cyrilzakka/clinical-trials huggingface dataset:
Study of the Impact of an Intervention Performed by a Clinical Pharmacist on Patients At Risk of Pneumococcal Infection At the End of Hospitalization

In France, Streptococcus pneumoniae is the leading agent involved in community-acquired bacterial pneumopathies and bacterial meningitis. The frequency of these infections is increasing in at-risk subjects. Paradoxically, pneumococcal vaccination coverage in this type of patient is limited at the national level, even though the French High Council for Public Health (HCSP) has been extending the 13-valent conjugate and 23-valent non-conjugate double vaccination in this target population since March 2017.

These patients generally benefit from regular medical follow-up involving several health professionals in hospital or outpatient clinics. In spite of this, one of the factors identified as a hindrance to pneumococcal vaccination is the absence of a proposal from the doctor.

We would like to assess compliance with the recommendations for pneumococcal vaccination according to the High Council of Public Health (HCSP) in at-risk patients leaving hospital. We also wish to measure the potential impact of an intervention by the clinical pharmacist on the application of these recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in one of the departments participating in the study
* At risk of pneumococcal infection according to HCSP recommendations (1)
* Negative pneumococcal vaccination status
* Adult patient (≥18 years old)

Exclusion Criteria:

* Under safeguard of justice
* Unable to receive informed information
* Patient having objected to the use of their data.
Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

Consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups:

Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B: The above two procedures will be performed in the reverse order The biopsies will be performed from different areas of the involved pleura with the two techniques. Thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥12 years
* Semirigid thoracoscopy being performed for diagnosis of the pleural effusion

Exclusion Criteria:

* Age ≥80 years
* SpO2 \<88% on room air
* Hemodynamic instability
* Myocardial infarction or unstable angina in the last 6 wk
* Lack of pleural space due to adhesions
* Uncorrected coagulopathy
* Failure to provide informed consent
Building Resilience In Caregivers of Trauma Survivors

The purpose of the study is to examine the role of demographics, pre-existing anxiety, depression, and substance use on caregiver depression anxiety, and substance use following a critical injury to a loved one, evaluate the factors that mediate the effectiveness of traditional psychotherapy using problem solving therapy to reduce depression, anxiety, and substance use and to evaluate the factors that mediate the effectiveness of providing an ICU diary and instruction on that diary to reduce depression, anxiety, and substance use.


Eligibility Criteria:
Inclusion Criteria:

* Must anticipate serving in a Caregiver role after the patient is discharged (A. Must be either a family member or close friend of a patient who has been admitted to the trauma/critical care service ICU B. Must anticipate spending time with the patient in a caregiver or other supportive role (e.g., emotional, social, financial) after the patient is discharged
* Caregiver and patient must report English as a primary language
* Patient and Caregiver must be able to provide informed consent
* Caregiver must be able to provide at least two forms of contact information
* Trauma Patient directly admitted to the ICU (Primary cause of admission is trauma, Injury must include trauma to the head/brain or polytrauma, Admitted directly to the hospital, Patient admission of at least 48 hours, Patient is currently admitted to the ICU, Patient is expected to survive more than 96 hours at 48 hours after admission, Patient has an abbreviated injury score greater than 3 (severe, critical, maximum), Fluent in English)
* Trauma patient must be able to communicate verbally

Exclusion

* Does not anticipate serving in a Caregiver role after the patient is discharged
* Caregiver is not a close friend or family member of the patient who has been admitted to the ICU
* Caregiver does not expect to serve in a supportive role to the patient
* Caregiver does not meet inclusion criteria as stated above
* Patient is not currently admitted to the ICU and or is not expected to remain in the ICU for 48 hours
* Patient is not expected to survive more than 96 hours
* Patient is not expected to require assistance prior to discharge
* Patient is not between 17 and 65 years of age
AML Cell Immunotherapy Using Chimeric Antigen Receptor T-cells

AML is one of the most aggressive forms of leukemia, where bone marrow transplantation remains the gold standard treatment, with its known associated toxicities and related mortality. Despite progress in the treatment of leukemic malignancies, especially the emergence of targeted- and immuno-therapies arising from biological genomic knowledge, there remains a need to provide additional strategies for refractory/relapsing (R/R) patients

Aim of this study is to collect biological samples of AML patients in order to validate our Chimeric Antigen Receptor T-cells immunotherapy approach


Eligibility Criteria:
Inclusion Criteria:

* AML patients adults and pediatrics

Exclusion Criteria:

* AML3
Cancer Leadership Training for Clergy Wives and Widows

Multiple cancer health disparities exist for underrepresented minority groups, such as higher late stage diagnoses and greater cancer-related deaths. Among African Americans, there is an increased cancer survivorship and caregiving burden, which necessitates more support and resources during these phases. The African American church has been evidenced to be a trusted source of resource and provide culturally competent care and contribute to decreasing these disparities. Importantly, the leadership of the African American churches are pivotal to the health and wellness of this population. One important leader is the clergy wife or widow, who is understudied but vital to the function of the church function and activities. The long-term goal of this proposed study is to develop a leadership training program for clergy wives and widows with emphasis on cancer survivorship and caregiving. The objective of this pilot project is to develop and test the Cancer Survivorship and Caregiver Leadership Education for Clergy Wives and Widows, with specific emphasis of cultural and spiritual considerations of African American cancer survivors and caregivers. The rationale for this project, is that African American clergy wives and widows can receive the necessary training to assist cancer survivors and caregivers in the management of physical, emotional, psychosocial, spiritual, and financial challenges. This study will be accomplished in four aims, which are 1) Develop skills and knowledge to perform an in-depth culturally sensitive need assessment and intervention map tailored for aging African American cancer survivors and caregivers, 2) To increase cancer survivorship and caregiving leadership education and activities for African American Clergy Wives and Widows, and 3) Enhance awareness of cancer-related health issues and its relationship to key determinants among aging cancer survivors and caregivers. This project is innovative in establishing a culturally and spiritually tailored intervention to develop the training of Clergy Wives and Widows to provide appropriate education for community dwelling African American survivors and caregivers. This research is significant because of its potential to inform cancer and caregiving related research and evidence-based practice for both health care professionals and community organizations and institutions to improve long term-health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Identify as either a clergy wife or widow
* Identify as African American and/or Black
* Live within the boundaries of Los Angeles County
* Be at least 18 years of age
* Speak and/or read English

Exclusion Criteria:

* Does not identify as a clergy wife or widow
* Does not self-identify as African American and/or Black
* Lives outside the boundaries of Los Angeles County
* Under the age of 18
* Unable to speak and/or read English
ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.

The main question it aims to answer is:

To quantify the relationship using comparison measurement from the same sample between the test device and the predicate device within the reportable range for ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode (S65, SP65) and heparinized mixed venous/arterial whole blood samples in capillary measuring mode (C65).

Eligibility Criteria:
Inclusion Criteria:

* The following are the inclusion criteria for the neonatal subjects:

  * The age of the subject must be ≤28 days.
  * Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
  * Subjects having a sample drawn as part of standard of care that meets the requirements for samples in this study.

The following are the inclusion criteria for the subjects providing placenta for cord blood:

• Delivery ≥38 weeks of gestation.

Exclusion Criteria:

* The following are the exclusion criteria for the neonatal subjects:

  * Subject who has already provided successful results from arterial, venous and mixed venous/arterial samples, to cover both syringe modes and the capillary mode and parameters.
  * Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.
  * Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).

The following are the exclusion criteria for the subjects providing placenta for cord blood:

• Subjects positive of HIV or Hepatitis C
Evidence-Based Psychological Treatment for Emotional Disorders Attended in Dominican Primary Care Units (PsicAP)

Emotional disorders affect millions of people all over the world. Thousands of Dominicans suffer from depression, anxiety, and other emotional disorders that have negative impact on their lives. Nevertheless, many of them do not receive a proper treatment. The purpose of this study is to describe a pilot project, in which a protocol of evidence-based psychological treatment for emotional disorders, supported by mHealth (mobile health), will be applied on Dominicans who attend Primary Care services. It will be a collaborative program, divided into three phases, and based on cognitive behavioral therapy. The hypothesis of this research is that this protocol is an effective strategy to treat emotional disorders.

Emotional disorders, such as anxiety, depression and somatic disorders, represent a serious public health issue. Many people who suffer from them do not have access to an adequate psychological treatment. Some of the reasons why this situation happens are: the high cost that tends to represent a proper psychological treatment, and, in countries like Dominican Republic, the lack of a protocol that guides health professionals of Primary Care Units on the diagnosis and treatment of these emotional disorders. The purpose of this study is to describe a pilot project, in which a treatment protocol for emotional disorders will be applied by trained mental health professionals in Dominican Primary Care Units. It will be a randomized controlled trial with 300 patients. To prove the effectiveness of this protocol, the phases of this study will be: 1) psychological assessment of the study sample; 2) seven sessions of conventional treatment offered to a control group, and seven sessions of the evidence-based psychological techniques, suggested by this new protocol, given to an experimental group; 3) psychological reassessment of the study sample. This protocol suggests transdiagnostic approaches and collaborative interventions, that include group-sessions and evidence-based psychological techniques derived from cognitive behavioral therapy. Also, the protocol will be supported by mHealth tools. Some of the points included in the protocol are: psychoeducation on emotional disorders symptoms, relaxation and breathing techniques, thought management, improvement of quality of life and relapse prevention.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 79 years old.
* Adults with mild or moderate levels of anxiety, depression or somatic disorders.
* Dominicans.
* People who are not receiving any psychological treatment.
* People who know how to read and write.

Exclusion Criteria:

* A diagnostic of severe mental/emotional disorder.
* Recent suicide attempt.
* Severe disability.
* People who do not meet sufficient criteria to be diagnosed with mental or emotional disorders.
ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography

This prospective, randomized trial will compare the extent of covered stent strut segments by assessed by Optical Coherence Tomography (OCT) of the ORSIRO DES with that of the XIENCE PRIME DES, which is the standard of choice of contemporary drug eluting stents (DES).

The ORSIRO drug eluting stent exhibits a favourable vascular healing profile from baseline to 6 months assessed by optical coherence tomography (OCT). Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive before the procedure a loading dose of P2Y12 antagonists (clopidogrel, prasugrel or ticagrelor). Eligible patients who do not meet the exclusion criteria and for whom PCI will be considered as the appropriate form of revascularization will be randomly assigned to the ORSIRO or the XIENCE PRIME DES in the relation 1 x ORSIRO: 1 x XIENCE PRIME. All patients will receive periprocedural intravenous aspirin and heparin or bivalirudin. After the intervention patients will receive aspirin indefinitely and P2Y12 antagonists for at least 6 months. The intravascular imaging by OCT will be performed at the 6-8 months follow-up angiography.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
* In women with childbearing potential a negative pregnancy test is mandatory.
* AHA type A, B1 and B2 lesions.

Exclusion Criteria:

* Lesion length \> 25 mm requiring a stent length \> 28 mm
* Target lesion located in the left main trunk.
* In-stent restenosis.
* Acute myocardial infarction
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 18 months or that may result in protocol non-compliance.
* Known allergy to the study medications: sirolimus, everolimus
* Inability to take dual antiplatelet therapy for at least 6 months.
* The presence of bifurcation lesions
* The presence of calcified lesions
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol
EmbryoGlue as an Embryo Transfer Medium

In Vitro Fertilisation (IVF) is an increasingly common treatment for infertility. Clinics which offer IVF are continuously trying to improve their success rates, measured by the numbers of IVF cycles which result in the birth of a live baby.

One factor which is thought to have contributed to the success of IVF is the improvements in the embryo culture media, that is, the fluid in which the embryo resides in the laboratory before being replaced into a woman's womb. This trial seeks to identify if IVF cycles in which a particular culture media called EmbryoGlue is used have better results when compared to IVF cycles in which a conventional embryo transfer media is used.


