cyrilzakka/clinical-trials huggingface dataset:
Range of Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Otherwise Healthy Smokers

Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. The endotoxin used for this study is obtained from the National Institutes of Health, and is called "Clinical Center Reference Endotoxin", or CCRE. The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in sputum cell samples that the scientists can measure. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. Eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. Scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but does not cause symptoms in our study subjects. In our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects who are current smokers without seeing any problems.

We are looking for people who currently smoke a minimum of a half a pack of cigarettes each day. You must not have any other health problems, be pregnant or nursing a baby, or actively trying to become pregnant or to father a child.

Eligibility Criteria:
Inclusion Criteria:

* current smoker
* healthy

Exclusion Criteria:

* no asthma
* no chronic health conditions
* no daily cough
* not pregnant or nursing a baby
* not actively trying to get pregnant or father a child
Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries

Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries

In pediatric age group patients undergoing laparoscopic surgery, total intravenous anesthesia (TIVA) and inhalation anesthesia methods are used as anesthesia methods in the intraoperative period; It is compared in terms of its effects on blood pressure, pulse, postoperative awakening time and awakening agitation.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-12 years
* Patients weighing over 10 kilograms
* Patients who will undergo inguinal hernia surgery
* ASA (American Society of Anesthesiologists) classification I and II pediatric patients.

Exclusion Criteria:

* Absence of systemic illness.
* ASA (American Society of Anesthesiologists) classification III and above pediatric patients.
Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment

The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate that, over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs in patients with active wAHAI.

wAIHA is a B-cell-mediated autoimmune disease in which red blood cells are targeted by autoantibodies, which leads to marked decrease in their lifespan. The investigators demonstrated two years ago in a multivariate retrospective study that the CD3+CD8+ HLA-DR+ T-cell population was associated to a better outcome. The investigators observed that the proportion of circulating CD3+CD8+CD25highFoxp3+ T cells was significantly higher in patients with wAIHA in remission than in controls and correlated to hemoglobin levels. Extensive phenotyping and functional analysis revealed that those cells were bona fide Tregs acting in an IL10-dependent manner. Finally, culture of PBMC from normal donors or active wAIHAI patients with low dose of IL2 promoted the expansion of functional CD3+CD8+CD25+Foxp3+. Those observations constituted the rationale to propose low dose of IL2 to treat patients with active wAIHA with the objective of demonstrating that this treatment is able to induce the expansion of CD8Tregs, over a 9 week treatment period.

Four courses of IL2 (aldesleukin \[Proleukin, Novartis\]) will be administered subcutaneously for 5 days. The first course will be limited to a dose of 1.5 million IU per day and followed by a 9 day wash-out. The other courses of 3 million IU per day will be initiated after a 16 day wash-out.

Patients will be evaluated on day 1 and day 5 of each treatment course, before the first and last administration of interleukin-2 and will also be evaluated at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years old)
* wAHAI defined by the presence of hemolysis and positive coombs test (IgG +/-C3)
* Absence of infection or other hematologic disease
* wAHAI not responding to conventional steroids despite a dose over 10 mg
* No treatment with rituximab for a minimum of 6 months
* Signed informed consent form

Exclusion Criteria:

* Less than 18 years old
* Cold AHAI
* IL2 allergy
* Chemiotherapy or immunosuppressive treatment
* Treatment with rituximab for less than 6 months
* Neoplasia or hematologic malignancy
* Aplastic anemia
* Neutropenia ≤ 1000 mm3
* Infection
* Hepatitis B or C
* wAHAI associated with systemic lupus erythematosus depending on ACR criteria
* Cardiac insufficiency
* Hypertension
* Pulmonary insufficiency
* Liver cirrhosis
* Thrombopenia below 50000/mm3
* Drug addiction, alcohol abuse
* Psychiatric disorder
* Absence of signed informed consent
Open Label Trial of Immunotherapy for Advanced Liver Cancer

The purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical intervention or with recurrent tumor after surgery.

