cyrilzakka/clinical-trials huggingface dataset:
Guided Discontinuation Versus Maintenance Treatment of Sirolimus in Pediatric Patients With Kaposiform Hemangioendothelioma

This randomized controlled trial aims to compare guided discontinuation with maintenance treatment of sirolimus in pediatric patients with KHE.

Kaposiform Hemangioendothelioma (KHE) is a rare vascular tumor that occurs in infants and children. KHE is characterized by sheets of spindle cells with an infiltrative pattern in the dermis, subcutaneous fat, and muscle. It is locally aggressive and can cause Kasabach-Merritt phenomenon, a serious life-threatening coagulopathy characterized by profound thrombocytopenia and hypofibrinogenemia. Sirolimus, one of the mTOR inhibitors, has become a new and very effective treatment, which is especially reliable for KHE with KMP and has acceptable side effects. However, there is yet no strong evidence on the best practice of treatment length of sirolimus. This randomized controlled trial aims to compare guided discontinuation with maintenance treatment in pediatric patients with KHE in order to provide a basis for the optimal treatment duration of sirolimus, as well as the clinical characteristics of pediatric patients who can safely reduce the dose till withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Participant diagnosed with KHE with or without KMP
* Participant age 0-12 years
* Participant with detailed medical records of the disease at the time of screening
* Participant with at least two years of remission of KHE and no previous toxicity or adverse events
* Participant with normal liver and kidney function
* Participant with signed and dated informed consent from the guardian(s)

Exclusion Criteria:

* Participant with other hematological diseases
* Participant with other solid tumor
* Participant with general disease such as hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency.
* Participant with infectious diseases
* Unwilling participant
Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

Adenomas are premalignant polyps of the colon that should be resected endoscopically. Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be conducted using the so-called piece meal technique in these cases. However, leaving polyp residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer may arise form adenomatous remnants. In case of difficult polyp locations endoscopic resection may also be time consuming. On the other hand endoscopists are facing an increased time pressure due to rising numbers of procedures during the last decades.

The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard endoscope. The EVD has small flexible branches on its outside. The branches turn out during withdrawal. By that the branches are getting in contact with colonic wall. This mechanism leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that resection circumstances may be improved by using an EVD. In addition, stabilizing the scope during resection may result in a reduced time effort. Until now no controlled trials exist investigating the effect of EVD on the time effect during polyp resection. Therefore a randomized controlled trial needed comparing standard polypectomy versus polypectomy using the EVD during routine colonoscopy procedures.


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy
* age ≥ 40 years

Exclusion Criteria:

* American Society of Anesthesiologists class IV or higher
* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
* contraindication for polyp resection e.g. patients on warfarin

Exclusion Criteria:

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Working With Doctors and Pharmacists to Help Parents Give Children's Liquid Medicines Safely

The study objective is to assess the impact of an automated electronic health record (EHR)-based intervention that leverages e-prescriptions to support pharmacist adherence to recommended dispensing practices, with the goal of reducing parent dosing errors.

Specifically, the study aims are to: 1) Examine the efficacy of the EHR-based intervention in improving pharmacy dispensing practices, including a) adherence to mL-only dosing and b) provision of optimal dosing tools; 2) Examine the efficacy of the EHR-based intervention in reducing parent dosing errors. The study will also explore whether implementation of the EHR-based intervention will reduce disparities in dosing errors by parent health literacy and LEP, and explore the efficacy of the EHR-based intervention in reducing ADEs.

A pre-/post-implementation study will be performed with English- and Spanish-speaking parents of children prescribed oral liquid medications in the pediatric emergency room, outpatient general pediatric clinic, and pediatric subspecialty clinics of 2 New York City hospital systems (NYU Langone Health - Brooklyn and NYC Health+Hospitals - Bellevue Hospital). Prior to implementation, e-Rx's will be generated by the EHR in the usual fashion; after implementation, e-Rx's will be generated by the EHR with instructions to the dispensing pharmacy to: 1) keep the dosing instructions in mL-only, and 2) dispense a specific dosing tool based on the amount prescribed.

