cyrilzakka/clinical-trials huggingface dataset:
Learning Excellence Program and Improvement of Quality Care

Improving the quality of care is a daily goal in pediatric intensive care units. Measuring patient and family satisfaction is recognized as an indicator of quality of care. A validated questionnaire was specially developed to study parental satisfaction in pediatric intensive care units. A positive multi-professional analysis of clinical situations, using appreciative inquiry, within a health service can create new opportunities for learning and innovation. The establishment of such a Learning From Excellence (LfE) program tends to increase the well-being and self-confidence of caregivers and promotes dynamic learning educational programs, including simulation.

It therefore seems important to assess the improvement in the quality of care in pediatric intensive care following the implementation of a Learning From Excellence program allowing positive reflection on practices as well as innovations within the service.


Eligibility Criteria:
Inclusion Criteria:

* All parents of children aged 0 to 18 who have been hospitalized in the pediatric intensive care unit over a period of 24 months once the research has been authorized and started

Exclusion Criteria:

* Parents unable to answer the questionnaire because they do not speak French
* Parents of children who died during their stay in the pediatric intensive care unit
Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy

The positive cases of coronavirus disease-2019 (COVID-19) in Indonesia has been increasing rapidly since the first case found in March 2020 to date. Coronavirus 2 (SARS-CoV-2) virus disrupts human normal immune system resulting in uncontrolled inflammatory response. Based on our research and experience in doing cell therapy for 9 years, activated platelet-rich plasma (PRP) produces anti-inflammatory effects in inflammatory condition that is beneficial for tissue regeneration. In this study, we aimed to evaluate the potential of autologous activated platelet-rich plasma (aaPRP) and the outcomes for treating severe Coronavirus Disease-2019 (COVID-19) patients in Intensive Care Unit (ICU).

PRP decreases IL-1β, IL-6, IL-8, and TNFα inflammatory genes expression while also reduces IL-1β and TNFα inflammatory cytokines production. PRP has also been showed to contain interleukin 1 receptor antagonist (IL-1RA), an anti-inflammatory cytokines that suppress IL-6 secretion.

Eligibility Criteria:
Inclusion Criteria:

* severe covid-19 patient in ICU

Exclusion Criteria:

* CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However,the existing tCES products effect on the whole brain networks and lack special waveforms. Therefore, we aim to develop a wearable tCES with high definition and special waveforms in this study. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. We expect that the novel high-definition tCES (HD-tCES) combined with the upper extremity rehabilitation can shorten the duration of rehabilitative periods, improve stroke patients' activity of daily living, reduce the care burden of patients' family, and subsequently decrease the cost of health care insurance.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20 years.
2. Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
3. 6 months to 5 years after stroke.
4. Muscular inelasticity (spasticity) 1-3 on the affected upper limb, evaluated by the Modified Ashworth Scale.

Exclusion Criteria:

1. Extremely sensitive to electrical stimulation and cannot tolerate it.
2. Contracture on upper extremities, and limitation in joint range of motion.
3. The muscle tone was severe spasticity,
4. Ossification or inflammation in muscle tissue.
5. A history of cardiopulmonary disease or arrhythmia.
6. With implantable medical electronic devices, like pacemaker.
7. Pressure sores or wounds on the skin of head and upper extremities.
8. Metal implants in the head (neck).
9. Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
10. A history of seizure or other brain pathology.
11. Brain surgery or severe brain trauma.
12. Drug or alcohol abuse.
13. Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.
Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases

The purpose of this study is to find out what effects, good and/or bad, radiation has on the lungs has on the patient and on synovial sarcoma which has spread to the lungs. The standard treatment for synovial sarcoma which has spread to the lungs is chemotherapy with or without surgery to remove the tumors in the lungs. However, tumors often come back in the lungs after chemotherapy and/or surgery. Since synovial sarcoma is known to be sensitive to radiation, this study is looking at whether radiation therapy which is targeted to the entire lung can further reduce the chances of the cancer returning. This type of radiation is commonly used in other types of sarcoma to treat the cancer once it has spread to the lungs and it may be very useful in synovial sarcoma as well.

In this study, a special type of radiation will be used, called Intensity Modulated Radiation Therapy (IMRT). With IMRT the radiation beams are more customized to focus more radiation on the tumor cells while delivering less radiation to areas like the heart. The goal of this study is also to measure pulmonary toxicity and see if IMRT is feasible and has less toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with synovial sarcoma confirmed by MSKCC pathological review
* Patients with single or multiple lung metastases at diagnosis or that develop over the course of treatment. After completion of all chemotherapy, lung metastases or must be ≤ 2cm.
* Age ≥12 months of age
* Karnofsky performance status (KPS) must be ≥ 70 for patients ≥ 16 years of age and Lansky performance status must be ≥ 70 for patients \< 16 years of age.
* Normal cardiac function
* No active coronary artery disease;
* No New York Heart Association class II, III or IV disease;
* No arrhythmia requiring treatment.
* Baseline echocardiogram with a shortening fraction of ≥27% or an ejection fraction ≥ 50%.
* Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start.
* Female patients who are lactating must agree to stop breast-feeding.
* Sexually active patients of childbearing potential must agree to use effective contraception.

Exclusion Criteria:

* Patients with a history of prior radiation therapy to the thorax.
* Patients requiring a field size \>40 cm as IMRT cannot be performed at extended SSDs.
* Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures

Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

However, main arterial closure devices use different technology to close the arterial puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs (an inner and an outer). For others, they are designed to close puncture sites delivering a single monofilament polypropylene suture mediated by needles.

The investigators hypothesis is based on a different efficacy between both arterial closure devices for peripheral arterial disease (PAD) patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Patient with peripheral arterial disease
* Endovascular examination or treatment compatible with a 5F to 7F sheath
* Walking ability
* Patient affiliated with a social security scheme
* Patient's signed informed consent form

Exclusion Criteria:

* Under-age patient
* Patient of age, but under legal guardianship or care
* Contraindication to endovascular treatment
* Use of a 8F or greater sheath
* Morbidity contraindicating same-day walking
* History of ipsilateral open common femoral artery surgery
* Stent at the puncture site
* Radial or brachial puncture
* Antegrade femoral puncture
* Acute ischemia
* Life expectancy of less than one month
* Patient refusal to take part in the study
* Participation in another therapeutic trial
* Pregnant woman
* Allergy to clopidogrel or aspirin
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in treatment-naïve and HIV-1 and hepatitis B virus (HBV) adults.


Eligibility Criteria:
Key Inclusion Criteria:

* Human immunodeficiency virus type 1 (HIV-1) co-infection:

  * Must be HIV antiretroviral treatment naive with plasma HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening
  * ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine and entecavir, following a diagnosis of HIV-1 infection (except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening)
  * Screening genotype report must show sensitivity to emtricitabine (FTC) and tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively, if genotype results from a local laboratory obtained ≤ 90 days prior to screening visit date show sensitivity to these drugs, this genotype will be acceptable to fulfill this inclusion criterion in the event that the genotype obtained at screening is not yet available and all other inclusion/exclusion criteria have been confirmed
* HBV co-infection:

  * Must be hepatitis B virus (HBV) treatment naive (defined as \< 12 weeks of oral antiviral treatment)
  * Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 IU/mL
* Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 10 x upper limit of normal (ULN)
* Total bilirubin ≤ 2.5 x ULN

Key Exclusion Criteria:

* Hepatitis C virus (HCV) antibody positive and HCV RNA detectable
* Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment
* Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
* Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
* Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Synbiotic Extensively Hydrolysed Feed Study

This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged \<13 months) currently using or requiring an extensively hydrolysed formula for the dietary management of CMA. Patients already prescribed an eHF (or other appropriate feed for CMA) at time of recruitment will undertake a 3 day baseline period in which their current symptoms, compliance, GI tolerance and acceptability towards their current feed is assessed, before introducing the study product for a period of 4 weeks. Patients who are not on an eHF (or other appropriate feed for CMA) at baseline will forgo this 3 day baseline period and immediately introduce the study product for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Aged \<13 months
* Currently using or requiring an extensively hydrolysed formula for the dietary management of cows' milk allergy
* Expected to receive at least 25% of their energy intake from the study feed
* Already fed with infant formula or hypoallergenic formula (either partially or fully)
* Written, informed consent from parent/carer

Exclusion Criteria:

* "Severe" cows' milk allergy (clinically judged to require an amino acid formula) or any other contraindications to the use of an extensively hydrolysed formula
* Exclusively breastfed infants
* Primary lactose intolerance
* History of poor tolerance to whey based EHFs
* Immunocompromised infants
* Premature infants (born \<37 weeks)
* Major hepatic or renal dysfunction
* Requirement for any parenteral nutrition
* Tube-fed via a post-pyloric route
* Participation in other clinical intervention studies within 1 month of recruitment to this study
* Investigator concern around the ability of family to comply with protocol and requirements of study
Culturally Responsive Person-Centered Care for Psychosis

This study will compare standard individualized care to person-centered care and community-integrating care for treating psychosis in adults of Hispanic or African descent.

Patient-centered care is a type of customized mental health care that is based on each individual's needs, values, and preferences. This type of care has become increasingly important, especially for members of ethnic minorities. However, although this type of care is, in theory, more effective than standard, less personalized care in treating psychotic disorders, there is a significant gap between theory and practice. Research has shown that this gap is particularly evident in the treatment of psychotic disorders in individuals of ethnic backgrounds. This study will address these disparities by comparing the effectiveness of standard individualized care versus person-centered care and community-integrating care in treating psychosis in adults of Hispanic and African descents.

This open-label study will consist of two phases. In Phase I, interview data on self-management of mental illness and treatment seeking behaviors will be collected and analyzed. In Phase II, participants from two urban mental health centers will be randomly assigned to receive one of three treatment combinations: standard care incorporating illness management recovery (IMR); IMR plus person-centered planning (PCP); or IMR plus PCP and community integration (CI). IMR will focus on nine topic areas: recovery strategies; facts about psychosis; a stress-vulnerability model; building social support; reducing relapses; effective use of medications; coping with stress; coping with problems or symptoms; and meeting health care needs. PCP will aid participants in discovering a vision of a desirable future and developing a plan for achieving that goal. Techniques will include providing direction in the planning process, involving significant others, generating focus on assets and capacities, identifying and providing access to integrated community settings, and promoting acceptance of setbacks as part of the path to success. CI will include recovery group sessions and community integration activities. Recovery groups will consist of 10 to 12 people per group, and will aid participants in asserting the skills they learned in IMR and PCP. Community integration activities will entail a variety of excursions and social and recreational activities in the community to promote community involvement and acquisition of social roles. All treatments will last a total of 6 months. Assessments of psychiatric symptoms, social functioning, quality of life, and community integration will occur at Month 6 and at a follow-up visit at Month 18.

Eligibility Criteria:
Inclusion Criteria:

* Of Hispanic and/or African origin
* DSM-IV diagnosis of an axis I psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic features)

Exclusion Criteria:

* N/A
A Study of TAS-205 for Duchenne Muscular Dystrophy

The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in patients with Duchenne Muscular Dystrophy.

Duchenne Muscular Dystrophy (DMD) is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3500 lives male births. DMD patients suffer from a relentless decline in muscle strength that impairs the ability of walking and breathing, resulting in their lives with wheelchairs and loss of upper body function. The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 after single and multiple doses in DMD patients. It is also evaluated if TAS-205 affects the urinary excretion of pharmacodynamic (PD) marker in DMD patients.

Eligibility Criteria:
Inclusion Criteria:

* Able to give an informed consent. If applicable, able to give an informed assent.
* Male and \>= 5 years and \< 16 years of age.
* Bodyweight of \>= 15.0 kg and \< 75.0 kg.
* Phenotypic evidence of DMD.
* Able to take tablets.
* If taking oral glucocorticosteroids no significant change in total daily dosage or dosing regimen after enrollment.
* Confirmed the urinary PD marker over its criteria.
* Able to follow the study protocol.

