cyrilzakka/clinical-trials huggingface dataset:
Packed Red Blood Cell Transfusion During Cardiac Arrest

The purpose of this pilot interventional study is to collect preliminary data on administering packed red blood cell (PRBC) during cardiac arrest (CA). The primary objective is to assess the feasibility of PRBC transfusion during cardiac CA to help optimize the methods required to augment cerebral and other vital organ oxygen delivery during cardiopulmonary resuscitation (CPR). The secondary objectives are to assess the effect of PRBC transfusion during prolonged cardiac arrests on cerebral oxygenation, end tidal carbon dioxide (ETCO2), return of spontaneous circulation (ROSC), survival to discharge, biomarkers of neural injury and inflammation, and neurological outcomes at hospital discharge, 30 days post-CA, and 90 days post-CA.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age ≥18 and \<85 years
* Experience prolonged, non-trauma-related in-hospital cardiac arrest, defined by cessation of heartbeat and respiration requiring CPR for at least 10 minutes

Exclusion Criteria:

* Age \<18 years old
* Age \> 85 years old
* Patients with DNR/DNI orders (Do Not Resuscitate/Do Not Intubate)
* Patients admitted to the hospital with a cardiac arrest arising from trauma
* Patients who achieve return of spontaneous circulation within 10 minutes of CPR
* Inability to start study product administration within 20 minutes of cardiac arrest onset
* Prisoners
* Women who are known to be pregnant
* Patients with a history of RBC antibodies or positive antibody screen prior to enrollment in the study, unless previously cross-matched units are available for transfusion.
* Patients with ultrasound evidence of right ventricular dilatation at time of CA
* Patients with known prior objection to receipt of blood products.
* Patients for whom administration of additional fluid volume is contraindicated (as determined by physician responsible for care)
* Physician objection based on concern that intervention would interfere with patient care plan
The Experience, Perceptions and Unexpressed Needs of Heart and Lung Transplant Patients Admitted to Intensive Care

Qualitative descriptive phenomenological study aimed to investigate the experience, perceptions and unexpressed needs of patients undergoing heart and lung transplantation admitted to intensive care unit through semi-structured interviews

It was conduct a qualitative phenomenological study which, through semi-structured interviews to investigate the experience , the perceptions and the unexpressed needs of patients undergoing heart and lung transplants within the specific context of " High Intensity Cardio-Thoraco-Vascular Hospitalization" of the IRCCS University Hospital of Bologna. The study aims at helping nurses to provide more adequate care, in order to meet the individual needs of patients and describe the meaning and essence of the hospitalization experience, through the in-depth analysis of the specific words pronounced by the patients themselves.

Below are the questions that guided the research:

What is the general experience of the intensive care patients? What are the experiences, the perceptions and the unexpressed needs of these patients in relation to their hospitalization in intensive care?

Eligibility Criteria:
Inclusion Criteria:

* able to understand and communicate in Italian
* transferred from intensive to sub-intensive care unit
* not affected by cognitive disorders
* who provides informed consent to the study

Exclusion Criteria:

* none
Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.

The enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of TB. The TB-antigen responsive T cell markers will be examined. The performance of each T cell marker for the diagnosis of active TB will be systematically evaluated.

Eligibility Criteria:
Inclusion Criteria:

* any patients suspicious of TB infection
* TB culture and Xpert test required
* Chest X-ray required

Exclusion Criteria:

* anti-TB therapy before the sample collection.
Clinical Evaluation of An Approved Contact Lens

This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a 14-day period.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 18 and 45 years of age.
4. The subject must have a valid spectacle prescription with expiration date not over 1 year.
5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 Diopters (D) to -6.00 D in each eye.
6. The subject's refractive cylinder must be ≤1.00 Cylindrical Diopter (DC) in each eye.
7. The subject must have best corrected visual acuity of logMAR 0.20 or better in each eye.
8. Subjects should own a wearable pair of spectacles and agree to wear them the day of the initial visit and every morning on subsequent visit days.
9. The subject must be a contact lens neophyte, defined as never having been dispensed contact lenses, or who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses.
10. The subject must have normal eyes (i.e. no ocular medications or infections of any type).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Use of any medication with known tear film effects within 2 weeks prior to and during the study.
5. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..
6. Any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
8. Any ocular infection.
9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
12. Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).
Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting

Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED).

The investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED.

The investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates.

The investigators also asses side effects and patient satisfaction in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic pain
* Numeric Pain Rating Scale (NPRS) \>5 /10
* Age between 18 and 75 years old

Exclusion Criteria:

* Medical pain (headache, chest pain,...)
* Respiratory, renal or hepatic insufficiency
* Drug addiction
* Medical or Chirurgical sinus history
* Oxygene saturation \< 90%
* Systolic blood pressure \< 90mmHg
* Head injury with a neurological Glasgow Coma Scale (GCS) \< 14
* Opioid allergy
* Facial traumatism
* Patient unable do understand or assessing NPRS
* Opiates administration within 6 hours before admission
Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients

The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:

1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?
2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Single organ kidney transplant recipient, currently receiving a specific immunosuppression regimen:

  1. Calcineurin inhibitor (tacrolimus or cyclosporine), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30)
  2. Calcineurin inhibitor (tacrolimus or cyclosporine), mTOR inhibitor (sirolimus or everolimus), and oral steroid (n = 30)
  3. mTOR inhibitor (sirolimus or everolimus), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30)
* Aged \>18 years
* estimated glomerular filtration rate (GFR) \> 15 mL/min/1.73m2
* Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result)

OR

* Healthy household cohabitant of kidney transplant recipient enrolled in trial (n = 30)
* Aged \> 50 years
* Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result)

Exclusion Criteria:

* Unable or unwilling to provide informed consent to participate in the trial
* No previous infection with Varicella zoster (chickenpox)
* Known allergy to or intolerance of the contents of the SHINGRIX vaccine
* Current pregnancy
* For healthy household cohabitants, history of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying.

The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.

The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver. Patient outcomes will be compared to objective performance criteria based on historical data from other Thoratec implantable ventricular assist devices.

Eligibility Criteria:
Inclusion Criteria:

The following are general criteria; more specific conditions are included in the study protocol:

* Listed for cardiac transplantation
* NYHA Class IV heart failure symptoms
* On inotropic support, if tolerated
* Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock

Exclusion Criteria:

The following are general criteria; more specific conditions are included in the study protocol:

* Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
* Existence of factors that would adversely affect patient survival or function of the LVAS.
* Intolerance to anticoagulant or antiplatelet therapies.
* Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
* Participation in any other clinical investigation that is likely to confound study results or affect study outcome.
Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.

For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks

Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks

Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* All patients were required to give written informed consent
* Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy.
* Antracycline-pretreatment during aduvant or palliative first line therapy
* Bidimensionally measurable lesion outside a previous radiation field.
* Age \>= 18 years
* Karnofsky Performance status \>= 70%
* Adequate heamatological, renal, cardiac and hepatic function
* No radiation of the measurable lesion during the study was allowed.

Exclusion Criteria:

* Only bone metastases
* Active infection
* Previous treatment with one of the study drugs
* Application of other cytotoxic chemotherapy
* Insufficent renal function (creatinine clearance \< 60ml/min)
* Known DPD deficiency
* clinically unstable brain metastasis
* pregancy or lactation
* other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin).
Curbing Tobacco Use in Suburban and Rural Schools

Primary, secondary, and tertiary specific aims are to answer the following questions about interactive, Internet-based tobacco control intervention directed towards 10th-graders:

1. Smoking Prevention (primary): Does the intervention result in a lower incidence of smoking initiation compared to standard care?
2. Smoking Cessation (primary): Does the intervention result in higher rates of smoking cessation compared to standard care?
3. Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit tobacco use compared to standard care?
4. Stages of Change (tertiary): Does the intervention have an impact on progression through the stages of smoking and spit tobacco acquisition and cessation compared to standard care?
5. Mediating Variables (tertiary): How are mediating variables associated with tobacco-use onset and cessation?
6. Testing Predictors: Investigate established and recently elucidated predictors of susceptibility to smoking at baseline and 12-month follow-up.
7. Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up
8. Testing Measures Across Race/Ethnicity: Explore predictors of susceptibility to smoking at baseline and 12-month follow-up to determine whether predictors differ among White, African-American, and Hispanic students.

The proposed study will test the effectiveness of the Internet-based cigarette smoking and spit tobacco (ST) prevention and cessation in-class curriculum for rural teens. Supplemented by "cyber-support" (chat room and bulletin board), the intervention program also will make use of a human social support environment (via trained school personnel, chat rooms, bulletin boards). The study will use a nested cohort design in which high schools are the unit of design, allocation, and analysis. Tenth-grade students (ages 14-16) within each intervention school will receive a 7-week interactive, Internet-based tobacco prevention and cessation curriculum. Using computerized surveys, study participants will be evaluated at baseline, 6-month, 12-month, and 18-month follow-ups. The study has been designed to permit analyses sensitive enough to detect differences for the two primary hypotheses: reductions in smoking initiation and smoking cessation. Trends in ST use after exposure to the intervention program will also be assessed. The design will also permit analysis of stage-of-change dynamics and mediators for both acquisition and cessation of both forms of tobacco.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 14-16 years of age (9th and 10th-graders) who speak, read and write English
2. Subjects are students from schools located in suburban and rural communities approximately 200 miles from Houston.
3. Subjects with approved parental consent

Exclusion Criteria:

1) Disruptive individuals who are not able to work with the program
Validation of Vital Signs Recording with VT-Patch Connected Devices in Children

: Patient readmission to PICU is a major point of concern for physicians because, although being a rare event, it has been strongly associated with more morbidity and death. Patient monitoring once they have left the PICU is drastically modified, and small connected devices could be an option to early identify patients at risk of PICU readmission. Such devices have been manufactured for the recording of vital signs in adults, but they do not exist for children.

Besides, studies have recently shown that devices that use optical sensors may be less accurate in individuals with dark skin pigmentation since dark skin tones impose a limitation on optical biometric sensing. The wearable and medical device industry has not sufficiently addressed this issue yet. This is one of the main challenges that need to be addressed in this area to make sure the connected devices using this technology will work with all different skin colours including very dark skin.

Main objective: Assess the accuracy of VT-Patch® to measure oxygen saturation (SpO2) in children with diverse skin colour.

Secondary objectives: Assess the accuracy of VT-Patch® to measure 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR), and temperature. Exploratory assessment of blood pressure (BP) measurement, ECG signal, and movement capture.

Design: Prospective validation study of VT-Patch® for the recording of 4 physiologic parameters and exploratory assessment of three additional parameters.

Methods: The study will be performed in two successive phases:

Run-in phase: Testing VT-Patch® on four children to assess the feasibility of the protocol.

Main study: validation phase of the devices on 12 children per age group (2 children per skin colour group) to assess its accuracy (VT-Patch® for less than 2 years old). The patients of the run-in phase will be included in the main study if no modification of the protocol is required. 5 physiologic parameters (HR, SpO2, RR, temperature, and ECG) will be prospectively and simultaneously recorded for 8 hours with VT-Patch® and the regular monitoring system implemented in the unit High-resolution database that will be the gold standard for evaluation. Vital signs recorded with the connected device will not be used for the clinical care of patients. The Skin colour of each patient will be assessed by the colorimetric Monk scale and as shown below.

Eligibility Criteria:
Inclusion Criteria:

* PICU monitoring for the next 24 hours

Exclusion Criteria:

* Recent cardiac or thoracic surgery
* Thoracic skin lesion that contraindicates the VT patch
* No parental consent
* Intermittent presence of one study observer in the patient room considered inappropriate by the physician or the nurse in charge because of the child's medical condition
Dairy Foods and Blood Pressure in Multi-Ethnic Children

To prevent excess increases in blood pressure in children by providing two servings of dairy foods as snacks daily at school. We hypothesize that children who receive the two dairy snacks will exhibit significantly less of an increase in blood pressure over six months as compared to control children.

The primary aim of the study is to determine the impact of dairy foods on blood pressure; however, we will also evaluate the effect of the intervention on body weight and composition. Specifically, we will evaluate change in body mass index (BMI, kg/m2\], waist circumference in all subjects and body composition by bioelectrical impedance (BIA) in a subset. We hypothesize that children receiving the dairy snacks will exhibit less increase in BMI and body fat than control subjects. We are studying a group of children at high risk for elevated blood lipids and glucose intolerance due to their racial/ethnic makeup and high prevalence of overweight and obesity. Thus, we will evaluate the impact of the intervention on blood lipids, glucose and insulin in a subset of subjects.

We hypothesize that children receiving the dairy foods will exhibit improvements in their lipids, glucose and insulin as compared to control children. We also plan to determine their eating habits through a 24 hour dietary recall at the beginning, middle and end of the study, with 2 additional recalls for the subset at each time point. Dietary behavior and self efficacy will be analyzed before and after the intervention through a questionnaire. Physical activity levels will be assessed by a short physical activity questionnaire on all students and through the utilization of accelerometers in the subset. Our control schools will undergo the same testing, but will not receive any intervention.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in the study
* Signed informed consent form by the parents and/or guardians
* Assent from the child

Exclusion Criteria:

* Children with food allergies or other dietary requirements that restrict their ability to consume the snack
* Children with a chronic medical condition that may influence blood pressure or calcium metabolism such as renal disease or type 1 diabetes mellitus