The proposed project is consistent with a growing national focus on promoting the adoption of evidence-based strategies to improve disease management that address the needs of those with low health literacy and LEP from groups like the Joint Commission and the AHRQ.


Eligibility Criteria:
Inclusion Criteria:

Caregiver/Child

1. English or Spanish-speaking
2. Parent or legal guardian of a child prescribed a liquid medicine in the NYU Langone Health - Brooklyn or Bellevue ED, general outpatient pediatric clinic, or specialty care clinics
3. 18 years of age or older
4. Child ≤8y discharged home with a Rx for ≥1 daily liquid medication dose ≤10mL, for use as a chronic or short course (≤14 days) medication
5. Primary person who will administer child's medications
6. Access to a smartphone that can take photos and send/receive text messages
7. Willingness and ability to participate

Pharmacy staff

1. Works at a pharmacy that dispensed index medicine to one of our study participants.

Exclusion Criteria:

Caregiver/Child

1. Does not have a working phone number
2. Not able to return for in-person follow-up visit
3. Was told to stop medication by provider after doctor/ED visit
4. Parent no longer having index medication bottle
5. Uncorrected hearing impairment
6. Self-reported poor visual acuity

Pharmacy staff

1. Staff with no responsibility in determining unit of measure to include on Rx's or type/capacity of the dosing tool to dispense for pediatric oral liquid medications.
BIOFLOW-III Belgium Satellite Registry

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences.

Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.

These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease
* Subject has signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow-up assessments
* Subject is ≥ 18 years

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Pregnancy
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint is not reached yet.
Optimization of Outpatient Surgery at the CHUM Using the LeoMed Telecare Platform

The main objective of this study is to carry out a medico-economic evaluation of a new platform for outpatient surgical care, by comparing the effectiveness and utility of the deployment of this trajectory on patients and the health system to a control group.

Outpatient surgery allows the patient to leave the hospital on the day of their surgery and thus avoid complete hospitalization. There are many advantages to this practice. Patients can remain in the comfort of their own home with the support of their family caregivers and the healthcare system can avoid incurring additional hospital costs and redirect these savings to other critical needs. However, despite the advantages of outpatient surgery, the tools and measures currently in place to supervise the preparation before the operation and the follow-up after the operation are suboptimal.

Following surgery, adverse events such as moderate to severe pain, nausea/vomiting, infection and bleeding from the operative site are very rarely sought out and detected by healthcare facilities. However, these are the main causes of readmissions or emergency consultations for patients.

In order to optimize the care offer, the anesthesiology department, the innovation and artificial intelligence center of the CHUM as well as the Quebec telecare platform LeoMed have joined forces in order to offer, through a health application, follow-up and personalized support for patients undergoing outpatient surgery.

The investigators believe that the integration of this platform in the course of care will allow early diagnosis of the main postoperative complications and therefore, prevent calls to the Health-Info line, emergency room returns, as well as readmissions or unscheduled postoperative consultations.

A patient-as-partner approach has been chosen in the initial phase, where 12 patients having had an outpatient surgery less than 6 months ago, will be recruited to test the platform. Another 12 patients, scheduled to undergo an outpatient surgery, will test the optimized support and follow up application. Their feedback will help to correct and/or improve the platform, if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old undergoing elective outpatient surgery under general or regional anesthesia
* Internet access for the patient or their caregiver from home
* Written, oral and spoken comprehension of French or English

Exclusion Criteria:

* Patient's or caregiver's inability to learn and use digital technologies
* Conversion of outpatient to inpatient hospitalization on the day of surgery
* Patient's refusal.
Vitamin D Supplementation in Childhood Atopic Dermatitis

The goal of this clinical trial is to investigate the therapeutic role of vitamin D supplementation in a subset of patients with atopic dermatitis (AD): children with disease onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D supplementation in patients with either wintertime onset or exacerbation of AD will improve Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve the Investigator's Global Assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age 2-17 years
* AD rated 10-72 by EASI scale
* Wintertime onset or exacerbation of AD

Exclusion Criteria:

