cyrilzakka/clinical-trials huggingface dataset:
Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane

Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators evaluate whether presence of FAF may correlate to the postoperative visual outcome for epiretinal membrane.

92 eyes with epiretinal membrane were performed vitreous surgery, epiretinal membrane removal and internal limiting membrane (ILM) peeling. Presence of hyperfluorescence in FAF at the macular area and best-corrected visual acuity (BCVA) was evaluated preoperatively and at postoperative 1, 3, and 6 months with ultra-wide angle imaging.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal for epiretinal membrane and had followed for more than 6 months.

Exclusion Criteria:

* The patients with follow-up less than 6 months.
Randomized Open Investigation Determining Steroid Dose

Dexamethasone has been approved for the treatment of severe COVID-19, but higher doses of steroids may be more effective. The purpose of this research study is to compare the current standard dose of dexamethasone 6 mg to a higher, weight-based dosing (0.2 mg/kg with maximum dose of 20 mg) to determine if it would be more effective against COVID-19 pneumonia.

Treatment for COVID-19 patients with respiratory failure has been vexing, but the use of steroids has shown promise. In a recent randomized control trial, dexamethasone 6 mg once daily showed a modest decrease in mortality among hospitalized COVID-19 patients who require oxygen supplementation or invasive mechanical ventilation. Other trials have shown that the inflammatory response to COVID-19 can be further attenuated at higher dosages of dexamethasone. These higher dosages have not been well studied and have not been directly compared to the current standard dose of dexamethasone 6 mg daily. We propose that a higher dexamethasone dose, equivalent to methylprednisolone 1 mg/kg/day which is routinely used to treat other inflammatory conditions of the lungs, may be more effective than the current standard dose in reducing mortality in COVID-19 patients with respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

* Adults greater or equal than 18 years old
* COVID-19 infection confirmed by positive PCR test
* Hypoxemia defined by an oxygen saturation \< 94% or the need for supplemental oxygen

Exclusion Criteria:

* Corticosteroid use for \> 48h within the past 15 days prior to enrollment
* Use of steroids with doses higher than the equivalent to dexamethasone 6 mg
* Use of immunosuppressive drugs
* Pregnant women
* Chronic oxygen use
* Known history of dexamethasone allergy
* DNR / DNI
* Patient or proxy cannot consent
The Level of Blood Brain Barrier Damage Biomarker in Acute Ischemic Stroke

Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB damage is regarded as a major pathophysiological mechanism of hemorrhagic transformation. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.

Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB injury often occurs in the early stage of ischemic stroke, leading brain tissue edema or even hemorrhagic transformation with the development of ischemic injury. The biomarker of BBB damage, such as the level of serum occludin, can reflect the extent of BBB injury. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled patients aged 18-80years.
2. Acute ischemic stroke
3. Informed consent obtained.

Exclusion Criteria:

1. Tumor stroke or hemorrhagic stroke or hemorrhagic cerebral infarction on admission.
2. Stroke or serious head trauma within the previous 3 months
3. inflammatory or infectious diseases, cancer, coagulation disturbance disease and severe renal and liver failure
4. blood sample occurred hemolysis or cloudy.
5. Incomplete clinical data
6. Platelet count of less than 100,000 per cubic millimeter
7. Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
8. Pregnant or breast-feeding women
9. Patients being enrolled or having been enrolled in other clinical trial -
Treatment of Renal Sarcoidosis by Methylprednisolone Bolus

Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown. Despite this treatment, most patients will have chronic kidney disease. From our previous studies, the investigators believe that high dose steroids by methylprednisolone bolus will improve patient outcome and renal function.

In a multicentric, randomized, open trial, the investigators will assess the efficacy of methylprednisolone bolus at 15mg/kg/d for 3 days before oral steroids on renal function improvement in renal sarcoidosis patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Acute kidney injury with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1,73 m2, defined by an increase of initial value \> 25% or an increase of \> 30 µmol/l, since at least 3 months.
* Sarcoidosis diagnostic criteria according to ATS/ERS/WASOG (Am J Respir Crit Care Med 1999)
* Renal biopsy compatible with renal sarcoidosis :
* Granulomatosis tubulo-interstitial nephropathy and extra-renal damage of histologically proved or suggestive sarcoidosis Or
* Tubulo-interstitial nephropathy without granuloma and extra-renal damage of histologically proved sarcoidosis
* Informed consent
* Patients with social security

Exclusion Criteria:

* Corticosteroids greater than 0,25 mg/kg/j prednisone equivalent
* Introduction of an immunosuppressant in the month before inclusion
* Another cause of renal granulomatosis or tubulo-interstitial nephropathy
* Isolated renal damage without extra-renal past or present damage for a sarcoidosis
* Chronic renal failure, prior sarcoidosis with eGFR \< 30 mL/min/1,73 m2
* Acute renal failure from other causes. If hypercalcaemia is greater than 3 mmol/L, the correction of any dehydration will systematically salt intake, followed of renal function control before inclusion.
* Pregnancy, nursing
* Tuberculosis
* Uncontrolled sepsis
* Uncontrolled psychotic state
* Hypersensibility to methylprednisolone hemisuccinate
* Drugs prescription causing wave burst arrhythmia and/or long QT on ECG
Cambridge 7 Tesla Cerebral Small Vessel Disease Study

CamSVD is jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.

We aim to explore and understand the underlying arterial pathology in Cerebral Small Vessel Disease (SVD) using ultra-high-field 7 Tesla MRI. We will optimise 7T Time-of-Flight MR angiography, blood suppressed MR sequence and phase-contrast (PC) MR angiography for visualization of perforating lenticulostriate arteries. This optimised sequences will be used to determine the range of arterial pathologies seen in individuals presenting with lacunar strokes. The pathologies of the perforating lenticulostriate arteries will be correlated with conventional clinical risk factors, cognition and radiological markers of SVD.


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic lacunar stroke with corresponding lacunar infarct on MRI

Exclusion Criteria:

1. Unable/unwilling to consent;
2. Age\<18;
3. Stroke aetiology due to cardio-embolism or large vessel disease;
4. Lacunar infarcts \>1.5cm;
5. Severe stroke (NIHSS score ≥16);
6. Evidence of cortical infarct of any size;
7. Other major neurological diseases;
8. Severe systemic diseases such as heart failure, liver failure and kidney failure or any illness in the judgement of the investigator that could affect participation in the study;
9. MRI contraindications e.g. metal objects in or on the body, claustrophobia, pregnancy, known allergy to gadolinium containing contrast agent, impaired renal function with estimated glomerular filtration rate (eGFR) \<59ml/min/1.73m2.
Comparison of Patient Centered Outcomes for People With Sickle Cell Disease in the Acute Care Setting

The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD,

The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.

Emergency Department care is marked by long delays, lack of efficacy, and conflict. A sub-specialty Infusion Center staffed by expert clinicians and delivering individualized care can improve care quality while reducing costs. The study will examine whether care provided in an Infusion Center (IC) is more patient centered and efficient than care provided in an Emergency Department (ED) for adults with Sickle Cell Disease (SCD) and uncomplicated Vaso-Occlusive Crisis (VOC).

Sites will prospectively enroll patients in VOC seen in participating centers from either the EDs or the ICs. Specific data from the acute visits (e.g. Times of arrival, time to first dose of analgesic, etc) will be captured. This study will compare: pain management, disposition of subjects (home or admission) and patient experiences of care delivery in both settings. Subjects will complete surveys/questionnaires to asses subjects' experiences in the setting where care was provided.

The four sites to participate in the study are Baltimore, Maryland (Johns Hopkins Hospital), Cleveland, Ohio (Cleveland Medical Center), Milwaukee, Wisconsin (Medical College of Wisconsin), and Baton Rouge, Louisiana (Our Lady of the Lake Hospital). A maximum of 500 subjects will participate in the study. Participants will be enrolled for 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.

Exclusion Criteria:

* Stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment.
* Patients who are pregnant.
* Patients who are unwilling or unable to sign consent.
Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors

To compare the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), oxidative stress, arterial stiffness and lipid parameters - in insulin naive patients with DMT2.

We recruited a total of 25 patients (23 completed the study) with T2DM who had uncontrolled disease on two or more oral antidiabetic drugs. After the wash-up period, they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin. Each insulin was applied for 12 weeks. At the beginning and the end of each phase, biochemical and oxidative stress parameters were analysed and augmentation index was measured. On three consecutive days prior to each control point, patients performed a 7-point SMBG profile. Oxidative stress was assessed by measuring thiol groups and hydroperoxides (d-ROM) in serum. For augmentation index measuring, we used SphygmoCor (AtCor Medical, Sydney, Australia) which allow non-invasive measurement of AIx on radial artery using strain gauge transducer placed on the tip of a pencil-type tonometer. This method is based on the principle of applanation tonometry

Eligibility Criteria:
Inclusion Criteria:

* a history of DMT2 for at least 1 year
* aged between 18 and 65 years (women obligatory postmenopausal)
* uncontrolled glycaemia on two or more oral antidiabetic drugs
* no prior use of insulin
* HbA1c ≥7.5%
* receiving statins (if not on statins, they were put on it)
* not on antiaggregant therapy (if on antiaggregants, they were temporarily excluded from therapy)

Exclusion criteria:

* the presence of malignant disease
* chronic liver disease
* renal impairment with creatinine clearance \< 60 ml/s
* severe cardiovascular disease or history of cardiovascular incidents (stroke, myocardial infarction, peripheral amputation)
* rheumatic and autoimmune diseases and the usage of glitazones or anticoagulant therapy
Treatment of Actinic Keratosis With 5% KOH Solution

This is a prospective single-arm multicenter medical device study to investigate the clinical efficacy and safety of the treatment of actinic keratosis with a 5% potassium hydroxide solution.

In total, 68 patients with actinic keratosis grade I/II, who meet all inclusion criteria and do not meet none of the exclusion criteria are to be enrolled and topically treated twice daily for up to 3 cycles of 14 days of treatment followed by 14 non-treatment days.

The primary objective is treatment success at the individual end-of-treatment visit of all AK lesions present at baseline and treated with the investigational product.

Beside this, adverse events will be collected at each visit and evaluated in order to investigate clinical safety.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age: 30 to 80 years
* Adults with AK grade I (mild) or II (moderate)

Exclusion Criteria:

* Number of lesions requiring treatment \> 10
* Lesion to be treated \> 20 mm (maximum diameter)
* Lesions directly adjoining to the eyes, eyelids, nostrils, mouth or mucosal tissue,
* Need for topical treatment of a cancerous area
* Presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion
* Presence of a persistent or relapsing lesion despite appropriate treatment with AKOHDerm or another appropriate treatment
* High risk of progression of AK according as assessed by a medical doctor
* Pharmacological or physical local therapy of AK in the area foreseen for treatment dur-ing the last 12 weeks
* Treatment with systemic corticosteroids during the last 2 weeks
* Planned concomitant treatment of the same AK lesions during the study in addition to study treatment
* Other skin diseases in the area of application which might interfere with clinical signs
* Known predisposition for hypertrophic scarring / keloidosis
* Primary or secondary immunodeficiency
* Treatment with interferons, interferon inducers or immunomodulators during the last 4 weeks
* Pregnancy and lactation
* No reliable contraception in women of child-bearing potential
* Other serious diseases which are according to the investigator in conflict with the par-ticipation
* Obvious unreliability or lack of cooperation - known addiction to alcohol, medicinal products or drugs
* Dependent relationship with sponsor or investigator
* Participation in a clinical trial within the last 30 days
* Previous participation in this study
Developing and Optimizing Transcranial Magnetic Stimulation for Motor Rehabilitation

This study aims to evaluate three different transcranial magnetic stimulation protocols and their impact on motor system neurophysiology and skill learning.

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that induces long-term changes in connections between neuronal networks. This and the ability to activate the whole motor system allows the use of TMS to facilitate motor recovery. The motor system has different excitatory states associated with ongoing mu oscillation. Here, the investigators will monitor brain mu oscillations in real-time non-invasively using electroencephalography and modulate the function of the motor system. The investigators will test the impact of three different TMS protocols on motor system neurophysiology and skill learning. These data will provide novel understanding needed to improve TMS approaches for individuals requiring motor rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* Able to read, understand, and sign the informed consent in English
* Right-handed

Exclusion Criteria:

* A sensory or physical impairment
* History of epilepsy or seizures in the family
* Non-removable metal or electronics (e.g., a cochlear implant, cardiac pacemaker, or implanted electronic devices) in your head or body
* A head injury with loss of consciousness
* Diagnosis of psychiatric or neurological disorder
* Skin defects or active infections on the scalp or hands
* Pregnancy or breastfeeding
Fatty Liver Disease Collaborative Research in China

A multi-center, prospective cohort study on the natural history of fatty liver disease in China

This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with liver biopsy-proven macrovesicular steatosis (\>5%) will be enrolled in the baseline cross-sectional analysis. Those who are either diagnosed as NAFLD or ALD, if meeting all the inclusion and exclusion criteria, will be enrolled in the following cohort study, will be followed up after 1 year, 3 years and 5 years with a visit window of +1 month.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed fatty liver disease, confirmed by liver biopsy.
* Specific biopsy requirements: qualified biopsy specimen within 6 months, \>5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
* Only patients with NAFLD or ALD are eligible for the 5-year follow-up cohort study.
* Willing to participate in the long-term follow-up and cooperative.
* Able to provide informed consent file.

Exclusion Criteria:

* Unable to provide informed consent.
* Patients are eligible for baseline cross-sectional analysis but not eligible for the cohort section, if having any of the following condition:

  1. Any end-stage liver disease.
  2. Any malignant tumor.
  3. Any infection of hepatitis virus or HIV.
  4. Any congenital liver disease such as Wilson disease.
  5. Any other serious disease of projected survival \< 5 years.
  6. Combined NAFLD and ALD.
Acne Detection Software (AcneDect)

This study is to create a self-learning software that can detect acne lesions. Patients take a picture of their face every single day for 3 months with a secure mobile phone and fill out a pre-designed questionnaire. After 3 months, the mobile will be collected back and the pictures will be evaluated by 3 dermatologists. The software is able to learn from the dermatologists' evaluation and -using machine learning- a mechanism that should be able to automatically detect acne to some extent will be established.


Eligibility Criteria:
Inclusion Criteria:

* Acne vulgaris

Exclusion Criteria:

* Refusal to participate
Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses

This proposal is designed as a pilot study for the use of laser ablation for local control of symptomatic (e.g compressive) benign thyroid masses in 20 patients.

Thyroid nodules are a very common clinical finding, with an estimated prevalence (based on palpation) ranging from 3% to 7% among the general population. With the widespread use of ultrasound (US), clinically unapparent thyroid nodule prevalence has dramatically increased with estimates at 20% to 76% in the general population. Moreover, 20% to 48% of patients with a single palpable thyroid nodule are found to have additional nodules when investigated by US.

Laser ablation therapy offer potential for the thermal destruction of soft tissue structures. The ability to deliver large doses of energy via small flexible fiberoptics makes laser therapy ideally suited for percutaneous treatment of unwanted tissue masses.

In this study we propose to treat symptomatic soft tissue thyroid masses in the head and neck region using a new FDA-cleard laser ablation system to safely and effectively debulk the tissue and therefore improve symptoms. Real time US monitoring will be performed of the ablation front to ensure complete treatment of the target lesion. All ablated regions will be followed by US with Doppler to document changes in size and vascularity. Local effects on thyroid function for thyroid mass treatment will be measured on follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented benign thyroid nodule, or cold thyroid nodule as documented by thyroid scan.
* Patient has been evaluated by endocrinology and endocrine surgery and has been deemed suitable candidate for procedure.
* The patient's nodule(s) size and number must be no larger than 5cm and a maximum of 3 nodules, respectively.
* All nodules must be greater than 1cm from the expected location of the recurrent laryngeal and vagus nerves determined under ultrasound.
* Required initial laboratory values: T3, T4. TSH, and Thyroglobulin (for treated metastatic lymph nodes)
* All patients must understand and sign a study-specific informed consent.

Exclusion Criteria:

* Thyroid mass in contact with trachea or esophagus.
* Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be ≥ 70,000/ul.)
* Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half-life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure.