cyrilzakka/clinical-trials huggingface dataset:
Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54

Low-dose CT Screening has been shown in two large trials in the United States (NLST) and Europe (NELSON) to increase overall survival in subjects 55 years of age and older with a strong smoking history. Unfortunately, in both North Carolina (NC) and South Carolina (SC), subjects are found to have the above referenced smoking history prior to reaching the minimum age in these studies. This study is aimed at decreasing the minimum age of screening in a high-risk population.

The primary objective of this study is to evaluate the lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT. Secondary objectives include evaluating the lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2); evaluating the positive screening rate at T0, T1, and T2; evaluating the impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates; and summarizing the incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening. Enrollment will continue until 174 subjects are identified in the evaluable population with a total of 1160 subjects anticipated to be enrolled and screened.

Eligibility Criteria:
Inclusion Criteria:

* Subject must meet all the following applicable inclusion criteria to participate in this study:

  1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  2. Age 40-54 years at the time of consent.
  3. A positive smoking history of greater/equal to 30 pack years and they are either currently smoking or have quit within the last 15 years.
  4. Ability to read and understand the English and/or Spanish language.
  5. Ability to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

* Subjects meeting any of the criteria below may not participate in the study:

  1. Known diagnosis of lung cancer in the past 5 years.
  2. Any known contraindication to having a low-dose CT Scan.
  3. Known pregnancy.
Choroidal Thickness in Myopes by SSOCT

Optical coherence tomography is a non-invasive and non-contact imaging modality that enables two-dimensional cross-sectional and three-dimensional volumetric imaging of tissue architecture.

It has evolved over the past decade as one of the most important ancillary tests in ophthalmic practice. It is a noninvasive imaging technique and provides high resolution, cross-sectional images of the retina, the retinal nerve fiber layer and the optic nerve head. With axial resolution in the 5-7 μm range, it provides close to an in-vivo 'optical biopsy' of the retina. Optical coherence tomography employs light from a broadband light source, which is divided into a reference and a sample beam, to obtain a reflectivity versus depth profile of the retina. The light waves that are back scattered from the retina, interfere with the reference beam, and this interference pattern is used to measure the light echoes versus the depth profile of the tissue in vivo.

Recently, a new type of optical coherence tomography instrument, called a swept source optical coherence tomography, was introduced. The Swept source optical coherence tomography uses a tunable laser (swept-source) as a light source with a longer wavelength that allows the light to penetrate deeper into tissues than the conventional spectral domain optical coherence tomography instruments. This, then, enabled the imaging of the choroid.

Because choroidal abnormalities such as vascular hyperpermeability, vascular changes, loss and thinning are critical to the onset and progression of many ocular diseases, ophthalmologists and researchers are shifting their interest to the choroidal abnormalities.

Being a major vascular layer of the eye , choroid plays an important role in ocular health, and is involved in the pathogenesis of many intraocular diseases such as age-related macular degeneration , polypoidal choroidal vasculopathy , central serous chorioretinopathy and myopic macular degeneration. Accurate measurement of choroidal thickness in vivo is an essential step in monitoring disease onset and progression that lead to choroidal thinning. Based on histologic study, choroidal thickness ranges from 170 to 220 um.

These disorders show the need for understanding the choroidal structure in ocular diseases and the importance of having database of choroidal thickness.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 years to 40 age.
* Spherical equivalent from zero to -8.
* Minimum corneal thickness from 500 to 540.
* Refractive power of cornea more than 41 diopter.
* Axial length from 22 to 26.

Exclusion Criteria:

* Corneal abnormalities such as ectasia.
* Eyes with dystrophic or degenerative diseases.
* Prior ocular surgery.
* Anterior or posterior segment inflammation.
* Glaucoma.
* Eyes with choroidal abnormalities or conditions that could affect choroidal thickness such as central serous chorioretinopathy, nevus, pregnancy, or haemangiomas.
* Patients with diabetes mellitus.
* Patients with optical media opacity that significantly disturb optical coherence tomography image acquisition.
Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* cancer treatment with need for central venous access
* Age \>18 yrs
* Suspected survival \> 4 weeks
* Need of central venous access \>4 weeks

Exclusion Criteria:

* Ongoing uncontrolled systemic infection
* Prescence of significant thrombosis/stenosis in arm or central veins
* Unability to communicate
* Probable upcoming need for dialysis fistula
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD

interventional trial for off label use of high dose atorvastatin 80 mg in intermediate AMD patients and correlate recovery response measured by dark adaptation recovery time with drusen volume reduction measured by SD-OCT

Dark adaptation recovery time is a sensitive marker of AMD progression in intermediate AMD, largely owing to drusen volume providing a transport barrier that slows the transfer of nutrients between the choroid and photoreceptors2. Consequently, dark adaptation may provide an early indication of response vs. nonresponse, aiding case-by-case decisions on continuation of treatment when patients experience adverse side effects (e.g., elevated CPK or liver enzymes) or when atorvastatin provides insufficient lipid control in patients also at high-risk for cardiovascular disease (and switching to an alternative statin might be desirable).