Eligibility Criteria:
Inclusion Criteria:

• Couples having embryo transfer for fertility treatment

Exclusion Criteria:

* Cycles in which elective freezing of all embryos is clinically indicated (e.g. severe risk of OHSS, biopsy patients)
* Use of donor gametes
* Having endometrial scratch technique this cycle
* Concurrent participation in clinical trial(s)
* Previously randomised to this study
* Planned self-fund of EmbryoGlue as transfer media
Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Feasibility of the IC-Flow Device

1. Primary Objective:

   Demonstrate that the IC-Flow Imaging device with Indocyanine Green (ICG) is a feasible technique when visualizing and identifying perfusion of organs when compared to The KARL STORZ VITOM II ICG System during open reconstructive surgical procedures
2. Secondary Objective:

   1. Evaluate the mean Assessment of handling properties using The IC- Flow versus The VITOM II.
   2. Evaluate the mean Surgeon preference Level using The IC- Flow tower, The IC-Flow Hand-held device versus The VITOM II.

Currently, there is no literature that supports the clinical application of the IC-Flow. However, we intend to perform this pilot study to determine safety and feasibility of said device in comparison to its homologue, FDA-approved VITOM II ICG System.

The device named The KARL STORZ VITOM II ICG System is an imaging system used in capturing and viewing fluorescent images. The system is FDA approved for all the indications that are going to be used in our study as well as the specialties involved It is composed of an open field multidirectional imaging arm and head, a light guide and a video processor/illuminator (FDA 510 (k) K171238, May 25, 2017).

As indicated by the Department of Health and Human Services from the FDA, the indications for use are the following: "The system is used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures." And "The system is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal procedures." Based on the information provided by the FDA, the device has no direct nor indirect effect on patients. Furthermore, the device predicts a safe use and it's intended to provide imagery feedback alone.

There is few clinical trials which broadly exemplify the alternate applications of ICG fluorescence as a diagnostic tool for intraoperative anatomical identification, in terms of structure, perfusion, and tissue viability. No significant increase of risks or dye-associated complications had been reported.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both genders
2. Minimum age: 18 years old
3. Spoken and written command of the language spoken in the country's center
4. Ability to understand and follow the study procedures and sign the informed consent
5. open surgical porcedures

Exclusion Criteria:

1. Known allergies to iodides
2. Known history of coagulopathy
3. Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out
Extended Evening Fasting: Metabolic Health and Energy Balance

This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial

Humans have evolved as a diurnal species, internally governed by the circadian system, which dictates our hormone regulation. 'Chrononutrition' is a sub-discipline which combines food timing with circadian physiology. The most popular method of time-restricted feeding in the UK is to skip breakfast. However, data from several meta-analysis have shown that skipping breakfast is associated with weight gain and insulin resistance, likely due to eating later into the evening/night and therefore, out of sync with our circadian rhythm. Recent research has shown that skipping dinner (evening fasting) has improved markers of cardio-metabolic health in clinical populations, although these are typically from longer-term studies. Despite these promising findings, it is not yet known whether these findings are population specific.

Therefore, the investigators are interested in examining the metabolic response pre and post intervention to see whether these promising findings can translate into a healthy population. Furthermore, the investigators will be monitoring subjective appetite, energy intake and expenditure to assess whether there is any short-term adaptation to a specific feeding window.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers.

  * Have maintained a stable weight for 6 months (self-reported).
  * No history of gastric, digestive, cardiovascular or renal disease (self reported).
  * Female specific: must be using a monophasic, low dose combined OCP (containing less than 50μg oestradiol and a synthetic progestin) OR females with regular menstrual cycles (self-reported).

Exclusion Criteria:

* Severe food allergies, dislike or intolerance of study foods or drinks.

  * Currently undergoing a lifestyle intervention (structured diet or exercise)
  * Diagnosis of a condition or currently undergoing treatment therapy known to affect glucose or lipid metabolism (e.g., type-2 diabetes, taking statins), or contraindications to exercise.
  * Use of medication or supplements that may affect hormone concentrations.
  * Excessive alcohol consumption (\>14 units/week).
  * Intensive training schedule (\>10 hours/week).
  * Female specific: currently pregnant or breastfeeding, the use of any hormonal contraception, and the self-reporting of short (\<24 d), long (\>35 d), or irregular menstrual cycles.