cyrilzakka/clinical-trials huggingface dataset:
(ACTH) for the Treatment of Sarcoid Uveitis

Sarcoidosis is a multisystem granulomatous disease that can affect nearly any organ in the body. While most commonly affecting the lungs, vision threatening eye involvement occurs in approximately 25% of patients with sarcoid. Eye involvement may lead to a chronic, sight-threatening uveitis which may result in cataract, glaucoma, and macular edema. The treatment of sarcoid uveitis involves the use of topical and systemic corticosteroids or potent immunosuppressive agents (medications that suppress the body's immune system) both of which can cause severe long-term side effects. The adverse effects of steroids may be avoided by treatment with the use as H.P. Acthar® Gel. The effectiveness of H.P. Acthar® Gel in the treatment of sarcoid uveitis and patient quality of live have not been previously examined. These issues, will be explored in this research.

The Investigator seeks to determine the efficacy of H.P. Acthar® Gel (40 units twice weekly injection) of on disease activity and severity in patients with sarcoid uveitis. The retrospective study will evaluate a series of quantitative outcome measures:

The degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 3 weeks, 6 weeks, 12 weeks and 24 weeks.

The degree of aqueous flare as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 4 weeks,12 weeks and 24 weeks.

Best Corrected Visual Acuity at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks.

Central Macular Thickness at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by Optical Coherence Tomography (OCT).

Intraocular pressure at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by applanation tonometry

Quality of life assessment using National Eye Institute Visual Function Questionnaire (VFQ-25)

The Investigator expects to retrospectively review the charts of 10 sarcoid associated uveitis patients treated with Acthar® Gel over a period of 1 year.

Eligibility Criteria:
Inclusion Criteria:

Presence of Sarcoid Uveitis as determined by

* clinical exam
* fluorescence angiography
* optical coherence tomography

Exclusion Criteria:

* Presence of long acting intraocular depots
* Women of childbearing age not using contraceptives
Enhancing Physical Function in the Long-term for Older Adults

The intervention being studied is a 12-week nutrition and physical activity intervention, delivered using videoconference technology by registered dietitian clinicians to maintain weight loss and functional gains in older adults who successfully completed a weight loss intervention. The "Legacy Intervention" will include cognitive behavioral strategies (e.g., goal setting, self-monitoring, and social support), and draw upon a toolbox of e-approaches, including daily and weekly text reminders, virtual exercise classes, virtual individual and group nutrition classes, and step tracking device.


Eligibility Criteria:
Inclusion Criteria:

* Participated in a weight loss intervention in the last 9 months and lost ≥ 3% body weight and improved SPPB score by ≥ 1 point or 6MWT by ≥ 50 meters
* Age ≥ 60
* Able to speak and understand spoken and written English.
* Able to record dietary intake and weight

Exclusion Criteria:

* Presence of unstable or symptomatic life-threatening illness
* Neurological conditions causing functional impairment, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke
* Inability to complete physical function assessment
* No access to internet connection to participate in the tele-intervention
* Unable or unwilling to use provided tablet to participant in tele-intervention
* History of cognitive impairment
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada

This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).

Data will be collected via web-based data capture by HCPs submitting surveys. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.

Eligibility Criteria:
Inclusion Criteria:

* HCPs have prescribed Fibristal for the indication of uterine fibroids within the past 6 months.
* HCPs have provided permission to share their responses in aggregate to Health Canada.

Exclusion Criteria:

* HCPs who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.
* HCPs who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past 5 years.
Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at the time of implantation
* Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
* Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
* CNC word recognition score less than or equal to 60% in the ear to be implanted
* CNC word recognition score less than or equal to 60% in the contralateral ear
* English spoken as the primary language

Exclusion Criteria:

* Conductive, retrocochlear, or central auditory disorder
* Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
* Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
* Developmental delays or organic brain dysfunction
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
* Unwillingness or inability of the candidate to comply with all investigational requirements
Comparative Effectiveness of Myofacial Release vs Cupping Therapy on Quality of Life in Restless Leg Syndrome With Knee O.A.

The aim of this study is to determine effectiveness of Myofascial Release and Cupping Therapy on Quality of Life in Restless Leg Syndrome with knee Osteoarthritis. Holding this aim, a Randomized control trial will be conducted at physiotherapy out patient department of Dow Institute of Physical Medicine and Rehabilitation.

The subjects will first be screened by the principal investigator, physiotherapist, using the criteria of International Restless Leg Syndrome Study Group (IRLSSG). Each selected subject will go for random allocation in one of the two treatment groups with different interventions with the help of a computer-generated randomization sheet. The group A will be provided with myofacial release whereas the group B will receive cupping therapy while cryotherapy and passive lower limb stretches (hamstring and calf muscles) will be applied to both the groups as standard treatment. Assessment will be done at baseline and will re-evaluate at the post intervention session through an assessment form. Physical therapist but not the principal investigator will assess who will be unaware to the type of intervention administered.

