cyrilzakka/clinical-trials huggingface dataset:
Effect of Evidence Based Teamwork System on Patient Safety Culture

This study aims to evaluate the effect of evidence-based teamwork system on patient safety culture among newly graduate nurses at Main Mansoura University Hospital

Developing a patient safety culture was one of the recommendations made by the Institute of Medicine to assist hospitals in improving patient safety and crucial for healthcare quality. Newly graduated nurses with lower levels of work experience, education, and work as part of a team in the healthcare setting are needed to develop communication and teamwork skill to improve patient safety culture . Ineffective communication and teamwork skill among newly graduated nurses are associated with negative patient safety culture outcomes, such as increased error rates, increased length of hospital stay, medication errors, pressure ulcers, and death. The implementation of modified TeamSTEPPS is highly expected to promote better interprofessional communication and teamwork skill between newly graduate nurses as well as improve patient safety culture. So that, this study aims to evaluate the effect of evidence-based teamwork system on patient safety culture among newly graduate nurses at Main Mansoura University Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. All full-time and part-time newly graduated nurses in all departments at Main Mansoura University Hospital within the last two years,
2. Who provide direct patient care
3. Willing to participate in the study.

Exclusion Criteria:

1. All newly graduated nurses who graduated more than two years
2. Who do not provide direct patient care were excluded from the study.
3. All newly graduated nurses through an outside registry or contract through a third party, on a per diem basis
4. Who floated to the intervention unit from another unit were excluded from the study.
Robotic-Assisted Laparoscopic Cystectomy

Robotic cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences.

Robotic Cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences. Our objective is to investigate our results from this novel procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robotic cystectomy at Beaumont Hospital

Exclusion Criteria:

* None
A Study to Learn How Different Amounts and Forms of the Study Medicine Called PF-06414300 Act in Healthy Adults

The purpose of this study is to learn about how different amounts of study medicine called PF-06414300 acts and is changed and eliminated from the body of healthy adult participants. The amount of PF-06414300 in blood after the medicine is taken by mouth will also be measured.

The study is seeking for participants who:

* Are male or female of 18 to 65 years of age.
* Are in good health condition.
* Have body mass index of 16 to 32 kilograms per squared meters; and a total body weight of more than 50 kilograms (110 pounds).

All participants in this study will receive either PF-06414300 or placebo (dummy pill) by chance. The study will have 2 parts; in the first part of the study (Part A), each participant will receive a total of 4 doses of PF-06414300 or placebo with at least 10 to 14 days between each dose. After each dose, participants will stay in study clinic for 4 to 5 days.

In the second part of the study (Part B), each participant will receive a total of 10 doses of PF-06414300 or placebo and participants will stay in study clinic for 14 days.

An optional Japanese cohort may be done later. The planned duration of participation from screening to follow up in Part A and B of this study is up to 12 to 14 weeks and 10 to 12 weeks, respectively.

Participants will also have their blood collected by the study doctors several times.


Eligibility Criteria:
Inclusion Criteria:

* Body mass Index (BMI) of 16-32 kg/m2; and a total body weight \>50 kg (110 lb).
* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs assessments, 12-lead ECGs and laboratory tests.
* Additional criterion for participants to be enrolled in the Japanese cohort only: Participants who have 4 Japanese biologic grandparents born in Japan; body weight \>45 kg (99 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension irrespective of age), hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 1 week prior to first dose.
* Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies

The purpose of the study aims to determine whether different concentrations of nitrous oxide (N2O) have different antidepressant effects for adults with treatment-resistant major depression.

Most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are referred to as treatment-resistant major depression (TRMD). New treatments for TRMD are needed, and one promising line of research are drugs known as N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD.

All patients will receive 3 randomized, one hour nitrous oxide inhalations to placebo (0% N2O), low dose (25% N2O), and high dose (50% N2O). Inhalation sessions will be at least 4 weeks apart. Mood will be assessed at baseline, 2 and 24 hours, and 1, 2, and 4 weeks post-inhalation for each dose.

Eligibility Criteria:
Inclusion Criteria

1. Adults 18-75 years of age;
2. Current diagnosis of unipolar major depressive disorder (MDD) without psychosis as confirmed by structured clinical interview for DSM-IV disorders;
3. A score of \>= 9 on the Montgomery-Åsberg Depression Rating Scale (MADRS);
4. Documented (i.e., chart review) lifetime failure to respond to \>=3 adequate dose/duration antidepressant treatment trials, ≥1 medication failure in the current depressive episode;
5. Good command of the English language.