Hepcortespenlisimut-L (V5) immunotherapy of HCC in an open label setting with baseline alphafetoprotein serum levels and CT scan image as primary endpoints with monthly follow-up thereafter. Additional endpoints will include blood biochemistry indices and safety monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
* HCC diagnosis documented prior to Study Entry by either cytology/histology, CT scan, and AFP serum test higher or equal to 30 IU/ml.
* All subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study.
* Health score status at baseline.
* Agreement to participate in the study and to give at least 3 samples of blood for lab tests.
* Readily available home or o other address where patient can be found.

Exclusion Criteria:

* Subjects who might have already taken V5 in prior trials and have no baseline data.
* Those who met inclusion criteria can be retrospectively enrolled.
* Pregnant or breast-feeding women are excluded.
* Subjects who have taken other immunomodulatory therapies within 2 months prior to Entry: systemic corticosteroids, immune globulin (IV gamma globulin, IVIG), interferons, interleukins, pentoxifylline (Trental), thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF); dinitrochlorobenzene (DNCB), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (Isoprinosine), polyribonucleoside (Ampligen), ditiocarb sodium (Imuthiol), any locally available immune modulators, and any other therapeutic or preventive HCC vaccine.
* Subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to Study Entry.
* Evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to HCC.
* Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma

The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form;
* Age 18-75；ECOG 0-2
* Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well.
* T3-4N0M0, T1-4N1-3M0 (according to AJCC2009)
* No radiotherapy, chemotherapy or other treatments pre(post)surgery
* PS ECOG 0-2
* Life expectancy of more than 3 months
* Hemoglobin(Hb)≥9 g/dL • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 109/L • Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN • Renal function: creatinine \< 1.5 x ULN
* No immuno-deficiency
* Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

* Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis
* Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
* Drug addiction, Alcoholism or AIDS
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
* Unsuitable to be enrolled in the trial in the opinion of the investigators
Analysis of Neurocognitive Elements of Attention After Chemotherapy

Data for this study will be obtained from the University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center. Participants will be recruited through Simmons Cancer Center. One hundred female breast cancer patients who have completed adjuvant chemotherapy will be enrolled. In order to reach this number, it is estimated that up to 125 eligible participants will need to be recruited. The study will last approximately two years. Participants will undergo one cognitive testing session, and each subject's total participation time will last no more than two hours.

The study visit will be scheduled for three to six months after completing adjuvant chemotherapy treatment. At the study visit, informed consent will be obtained and neurocognitive attention testing will be performed. The assessments chosen were carefully selected based on breadth, psychometric properties, standardized broad clinical use, good external validity and time efficiency. The testing time for the battery of neuropsychological tests is approximately 45-60 minutes. Participants will also be asked to complete a packet of several questionnaires including several self-rated measures of mood and quality of life, in addition to a brief questionnaire to obtain information about exercise, sleep, and education and employment backgrounds. It is estimated that questionnaire completion will require no more than 30 minutes. Participants will be seen on only one occasion, and may receive, upon request, written feedback about the results of the evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Women;
* diagnosed with breast cancer Stages I-IV; and
* completed a treatment regimen of adjuvant chemotherapy three to six months prior to evaluation.

Patients may be receiving anti-hormonal treatment. All subjects will be native speakers of English who have a minimum of a high school education (or GED equivalent) in order to ensure the validity of the neuropsychological tests that will be administered. In order to limit age effects, participants will be between the ages of 40 and 70 years.

Exclusion Criteria:

* Subjects with a previous history of stroke, head injury with loss of consciousness greater than 30 minutes, major surgeries within the past 6 months unrelated to their breast cancer treatment, pre-cancer major Axis I psychiatric disorder, diagnosis of adult Attention Deficit Disorder, or other pre-existing disorder with known cognitive impairments (e.g. dementia, intellectual disability) will be excluded.
* Non- English speakers and subjects under the age of 40 or over the age of 70 will not be included.
Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion

This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Females must be of non-childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy)
An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.