Eligibility Criteria:
Inclusion Criteria:

* All subjects with intermediate AMD diagnosis in one or both eyes will be considered, regardless the severity stage and subtype of disease in the other eye.

High-risk iAMD (numerous large, confluent drusen covering ≥ 0.5 disk area, with or without pigmentary changes but having no evidence of GA or CNV) in the study eye

Subjects can have either:

(i) Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.

Exclusion Criteria:

* Patient previously taking high dose Atorvastatin 80 mg
* Patients previously taking other statins than high dose atorvastatin, in whom primary care provider (PCP) feels cannot be safely moved to high dose atorvastatin or those in which high dose atorvastatin is deemed contraindicated by PCP
* Patients with known adverse reaction to statins
* Patients with severe renal disease or multiple comorbidities
* Age \>85 years
* Pregnancy
* Patients with concomitant use of cyclosporine
* Active uveitis;
* Ocular infection;
* Any retinopathy other than AMD;
* Media opacities;
* Refractive error equal or superior to 6 diopters (spherical equivalent);
* Any previous retina surgery;
* Other ocular surgery or intra-ocular procedure in the study eye (injection other than anti angiogenic injection, laser) within the 90 days prior to enrollment
PROMISE International

The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

This study will investigate the safety and effectiveness of the LimFlow System for creating an arterio-venous fistula in the below-the-knee vascular system using an endovascular, minimally invasive approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be \> 21 and \< 95 years of age
* Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6
* Assessment that no conventional surgical or endovascular treatment is possible
* Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be \<50% stenosed
* Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits

Exclusion Criteria:

* Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder
* Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study
* Life expectancy less than 12 months
* Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment
* Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment
* Patient currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment
* Patient unable to give consent
* Pregnant or breastfeeding women
* Documented myocardial infarction or stroke within previous 90 days
* Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis
* Patients with vasculitis and/or untreated popliteal aneurysms
* Patients with acute limb ischemia
* Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft
* Lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion
* Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)
* Known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
* Severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of \< 40%, NYHA Classification III-IV)
XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization

This study will evaluate the use of x-ray fused with MR images as an imaging tool to help guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.

Cardiovascular interventional procedures are currently conducted under the guidance of X-ray fluoroscopy. Magnetic resonance imaging (MRI) can provide increased soft tissue information about the cardiovascular system. By combining the familiar X-ray environment with superior magnetic resonance imaging, the investigator hopes to enhance and expand the capabilities of cardiac catheterization techniques.

The investigator will conduct cardiac catheterization procedures using XFM guidance in pediatric research patients who are undergoing medically necessary procedures. The investigator aims to decrease the exposure of these patients to the routine hazards of ionizing radiation and contrast exposure compared to the standard of care approach.

Eligibility Criteria:
Inclusion Criteria:

1. Children and adults of any age
2. Undergoing clinically-indicated cardiovascular catheterization

Exclusion Criteria:

1. Cardiovascular instability precluding baseline medially-necesary MRI
2. Women who are pregnant
3. Women who are nursing and who do not plan to discard breast milk for 24 hours
4. All patients who are medically judged to have contraindication(s) to MRI scanning. Contraindications include implanted metal devices which are contraindicated for MRI scanning
Nitrosomonas Eutropha on Nitrolipids in the Skin

We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and inflammatory cytokines on the skin.

We are looking to see how the nitrosomonas alters nitrolipids in the skin and the inflammatory cytokines of the skin.

We will be using healthy subjects over the course of 2 weeks.

Subjects will be using a neutral cleanser for one week prior to the study, skin microbiome,facial photography, lipid and cytokine measurements will be taken at baseline. Subjects will then start using nitrosomonas spray twice daily for one week.

There is a portion of the study where the subjects will have skin microbiome, facial photography, lipid measurements, blood pressure measurements and a bloow draw before and after using the nitrosomonas spray for one week.

Eligibility Criteria:
Inclusion Criteria:

* Those aged 18 and over
* Healthy Subjects with clear skin

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
* Those who have started new oral medication in the last four weeks
* Those who have used systemic antibiotics in the last month
* Those who have used isotretinoin in the last 6 weeks
* Those who have used topical antibiotics or retinoid in the last two weeks.
* Those who have autoimmune or metabolic diseases
* Those who have changed brands of oral contraceptive within the last four weeks
* Those who have chronic medical disorders
* Those whose with active skin infections
* Concomitant use of nitrates
* Concomitant use of anti-hypertensive agents
* Those with syncopal episodes
Project IMPACT Immunizations (IMProving America's Communities Together)

The primary objective of this study is to evaluate how implementing an innovative care model that provides the pharmacist access to a patient's vaccine history at the point-of-care impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations.

