cyrilzakka/clinical-trials huggingface dataset:
Effects of Egg Consumption on Carotenoid Absorption From Co-consumed, Non-Egg Food

The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in limited availability of certain nutrients found in these foods such as carotenoids. Dietary carotenoids have health beneficial properties and are known to fight against disease. Eggs are known to be a good source of carotenoids and eggs may improve the absorption of carotenoids found in co-consumed fruits and vegetables. Therefore, we are interested to see if consuming eggs with a mixed-vegetable salad will increase carotenoid absorption.

The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily. However, average fruit and vegetable intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables may further result in the limited availability of fat soluble, health-promoting, phytochemicals such as carotenoids from these foods. Dietary carotenoids have beneficial biological properties including antioxidant and anti-inflammatory effects and scientific research supports the protective effects of carotenoids against many degenerative diseases, including cardiovascular diseases, age-related macular degeneration, and some types of cancer. Therefore, either low intake or inefficient bioavailability of carotenoids from fruits and vegetables may reduce their potential effectiveness as disease preventative compounds. The bioavailability of carotenoids from a meal can be affected by several factors, including food matrix, type of food processing or cooking, interactions with other dietary compounds during digestion and absorption, gut status which may affect digestion and absorption processes, and nutritional status. Co-consumption of carotenoid rich foods with dietary lipids may be one of the most effective stimulators of carotenoid absorption among factors that influence their bioaccessibility and bioavailability. Eggs are known to be a highly bioavailable source of carotenoids, presumably due to the presence of lipid and phospholipid in egg yolk. The highly bioavailable nature of carotenoids from eggs suggest that egg derived factors may be leveraged to improve bioavailability of other carotenoids found in co-consumed fruits and vegetables. While promising, very limited data exist on the impact of a co-consumed food source of lipid, such as eggs, to enhance carotenoid absorption. This study is designed to assess the beneficial effects of egg consumption on carotenoids absorption from a complex meal, beyond those found in egg.

Eligibility Criteria:
Inclusion Criteria:

Male 19 to 45y BMI 18.5-29.9kg/m2 generally healthy non-smoker

Exclusion Criteria:

Female deep vein thrombosis intestinal disorders fasting blood glucose \>110mg/dL smoking drinking more than 3 alcoholic drinks per day taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).

This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.

Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.

Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.

Eligibility Criteria:
Inclusion Criteria:

1. 4 years to 70 years, expected survival \> 3 months
2. CD19 positive B-cell acute lymphoblastic leukemia
3. Karnofsky Performance Status (KPS) \>70
4. Relapsed after allogeneic or autologous stem cell transplantation (SCT);
5. Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）
6. No serious allergic constitution
7. No other serous diseases that conflicts with the clinical program
8. No other cancer history
9. No serious mental disorder
10. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive
3. Active hepatitis B or hepatitis C infection
4. Recent or current use of glucocorticoid or other immunosuppressor
5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases
6. Transaminase \>2.5 ULN, Bilirubin \>3 ULN，Creatinine\>1.25 ULN
7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products
8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
INOCA-NA a Local Prospective Registry

The present study has the following objectives:

1. To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography (CA) c/o Division of Cardiology - Federico II University Hospital;
2. To stratify in INOCA endotypes patients according to the presence or absence of alternative (i.e. non obstructive CAD) causes of myocardial ischemia detected during CA clinically indicated through physiology tests;
3. to implement a stratified therapy in these patients considering the different INOCA endotypes and evaluate the impact on angina class and quality of life as well as cardiac hospitalization and coronary revascularization during 5 year follow up

Eligible patients with angina and/or positive stress test undergoing clinical indicated CA detecting non-obstructive CAD will be studied as follows:

* Functional evaluation by fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of any stenosis that is angio- graphically considered \&gt; 50%;
* In case of stenosis \&lt;50% or \&gt;50% but with negative functional evaluation (FFR \&gt;0.80 and iFR/RFR

  \&gt;0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed. IMR and CFR will be evaluated, using an intracoro- nary wire;
* In case of CFR\&gt;2.0 and IMR\&lt;25, acetylcholine test will be performed. Intracoronary acetylcholine (ACh) will be administrated to detect epicardial (fo- cal or diffuse) or microvascular spasm.

Eligibility Criteria:
Inclusion Criteria:

* Clinical presentation of chronic ischemic heart dis- ease (IHD), requiring coronary angiography for the diagnosis;
* Absence of obstructive coronary artery disease (CAD) at coronary angiography;
* Age \&amp;gt; 18 years.
* Ability to provide a valid informed consent to the study procedure at the time of baseline evaluation;

Exclusion Criteria:

Clinical presentation of acute coronary syndrome (ACS) or cardiogenic shock;

* Presence of obstructive CAD with at least 1 significant coronary artery stenosis, defined as diameterstenosis \&amp;gt;50% and FFR ≤0.80 (or iFR/RFR ≤0.89);
* Previous coronary artery bypass grafting (CABG);
* Left ventricular systolic dysfunction, defined as ejection fraction (EF) \&amp;lt;40%;
* Severe valvular heart disease;
* Pregnant or breastfeeding women
* Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (adenosine, nitrates, acetylcholine)
* Inability or unwillingness to provide a valid in- formed consent to the study procedure at the time of baseline evaluation.
Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation

To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation.