* Active skin infection
* History of summertime onset or exacerbation of AD
* History of underlying illness causing immunosuppression within the past 2 years (eg. hematologic malignancies)
* Medications causing iatrogenic immunosuppression (eg. cyclosporine; azathioprine, oral steroids) taken within the past month
* Parathyroid disease
* Acute or chronic renal disease
* Hypercalcemia or hypocalcemia
* Thyroid disease
* History of osteomalacia or Paget's disease of bone
* History of malabsorption (eg cystic fibrosis)
* Planned trip to sunny climate during the one-month study
The Role of a Clinical Pharmacist in Lifestyle Modification in Type 2 Diabetic Patients With Peripheral Neuropathy

The aims of this study are to determine the prevalence of diabetic peripheral neuropathy among the diabetic patients, to determine the association between the clinical profiles of the diabetic patients (diabetes type, diabetes duration, HbA1c, body mass index, hypertension, total cholesterol) and the diabetic peripheral neuropathy DPN and the rational poly pharmacy used to control pain.


Eligibility Criteria:
Inclusion criteria

1. Aged 18 years or older.
2. Both sex.
3. Diagnosed with type 2 diabetes at least one year previously.
4. Took at least one prescribed medication for diabetes.
5. Diagnosed as diabetic peripheral neuropathy based on clinical

Exclusion Criteria:

1. History of alcohol consumption.
2. Thyroid gland disorder.
3. Any kidney disorder.
4. Any conditions that could confound assessment of pain due to diabetic peripheral neuropathy.
5. Have foot injury or open sore.
6. Pregnant females or who plan to become pregnant during the study period.
7. Any serious medical condition that might prevent completion or hinder compliance with exercise.

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DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise

Patients with wear and tear in their knees (osteoarthritis) are often referred to orthopaedic surgeons following a sudden worsening of pain and mechanical symptoms (grinding, locking, giving way) in their knee due to tears of their meniscal cartilages. These tears are described as degenerative as they are not usually caused by a single injury but rather accumulation of wear and tear. It is not clear from the current available evidence what the best treatment for these patients is. Their underlying arthritis is not bad enough to require joint replacement yet and they were usually managing well with minimal problems from their knee until experiencing the meniscal tear. However, some of their symptoms are likely to be due to the arthritis rather than just the tear. Current treatment for these patients is usually in the form of conservative treatment with physiotherapy and supervised exercise or using arthroscopy (key-hole surgery) to trim the damaged area of the meniscus. We know from previous research that most of these patients will improve over time to some extent but it is not clear whether a greater improvement can be expected following surgery and if so, whether this applies to all patients with this problem or not.

Our study is intended to compare the outcome of patients with proven degenerative meniscal tears imaged on MRI scans, when they are assigned to arthroscopy followed by supervised exercise or supervised exercise alone. They will be randomly assigned and the outcome will be assessed using patient-completed questionnaires (Knee Outcome Osteoarthritis and injury Score \[KOOS\], SF12, visual analogue score for pain) and whether the patients go on to require further surgery during the period of the trial. The patients will be assessed at baseline, at 6 weeks, 6 months, 12 months and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Age over 45 years
* Knee pain in the presence of a medial meniscal tear on MRI.

Exclusion Criteria:

* History of trauma to the knee or ipsilateral lower limb in the past 2 years
* Inability to engage in postoperative rehabilitation
* Lacking capacity to consent
* Evidence of infection
* Previous knee surgery other than arthroscopy (diagnostic or partial meniscectomy) Neurological disease
* Inflammatory arthritis
* Loose bodies
* Ligament injuries causing symptomatic instability
* Women who are pregnant
* Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
* Uncontrolled disease states, such as moderate/severe asthma, COPD or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids, or recurrent infections.
Strength and Function Following Total Hip Arthroplasty

To determine if patients who receive an 8 week, comprehensive, multi-component rehabilitation program (CMC) have better strength and functional performance compared to a control group (CON).

The investigators hypothesize that functional performance and strength in the muscles surrounding the hip and the knee will be greater in the multi-component rehabilitation group compared to the control group.

