cyrilzakka/clinical-trials huggingface dataset:
Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport

Lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) and magnetic resonance lymphography (MRL) of the upper extremities. The purpose of the study is to establish if NIR-ICG is a valid clinical outcome for quantifying lymphatic vessel drainage.

Lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid arthritis) remains a major health concern. Efforts to develop effective treatments for this condition have been limited by the absence of quantitative outcome measures for lymphatic function. Published articles have supported the fact that human lymphatic contractions can be readily visualized after intradermal administration of micrograms of Indocyanine Green using laser-induced fluorescence. We recently demonstrated the feasibility of NIR imaging to quantify lymphatic drainage in the hands, wrists and forearms of healthy volunteers following intradermal web space ICG injection into the hand . To establish this emerging technology as a valid clinical outcome measure, however, we must address two major questions that confound interpretation of the imaging results: 1) are the ICG filled vessels lymphatic vessels and/or small veins?; and 2) does NIR-ICG imaging following web space injection fully capture lymphatic flow from the metacarpophalangeal (MCP) joints that are most commonly involved in RA? To answer these questions, healthy patients will be recruited to have intradermal and intra-articular injections of ICG and gadolinium followed by an imaging sessions (NIR or magnetic resonance imaging) to measure lymphatic contraction rates and flow.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent.
* Subjects must be 18 years old or older.

Exclusion Criteria:

* Active systemic disorders or inflammatory conditions (i.e., chronic infections with hepatitis B, hepatitis C or HIV) that would confound the study results.
* Known sensitivity to iodine because of residual iodide in indocyanine green
* Known sensitivity to gadolinium
* Any history of kidney disease
* Pregnant women should not participate; pregnancy tests will not be performed.
Educating and Supporting Primary Care Providers in the Implementation of Evidence-based Practices for ADHD

Although numerous studies have demonstrated that a high percentage of primary care providers (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing ADHD, many fail to implement these guidelines correctly. The goal of this project is to increase the use of evidence-based practices (EBP) for assessing and treating children with ADHD between 5 and 12 years in the context of primary care practice. This randomized controlled trial will evaluate the whether a 3-part intervention (education about ADHD management and communication training, collaborative consultation, and performance feedback regarding use of EBPs) is effective in improving EBP use among primary care providers.


Eligibility Criteria:
Primary Subjects: Clinicians

Inclusion Criteria:

* Non-resident clinician (physician or nurse practitioner) at participating site

Exclusion Criteria:

* Residents

Secondary Subjects: Families

Inclusion Criteria:

* Children aged 5-12 years receiving care from a clinician enrolled in the study for ADHD and their parents

Exclusion Criteria:

* Autism spectrum disorder
An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES) in patients in a real-world setting. The stents being observed are not investigational, that is, they have been approved for use in the general population.

The D.E.S.cover Registry is a prospective, multi-center, observational study. Consecutive patients undergoing PCI procedures will be asked to consent to participate in this study. For these patients, baseline, clinical and angiographic characteristics, as well as certain procedural and clinical events will be recorded using standardized case report forms. Outcomes will be assessed during hospitalization and at one, six and twelve months after discharge. Depending on results from the first year of follow-up, the study may be extended with an additional one or two years of follow-up.

The strategy for achieving the scientific objectives of the Registry is to document actual, real-world PCI practice and outcomes. Accordingly, the D.E.S.cover Registry does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the D.E.S.cover Registry database.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing percutaneous coronary intervention at an enrolling center by study investigators

Exclusion Criteria:

* Patient refusal or inability to provide written informed consent and/or HIPAA authorization
The Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.

The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 expression in serum and peripheral blood T cell are expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum..The investigators have designed to detected the expression levels of PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral blood T cell and serum.By using variance analysis of repeated measures design information. Thus exploring the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum,guiding clinical practice of immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological histology and/or cytology confirmed non-small lung cancer;
2. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.