Drug-eluting stents (DES) substantially reduce restenosis compared with bare metal stents and represent a significant advance in percutaneous coronary interventions (PCIs). Accordingly, DES have been rapidly adopted into practice and are currently used in the majority of PCI procedures. Despite their rapid acceptance, DES are not without limitations. In particular, patients who receive DES (like those who receive conventional bare metal stents) remain at risk of a 1% to 2% incidence of stent thrombosis, which is often associated with devastating consequences like death or myocardial infarction. Understanding and eliminating mediators of stent thrombosis are thus important goals for optimizing the clinical benefits of DES. Delayed endothelial coverage after DES implantation has been demonstrated and is thought to prolong the window of vulnerability to stent thrombosis. Consequently, current recommendations for DES are: dual antiplatelet therapy for at least 12 months in patients at low risk of bleeding, especially with " off-label " use. Because of rare but severe very late stent thrombosis, the dual antiplatelet therapy is more and more prescribed in clinical practice for several years.But it has been clearly demonstrated that the combination of aspirin and clopidogrel (the thienopyridine the most used) significantly increase the rate of severe and moderate bleedings when compared to aspirin alone. This is important if we consider the possibility or the necessity to prolong the combined antiplatelet therapy after stent implantation.ProposalTo compare treatment with aspirin alone versus the combined antiplatelet treatment with aspirin and clopidogrel after 12 months of combined antiplatelet treatment after DES implantation

NB : On the decision of the sponsor, the latest patient monitoring was advanced to September 30, 2014 instead of January 2015.

Eligibility Criteria:
Inclusion can be done either after stenting or 12 months later :

A: Patients admitted for DES implantation can be selected. After 12 months of bi therapy, they will be randomized

B: patients who have got a DES implantation 12 months before can be selected and randomised

Inclusion criteria:

* Patients on aspirin and clopidogrel therapy at 12 months after DES implantation
* Informed, written consent by the patient

Exclusion criteria:

* DES in left main coronary artery
* Oral anticoagulation therapy with coumadin derivatives
* Active bleeding; bleeding diathesis; history intracranial bleeding
* Known allergy or intolerance to the study medications: aspirin and clopidogrel
* Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
* Patient's inability to fully comply with the study protocol
Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to knee osteoarthritis.

VSELs come from the patient's peripheral blood, and will be injected in the most painful knee, or the worse knee on physical examination. Then follow-up the knee pain and imaging changes at 6 months and 1 year after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients had moderate to severe osteoarthritis of both knees.
* Those had mechanical pain of knee joints, which was aggravated by walking or stair climbing.
* Those complained of gelling pain of knee joint.
* Those have crepitus and limitation of the joint range of motion with joint bony hypertrophy on physical examination, X-rays showed narrowing of joint space and osteophyte formation

Exclusion Criteria:

* Diabetic foot and patients with obvious edema in the legs caused by various causes
* Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
Family-Focused CBT Skills App and Standard Self Help Options for Childhood Anxiety

Anxiety disorders are among the most common psychological disorders, with prevalent onset in childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the first-line treatment for pediatric anxiety, significant barriers remain in accessing CBT and other evidence-based treatments (EBTs), and credible self-help resources based in EBT concepts. This study evaluates a family-guided CBT game application (Anchors App), targeted to children ages 6-11 and their families, which focuses on delivering adaptive CBT-based coping skills to those who have sub-clinical to mild anxiety and related symptoms in a convenient and portable platform. Anchors App will be evaluated in two forms (standard and "parent-enhanced") in comparison to use of a self-help book or waitlist control. The rapid advancements in technology allows richer interactive capacity, content scalability, customizability, and subscription to a broader range of content, which this app capitalizes on in order to increase access to CBT skill concepts directly to pediatric stakeholder populations. If found to be effective, Anchors App has the opportunity to promote engagement of EBT concepts in every-day use through smartphone technology, and will change the landscape of mental health prevention and early intervention for children and families.


Eligibility Criteria:
Inclusion Criteria:

* Availability of mobile technology (e.g., smart phone, tablet)
* Internet access
* English language spoken in the home

Exclusion Criteria:

* Child in current or recent (last 2 months) psychotherapy
* Child currently taking psychotropic medication
* Parent or child endorsing symptom greater than 2 standard deviations above the mean on clinical measures
* Parents express feeling unable to assist child with current degree of symptoms
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

The Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar LA-EP2006 with the reference pegfilgrastim in woman with early stage breast cancer receiving (neo)-adjuvant myelosuppressive chemotherapy. Patient received TAC (intravenous docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) on day1 of each cycle, for six or more cycles. A total of 308 patients were randomized to LA-EP2006 (n=155) or reference Neulasta® (n=153). Treatment was given subcutaneously on day 2 of each cycle. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9 cells/L). LA-EP2006 was equivalent to the reference product in DSN (difference: -0.16 days; 95% CI \[-0.40, 0.08\]). Further, LA-EP2006 and the reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven breast cancer
* eligible for six cycles of neoadjuvant or adjuvant chemotherapy

Exclusion Criteria:

* concurrent or prior chemotherapy for breast cancer
* concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
* concurrent prophylactic antibiotics
* previous therapy with any G-CSF (granulocyte-colony stimulating factor) product

Other protocol-defined inclusion/exclusion criteria may apply.
Simplified Inferior Vena Cava Collapsiblity

Fluid administration is a cornerstone therapy in critically ill patient. Fluid restriction or overload can therefore change patient's outcome and mortality. Close monitoring of PR (capacity of increase the cardiac output after fluid therapy) is recommended by experts' guidelines. Few bedside simple tests are available to predict PR in spontaneously breathing patients.