The purpose of this study is to evaluate the effectiveness and tolerability of topiramate compared to placebo in patients with binge eating disorder receiving Cognitive Behavior Therapy (CBT)

This was a 21-week multicenter, double-blind, parallel-group, randomized controlled trial comparing the efficacy and tolerability of an add-on treatment with 200mg of topiramate versus placebo in obese patients with BED receiving group CBT. The aim of this trial is to investigate the efficacy and tolerability of adjunctive topiramate to CBT in obese patients with BED through improvement in binge eating, related psychopathology, and weight loss. The study hypothesis is that the patients using topiramate + CBT will loose more weight than patients using placebo + CBT.Tolerability will be investigated through reported adverse events and dropouts, with reasons for leaving the study being analyzed. The randomized patients will receive capsules of topiramate (25 mg, 50 mg) or placebo correspondent daily for 21 weeks

Eligibility Criteria:
Inclusion Criteria:

* Have been meeting the diagnostic criteria for binge eating disorder (according to the Diagnostic and Statistical Manual for Mental Disorders - IV Edition criteria) with at least 2 days of binge eating per week and severity at least moderate defined by binge eating scale (score = 17)
* BMI = \> 30 kg/m2 to \< 46 kg/m2
* Women must be post menopausal for at least one year or surgically sterilized (hysterectomy, tubal ligation), or practice sexual abstinence or use an acceptable method of birth control (i.e. a hormonal contraceptive, spermicide plus barrier method, intrauterine device and/or vasectomized partner)

Exclusion Criteria:

* Has a history or actual diagnostic of significant psychiatric disorder (schizophrenia, psychosis, major affective disorder, suicide risk, dementia, abuses alcohol or other drugs)
* has a malignancy or a history of malignancy within the past 5 years (except basal cell carcinoma)
* evidence of uncontrolled thyroid disorders
* uncontrolled hypertension (defined as a diastolic blood pressure \>110 mm/Hg and/or a systolic blood pressure \>180 mm/Hg with or without medication). Hypertensive patients on medications must have been on the same dose of the same antihypertensive medication for at least two months
* history or significant renal failure or glaucoma.
Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects

Safety and tolerability study in healthy volunteers


Eligibility Criteria:
Inclusion criteria:

* Healthy male 18-50 years
* Nonlactating female 18-50 years
A Safety and Efficacy Study Evaluating ET-01 in Subjects with Transfusion Dependent Β-Thalassaemia

This is a single-arm, open label, multi-center, single-dose phase 1 study in subjects with transfusion dependent β-thalassaemia. The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using ET-01.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects and/or legal representative fully understand and voluntarily sign informed consent forms.
* Diagnosis of transfusion dependent β-thalassemia (β-TDT) as defined by protocol.
* Be not appropriate to receive conventional allogeneic hematopoietic stem cell transplantation.
* Lansky/Karnofsky score ≥ 70%.
* Eligible for hematopoietic stem cell transplantation and conditioning with busulfan as per investigator's judgement.

Other protocol defined inclusion criteria may apply.

Key Exclusion Criteria:

* Subjects with associated α-thalassemia.
* Subjects with any clinically significant acute or uncontrolled infections.
* History of uncontrolled epilepsy or other mental disorders.
* Previous treatment with allogeneic bone marrow transplantation or gene therapy.

Other protocol defined exclusion criteria may apply.
Scan-rescan Reproducibility of Myelin Sensitive MRI Techniques

This study is to assess the variation in the measurements of myelin sensitive MRI techniques in both white and grey matter in the brain.

Magnetization Transfer Imaging (MTI) permits the assessment of the integrity of macromolecules in brain tissue, such as myelin and cellular/axonal membrane components.

Multi-echo Susceptibility-Based imaging (SBI) provides quantitative susceptibility maps and T2\* maps that - when combined - permit the disentanglement of myelin from iron and various phases of myelin degradation.

Myelin Water Imaging (MWI) quantifies the water trapped between myelin layers by separating the multiple water components in T2 relaxometry data. In fact, the presence of myelin on water pools bound to it provokes a loss in magnetic resonance (MR)-signal coherence, which is more rapid than the one characterizing the water pools located within the axons or in the cytoplasm.