Exclusion Criteria:

1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
2. Patients with a history of autoimmune disease;
3. Patients with participating in other clinical trials at the same time;
4. Other cases that researchers believe that patients should not participate in the present trial.
Optical Angiography in Glaucoma

Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. It has been speculated for a long time that vascular factors may also contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that small retinal vessel calibre are associated with the disease. In the recent years tremendous enhancements in the field of optical coherence tomography has been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that patients with glaucoma show altered vascular morphology compared to healthy subjects. This is of importance because it may clarify the degree of vascular involvement in glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated IOP ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test \< 10dB

Exclusion Criteria:

* Normal ophthalmic findings, IOP ≤ 20mmHg
* No history of elevated IOP
* No signs of glaucomatous disc damage
Detection of Functioning Pituitary Microadenoma: PET/MRI Versus PET/CT

This is a prospective case-control study to compare the usefulness of 18F-FDG PET/MRI with that of 18F-FDG PET/CT in detection of functioning pituitary microadenomas.A single dose of 370 Mega-Becquerel (MBq) 18F-FDG will be injected intravenously.Visual and semiquantitative method will be used to assess the PET/MRI and PET/CT images.

Magnetic resonance imaging (MRI) may be insufficient to locate functioning pituitary microadenoma.This study compared the usefulness of 18F-FDG PET/MRI with that of 18F-FDG PET/CT in detection of functioning pituitary microadenomas in patients with inconclusive conventional MRI findings. Trans-sphenoidal adenomectomy was performed within 2 weeks of imaging.The PET/CT and PET/MRI findings and tracer uptake levels were correlated with the surgical findings and pathological results.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were pathologically diagnosed with pituitary adenoma after surgery were recruited, and were able to provide basic information and sign the written informed consent form.

Exclusion Criteria:

* The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.
Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function

This is an open-label, single dose study designed to assess the pharmacokinetics and safety of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal function.

Up to 48 subjects will be selected and enrolled according to the subject selection criteria: 8 subjects with mild renal impairment (Group 1), 8 subjects with moderate renal impairment (Group 2), 8 subjects with severe renal impairment (Group 3), 8 subjects with end stage renal disease that are not yet on dialysis (Group 4), 8 healthy subjects with normal renal function (Group 5), and 8 subjects with end stage renal disease on hemodialysis (Group 6).

Eligibility Criteria:
Inclusion Criteria: All Subjects

* Females must have negative results for pregnancy tests performed:

  * At Screening on a urine specimen, and
  * On a serum sample obtained on Study Day -2 (prior to dosing).
* Body Mass Index (BMI) is ≥ 18 to ≤ 38 kg/m2, inclusive.
* Body Weight \> 50 kg.

Subjects with Normal Renal Function

In addition to the main inclusion criteria above for all subjects, the following criteria must be met for subjects with normal renal function enrolled in Group 5:

* Judged to be in general good health based upon the results of a medical history, physical examination, and 12-lead electrocardiogram (ECG).
* At screening, estimated GFR (by MDRD equation) should be ≥ 90 mL/min/1.73 m2.

Subject with Renal Impairment

In addition to the main inclusion criteria for all subjects, the following criteria must be met for all subjects with renal impairment enrolled in Groups 1, 2, 3, 4 and 6:

* Judged to be in stable condition and acceptable for study participation based upon the results of a medical history, physical examination, laboratory profile and ECG.
* Presence of chronic renal impairment as indicated by medical history and a screening estimated GFR (by MDRD equation) \< 90 mL/min/1.73 m2.
* Subjects with ESRD undergoing hemodialysis should have been receiving dialysis for at least 1 month.

Exclusion Criteria: - History of significant sensitivity to any drug.

* Pregnant or breastfeeding female.
* Recent (6-month) history of drug or alcohol abuse.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.
* Subjects on strict vegetarian diet.
Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure

After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials.