The participants will be enrolled and following surgery, randomized into one of two treatment groups (CMC or CON). Prior to randomization, both groups will participate in two weeks of home rehabilitation consisting mobility training and activities of daily living. After randomization, the CMC group will receive physical therapy 2x/ week for 8 weeks from a licensed physical therapist and member of the investigative team starting 2 weeks after Total Hip Arthroplasty (THA). The CON group will continue activities provided by their home rehabilitation therapist for 8 weeks. The CON group will then participate in the CMC intervention beginning 10 weeks after THA. These patients will complete pre-operative and post-operative testing as described above.

The CMC group will receive a multi-component program focused on rehabilitation of the abdominal and core musculature, neuromuscular re-education through therapeutic exercise as well as hip and knee muscle strengthening beginning 2 weeks after THA. The CON group will participate in physical therapist recommended activities based on their home rehabilitation and then will complete the same multi-component rehabilitation intervention beginning 10 weeks after THA.

Eligibility Criteria:
Inclusion Criteria:

* receiving a total hip replacement secondary to MD diagnosed end-state osteoarthritis only
* cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study.

Exclusion Criteria:

* HbA1c levels greater than 7% based on medical records
* neurological, vascular or cardiac problems that limit function
* moderate or severe osteoarthritis or other orthopaedic conditions in the non-operated lower extremity
* lower back pain which interferes with activities of daily living
* diagnosed disease which affects muscle function (Parkinson's, Fibromyalgia, Multiple Sclerosis)
* history of vestibular dysfunction
* body mass index greater than 40
* alcoholism or drug abuse
A Study to Examine the Human Papillomavirus Types Exposure in Women From Southern Africa and Brasil

This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana, South Africa and Brasil have been exposed to during their life. The Human Papillomavirus causes cervical cancer. Different types are more likely to lead to cancer than other types. A vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause cervical cancer in America and Europe. What HPV type cause cancer in other countries is not as well studied.

Hypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil (6,11,16,18) will be \<50% in HIV seropositive women in resource limited countries.

Plasma from HIV seropositive women will be taken and sent to MERCK in the USA to evaluate what the antibody titers of HPV 6,11,16 and 18. .

Eligibility Criteria:
Inclusion Criteria:

* HIV seropositive women 18 years of age and older Consent signed per local IRB requirement

Exclusion Criteria:

* Can not give blood
Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use

The purpose of this study is to investigate whether perioperative single-dose administration of ketorolac (Toradol) can reduce post-operative pain after breast surgery, thereby decreasing post-operative opioid use.

The investigators will perform a double blinded, prospective randomized trial of perioperative ketorolac (Toradol) on breast reduction and breast reconstruction procedures. Patients will be randomized into three groups: group 1 will receive a perioperative dose of ketorolac (Toradol, 15mg), group 2 will receive ketorolac (Toradol, 30mg), and group 3 will be the control and receive a placebo of saline. Patients will be asked to complete a diary or log of their average pain and pain medication use to be turned in at a 2 week follow up visit.

The patients, surgeons, anesthesiologist will not know whether the patient received ketorolac (Toradol) intraoperatively. Patients' pain will be assessed using pain scores in the immediate post-operative period, on post-operative day 1, and at their two-week follow up appointment. If patients leave the same day then they will only have two pain score assessments; on day of surgery and at their two-week follow up. Additionally, patients will be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being extreme pain) in morning and evenings using a patient diary for the two week post-op period. The patient's opioid use will be measured by their opioid use during their hospital stay, as well as how many prescription narcotic pills the patient used to manage their pain at home, as documented using the patient diary.

Eligibility Criteria:
Inclusion Criteria:

* Patient consents to study
* Adult females needing breast reconstruction or breast reduction (day surgeries)

Exclusion Criteria:

* Patients with known kidney disease
* Patient does not consent
* patients with history of bleeding disorder, peptic ulcer disease, renal disease, blood thinners use, bariatric surgery and any other contraindications of Toradol use
* patients currently taking aspirin
* pregnant women (not standard to operate on this population anyway)