cyrilzakka/clinical-trials huggingface dataset:
The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

The PAINFREE (Improving PAIN control following FRactures; towards an Elder-friendly Emergency department) Initiative is a patient-centered multifaceted intervention which aims to improve pain management in patients 75 years and older presenting with a fracture at 7 Emergency Department of participating Montreal hospitals:

1. Montreal General Hospital
2. Royal Victoria Hospital
3. Ste Mary's Hospital
4. Hôpital de Verdun
5. Hôpital du Sacré-Coeur de Montréal
6. Jewish General Hospital
7. Lakeshore General Hospital

Using a stepped-wedge cluster randomized trial design, we will implement PAINFREE sequentially in 7 Emergency Departments (EDs) in the greater Montreal area where as each ED site acts as its own control and provides data in both pre- and post-implementation periods. Mixed methods analysis will be used to link quantitative (pain management indicators pre- and post-implementation) to qualitative (feasibility, fidelity and acceptability of implementation) data sets to facilitate data triangulation to evaluate the effects of PAINFREE in real world settings.

PAINFREE Initiative at each site includes 3 phases: pre-implementation, implementation, and post-implementation. The approach is patient-centered and is composed of three complementary components: a patient component, a physician component, and a nursing component.

Each program phases include the following steps:

1. Pre-implementation (2 months):

   1. In all study sites, distribution and analysis of a web-based survey for nurses to document factors that can impact PAINFREE implementation in their environment
   2. Review of medical records of the target population for extraction of selected variables
2. PAINFREE implementation (6 months):

   1. Awareness campaigns will be organized throughout the institution of each study site (posters, brochures, billboards, lanyards)
   2. Profession-specific educational presentations (1 hour) for physicians and nurses, accredited as part of continued professional development programs
   3. Distribution of standardized point-of-care tools to improve pain assessment and documentation (pocket cards, use of validated pain scales), treatment (standardized prescription) and re-assessment
   4. Distribution of educational material and tools targeting pain care literacy (pain scale interpretation, pamphlet) for patients and their families
3. Post-implementation (4 months):

   1. Review of medical records of target population for extraction of selected variables
   2. Distribution of report cards comparing each ED's post- and pre-intervention performance on pain management indicators and comparing their performance to that of other sites
   3. Phone call interviews with patients
   4. Focus group interviews (physicians and nurses)

Eligibility Criteria:
Inclusion Criteria:

* Age 75 years old or older
* Visiting Emergency Departments for a fracture

Exclusion Criteria:

* Having a skull fracture
* Having only fingers or toes fractures
Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding

three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures
Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects

Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects

Phase 1, Open Label, Randomized, Single dose, 3 Period, 3 treatment study to evaluation the relative Bioavailability of D-0502 tablet formulation in healthy female subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects between the ages of 18-55
* Required evaluation by Investigator for screening and enrollment
* Agreement and compliance with the study and follow-up procedures

Exclusion Criteria:

* Significant medical history or current comorbidly determined by the Investigator.
* Pregnant or nursing women
The Effect of MDZ on Movement During UIA Clipping

This study is a randomized, controlled, double-blinded, and parallel design study. A total 64 patients will be randomized to receive midazolam or normal saline during unruptured intracranial aneurysm clipping surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo elective unruptured intracranial aneurysm clipping surgery
* American Society of Anesthesiologists grade 1,2,3
* age \> 18 year old

Exclusion Criteria:

* Refuse to participate to the study
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* Allergic history of benzodiazepine
* Pregnant
Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients

Surgical manipulation and handling of a tumor may cause dissemination of cancer cells through peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may have preventive effect on positive peritoneal cytology occurred during gastrectomy in patients with gastric cancer.

Peritoneal dissemination of gastric adenocarcinoma cells is the most frequent cause of death in patients with gastric cancer. Spreading of these cells occur by three routes: direct seeding via infiltration through gastric wall, via blood vessels and via perigastric lymphatic channels disturbed during lymph node dissection. Conversion of negative preoperative peritoneal cytology to positive cytology after curative gastrectomy has been shown by previous studies.

Although extensive intra-operative peritoneal lavage (1 L of physiologic saline 10 times) has been shown to be an effective method to eliminate cancer cell dissemination during surgery, to cause significant improvement in survival after gastrectomy, widespread use of this approach has not existed most probably due to its time consuming technical difficulty. Therefore,intra-operative peritoneal lavage (1 L of physiologic saline 3 times) may be used more frequently during gastric surgery.If it is possible to show effectivity of intra-operative peritoneal lavage using a total of 3 L physiologic saline to eliminate cancer cell dissemination occurred before or after gastric surgery, use of this approach may gain acceptance to decrease risk of peritoneal metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopically proven gastric adenocarcinoma
* Standard gastrectomy and a D2 lymph node dissection;
* Desire to attend the study protocol

Exclusion Criteria:

* Metastatic or overt peritoneal disseminated cancer
* Undesired reaction to attend the study protocol
A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®

The purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit 1.
* Patients being prescribed either Symbicort SMART or a free combination of ICS and LABA with SABA as rescue inhaler and being on that treatment for at least 3 month.
* A history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to Visit 1.
* A severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following:

  * Oral/systemic GCS treatment due to asthma for at least 3 days
  * Unscheduled health-care visit due to asthmaHospitalization or emergency room visit because of asthma requiring treatment with oral/systemic GCS

Exclusion Criteria:

* Intake of oral, rectal, or parenteral GCS within 30 days prior to visit
* Use of ß-blocking agents
* Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.
PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.