Exclusion Criteria

1. Meets criteria for any DSM-IV diagnosis for schizophrenia, bipolar, schizoaffective, obsessive-compulsive, personality, or panic disorders;
2. Any recent (within past 12 months) history of substance dependence or abuse (except tobacco), determined by reported history or urine drug screen;
3. Ability to become pregnant and not using effective contraception;
4. Contraindication against the use of nitrous oxide:

   1. Pneumothorax
   2. Bowel obstruction
   3. Middle ear occlusion
   4. Elevated intracranial pressure
   5. Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12
   6. Pregnant patients
   7. Breastfeeding women
5. Inability to provide informed consent;
6. Any other factor that in the investigators' judgment may affect patient safety or compliance
Retina Microvascular Remodeling and Cognitive Function In Hypertension

This study aims to determine the relationships between retina micro-vascular remodeling and cognitive function in hypertensive patients.

The study plans to enrol 160 patients (100 patients with mild cognitive impairment -MCI- and 60 without MCI).

Our project stands on physiopathological and cognitive angles, and is mainly based on the major role of large and small arteries elasticity on cognitive aging. It will benefit from the recent innovative accurate and non invasive techniques such as MRI for central large arteries and adaptative optics for retina arterioles imaging.

Study population is the following:

* 60 patients with hypertension and no MCI,
* 50 patients with hypertension and stable MCI, without dementia
* 50 patients with hypertension and progressive MCI, without dementia

Every patients will perform a medical interview and examination, an MRI (brain + aorta), adaptative optics imaging, a cognitive tests and a blood test.

Primary outcome is to determine the relationships between retina micro-vascular remodeling and cognitive function in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 65 or more
2. hypertension (BP ≥140/90 mmHg and/or antihypertensive treatment)
3. Signed informed consent by the patient
4. Sufficient mastery of the French language to perform neuropsychological tests

Exclusion Criteria:

1. Impossibility to visualize the retinal : severe cataract
2. Dementia (defined by MMSE\<20)
3. Clinical stroke
4. Severe or resistant Hypertension
5. Hypertension treated with more than 3 different pharmacological classes
6. any other disease that may interfere with the assessment of cognitive disorders (epilepsy, Parkinson's disease, major depression, schizophrenia, manic-depressive)
7. Enrolment in a therapeutic trial that could interfere with the main objective
8. Less than 4 years of formal education
9. Illiterate, unable to read, write or count
10. major physical problems that may interfere with the tests (sight, hearing, ...)
11. Short term life threatening disease
12. Non-affiliation to a healthcare system
13. Consent refusal
14. Contraindication to MRI including claustrophobia, metallic devices, pacemaker, mechanical valve implanted before 1985, and nursing, as well as technical contra-indication: patient diameter \> 70 cm or/and weight \> 250 kg
Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children

To determine if treatment of pre-school children with a history of wheeze who present to an Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve their symptoms more quickly, will require less short acting beta agonist (SABA), and allow these children to remain symptom free for a longer period of time.


Eligibility Criteria:
Inclusion Criteria:

* 12-60 months
* wheeze on auscultation

Exclusion Criteria:

* antibiotic use in the past 30 days
* macrolide allergy
* underlying medical condition
* significant co-morbidities
* current enrollment
* language barrier or no access to phone for follow up
Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 with chronic genotype 2 or 3 HCV infection
* HCV RNA \> 10,000 IU/mL at screening
* Subjects must be treatment naive or treatment experienced
* Presence or absence of cirrhosis; a liver biopsy may be required
* Healthy according to medical history and physical examination with the exception of HCV diagnosis
* Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion Criteria:

* Prior use of any other inhibitor of the HCV NS5B Polymerase
* History of any other clinically significant chronic liver disease
* Evidence of or history of decompensated liver disease
* HIV or chronic hepatitis B virus (HBV) infection
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of immunosuppressive agents or immunomodulatory agents
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator
Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic

The purpose of this study is to test the usability of the Plan To Thrive smartphone application with cancer survivors. This study will involve three visits (baseline, follow-up, and feedback assessments). Between the baseline and follow-up time points, patients will undergo a 90-day period in which they will engage with app content. It is hypothesized that cancer survivors in this study will find the smartphone application, Plan to Thrive, an acceptable and feasible way to access post-treatment information. In addition, the investigators will explore preliminary efficacy by examining changes over time in primary (patient activation, patient knowledge and adherence to follow-up care recommendations and health behaviors) and secondary outcomes \[symptom burden, health-related quality of life and patient satisfaction\].


Eligibility Criteria:
INCLUSION CRITERIA:

* At least 18 years of age or older
* Prior history of cancer
* Completion of primary cancer treatment (i.e., surgery, chemotherapy and/or radiation; but can be receiving hormonal treatment)
* Have an e-mail account and reliable broadband access to the Internet
* Able to read, understand, and speak English sufficiently to understand study questionnaires and consent form

EXCLUSION CRITERIA:

* Has a medical condition with a life expectancy of fewer than 12 months
* Physical or cognitive disability that would prohibit them from participating in study procedures
* Having prior inpatient psychiatric treatment, or overt signs of, severe psychopathology (e.g., psychosis, substance dependence, suicidality)
(YMP) Young Moms Program

Young Moms Program (YMP) is designed to address systemic barriers to the health and stability of young moms and their children such as the lack of coordination of service delivery or logistical barriers within the health system. The YMP also streamlines the referral pipeline, connecting moms to evidence-based resources, and ensuring children complete all recommended assessments prior to kindergarten.