This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on :

* Renal function improvement
* Vasculopathy and major cardiac event reduction
* Maintenance of immunosuppressive efficacy


Eligibility Criteria:
Inclusion Criteria:

* Male or female cardiac recipients over 18 years old
* First or second heart transplant, more than one year following surgery
* Patients with renal failure assessed by cGFR 30 to 60 ml/min/1,73m² calculated by MDRD4 formula
* Patients volunteer to participate in the study, with a written informed consent signed
* Affiliation to a national health insurance program

Exclusion Criteria:

* Current CNI-free immunosuppressive regimen
* Patients currently or previously treated with a mTOR inhibitor any time prior randomization
* Patients who are recipients for a multiple solid organ transplant
* Treated acute rejection episode within three months prior randomization
* Congestive heart failure (NYHA class III or IV) and/or VEF \< 30 % and/or patient waiting for a re-transplantation
* Scheduled surgical intervention
* Platelet count \< 50 G/l
* Severe hepatic insufficiency (SGPT and/or SGOT \> 3N)
* Major lipidic profile abnormalities (total cholesterol \> 3g/l and/or TG \> 5g/l)
* Proteinuria/creatinuria \> 0,08 g/mmol
* Severe renal failure attested by cGFR \< 30 ml/min/1.73m² (MDRD4)
* History of Hypersensitivity to everolimus, sirolimus or excipients
* History of Hypersensitivity to macrolides
* Pregnancy and breast feeding
* Childbearing age women without efficient contraception
* Law protected patients
* Patients in emergency unable to express their consent
* History of Hypersensitivity to cyclosporine or St-John's wort, stiripentol, bosentan, rosuvastatin
* History of Hypersensitivity to tacrolimus, macrolides or excipients
* History of Hypersensitivity to azathioprine
* History of Hypersensitivity to mycophénolate mofetil or excipients
Effect of Magnesium Sulphate on Coagulation

Arterial and venous thrombotic events are the clinical manifestation of postoperative hypercoagulability. Altered serum magnesium may play a role in the balance of coagulation. In this study, the investigators investigated the effect of magnesium sulphate on the postoperative coagulation change in total intravenous anesthesia (TIVA).


Eligibility Criteria:
Inclusion Criteria:

* ASA Ⅰ-Ⅱ patients undergoing pelviscopic gynecologic operation under general anesthesia.

Exclusion Criteria:

* Pregnancy
* Previous known hematologic disorder
* Recent medication interfering with hemostasis
* Severe anemia
* Liver disease
* Cardiovascular or respiratory disease
Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy

Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can be minimized with tight glucose control. A number of studies in non-pregnant populations have highlighted the feasibility, acceptability and efficacy of text messaging interventions for improving diabetic compliance and control. This study will investigate whether a text messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and whether this intervention can improve compliance with diabetes care, glucose control and pregnancy outcomes. The study will also assess satisfaction with the intervention itself.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18-50 years
* Planned delivery at Hospital of the University of Pennsylvania

Exclusion Criteria:

* Gestational age greater than 34 weeks at initial visit in the Penn Perinatal Diabetes Program
* Women who are unable to read English as all text messages will be in English
* Women who do not have a cellular phone capable of receiving text messages as this is the study intervention
Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis

The Primary Aim of this study is to validate a questionnaire as a screening tool to identify subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators believe that there will be difference between subjects with NSF and other skin conditions and normal skin.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 years of age or older.
2. Willing and able to understand and provide oral informed consent.
3. Able to complete study and comply with study procedures.

Exclusion Criteria:

1. Subject is unable to provide oral consent.
2. Psychiatric or other conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients

Ultrasonographic evaluation of respiratory muscle thickness in stroke patients, determination of its correlation with pulmonary function test (PFT) , and the first evaluation method to determine respiratory rehabilitation goals and to use it in the follow-up of the effectiveness of the treatment.

The study is planned as a cross-sectional prospective study. Healthy volunteers and stroke patients who are planned to be hospitalized in the Stroke clinic for rehabilitation in Istanbul Physical Medicine Rehabilitation Training and Research Hospital are evaluated and included in the study according to the inclusion and exclusion criteria.