We are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin.

Antiseptics are routinely utilized to prevent infections of vascular catheters. We are evaluating the addition of methylene blue and light activation on skin to determine whether this inexpensive and non-toxic treatment can decrease skin pathogens and prevent blood stream infections of long-term vascular catheters. This is a pilot study of normal volunteers to determine the effect on the microbiome of the addition of methylene blue and light activation on antiseptic-treated skin.

Eligibility Criteria:
Inclusion Criteria:

* Normal individuals without skin problems

Exclusion Criteria:

* Smokers
* Diabetics
* Atopic dermatitis
* G-6-PD deficiency
* Eczema
* Other skin conditions
* Allergies to methylene blue or chlorhexadine
Pressure Variability Study

The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.

This is a prospective, multi-center, observational study with enrollment up to 30 subjects at 2 U.S. sites. All study data can be collected on a single day as a one-time visit (lasting approximately 90-120 minutes).

This study is a Non-Significant Risk (NSR) Investigational Device Exemption (IDE) study as LINQ™ HF investigational RAMware is required to activate additional sensors in the Reveal LINQ ICM.

The patient will come to the clinic for a single in-office visit. PA pressure will be measured while the patient is in a variety of positions and during different respiratory exercises and after brief exertion. Data will be collected on eCRFs.

The effects of the different postures, respiration and exertion will be quantified using descriptive statistics (mean, standard deviation).

Eligibility Criteria:
Inclusion Criteria:

* Investigator believes the patient's condition is sufficiently stable to safely participate in the study procedures
* Subject is currently implanted with a commercially available pulmonary artery pressure sensor and device communication has been reliable (recent history of successful communications with patient communication system)

Exclusion Criteria:

* Subject has a history of primary PAH
BREATHE-Peds Pilot - I Focus Group Interviews

The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (FQHCs) in urban communities. Aim 1 (Phase I) involves developing the intervention through focus groups with early adolescents and caregivers. Aims 2 and 3 (Phase II) involve preliminary testing of the intervention through a pilot randomized controlled trial. This record is for Phase I only.

Despite high asthma prevalence and morbidity among adolescents (highest among Black and Hispanic youth and early adolescents aged 10-14), there is a lack of developmentally appropriate interventions for this at-risk group. Racial and ethnic minority early adolescents have sub-optimal asthma self-management. Critical health behaviors that emerge during early adolescence affect lifelong patterns; therefore, early adolescence offers a unique opportunity to intervene. Additionally, successful self-management requires the right division of responsibility between adolescents and their caregivers. Thus, intervening simultaneously with early adolescents and their caregivers who can help support the adolescent's growing autonomy to self-manage their condition has the potential for a synergistic effect.

Prior studies have demonstrated the effects of improved asthma control of BREATHE, a brief one-time shared decision-making intervention for Black adults with uncontrolled asthma that utilizes motivational interviewing delivered by primary care providers. This study (i.e., Phase I) attempts to build on these promising results by adapting BREATHE to caregiver-early adolescent dyads. Phase I of the study will involve conducting up to 6 focus groups to identify components of BREATHE that are relevant to racial and ethnic minority early adolescents with uncontrolled asthma receiving care at FQHCs in urban communities and their caregivers. Focus groups will be composed of \~10 participants each: (a) two groups of early adolescents aged 10-14 with asthma; (b) two groups of the caregivers of the youth in Group A; and (c) two groups of adolescent-caregiver dyads who did not participate in Group A or B. Investigators will use the focus group results to write BREATHE-Peds, making modifications based on feedback from two primary care providers and two pediatric pulmonologists.

Eligibility Criteria:
Inclusion Criteria (adolescents):

* Aged 10-14 years
* Physician-diagnosed persistent asthma (defined as being prescribed a controller medication)

Exclusion Criteria (adolescents):

* Serious mental health conditions
* Developmental delay

Inclusion Criteria (caregivers):

* Informal caregivers (e.g., parent, grandparent) of adolescents aged 10-14 years with physician-diagnosed persistent asthma

Exclusion Criteria (caregivers):

* Serious mental health conditions
Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

Today the Whipple procedure is the preferred operation for malignancy in the pancreas. In abdominal surgery this procedure is known for its high surgical stress-response in the patient, which has been attempted to be resolved with the introduction of preoperative high-dose steroids and goal-directed fluid therapy (GDT). Despite this effort, complications still occur regularly (30%) in the first weeks after the operation here at Rigshospitalet. Therefore there is still a challenge in the patients who have undergone the Whipple procedure in the acute postoperative phase. This shows in for example at Rigshospitalet, where 50% of the patients continue to be in the need of vasoactive medication the morning after the operation.

Nevertheless, no studies have in detail described the acute (\<24h) postoperative phase. There is also an importance in the fact that there is often no description or control over other important factors, for example medicine with influence on the circulatory system, fluid treatment and response to this etc..

The purpose of this study is to investigate what issues or complications, in particular those of circulatory matter that occurs in this particular group of patients 24 hours after the operation. Furthermore there is lacking a description of which cause-response- link there can be between early and later (30 days) complications, as well as when each of these complications occur. Therefore, there will also be collected data on complications within the first 30 days after the operation for the purpose of a later secondary publication with the same authors.


Eligibility Criteria:
Inclusion Criteria:

* the patient has undergone the Whipple procedure
* The patient is over 18 years ol
* The patient has signed a consent statement from the postoperative therapy ward

Exclusion Criteria:

* The patient did not receive 125 mg of methylprednisolone prior to the operation
* The patient did only undergo pancreatectomy
* The patient wasn't given epidural anesthesia
* the patient was given anesthesia through a mask
Herombopag + rhTPO in Severe Immune Thrombocytopenia

Severe immune thrombocytopenia (ITP) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. Some patients with severe ITP did not respond to first-line treatment including steroids and IVIG. It was critical for them to use effective treatments to promote platelet and reduce the risk of fatal bleeding. In this study, the patients with severe ITP will be treated with hetrombopag, rhTPO, and the combination of hetrombopag and rhTPO, respectively. The effect evaluation includes the increase of platelet number and decrease of bleeding scores. Changes of coagulation, platelet activation, fribrinolysis influence, and thrombotic events will also be accessed for the safety of treatments. The aim of this study is to demonstrate that the combination of hetrombopag and rhTPO for severe ITP is more effective than the other two monotherapy and does not increase thrombotic events or thrombosis risk.

Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group. The effective rate of treatment, the rate and amplitude of platelet increase, the response time of platelet maintenance, and the effect of combination therapy on hemostasis will be compared. At the same time, the investigators will analyze the markers of thrombosis and thrombotic events to assess the safety of combination therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female,70 ≥age≥18；
2. Diagnosed as primary immune thrombocytopenia；
3. Platelet count was less than 10 × 10E9 / L with active bleeding, or bleeding score ≥ 5 points；
4. No use of IVIG, Avatrombopag, Eltrombopag or Romiplostim 2 weeks before treatment；
5. Rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks.
6. There was no history of platelet transfusion one week before treatment.

Exclusion Criteria:

1. Secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded；
2. Patients with active malignant tumors, pregnancy, severe cardiovascular， cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded；
3. Patients deemed unsuitable for enrollment by the investigator；
4. Patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease;
5. Patients reject to participate in the study.
High Risk Screen of Childhood Late-onset Pompe Disease in Pediatric Outpatient Clinics

Establish of high-risk screening criteria to earlier identify possible childhood LOPD for early treatment and better prognosis. Therefore, validation of the high-risk screening criteria for childhood LOPD will be critical for identifying children of LOPD in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Children who are \>1 year and \< 18 year of age from pediatric neurology, pediatric orthopedics and pediatric rehabilitation in NTUH

Exclusion Criteria:

* Children who have been diagnosed as specific neuromuscular disorders.
The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing

Reflexology massage applied before burn dressing reduces pain, anxiety and sleep problems

Reflexology massage regulates blood circulation and energy, gives a feeling of relaxation and provides homeostasis. During reflexology massage, relaxation music is recommended because it contributes to the relaxation of the individual. In the literature, reflexology massage and music therapy are used in different pain management, and these methods reduce anxiety and improve sleep quality. However, there is no study in which reflexology massage and passive music therapy are used to reduce pain, anxiety and sleep problems associated with dressing of burn individuals. It is thought that reflexology massage and passive music therapy will reduce pain, anxiety and sleep problems in dressing changes of burned individuals.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years,
* illiterate,
* without any mental and psychological disease and able to communicate with the assessor
* no hearing problems,
* moderate or severe burns,
* 2 days or more after burn injury,
* proliferation phase of wound healing,
* No open wound, infection or circulatory problems in the area where reflexology will be applied.
* Not having diabetes,
* not using any pre-dressing complementary medicine,
* non-pregnant,
* having no pacemaker,
* agreeing to participate in the study.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria.
Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery
* Males and females 18 years and older
* Able to provide written informed consent

Exclusion Criteria:

* Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss
* Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker
* History of Uveitis
* Ipsilateral intraocular surgery prior to cataract surgery
* CME greater than one year duration