Exclusion Criteria:

* Current diagnosis or history of any drug allergy.
* A forced vital capacity (FVC) \< 50% of predicted value.
* A left ventricular ejection fraction (EF) \< 50% or fractional shortening (FS) \< 25% based on echocardiogram (ECHO).
* Ongoing immunosuppressive therapy (other than corticosteroids).
* With severe disease such as hepatic disease, kidney disease and others.
* With any systemic allergic disease or any chronic inflammatory disease.
* Treated with any other investigational agents within 90 days.
* Positive reaction in hepatitis B surface antigen (HbsAg), hepatitis C antibody test (HCV), or human immunodeficiency virus (HIV) test.
Midwifery Students' Performance Before and After Teaching Fundamentals of Documentation

Midwives are responsible for documenting and keeping care facts in midwifery departments. Inaccurate documentation or even minute error in reporting may lead to burdensome responsibility for midwives. This study has been conducted aimed to compare midwifery students' performance before and after teaching fundamentals of documentation. In this quasi-experimental study, 28 midwifery students were participated. Data were collected by a questionnaire including a. demographic data and b. Scenarios (1) and (2) of an imaginary patient with physician order and a checklist contain 11 elements of documentation


Eligibility Criteria:
Inclusion Criteria:

* midwifery students studying at mashhad school of nursing and midwifery

Exclusion Criteria:

* any other discipline
Prostate Cancer: Family Care for Patients and Spouses

The purpose of this study is to determine if a family-based intervention (The FOCUS Program) can improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouses.

The purpose of this study was to determine if a family-based intervention (The FOCUS Program) could improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouse/partners. Aim 1. The first aim was to determine if the family intervention could improve several proximal clinical outcomes (less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, better family communication, higher self-efficacy, and more problem-focused coping) and improve the distal clinical outcome, quality of life, in a culturally and economically diverse sample of men with prostate cancer and their spouses. Aim 2. The second aim was to test a stress-coping model designed to predict which prostate cancer patients and their spouses are at higher risk of poorer long-term quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of prostate cancer
* Willing spousal partner
* Speaks and understands English
* Mentally and physically able to participate
* Minimum life expectancy of 12 months
* Lives within 70 miles

Exclusion Criteria:

* Multiple primary cancers
* Watchful waiting status
* Spouse with cancer diagnosis in previous year
REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry

Intraoperative hypotension is common during major noncardiac surgery and is associated with adverse postoperative outcomes. Propofol, the most commonly used intravenous anesthetic agent worldwide, is associated with hypotension on induction and maintenance of general anesthesia. Remimazolam is a newly developed short-acting benzodiazepine drug and has been approved for use in procedural sedation and general anesthesia. It was associated with a lower incidence of hypotension during procedural sedation in previous studies. The aim of this study is to tested the primary hypothesis that total intravenous anesthesia with remimazolam reduces the duration and severity of hypotension during major noncardiac surgery compared with total intravenous anesthesia with propofol.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥45 years;
* Undergoing elective major surgery under general anesthesia (expected surgery time \>2 h, expected length of postoperative stay \>2 d);
* Need for intraoperative invasive blood pressure monitoring via arterial line;
* Fulfilling ≥1 of the following criteria (a-k):

  1. history of coronary artery disease;
  2. history of stroke;
  3. history of congestive heart failure;
  4. preoperative NT-proBNP \>200 pg/mL;
  5. preoperative high sensitivity troponin T \> 14 ng/L;
  6. age ≥70 years;
  7. diabetes requiring medical treatment;
  8. ASA status 3 or 4;
  9. history of chronic kidney disease (preoperative sCr \>133μmol/L or 1.5 mg/dL);
  10. preoperative serum albumin \<30 g/L;
  11. preoperative hemoglobin \<100 g/L.

Exclusion Criteria:

* Undergoing organ transplantation, cardiac, neurological, or adrenal gland surgery;
* Planned intraoperative MAP higher or lower than 65 mmHg;
* Severe untreated or uncontrolled hypertension (preoperative SBP \>180 mmHg and/or DBP \>110 mmHg);
* End-stage renal disease requiring renal-replacement therapy;
* ASA score ≥5;
* Preoperative requirement of vasopressor infusion;
* Unable to receive bispectral index monitoring;
* Known allergy to benzodiazepines, propofol, opioids or cisatracurium;
* Current participation in another interventional study;
* Previous participation in this study;
* Pregnant or breastfeeding women.
MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry

Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.


Eligibility Criteria:
Inclusion Criteria:

* Patient is going to be treated with Myval THV
* Age ≥ 18 years
* Ability to give informed consent

Exclusion Criteria:

* Pregnant and lactating women
* Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
* Patients in whom anti-platelet and/or anticoagulant therapy are contra-indicated.
* Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry