cyrilzakka/clinical-trials huggingface dataset:
BMN 110 US Expanded Access Program

The Expanded Access Program (EAP) is an open-label, multicenter program to:

1. Provide patients who have been diagnosed with Mucopolysaccharidosis IVA (MPS IVA) access to BMN 110 until commercial product is available
2. Collect additional information on the safety and tolerability of BMN 110 administration in patients with MPS IVA

Patients enrolled in the EAP will receive 2.0 mg/kg intravenous infusions of BMN 110 every week during the program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MPS IVA as confirmed by either N-acetylgalactosamine-6-sulfatase (GALNS) enzymatic test (GALNS activity in affected range, beta-galactosidase and a second lysosomal sulfatase activity within normal range) or molecular diagnostic test (two mutations in GALNS identified that have previously been associated with an enzyme defect).
* Willing and able to provide written, signed informed consent, or in the case of patients under the age of 18, provide written assent (as required by the IRB) and written informed consent by a legally authorized representative after the nature of the program has been explained, and prior to any program assessments or evaluations.
* Sexually active patients must be willing to use an acceptable method of contraception while participating in the program.
* Females of childbearing potential must have a negative pregnancy test at Baseline and be willing to have additional pregnancy tests during the program.
* Willing and able to comply with all program procedures.

Exclusion Criteria:

* Pregnant or breastfeeding at Baseline or planning to become pregnant (self or partner) at any time during the program. Patients who become pregnant during the program will be discontinued from the program.
* Currently enrolled in an ongoing clinical study of BMN 110.
* Discontinued from a BMN 110 clinical study secondary to a safety-related event.
* Use of any investigational product (other than BMN 110 in a clinical study) or investigational medical device within 30 days prior to Baseline, or requirement for any investigational agent prior to completion of all scheduled program assessments.
* Not a current US resident or expecting to have travel plans outside the US during the planned period of participation in the Expanded Access Program (EAP) that may interfere with dosing regimen, scheduled program visits and safety monitoring.
* Any condition that, in the view of the Investigator or sponsor, places the patient at high risk of poor treatment compliance or of not completing the EAP.
Study for Breathing Interventions in Congestive Heart Failure

Slow breathing may reduce stress. Adults with congestive heart failure have higher stress than the general population. This study will examine if using slow breathing is feasible among adults with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Documented heart failure from medical chart review with signs and symptoms consistent with disease
* Reduced left ventricular function with ejection fraction of less than or equal to 40%
* English speaking

Exclusion Criteria:

* New York Heart Failure Association Class I or IV
* Myocardial infarction in the last 3 months
* Cardiac surgery in the last 3 months
* Significant valvular heart disease
* Uncontrolled cardiac arrhythmias
* Uncontrolled diabetes mellitus (hemoglobin a1c ≥ 8)
* Uncontrolled hypertension
* Systolic greater than 140 mmHg
* Diastolic greater than or 90 mmHg
* Cognitive impairment (Mini-mental state exam less than or equal to 24)
* Acute major depression in the last 3 months
* Other psychiatric conditions including schizophrenia or bipolar disorder
* Attention-deficit-disorder or attention-deficit-hyperactivity disorder
* Musculoskeletal condition limiting capacity to perform simple movements such as significant chronic lower back pain or neck pain
* Unstable or severe chronic lung conditions
* Current participation in a mind-body practice/program
* Current cancer other than non-melanoma skin cancer
* Regular swimmer
* Plays wind or brass musical instruments
Evaluating a Virtual Stepped Care Portal in Youth Awaiting Tertiary Chronic Pain Care: An Implementation-Effectiveness Hybrid Type III Study

Pain is one of the most common symptoms of extreme stress in youth. Without treatment, short-term pain can last for months to years (called 'chronic pain'; CP), a problem already affecting 1 in 5 Canadian youth. The COVID-19 pandemic is one of the greatest threats to youth mental health seen in generations. CP in childhood can trigger a wave of mental health issues that last well into adulthood. In 2019, we learned that "access to pain care" is poor and a priority for youth with CP and their families. Unfortunately, COVID-19 has only made access more difficult. In 2020, we created an online "stepped care" program called the Power over Pain Portal for youth with CP. Stepped care is a promising way to improve access to CP care by tailoring care based on the symptoms each youth is experiencing. Like a ladder, youth start with one type of care and then "step up" or "step down" to more or less intense care depending on what they need. Over the past year, funded by CIHR, we worked with hundreds of youth and healthcare professionals across Canada to understand how the pandemic has affected pain and mental health. We also summarized all online pain self-management programs including peer support for youth to find the best resources to include in the Portal and will translate the portal content into French. Together with a diverse group of youth with CP, we have now co-designed the online Portal. The next step (focus of this grant) is to test the Portal with youth to ensure it can be implemented and is helpful. We will recruit 93 youth with CP waiting for specialist care at 11 CP clinics across Canada to use the Portal for 4 months. We will see how they use the Portal and if it helps to improve their pain and mental health. This study is important because it will allow us to understand how the Portal works in the real world before wide public release (English and French) to support all youth in Canada with CP with accessible, evidence-based pain care.


Eligibility Criteria:
Inclusion Criteria:

* Experience chronic pain
* Speak and read English or French
* Have access to internet / smartphone (or are willing to be loaned a study phone with a data plan)
* Are on the waitlist of a tertiary care CP clinic in Canada
* Intend to use the PoP Portal for at least 4 months
* Have the capacity to consent

Exclusion Criteria:

* Have moderate to severe cognitive impairments that may impact their ability to understand and use the PoP Portal or complete self-reported clinical outcome measures
* Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality as assessed by the PoP Portal screening. Youth who have co-occurring clinically significant anxiety or depression that is currently being treated will be eligible if they meet other inclusion criteria.
Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in COVID-19 Patients

The goal of this observational study is to learn about the function of lung and diaphragm ultrasound during weaning from mechanical ventilation in COVID-19 patients. The aim of this study was that the lung ultrasound score and diaphragm muscle mobility could be a potential predictive factor of weaning success.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years,
* critically ill patients with COVID-19 (defined as those requiring mechanical ventilation due to respiratory failure), and eligible for their first SBT according to the attending physician's judgement that the underlying disease which led to intubation had sufficiently resolved.

Exclusion Criteria:

* patients with previous cardiothoracic surgery or pleurodesis and patients who presented with stridor (due to upper airway involvement) as a cause of extubation failure
* neuromuscular disease
Distal Radius Buckle Fracture RCT

This study evaluates the influence of cost information on decision-making for immobilization for treatment of distal radial buckle fractures. Half of the participants will receive cost information from an orthopaedic surgeon prior to making their decision for treatment, while the other half will receive cost information from another member of the study team after they had made their decision treatment.

Research has shown equipoise in treatment outcomes after casting and splinting for pediatric buckle fractures. Despite the similarly favorable treatment outcomes associated with both casting and splinting these fractures, there is wide disparities in cost between the two types of immobilization. However, cost information is not routinely presented to families during the discussion of immobilization types.

The primary objective of this study is to determine if cost information influences family decision-making about immobilization type after pediatric buckle fractures. A secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 4 to 14 years with a buckle fracture for which they will be treated with a cast or a splint.
* Parental/guardian permission (informed consent) and, if appropriate, child assent.
* Parent of a child ages 4 to 14 years with a buckle fracture that requires treatment with either a cast or a splint.
* Parental/guardian permission (informed consent).

Exclusion Criteria:

* Non-English speaking subjects.
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Tonation Breathing Technique Method to Ease Aromatase Inhibitor-induced Joint and/or Muscle Pain

This clinical trial evaluates how well tonation breathing techniques (use of a breathing and tonation \[creating sounds\]) works to ease pain joint and/or muscle pain in patients with stage I-III breast cancer and currently take an aromatase inhibitor. Tonation breathing techniques may help relieve pain in patients with stage I-III breast cancer who are receiving aromatase inhibitor.

PRIMARY OBJECTIVE:

I. To study impact of active participation of patients in producing tones in combination with breathing technique, i.e., tonation breathing techniques (TBT) to reduce aromatase inhibitor induced musculoskeletal symptoms.

OUTLINE:

Patients participate in tonation breathing techniques twice daily (or more if pain occurs) for 2 weeks. Patients also complete questionnaire at baseline and at 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Females with stage I-III breast cancer taking adjuvant aromatase inhibitor (AI) (either standard dose of anastrozole 1 mg daily or letrozole 2.5 mg daily or exemestane 25 mg daily) for greater than 30 days experiencing AI induced musculoskeletal pain scores of 5 or higher on a Likert scale will be enrolled
* Subjects should have completed any planned surgery for breast cancer, chemotherapy and radiation therapy at least 30 days prior to enrollment
* Patients should have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
* Patients should be at least 18 years old with no maximum age limit

Exclusion Criteria:

* Patients should not have significant underlying pulmonary disease
Emotional Intelligence and Relaxation Techniques for Mental Health and Sleep in Older Adults

This topic highlights the role of emotional intelligence and relaxation techniques in enhancing mental health for adults over 60. Emotional intelligence, which involves understanding and managing one's emotions, can improve emotional well-being in older adults facing challenges like loneliness and anxiety. Sleep disorders are common in this age group and can lead to increased mental health issues such as depression. Relaxation techniques, including meditation, yoga, and deep breathing, have been shown to reduce stress and improve sleep quality. By integrating emotional intelligence and relaxation practices into daily life, older adults can enhance their overall quality of life and mental health.


Eligibility Criteria:
Inclusion Criteria:

* People aged 60 years or older.
* Older adults with mental health problems, such as anxiety, stress, or mild depressive symptoms.
* Participants who report difficulty falling or staying asleep, or who have some type of sleep disorder (such as insomnia or fragmented sleep).
* People willing to participate in emotional intelligence interventions and relaxation techniques.
* Older adults who live in a stable environment (private housing, community centers, etc.) and who have sufficient cognitive abilities to understand and follow basic instructions for relaxation techniques.

Exclusion Criteria:

* People under 60 years of age.
* Older adults with serious psychiatric disorders, such as advanced dementia, schizophrenia, or uncontrolled bipolar disorder, that could interfere with effective participation in the interventions.
* Participants with serious physical health problems, such as unstable heart disease or advanced respiratory failure, that could be worsened by relaxation techniques or limit their participation.
* People who are already receiving specific treatment for sleep disorders that includes medication or intensive psychotherapeutic interventions, since these could interfere with the results of the study.
* Older adults with severe sensory limitations (such as deafness or uncorrected blindness) that prevent them from understanding or adequately performing the proposed relaxation techniques.
Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World

DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use. This study will record post market clinical data on the use of a number of MDR-CE marked devices that are part of the Chattanooga Intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy (Stim), Intelect® Transport 2 Combo and Intelect® Transport 2 Ultrasound).

This clinical investigation is a post-market, real word, international, multi center, prospective, observational study to confirm the safety and performance of the Chattanooga Intelect® when used in accordance with their approved intended use, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with musculoskeletal and skeletal muscle deficit disorders assigned to be treated with any of the Intelect® devices according to the current clinical practice at the selected sites and based on the opinion of the Investigator.
2. Patient male or female with age ≥18 years old.
3. Patient able to provide written informed consent. For France only: To be affiliated to the social security system or to be beneficiary of such system

Exclusion Criteria:

1. Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment.
2. Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.
Patient-Specific Techniques for Hip Replacement

Background

* In the 19th century, Sir John Charnley successfully introduced total joint replacements for hips. In order to prevent implant fixation failure and accelerated polyethylene wear, it was initially recommended that implants were systematically positioned in a "biomechanically-friendly" way, which disregarded most of the individual anatomy (medialized acetabular cup, systematized cup version and inclination, etc.)
* While those initial surgical techniques made popular and clinically successful total joint replacements, many complications (aseptic loosening, pain, excessive wear) have remained and mainly the persistence of frequent instability after THA. In response to those complications, many improvements were developed in the area of joint replacement over the last few decades, with one the most recent dating from 2017 and being the development of a surgical technique Rationale
* The kinematic alignment (KA) technique for total hip arthroplasty (THA) aims at restoring the acetabular center of rotation and as much as possible the constitutional acetabular anteversion by using the transverse acetabular ligament (TAL) as a reference landmark. Also, the technique aims (1) at making personalized choice for the hip component design, (2) at defining the cup positioning, and (3) at sometimes considering additional spine surgery based on the assessment of the individual spine-hip relation.
* KA techniques for hip replacements are relatively new, likely to become popular over time, and their true value remains to be determined.

* Objective: Evaluation of the kinematic alignment technique for hip prostheses in patient with hip osteoarthritis
* Hypothesis: the consideration of hip pathoanatomy and lumbo-pelvic kinematic disorder when planning a hip replacement is likely to decrease the risk of prosthetic dislocation and improve patient function and satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritic hip patients eligible for primary total hip arthroplasty (THR).
* \> 18 years-old with no upper age limit
* Affiliated to a social security scheme

Exclusion Criteria:

* Pregnant or lactating women or in age to procreate without contraceptive treatment
* History of mental illness or neurological deficit or adults lacking capacity to consent for themselves
* Prisoners or young offenders
* Persons who might not adequately understand verbal explanations or written information given in French, or who have special communication needs
* Subjects having been or being frequently x-ray examination
* Heart failure with risk of exercise angina or comorbidity(ies) significantly affecting patient function
* Any participants who are involved in current research or have recently been involved in any research prior to recruitment.
Home Exercise and Resiliency Training (Heart) Club

The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.

This study will require two in-person visits to the exercise physiology lab as well as virtual follow-up visits. Visit one will require participants to complete a cardiopulmonary exercise test (CPET), liver ultrasound, 6-minute walk, grip strength test, arm circumference measure, body composition analysis, anthropometrics measurement, surveys and a biomarker blood sample collection. The second in-person visit will require participants to complete a final cardiopulmonary exercise test, liver ultrasound, 6-minute walk, grip strength test and arm circumference, biomarker blood sample and final survey.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with Fontan physiology
* 19 years old at age of enrollment

Exclusion Criteria:

* Height less than 130 centimeter (cm)
* Pregnancy or the plan to become pregnant during the study period
* Current intravenous inotropic drugs
* Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment
* Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment
* History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms)
* Inability to complete exercise testing at baseline screening
* Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results
Educational Program on Self-Management for Women with Post-Mastectomy Lymphedema

Post mastectomy lymphedema is a chronic disease that negatively affect physical, social, psychological and emotional well-being, so Patient education regarding self-management is crucial to enhance women's self -care and quality of life.

Improvement in screening and treatment modalities of breast cancer has translated into higher survival rates in these patients. Unfortunately, this gain in survival leading to high prevalence of serious consequences of cancer treatments. Among these, post mastectomy lymphedema. It was estimated that 10 million women had breast cancer- related lymphedema (BCRL) worldwide, with 3-5 million affected in the United States. Approximately one in five women undergoing breast cancer surgery at risk for developing lymphedema .

Post-mastectomy lymphedema is a chronic and progressive tissue swelling caused by the abnormal buildup of protein-rich fluids in the interstitial space due to disrupted lymphatic drainage. This swelling results in physical symptoms such as heaviness, pain, decreased flexibility or tightness, stiffness, fatigue and numbness in the affected extremity. Its long-term burden extends beyond these physical symptoms, to significantly impact social, psychological, emotional functioning .also pose financial burdens to patients, the healthcare system, and society which lead to poor quality of life .

Lymphedema self-management constitutes the standard lymphedema treatment that should be maintained throughout life. In this context, the nurse's role becomes magnified. Self-management is the ability of individual to manage one's own chronic condition, encompassing the management of symptoms

, physical and psychosocial impacts, treatment, and incorporating these management practices into daily activities to attain optimal quality of life.

Nurses contribute significantly in management of post mastectomy lymphedema through educating the patients about lymphedema self-care behaviors which are important to control lymphedema symptoms, decrease lymphedema stages and prevent further progression of the disease. Lymphedema self-care involves maintaining risk-reduction behaviors, exercising, weight control, good nutrition, healthy lifestyle behaviors, caring and proper fit of compression garments, self-lymph drainage, skin care, signs and symptoms, preventing and managing infections.

Eligibility Criteria:
Inclusion Criteria:

* women diagnosed with post-mastectomy lymphedema,free from other disabling conditions impeding self-care practices, No prior participation in lymphedema-related educational programs, and provided an agreement for participation in the study

Exclusion Criteria:

* Women with mental problems
* Unable to communicate with health team
Parental Coping With Challenging Behavior in Mucopolysaccharidosis Type I-III

The study quantitates behavioral challenges in mucopolysaccharidosis type I-III and parental coping strategies

This is a prospective, cross-sectional, observational study quantitatively assessing

1. challenging behavior in children with MPS, an orphan, progressive, neurodegenerative metabolic disorder, and
2. parental coping strategies for this challenging behavior.

Patients registered at the German Society for Mucopolysacchardoses giving written informed consent are eligible. The study is based on questionnaires. IRB approval was obtained.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mucopolysaccharidosis type I, II or III
* Written informed consent
* Patient is registered at the German Society for Mucopolysaccharidosis

Exclusion Criteria:

* Patient / Family does not give written informed consent.