This application is a community-engaged research collaboration between the non-profit Imprints Cares, the Wake Forest Baptist Medical Center (WFBMC) Birth Center, and Wake Forest School of Medicine (WFSOM). This project addresses the myriad risks associated with young moms ≤ 21 years old. Because YMP is a tiered program model, services meet parents where they are through a "warm hand-off" approach that uses one-on-one consultation and assessment-based interventions.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be an immediately post-partum mother
* Subject will reside with her newborn
* Subject must be referred from either the Birth Center at Wake Forest Baptist Health or from one of the Wake Forest Baptist Health Patient Priorities Care (PPC) partner practices
* Participants must speak English or Spanish

Exclusion Criteria:

* Newborn of participating mothers must be \>= 35 weeks of gestation and not have an extended neonatal intensive care unit (NICU) stay
Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

Carepartner and Collaborative Integrated Therapy (CARE-CITE) is a novel, web-based carepartner focused intervention designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. The proposed study will evaluate the application of the CARE-CITE intervention paired with usual and customary care during the sub-acute stroke.

Stroke is a leading cause of serious, long-term disability in the United States, and has a particularly harmful impact on individuals and families. Approximately 4.8 million stroke survivors require assistance from family members who are often untrained and ill prepared for the burdens associated with stroke rehabilitation. Family carepartners are key contributors to stroke recovery, but their efforts can lead them to experience a high level of burden and depressive symptoms, reduced quality of life and increased stress in the context of high levels of family conflict surrounding the recovery process. Rehabilitation therapy interventions have primarily targeted stroke survivor outcomes without specifically addressing the well-being of the carepartner.

The researchers of this study have developed a theory-based, family-centered intervention, Carepartner and Collaborative Integrated Therapy (CARE-CITE), designed to engage carepartners during stroke survivor upper extremity (UE) functional task practice in the home. Residual UE impairments occur in up to 80% of stroke survivors and are a primary factor in loss of functional independence. CARE-CITE guides the carepartner in collaborative goal setting and providing autonomy support (characterized by empathy, choice and reducing use of controlling language) for the stroke survivor to promote motivation and creative problem solving in UE self-management.

Participating stroke survivor and carepartner dyads will be randomized to receive the CARE-CITE intervention with usual customary care, or usual customary care alone for four weeks.

Eligibility Criteria:
Inclusion Criteria for Stroke Survivors:

* 1-3 months post ischemic or hemorrhagic event
* discharged from inpatient neurologic rehabilitation to their home
* have minimal to moderate upper extremity (UE) deficits (actively initiate 20 degrees of wrist and 10 degrees of finger extension)
* no severe cognitive deficits (Mini -mental test \>24)
* no physician determined major medical problems that would limit participation in outpatient therapy

Inclusion Criteria for Carepartners:

* spouse/partner or family member
* dwelling in the same household
* self-identify as the primary caregiver of the stroke survivor
* \>21 years old
* able to read and write English
* have no significant cognitive deficits (Mini -mental test \>24)
* familiar with using a computer and accessing websites, or with using a tablet

Exclusion Criteria:

* none
Effect of the Membrane Blue Dual® Dye on the Retinal Sensitivity in Macular Hole Surgery

The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years.

This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. To be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. This sensitivity decrease could be induced by the dyes used during surgery.

This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models.

It would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. Only microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive technique that explores the macular visual field. It is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* lower idiopathic macular hole inferior or equal to 600 micron millimeter
* undergoing macular hole surgery

Exclusion Criteria:

* Myopia \> -3 diopters
* pregnant women
* no Health Insurance coverage
* refusal to participate in the study
FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (FLIMMA)

All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Male or female
* Patients having pigmented lesions with suspicion of dysplastic nevus or melanoma, in whom an excision is performed in order to exclude or diagnose malignant melanoma
* Patients who gave their written informed consent.

Exclusion Criteria:

* Patients with skin type V and VI according to Fitzpatrick's scale;
* Where there is a risk that the scanning head is torn off be-cause the patient cannot be placed at rest (e.g. due to motoric disorders like tremor, convulsions, tics, compulsive acts
* Patients who cannot understand the patient information and provide informed consent
* Deep dermal lesions ≥ 5 mm beneath the stratum corneum
* Clinically or reflected-light microscopically obviously non-melanocytic lesions
* Peri- and subungual lesions
* Mucosal lesions
* Lesions with trauma, erosion (superficial defect), excoriation (defect down to the basement membrane) or ulceration (deep substantial defect) on more than 50 % of the lesion area (measurements must in any case not be carried out directly on the trauma, erosion, excoriation or ulceration)
* Tattooed lesions
* Pregnant or breast feeding women
* Patients suffering from albinism
* Lesions with dominant (\>50%) regression
* Lesions which are not suitable to fix the scanning cap