A method based on a spiral acquisition that achieves a myelin-specific signal in clinically compatible scan times is currently applied: T1 relaxometry (quantitative T1, qT1) - which measures the time that a perturbed nuclear spin distribution needs to get back to equilibrium in the longitudinal plane- is sensitive to a number of components of the brain tissue such as myelin, axonal diameter and the overall architectural organization of the brain tissue.

Finally, multi-shell diffusion allows the application of mathematical models of diffusion compartments, which in part are influenced by myelin integrity.

The goal of this study is to assess the stability of these techniques in scan-rescan experiment on 20 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* No neurological or psychiatric disorder

Exclusion Criteria:

* Pregnancy
* Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).
* Inability to give consent.
Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) (PEDIA-FICK-ICU)

Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring.

The goal of this clinical trial is to evaluate the feasibility of cardiac output measurement by Fick's method, non-invasive and allowing continuous monitoring, in comparison to echocardiography in pediatric intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Patient under 18 years old
* Patient over 10 kg
* Patient requiring intubation or intubated with a cuffed tube
* Patient requiring a central venous line in superior vena cava territory

Exclusion Criteria:

* Mechanical ventilation with leak
* Bad echogenicity preventing echocardiography
* Absence of written informed consent
* Patient not affiliated to French Health Insurance or not covered by public health insurance
* Patient with a legal protection
Impact of Visual Arts Immersion

The purpose of this study is to enhance engagement, coping and self-reflection by attuning nurses to creative and observational skills drawn from a visual arts pedagogical framework. To fulfill this goal, the investigators will cultivate an existing relationship between NYU Langone Health (NYULH) Nursing, the NYU Health Sciences Library, and museum educators at The Met to design and deliver an intervention of museum educator-led workshops that introduce nurses to arts appreciation skills to improve their practice and overall wellbeing. Participants will be asked to complete two surveys, pre- and post-intervention, Cultural Awareness Scale (CAS), which measures cultural awareness, sensitivity, knowledge and skills, and the Interpersonal Reactivity Index (IRI), which measures four separate aspects of empathy and its relationships with measures of social functioning, self-esteem, emotionality, and sensitivity to others. We will also solicit qualitative feedback via REDCap survey at the end of the intervention to gain insight into nurse's experiences of the art immersion program.


Eligibility Criteria:
Inclusion Criteria:

1. A Registered Nurse at NYULH
2. Willing to provide an email address or cell phone number of choice
3. Willing to attend one workshop in person at The MET and one virtually via WebEx
4. Willing and able to provide consent
5. Age 18 years of age or older

Exclusion Criteria:

1. Not a Registered Nurse at NYULH
2. Not willing to provide an email address or cell phone number of choice
3. Not willing to attend one workshop in person at The MET and one virtually via WebEx
Application of Ultrasonic Elastography in Lung Lesions

Elastography is an imaging of tissue elasticity or stiffness and is currently emerging as a mainstream tool for ultrasound-based diagnosis. This compressibility property of materials, mathematically expressed as the change in tissue displacement as a function of its distance from the compressing device, is known as strain and is the parameter that is imaged in an elastogram.

Elastography has currently shown promising result in differentiating viscoelastic nature of various organs, which is a consequence of certain underlying diseases.

At present, there are limited literatures revealing the application and feasibility of ultrasonic elastography in lung lesions. This is essentially important as it may serve as an adjuvant to B-mode ultrasound. The investigators aimed at exploring the application and feasibility of ultrasonic elastography on lung lesions.

Patients performed conventional B-mode ultrasound, subsequently followed by ultrasound elastography. The strain ration was measured and was compared between necrosis, atelectasis, consolidation and tumor.

Eligibility Criteria:
A. Inclusion Criteria:

Patients with radiographic findings of:

1. consolidation
2. obstructive pneumonitis
3. tumors

B. Exclusion Criteria:

1. Patients with poor acoustic window
2. Unable to hold breathing
3. Not cooperative
4. Presence of pleural effusion