraindication to administration of liposomal bupivacaine
* Subsequent surgeries after index surgery
Myocardial Perfusion in Type 2 Diabetes

The investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries.

Myocardial blood flow reserve will be determined by quantitative contrast Stress echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1) and after optimization of medical treatment four months later (Phase 2).

Early stages of epicardial atherosclerosis in patients with type 2 diabetes are associated with an impairment in endothelium-dependent dilation of the coronary microvasculature, indicating that the pathophysiological consequences of atherosclerosis may extend into the coronary microcirculation.

The investigators will evaluate three parameters of myocardial quantification with contrast Stress echocardiography and correlate with HbA1C levels.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Normal echocardiogram
* Absence of obstructive epicardial coronary disease

Exclusion Criteria:

* Obstructive coronary disease
* Heart valve disease
* COPD
* Cardiac Arrhythmias
* Cardiomyopathy
Rapid POC GAS Diagnostics in the Paediatric ED

Randomized trial evaluating effectiveness of rapid point-of-care molecular GAS diagnostics as compared to standard culture-based techniques for the management of children aged 3-18 years of age presenting with sore throat to McMaster Children's Hospital Emergency Department.


Eligibility Criteria:
Inclusion Criteria:

* all those presenting who have a throat swab ordered for GAS testing

Exclusion Criteria:

* those who took antibiotics effective against GAS within 72 h of ED presentation
A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants

The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations
* Women and men must agree to follow specific methods of contraception if applicable.
* Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants

Exclusion Criteria:

* Women who are of childbearing potential
* Women who are breastfeeding
* Any acute or chronic medical illness
* History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration)
* History of heart disease or conduction disorders
* Head injury in the last 2 years, intracranial tumor, or aneurysm
* Known abdominal aneurysm
* Current or history of rectal bleeding, hematemesis, or hematuria

Other protocol-defined inclusion/exclusion criteria apply
Nipple Stimulation for Labor Induction

This study will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins.


Eligibility Criteria:
Inclusion Criteria:

* Week 37 + 0 and on
* PROM (premature rupture of membranes)
* Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section)
* Not in active labor - without regular contractions fetal monitor, cervical dilation \< 4 cm and effacement \< 80%.

Exclusion Criteria:

* Water break \> 24 hours at the time of admission to the delivery room
* Active vaginal bleeding with suspected placental abruption
* Maternal fever
* Multifetal pregnancy
* Women with contraindication for vaginal birth
* Preeclampsia
* IUGR (intrauterine growth restriction)
* Macrosomia
* Non-reassuring fetal heart tracing
The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold

A randomized parallel-group two arm superiority trial with an allocation ratio 1:1, both participants and investigators blinded.

The zinc lozenge that will be used in the study is a commercial product available from the University Pharmacy, Helsinki, Finland. The product is classified as a "medical device" and it is not regulated according to the jurisdiction for medicines.

Each lozenge contains 13 mg elemental zinc as zinc acetate. The instruction in the commercial package for common cold patients is to dissolve slowly 6 lozenges per day in their mouth, which totals to 78 mg/day of elemental zinc, at most for 5 days. The same instruction will be used in this trial.

The University Pharmacy prepared 200 placebo lozenge packages so that the placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste. 200 packages of zinc lozenges will be used as the active intervention. The packages will contain 30 lozenges (6 lozenges/day × 5 days).

The packages of lozenges will be distributed to the enrolled participants in November 2017. The participants will be instructed to keep the package readily available so that, when they catch the common cold, they will find the package and they can start to take the lozenges according to the instructions.

The participants will be instructed to start taking zinc lozenges as soon as they start to suffer from the first symptoms of the common cold. The participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible. The duration of intervention is for the maximum of 5 days. If the symptoms disappear before 5 days, the participant may stop the usage of the lozenges.

There will be no limitations for other treatments that participants wish to use for treating their colds.

Participants will be requested to respond to a web-based symptom questionnaire daily from the first day of the treatment to the recovery from the common cold, or to a maximum of 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years, recollecting that they usually have had ≥1 colds per winter.

Exclusion Criteria:

* pregnancy or lactation; chronic runny nose or chronic cough.
Abdominal Aortic Aneurysm Surgery and Thrombosis

The aim of our study is to evaluate the incidence of post-operative thrombotic complications after abdominal aortic aneurysm surgery in the context of atherosclerosis or infectious aneurysm and its links with preoperative inflammation and hemostasis.

Abdominal aortic aneurysm (AAA) develops in the context of atherosclerosis or infection (aortitis or mycotic aneurysm). AAA and its surgery are associated with pro-thrombotic modifications of hemostasis, which persists in the post-operative period. Pro-thrombotic reactions occur in the intraluminal thrombus. Inflammatory cells recruitment is mediated by adhesion molecules from the activated endothelium, such as "vascular cell adhesion molecule-1" (VCAM-1), "intercellular adhesion molecule-1" (ICAM-1), P-selectin and E-selectin.

In the setting of infection, neutrophil death process occurs, the NETosis, with the liberation of Neutrophil Extracellular Traps (NETs), containing DNA and histones. NETs are associated with thrombosis and various studies have already quantified NETosis biomarkers in plasma from patients with thrombotic disease, such as MPO-DNA (DNA coupled myeloperoxidase).

In the clinical perioperative setting, patients with aortitis scheduled for AAA surgery shwoed exhibit thrombotic events.

The hypothesize was that patients with aortitis have an inflammatory and hemostatic activation different from patients who develop AAA in atherosclerotic condition, and that inflammation is a risk factor of postoperative thrombotic events.

Eligibility Criteria:
Inclusion Criteria:

* patient \>18 years-old;
* patient scheduled for AAA surgery by laparotomy in the vascular surgical unit at Bordeaux University Hospital;
* patient who gave his/her authorization for the use of its medical data and results of blood analyses performed on residual plasma and results of aortic material analyses

Exclusion Criteria:

* patient who do not understand the study (not fluently French speaking or unable to give his/her consent);
* patient with a pre-existing hemostatic disorder;
* patient scheduled for an endovascular surgery and benefiting from a secondary laparotomy
Effects of Cognitive-Motor Exergame Using Dividat Senso on Physical and Cognitive Function in Stroke Patients

The objective of this randomized controlled trial is to assess whether exergaming using the Dividat Senso platform more effectively enhances physical and cognitive functions in patients with chronic stroke compared to standard balance exercises. The primary questions it seeks to answer are:

* Does exergaming with the Dividat Senso lead to greater improvements in physical function, as measured by outcomes such as the Functional Gait Assessment and the Short Physical Performance Battery?
* Does exergaming with the Dividat Senso result in greater enhancements in cognitive function, evaluated through measures such as the Trail Making Test (Parts A and B) and the Stroop Test?

Researchers will compare two groups:

* An ExerGame group, receiving exergaming with the Dividat Senso in addition to standard rehabilitation.
* A Control group, receiving standard balance exercises.

Participants will:

* Undergo a four-week training period, consisting of five sessions per week, with each session lasting 30 minutes.
* Receive standard rehabilitation, including neurodevelopmental treatment and occupational therapy, alongside their assigned balance or exergame exercises.
* Complete baseline and post-intervention assessments of physical function (using the Functional Gait Assessment and the Short Physical Performance Battery) and cognitive function (using the Trail Making Test and the Stroop Test).
* During each exergame session, participants in the ExerGame group will interact with the Dividat Senso platform, performing weight-shifting, stepping, and task-oriented balancing exercises guided by real-time feedback on a virtual interface.
* Participants in the Control group will perform standard balance exercises emphasizing weight transfer in anterior-posterior and medial-lateral directions.

This study aims to clarify the efficacy of exergaming as a dual-task intervention for chronic stroke rehabilitation, potentially offering a more engaging and effective approach to improving both motor and cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic stroke (≥6 months post-stroke) confirmed by medical records
* a score of 21 or higher on the Korean version of the Mini-Mental State Examination
* ability to walk independently ≥10 meters with or without assistive devices

Exclusion Criteria:

* hemianopia
* other neurological disorders (e.g., Parkinson's disease, multiple sclerosis)
* progressive or uncontrolled medical conditions (e.g., unstable cardiac disease, uncontrolled diabetes)
* musculoskeletal conditions that could interfere with balance or gait performance
* participation in other interventional studies within the past year
Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation

The objective of the study is to evaluate with clinical parameters the performance of Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with symptoms of xerostomia.


Eligibility Criteria:
Inclusion Criteria:

* Age range between 18 and 75 years of age
* Clinical symptoms of xerostomia
* Difference in whole salivary flow between resting and stimulating conditions
* Patient ASA type I to III
* Absence of at least one mandibular third molar inferior, but at least partially dentated in the mandible

Exclusion Criteria:

* Patients with antimicrobial treatments in the three previous months
* Smokers
* Intake of bisphosphonates
* Limitation of mandibular opening
* Interoclusal distance smaller than 10 millimetres
* Lack of adequate bone availability for implant placement
A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)

The primary objectives of this study are to compare the safety, tolerability, and mean change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to latanoprost 0.005% following ocular instillation once every evening for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-85 (inclusive) with confirmed diagnosis of OHT or OAG
* Confirmed diagnosis of bilateral OHT or mild to moderate chronic OAG
* Able to undergo washout of all ocular drugs
* An IOP ≥ 24 mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least 1 eye; but \< 36 mmHg in both eyes at both Day -5 and Day 1
* Central corneal thickness 500-620 µm at screening and Day -5 in both eyes
* Best corrected visual acuity (BCVA) of +0.7 Log Mar or better

Exclusion Criteria:

* Any history of severe ocular trauma in either eye at any time
* History of angle closure or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of Screening Visit in the study eye(s)
* Cataracts that prevent observation or photography of the fundus in either eye
Efficacy of rTMS and VCT on Upper Limb Function in Patients With Stroke

Stroke is the major cause of motor impairment and physical disabilities in the adult population. Spasticity and loss of dexterity are the common problems in stroke. Recently, current interventions, such as cycling training, virtual reality (VR) and repetitive transcranial magnetic stimulation (rTMS), were used for the treatment of upper extremity (UE) dysfunction in patients with stroke. However, few studies investigated the effects of the combinations of different treatment strategies using by integrating brain imaging and motor control studies. This project proposes different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: combined inhibitory/facilitatory rTMS, VR-based cycling training (VCT), and combined rTMS and VCT. We hypothesize that the treatment effect of the combined protocol (optimal rTMS protocol and VCT) is more effective than single treatment due to integration of central and peripheral effects. Different treatment protocols will induce different changes in the brain reorganization and motor control, which further improve motor function, activity, participation, and health related quality of life (HRQOL).

This study aims to 1. identify the immediate effects of different treatment protocols in for UE training in these patients through brain image, motor control and clinical measures; 2. to determine the maintaining therapeutic effects; 3. to elucidate the most optimal treatment protocols; 4. to determine the neuro-motor control mechanism underlying clinical improvement; 5. to determine the clinimetric properties of the brain imaging and motor control measure that are responsive and valid for detecting changes after treatment protocol intervention, and 6. to identify clinical predictors influencing the outcome for treatment protocols.

The research will offer valuable motor control biomarkers for outcome prediction and targeting patients who benefit from new protocols. This project is significant for the translational and evidence-based medicine on stroke neurorehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* first stroke
* chronic stroke (onset \> 3 months)
* unilateral cerebral lesion with hemiparesis or hemiplegia
* age of 20-80 years
* no epileptic spikes on the EEG

Exclusion Criteria:

* brain stem or cerebellum stroke
* epilepsy
* aneurysm
* arteriovenous malformation
* psychiatric disease
* degenerative disease
* severe cognitive and communicative impairment or aphasia
* severe medical disease
* active medical problems
* metal implant in the body
* pregnancy
* poor cooperation with assessments
Pharmacist Interventions in Cholesterol Management of Very High Risk Patients

The primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention.

Studies have shown prevention of cardiovascular adverse events is directly proportional to percent reduction in low-density lipoprotein (LDL). This evidence explains why LDL targets for secondary prevention have continued to be lowered. Cholesterol guidelines have been updated recently and encourage the use of multiple lipid lowering therapies, in addition to statins, for secondary prevention. However, these novel agents can be expensive and difficult to acquire, making prescribing challenging for providers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of coronary artery disease
* low-density lipoprotein (LDL) \> 55
* Primary Care Physician at 1 of 6 identified clinics

Exclusion Criteria:

* Patients who are no longer an active patient of one of the internal medicine practices
* Patients whose cholesterol is managed by another practice
* Women of childbearing age/potential
* Patients residing in hospice/Long Term Care facilities
* End-stage liver disease
Clinical Evaluation of Patients With X-linked Retinoschisis

The purpose of this study is to evaluate subjects with X-linked retinoschisis in a clinical setting to collect data on disease progression.

The objective of the study is to evaluate subjects with XLRS in a clinical setting and gather data on disease progression. The data from this study will enhance the understanding of the natural history of this rare disease and will facilitate appropriately powered safety studies in a future gene therapy trial in humans.

Eligibility Criteria:
Inclusion Criteria:

Main Study:

* Clinical diagnosis consistent with XLRS
* Documented disease causing RS1 mutation
* 7 years of age or older
* Able to provide informed consent/assent
* Male

CAI sub-study:

• Presence of maculoschisis

Exclusion Criteria:

Main Study:

• Other eye diseases that might affect the results (e.g. history of retinal detachment, glaucoma, cataracts that prohibit imaging, or any other eye pathology that in the opinion of the investigator would preclude enrollment)

CAI Sub-study:

Exclusion Criteria

* Already being treated with CAIs
* Previous documented failure to respond to CAI treatment

Any drug-specific contraindication/precaution listed below (from www.micromedex.com):

Topical Eye Drop Dorzolamide Hydrochloride

Contraindications:

• hypersensitivity to dorzolamide products, including sulfa allergies

Precautions:

* dorzolamide is a sulfonamide that is absorbed systemically, sulfonamide hypersensitivity reactions may occur
* angle-closure glaucoma
* concomitant use of oral carbonic-anhydrase inhibitors
* conjunctivitis and lid reactions reported with chronic administration
* moderate to severe renal (CrCl less than 30 mL/min) or hepatic insufficiency
* ocular infection or inflammation
* recent ocular surgery

Topical Eye Drop Brinzolamide

Contraindications:

• hypersensitivity to any component of the product, including sulfa allergies

Precautions:

* concomitant use of oral carbonic anhydrase inhibitors is not recommended
* contact lens use; remove contact lenses prior to administration, allow 15 minutes before reinsertion
* hypersensitivity to sulfonamides; severe reaction may occur; discontinue if signs or symptoms appear
* low corneal endothelial cell counts; increased risk of corneal edema
* renal impairment, severe (CrCl less than 30 mL/min); use not recommended