Demographic data of patients (gender, age, height, weight, body mass index, comorbidity status, smoking/alcohol use, dominant extremity, stroke etiology, duration, side), functional status (Brunnstrom stages, Functional Ambulation Scale (FAS), Daily Living Activity (ADL) Index), Pulmonary Function Test (PFT) measurement results and bilateral diaphragm and abdominal muscle thicknesses and thickening ratio in ultrasonography, demographic data of healthy volunteers (gender, age, height, weight, body mass index, comorbidity status, smoking/alcohol use, dominant side), PFT measurement results and the dominant side diaphragm and abdominal muscle thicknesses and thickening ratio in ultrasonography is done and included in the study.

In the ultrasonographic evaluation of the participants, using a 7-12 Mhz linear Probe, measurements are made of the diaphragm at the end of tidal expiration and forced inspiration, abdominal muscles at the end of tidal expiration and at the end of forced expiration, while all respiratory muscles are lying in the supine position. Diaphragm thickness is measured between the 8th and 9th ribs at the level of the anteroaxillary line, rectus abdominis; 4 cm lateral of the umbilicus, transversus abdominis, external oblique, internal oblique muscles' measurement is made from the middle of the lowest part of the 12. rib and the highest point of the iliac crest and 2.5 cm in front of the midaxillary line. All measurements are repeated 3 times and the average value will be recorded.

Vital capacity\[VC\], forced vital capacity \[FVC\], forced expiratory volume 1 second \[FEV1\] , FEV1/FVC, maximal expiratory flow rate \[PEF\], maximum inspiratory pressure \[MIP\] maximum expiratory pressure \[MEP\] in patients' PFT \] measurement results are checked.

Intragroup and intergroup data are compared.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or Hemorrhagic stroke patients
* Stroke duration \>6 months
* Mini-mental test score \>24

Exclusion Criteria:

* Individuals with acute or chronic lung disease
* Patients with a history of thoracic or abdominal surgery
* Patients with other neuromuscular diseases
* Aphasia type with impaired understanding
* Facial paralysis
Electronic Cigarettes in Smokers With Mental Illness

People with mental illness are more likely to smoke and are more severely addicted to nicotine than the general population. As a result, the number of deaths related to tobacco is higher.

Smoking is highly addictive because it delivers nicotine very quickly. Research studies show that people who use nicotine replacement therapies (such us patches, gums, etc) are more likely to quit smoking than those who try to quit without using these nicotine products. Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals contained in tobacco cigarettes.

Given the increasing popularity of e-cigs, there is an urgent need to improve our understanding of both the potential benefits and risks of e-cigs use in people with serious mental illness. In this pilot we propose inviting 50 people with schizophrenia (or schizophrenia-related disorder) who are not intending to quit smoking in the near future to take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week period in which they will not receive free e-cigs and we monitor which products participants choose, and a final 24-week follow-up visit. During the 24-week study period we will assess the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants, nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as well as the e-cigs perceived benefits and risks.


Eligibility Criteria:
Inclusion Criteria:

* smokers (≥ 5 cigarettes/day for \> 1 yr and breath CO \> 5 ppm)
* ages 18-65 years
* ICD-10 diagnosis of schizophreniform, schizophrenia, schizoaffective or bipolar disorder

Exclusion Criteria:

* used e-cigs on \> 2 occasions in the past 30 days;
* intend to quit smoking within the next 30 days;
* currently use medications that may reduce smoking (bupropion, varenicline, NRT, naltrexone, buprenorphine, acamprosate, baclofen, clonidine, nortriptyline, anti-seizure medications, disulfiram);
* have unstable psychiatric conditions (hospitalization or change in dose of chronic medication in the past 30 days);
* People with a serious medical condition including uncontrolled high blood pressure, something wrong with their heart or blood vessels that occurred or got worse in the past 3 months (including fast or irregular heart rhythm, angina, chest pain, had a heart attack or stroke).
* People who have ever had a serious stomach ulcer, and/or phaeochromocytoma (tumor of the adrenal gland).
* People who in the last 3 months have had severe heartburn; or a stroke, or unstable kidney disease, unstable liver disease, uncontrolled over-active thyroid gland
* met DSM-IV criteria for drug dependence
* have medical contraindications to nicotine, since nicotine intake may increase in this study;
* have past-month suicidal ideation or past-year suicide attempt.
* are pregnant, as determined through a pregnancy test