Outcome measures will be Pittsburgh sleep quality index, Visual Analog Scale for pain assessment, Restless leg syndrome Quality of life questionnaire (RLS-QOL), International Restless leg syndrome Study Group Rating Scale (IRLSSG RS) and passive straight leg raise (PSLR). Total 12 sessions will be given for duration of 4weeks on alternate days.


Eligibility Criteria:
Inclusion Criteria:

1. grade 2, 3 and 4 knee OA by the Kellgren Lawrence classification
2. Bilateral or unilateral both knee OA
3. Age 40 to 70 years
4. Patients who were meeting the International Restless Leg Syndrome Study Group (IRLSSG) eligibility criteria

Exclusion Criteria:

1. patients with cognitive dysfunction
2. Rheumatoid arthritis
3. patients with neurological disorders
4. Medical conditions covering (cardiovascular disease, neurological disorders, severe psychiatric illness or pregnancy)
A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial Asthma

The purpose of this study is to investigate/assess the treatment of moderate to severe asthmatics with inhaled corticosteroid.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female moderate to severe asthmatic patients, from 18-75 years of age.
* Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months.
* No concomitant lung disease or significant medical conditions
* Fluticasone propionate 500mcg daily or greater, or equivalent (Mometsaone 800 mcg, triamcinolone 2000 mcg, Flunisolide 2000 mcg, Budesonide DPI 800 mcg, Beclomathasone HFA 500 mcg, Beclomethasone CFC 1000 mcg, Forced expiratory volume in 1 second (FEV1) at screening will be ≥ 70% of the normal predicted.
* Evidence of asthma, demonstrated by one of the following: Historical evidence confirmed by their treating physician or Demonstration of ≥ 12% reversibility of FEV1 using a standard dose of salbutamol (up to 400 µg) within 30 minutes.
* Female subjects of child bearing potential must be using two forms of contraception or postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion.
* Body Mass Index between 18 and 30. Body weight should be less than 100 kg.

Exclusion Criteria:

* Smokers
* Concomitant medications: Except for short- and long-acting β-agonists and medication which may be required to treat adverse events, all other medications, other than study drug should be avoided from screening until all of the study completion evaluations have been conducted. Paracetamol is acceptable.
* Medical conditions: history of clinically significant drug allergy; any significant medical condition. For example, a history of any pulmonary disorder other than asthma.
* Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of the drug.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation.
* Significant illness within the two weeks prior to dosing.
* A past personal or close family medical history of clinically significant cardiac abnormalities
* History of history of fainting, orthostatic hypotension, sinus arrhythmia, etc.
* A known hypersensitivity to Fluticasone propionate or drugs similar to Fluticasone propionate.
* History of immunocompromise, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within the 12 months prior to dosing

Other protocol-defined inclusion/exclusion criteria may apply
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

This study is a Phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with RVVC. The primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of VVC in subjects with RVVC based on Clinical Success. Approximately 320 subjects are planned to be enrolled into the study. All subjects will receive treatment with oral fluconazole for their acute episode present at screening. Subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo.

Subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label Sub-Study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of symptomatic VVC with microscopic examination with KOH positive for yeast and normal vaginal pH.
* History of 3 or more episodes of VVC in the past 12 months.
* Culture confirmation and resolution of the signs and symptoms of the initial VVC episode (with treatment).
* Able to take oral tablets and capsules.

Key exclusion Criteria:

* Vaginal conditions other than recurrent VVC that may interfere with the diagnosis or evaluation of response to therapy.
* Recent use of systemic and/or topical vaginal antifungal products.
* Pregnant.
* History of major system organ disease.
Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

Type I laryngeal cleft evaluation and treatment in the pediatric population is an emerging science. The largest published series of pediatric patients with type I laryngeal clefts shows conflicting evidence in terms of outcomes, resolution of dysphagia and method of treatment. A comparison of quality of life outcomes before and after injection laryngoplasty has not been carried out. The investigators hypothesize that injection laryngoplasty significantly improves symptoms and quality of life related to dysphagia in a pediatric population with laryngeal clefts.

Dysphagia with aspiration is a common disorder in the pediatric population. Aspiration with feeds is diagnosed on modified barium swallow studies and patients are referred to the pediatric otolaryngologist to assess the airway for a possible laryngeal cleft. Type I laryngeal cleft can lead to dysphagia and aspiration in young children. However, diagnosis of type I laryngeal cleft can be difficult and subjective at microlaryngoscopy in the operating room. Type I laryngeal cleft evaluation and treatment in the pediatric population is an emerging science. The largest published series of pediatric patients with type I laryngeal clefts shows conflicting evidence in terms of outcomes, resolution of dysphagia and method of treatment. It is generally recommended to do an injection laryngoplasty at the time of airway evaluation as a diagnostic and therapeutic measure. Improvement in symptoms supports the diagnosis and can serve as either definitive treatment with repeated injections or as a preemptive treatment in preparation for surgical repair. A comparison of quality of life outcomes before and after injection laryngoplasty has not been carried out. Thus, the aim of this study is to determine if injection laryngoplasty improves symptoms and quality of life related to dysphagia in a pediatric population with laryngeal clefts.