A team of investigators from Lille (Roger Salengro hospital) have already showed that inferior vena cava collapsibility (cVCI) accuracy of prediction of PR is excellent in standardized sponteanous breathing patient. However, the standardized inspiration maneuver remains challenging because requiring specific and non-widely available equipment.

The primary objective of this study is to confirmed the excellent accuracy of cVCI to predict PR when standardized inspiratory maneuver is simplified.

The secondary objective is to test cVCIs in different period of cardiac cycle guided by electrocardiogram.

After receiving a loyal information patients will give their non-objection. During systematic echocardiography, patients will have to breathe in different conditions in order to homogenize their inspiratory effort. This maneuver will be repeated three times.

Eligibility Criteria:
Inclusion Criteria:

* Patient requiring an evaluation of PR by echocardiography for
* Presence of at least one clinical sign of acute circulatory failure (Mean Arterial Pressure \< 65 mmHg, mottling, tachycardia with Heart Rate \> 90 bpm, capillary refill time \> 3 sec, oliguria (urine output \< 0,5 mL/kg/h over 1 hour or more))
* Noradrenaline administration
* Age \> 18 years old
* Spontaneous breathing patient requiring oxygen administration without mechanical assistance

Exclusion Criteria:

* Intolerance of inspiratory maneuver defined by:

  * Clinical sign of acute respiratory failure
  * Active abdominal expiration
* Hemodynamic response of passive leg raising not evaluable:

  * Intracranial hypertension
  * Impaired transthoracic or abdominal echogenicity
  * High grade aortic insufficiency
  * Pregnancy
  * Abdominal compartment syndrome
  * Lower limb amputation
* Urgent hemodynamic therapy within half an hour
* Modification of hemodynamic support (fluid therapy or modification of catecholamine dose)
Defining the Operating Parameters for a Rebound-esthesiometer

The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.

Corneal sensitivity is the most important protective mechanism of the eye. Thus, measuring it at any given time gives important indicators of corneal physiology, especially in the diagnostics of corneal and systemic diseases (e.g. diabetes, herpes simplex and keratitis) and recovery from ocular surgery. Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused. This results in suboptimal, even poor, diagnosis and treatment for patients.

In this study the operating parameters for a state-of-the-art esthesiometer are defined. The operating principle is based on existing rebound technology which is already approved for IOP measurement.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Informed consent signed

Exclusion Criteria:

* Signs of infectious or inflammatory disease of anterior eye at the time of presentation.
* During last two weeks, any of the following events or conditions occurred or was present: inflammatory or infectious ocular condition, surgical or other intervention or therapy, other abnormal ocular event.
* Unable to give informed consent.
* Directly or indirectly indicated vunerability.
Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain

This study was performed to compare the effects of oxycodone and fentanyl on airway and hemodynamic responses and postoperative pain during recovery period in patients undergoing laparoscopic cholecystectomy.

This study was approved by the committee of Institutional Review Board of the Yeungnam University Hospital, Daegu, Republic of Korea. 90 patients were enrolled in this study and written informed consent was obtained from all patients. We included patients with ASA physical status classification I or II, and aged 18-65 years scheduled for elective laparoscopic cholecystectomy.

Patients were assigned to one of three groups by computer-generated randomization, fentanyl group (group F, N=30), oxydodone group (group O, N=30), or control group (group C, N=30). 10 minutes before completion of surgery, patients received 2 mL mixture of fentanyl 1 ㎍/kg or oxycodone 0.08 mg/kg with isotonic saline or isotonic saline 2 mL intravenously in accordance with allocated study groups by an anesthesiologist who was blinded to group treatment.

Airway reflex responses including coughing, breath holding, bucking, and laryngospasm were recorded at point of awareness, extubation, and 3 min after tracheal extubation. Hemodynamic responses were recorded at the completion of surgery (T1), at the point of awareness (T2), at the point of extubation (T3), and 3 min after tracheal extubation (T4). Coughing severity was assessed using a 5-point scale. In the recovery room, hemodynamic responses were evaluated every 5 min for 30 min. The postoperative pain intensity was assessed 5 and 30 min in the postanesthetic care unit (PACU) using numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status classification I or II, and aged 18-65 years scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria:

* allergy to either fentanyl or oxycodone, history of chronic other opioids or analgesics use, history of cardiac, hepatic, or renal disease, other comorbid conditions, cognitive impairment or body mass index more than 35 kg/m2