This is a multi-site, observational study investigating the impact of implementing an innovative care model on the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations. The innovative care model enables the pharmacist to utilize a bi-directional IIS to assess patients' vaccination histories, identify unmet vaccination needs, and document the care provided. Data will be collected in the bi-directional IIS. Aggregate de-identified data will be reported to the researchers at the midpoint and conclusion of the study. The project duration has been established to allow sufficient time for each pharmacy to implement the innovative care model and monitor each pharmacy for a 6-month study period. The American Pharmacists Association (APhA) Foundation has an a priori intent to publish the project results.

Eligibility Criteria:
Inclusion Criteria:

* Individuals eligible to be enrolled in the study include any person at least 18 years of age receiving an influenza vaccination from a participating pharmacy site.

Exclusion Criteria:

* n/a
Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)

The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
* Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)
* Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase \[ALT\]) levels above the upper normal limit for gender
* Documented chronic hepatitis C (CHC) of genotype 1/4/5/6
* A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4

Exclusion Criteria:

* Known hypersensitivity for any active ingredient or constituent
* Pregnancy or lactation
* Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
* Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
* Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance \<50 mL/minute
* Hepatitis of immunologic origin or medically documented history of auto-immune disease
* Severe hepatic disorder or decompensated cirrhosis
* Pre-existing thyroid disorder, except if under control with classical treatment
* Epilepsy or central nervous system disorder
* Hemoglobin pathology, eg, thalassaemia, sickle cell anemia
Comparing Unimanual and Bimanual Mirror Therapy for Upper Limb Recovery Post Stroke

The purpose of this randomized controlled study is to

1. Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan area;
2. Evaluate the effectiveness of home MT versus traditional home exercise program; and
3. Evaluate the superiority of unimanual or bimanual MT intervention protocols for chronic stroke subjects with moderate hand deficits. Subjects from occupational therapy at the Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular accident (CVA) or stroke will be divided into three (3) groups:

   * Control Group subjects will participate in standard occupational therapy rehabilitation protocol plus a traditional home based exercise program.
   * Experimental group 1 subjects will participate in standard rehabilitation protocol plus unimanual home based mirror therapy program
   * Experimental group 2 subjects will participate in standard rehabilitation protocol plus bimanual home based mirror therapy program.


Eligibility Criteria:
Inclusion Criteria:

* First time unilateral stroke \> 3 months post stroke.
* Cognitively be able to follow direction
* Cognitively be able to consent to participation in research study
* Moderate/severe deficits as per the Fugl-Meyer assessment score from 10-50 and the ability to grasp and release a small towel or washcloth.

Exclusion Criteria:

* Complex medical problems, that would render the subject unable to participate in an extensive home program
* History of pre-existing neurological or psychiatric diseases, orthopedic conditions of the upper limbs, or peripheral nerve injuries that render the subject unable to sit or to move either upper limb
* Hearing and vision impairments which may impede subjects participation in the home program
* Perceptual deficits such as apraxia, neglect, or agnosias as per clinical evaluation which may impede subjects participation in the home program
* Botox injection in affected arm/hand within 3 months
* Global aphasia that may interfere with understanding instruction for testing or home exercise program.
Fasted Exercise Training in Type 2 Diabetes

This study compares aerobic exercise training performed before breakfast (i.e., in the fasted state) to similar training performed after breakfast in people with type 2 diabetes. Training will take place over 16 weeks.

People with type 2 diabetes (T2D) are encouraged to increase their physical activity (PA). Sometimes, increasing the amount of PA can be difficult. Therefore, simply recommending that individuals preform more exercise may not be effective in the long term. Recent short-term studies have started to explore how to maximize the effect of a single bout of exercise. For example, short term studies suggest that exercise performed after a meal may decrease blood sugars more than exercise performed after a meal. However, research in people without diabetes shows this may not be the best approach in the long-term. To date, no long-term study has compared the effects of exercise performed at different times of the day in people with T2D.

This study will compare the effects of 16 weeks of regular exercise before breakfast compared to 16 weeks of regular exercise after breakfast. It is expected that exercise before breakfast (i.e., in the fasted state) will lead to greater improvements in blood sugar control, without the addition of more exercise. It could be very motivating for people with diabetes to know that they can get more benefits from exercise by changing when exercise is performed, rather than trying to increase the amount of exercise.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed type 2 diabetes
* Treated with diet and/or glucose lowering medications, but not insulin, for at least 6 months
* Sedentary (defined as reaching \<150 minutes of aerobic exercise per week)
* A1C below 9.0%
* BMI ≥25 kg/m2
* Central obesity as determined by waist circumference according to Diabetes Canada cutoffs:
* greater or equal to 94cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent,
* greater or equal to 90cm for males of South Asian, Chinese, Japanese, South and Central American descent,
* greater or equal to 80cm for females
* Able to walk for 50 minutes

Exclusion Criteria:

* Smoking
* Consuming more than 10 alcoholic drinks/week
* History of stroke, myocardial infarction, or coronary artery disease
* Resting heart rate \<100 bpm
* Resting blood pressure \<160/100 mmHg
* Implantable device, such as a pacemaker, that would not be safe for Magnetic Resonance Imaging