Eligibility Criteria:
Inclusion Criteria:

* chief complaint of dysphagia and/or aspiration detected on a clinical swallow assessment and/or modified barium swallow study
* able to withstand general anesthesia and direct microlaryngoscopy in the operating room

Exclusion Criteria:

* inability or parent refusal to undergo procedure under general anesthesia in the operating room
Motivational Interviewing for Nurses' Smoking Cessation

This study's objective was to test the efficacy, acceptability and feasibility of a motivational interviewing (MI) based smoking cessation intervention with nurses.

Despite the important role that health professionals have in reducing tobacco use, many have a smoking habit themselves. The prevalence of smoking is particularly high among nurses. A smoking cessation intervention for nurses who smoked, based on MI, was designed and evaluated following the UK Medical Research Council's (MRC) framework for complex interventions.

Eligibility Criteria:
Inclusion Criteria:

* Nurses who were smokers
* Nurses willing to participate in the study

Exclusion Criteria:

* Nurses who were pregnant
Dinutuximab Beta at the HUS and the Toulouse Oncopole

In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 2 years to 25 years
* Male or female gender
* Subjects suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023.
* Subject (and/or holders of parental authority) not opposing, after information, the reuse of the child's data for the purposes of this research and agreeing to respond to the quality of life survey.

Exclusion Criteria:

* Patient or parents of the minor having expressed their opposition to participating in the study.
* specific clinical forms of the disease,
* interfering treatments and associated diseases.
A Randomized Controlled Trial of a Nurse Delivered Stage-matched Smoking Cessation Intervention to Promote Heart Health of Cardiac Patients

This study is a randomized controlled trial designed to evaluate the effectiveness of a nurse delivered stage-matched intervention to cardiac patients for cessation of tobacco use. Review of literature shows that there is a clear lack of empirical evidence on (1) using nurses to deliver stage-matched smoking cessation interventions, and (2) the effectiveness of such intervention for cardiac patients in Chinese populations. The ultimate goal of the intervention achieve a higher quit rate in the intervention group than in the controls. In addition, the change in the patient's smoking behaviour such as reduction of the number of cigarettes smoked, and progression to a higher stage of readiness to quit, will also be measured. This study is the first step to address the urgently needed data for (1) promoting the delivery of nurse-run stage-matched smoking cessation interventions to help patients stop smoking, (2) developing smoking cessation policy and programmes in the hospitals and for the health care system, and (3) contributing an evidence-based approach to orientate clinical services towards prevention, so as to reduce premature deaths and the enormous disease burden of our society.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is admitted to the participating centres and is a current smoker who has smoked daily in the past 7 days prior to hospitalization.
* Patient speaks and reads Cantonese/Chinese

Exclusion Criteria:

* Patient who is clinically too ill and not suitable to complete questionnaire and/or receive intervention.
* Patient who does not speak or read Chinese
ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment during cesarean section

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment during cesarean section

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Bingocize: A Novel Mobile Application for Older Adult Health

This study tests the effectiveness of using a new mobile application (Bingocize®) to improve older adults' (a) adherence to an engaging exercise program, and (b) aspects of functional performance, health knowledge, dietary habits, and cognition.

Health-promoting interventions designed to improve physical and mental fitness can help reduce health care costs; they can also help maintain, or even improve, older adults' quality of life. However, getting older adults to adhere to health-promoting exercise interventions remains difficult because such programs are often perceived as being time-consuming, painful, or unenjoyable. The present study's objective is to investigate the effectiveness of a novel technological exercise intervention program for older adults (Bingocize); in doing so, the program has the potential to improve older adults' independence and quality of life. Older adults will participate in a pre/post-intervention design with random assignment to either the experimental or one of three comparison/control groups; each group will play Bingocize in a social setting with other older adults. Participants in the experimental group will use the app to engage in twice-weekly Bingocize sessions for twelve weeks (i.e., Bingo+Exercise+Health Education); control groups will also use the app for twelve weeks but for either health education-only, exercise-only, or bingo-only.

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected normal vision
* Mobility (i.e., not wheelchair bound)
* English is native language
* Minimum physical standards (e.g., ability to walk at least 10 meters)
* No structured physical activity programs \>150 minutes/week in last 6 months

Exclusion Criteria:

* Severe neurological impairments (e.g., Parkinson's)
* Colorblindness
* Dementia