cyrilzakka/clinical-trials huggingface dataset:
Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases

Paediatric rheumatisms represent a large group of inflammatory and non-inflammatory diseases of the locomotion system. The annual rate incidence of children diagnosed with rheumatic disease in Switzerland (canton of Vaud) is 56.8 for 100'000 children. These children experience a chronic course of the disease impacting on their quality of life and family functioning. Their medical treatment is significant and may last for life. Caring for these children involves a multidisciplinary approach. Control of the disease and management of the symptoms becomes of foremost importance to minimise disability and pain. In addition to medical care, the supporting role of nurses in the care of children with rheumatic diseases and their family aims to limit the potential for further deformity, disability, and psychological complications. In particular, they play a key role in supporting the specialist team caring for patients with rheumatism disease, recognising poor disease control and the need for changes in treatment, providing a resource to patients on treatment options and how to access additional support and advice, and identifying best practice to achieve optimal outcomes for the patients and their family. Nurses also ensure the link between medical practitioner, other health providers, and family, thus play a key role in the follow-up care of the child and its family. Follow-up of children and their family can be ensured by regular telephone consultation (telenursing) made by experienced nurse specialists in rheumatology. However, the effectiveness of telenursing remains to be proven in children with chronic rheumatic diseases. The aim of this study is, therefore, to evaluate the effect of a telephone nursing intervention on the outcomes of family and children with rheumatism chronic disease.

This randomised crossover, experimental longitudinal study will be carried out in the outpatient clinic of paediatric rheumatology of a tertiary referral hospital in canton of Vaud. The population will consist of children newly diagnosed with inflammatory rheumatologic diseases and one of their parent. The nurse-led intervention will consist of providing a monthly telephone call by a qualified and experienced nurse specialist in paediatric rheumatology and TN to ensure follow-up of the children and their family. The intervention will focus on providing affective support, health information, and aid to making decision.


Eligibility Criteria:
Inclusion Criteria:

* Children under the age of 17 years at the time of enrolment into the study
* Newly diagnosed (within 24 months from the enrolment date) with inflammatory rheumatologic diseases
* Registered as outpatient in the clinic of paediatric rheumatology
* A parent (the mother or the father or the guardian) on behalf of their children.

Exclusion Criteria:

* Children and parents who do not understand and speak French
* No access to a telephone line.
Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients

Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood.

The goal of this multi-phase study is to co-develop (with patients), test, and implement a smartphone app called "Digital Solution for Pain in Adolescents" (Digital SPA) which can provide pain management resources to children with chronic pain and their parents, preventing future disability.

Participants will: participate in individual and group interviews, respond to questionnaires online and try a smartphone app (adolescents) or a website (parents).

Phase 1) Focus groups with patients, parents and clinicians (n = 5-6 each) will inform about unmet pain care needs, and provide a starting point for co-designing the intervention.

Phase 2) Content creation and usability testing will be based on the results of Phase 1 and the theory-driven development will follow the latest available evidence and the World Health Organization guidelines on the management of chronic pain in children. The intervention will use validated psychological techniques (particularly Cognitive Behavioral Therapy and Acceptance and Commitment Therapy) focused on improving functioning by teaching pain coping skills, such as: relaxation, goal setting, sleep management, behavioral activation, self-management of negative thoughts and emotions, and communication skills.

Phase 3) Effectiveness and Implementation study. Participants (n = 195) will be adolescents 12-17 years old with chronic pain admitted into any of 6 large hospitals in Spain and one of their parents.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents age 12-17 years
* Has had non-oncologic chronic pain for at least 3 months (e.g., abdominal pain, headache or musculoskeletal pain)
* Has Internet access
* One parent is willing to participate (and both give consent for their child to participate)

Exclusion Criteria:

* Diagnosis of a comorbid serious health condition (e.g., cancer)
* Parent or child does not speak or read Spanish
* Active psychosis or suicidal ideation
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

The purpose of this study is to compare progression free survival for SU011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or metastatic breast cancer
* Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
* Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
* Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease

Exclusion Criteria:

* More than two chemotherapy regimens for advanced disease
* Uncontrolled/symptomatic spread of cancer to the brain
Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.

Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing non-craniocerebral surgery under elective general anesthesia
* Age ≥65 years old
* American society of Aneshesiologists Grade I to III
* Sign informed consent

Exclusion Criteria:

* Patients who are expected to retain tracheal intubation after surgery
* Disturbance of consciousness, mental disorder, inability to cooperate
* Expected survival \< 3 months
* The estimated operation time is \< 2 hours
* The expected postoperative hospital stay is \< 5 days
Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis.

This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy \& intensity of intraoperative \& postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patient (ASA I or II).
* Mandibular Posterior teeth with:

Preoperative sharp pain, Absence or slight widening in the periodontal ligament (PDL), Vital response of pulp tissue to cold pulp test.

* patients who agree to provide written consent and the patients able to understand the pain scale and attend for recall appointments

Exclusion Criteria:

1. Patients allergic to anesthetic solutions \& other NSAIDs.
2. Pregnant or nursing females.
3. Patients having significant systemic disorder (ASA III or IV).
4. Gastrointestinal disorders.
5. If the initial diagnosis revealed pain in more than one tooth.
6. Hemostatic disorders or anti-coagulant therapy during the last month.
7. Consumption of opioid or non-opioid analgesics or NSAIDs during the last 12 hours before treatment.
8. Teeth that have:

   i. Periodontal involvement (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility).

   ii. No possible restorability. iii.Signs of pulpal necrosis; associated sinus tract or swelling.

   -
Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

Magnetic endoscopic imaging (scopeguide) is known to be helpful for colonoscope insertion, especially beginner endoscopist. In this trial, study was designed to show the efficacy and safety pertinent to scopeguide use in detail.

Colorectal cancer is one of the most commonly diagnosed malignancies worldwide. Colorectal cancer screening significantly reduced the incidence and mortality, and colonoscopy is generally recognized as a standard method. Among them, magnetic endoscopic imaging (MEI, Scopeguide, Magnetic Enhanced Instrument, Olympus, Japan) is a non-radiological imaging instrument that can display the three-dimensional configuration and position of the colonoscope in the abdominal cavity in real time. This study aims to investigate the effectiveness of colonoscopy by measuring the insertion-related index of the colonoscopy according to the scope guide for only beginners of endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* age 19-80
* the patient who visit to examine the colonoscopy

Exclusion Criteria:

* the patient who has a pacemaker
* the patient who has electronic devices in the body
* bowel obstruction and bleeding
* glomerulus filter rate \< 30
* inflammatory bowel disease, pregnancy
* previous history of bowel resection and abdominal surgery
* who refuse to write the informed consent
* previous history of allergic reaction to sedative drugs and beans, egg
* SBP \<80, SpO2\<90
Regional Analgesia at the Pediatric Emergency Department

Approximately two years ago, ultrasound-guided regional blocks technique was introduced into routine use in the pediatric emergency department at Hillel Yaffe Medical Center. Since then, nearly 300 different blocks have been performed.

Study Objective: To collect a registry database of complication rates associated with regional analgesia during routine pediatric emergency department care between 2023 and 2025.

Adequate pain management is a key component of pediatric emergency care. The use of regional analgesia, particularly ultrasound-guided regional blocks, has gained momentum in recent years as part of pain management, reducing the need for opioids and serving as a safe and effective alternative to procedural sedation.

For anesthesiologists, this is now a routine tool mainly performed in the operating room. In adult emergency medicine, this tool has also been integrated and is sometimes performed by emergency physicians.

In children, performing ultrasound-guided regional blocks presents additional challenges compared to adults. The primary challenge in an unsedated child is maintaining cooperation throughout the procedure. Other difficulties include limited maneuverability due to their smaller size, reduced allowable volume of local anesthetics (based on weight), and more. For these reasons, most ultrasound-guided regional blocks in children are performed in the operationg room after sedation or general anesthesia. There are only a few case reports describing the use of simple ultrasound-guided regional blocks performed by emergency physicians in pediatric ED settings.

Approximately two years ago, this technique was introduced into routine use in the pediatric emergency department at Hillel Yaffe Medical Center. Since then, nearly 300 different blocks have been performed.

Study Objective: To collect a registry database of complication rates associated with regional analgesia during routine pediatric emergency department care between 2023 and 2025.

Eligibility Criteria:
Inclusion Criteria:

* Children who visited the pediatric emergency department between 2023-2025 and underwent a nerve block during their visit.

Exclusion Criteria:

* Children who visited the emergency department but had the nerve block performed outside the emargency department setting (e.g., inpatient wards or operationg room), or if the block was performed by a physician not affiliated with the pediatric emergency department.
A Study to Evaluate Safety of ASC40 Tablets in Patients with Moderate to Severe Acne Vulgaris

This is a multicenter, open-label study designed to determine the long-term safety of ASC40 (Denifanstat) tablets in patients with moderate to severe acne vulgaris enrolled in the ASC40-303 Phase III study. All subjects are eligible for study eligibility screening after enrollment in ASC40-303 Phase III study, and all eligible subjects with moderate to severe acne vulgaris will receive ASC40 (Denifanstat) tablets after signing informed consent. The investigational drug will be administered orally once daily (QD) for up to 40 weeks. There will be a total of 7 visits for screening and follow-up. The tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have successfully completed a 12-week Phase III study of ASC40-303;
* Have fully understood this research and voluntarily signed the informed consent;
* The fertile male and female subjects of reproductive age agreed to use effective contraception from the time they signed the informed consent until 3 months after the final administration of the investigationa drug;
* Subjects are willing and able to complete the study, understand and comply with the study requirements, comply with the study requirements restrictions and related education, use the investigational drug as prescribed by the physician, and follow up according to the study schedule.

Exclusion Criteria:

* Discontinue participation in the ASC40-303 Phase III study for any reason;
* Are receiving/planning to receive any systemic acne medications, systemic retinoids, systemic corticosteroids, or any androgen/antiandrogen therapy (e.g., testosterone, spironolactone);
* Pregnant, nursing, or planning a pregnancy during the study period;
* Have major complications (including clinically significant abnormalities in clinical laboratory tests), mental disorders, or other factors deemed unsuitable for study participation by the investigator.
Safety and Efficacy Study of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders

The purpose of the study is to determine if SJP-0035 ophthalmic solution is effective in promoting corneal epithelial wound healing in conditions associated with corneal epithelial disorders.

There is currently no product approved for corneal epithelial wound healing. A Phase 1 Study SJP-0035/1-01 was conducted in healthy volunteers to investigate the safety, tolerability, and pharmacokinetic profile of SJP-0035 ophthalmic solution and to determine the appropriate dose to be evaluated in patients with moderate to severe corneal epithelial disorders.

This Phase 2a study is being conducted to evaluate the safety and efficacy of SJP-0035 ophthalmic solution in patients to promote corneal epithelial wound healing in conditions associated with corneal epithelial disorders.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 75 years, inclusive.
* Has moderate to severe superficial punctate keratitis (SPK) and/or corneal erosion in 1 or both eyes.
* Has symptoms caused by corneal epithelial disorders.
* Has not obtained improvement from previous treatment for the SPK or corneal erosion within the last 30 days.
* Is a female of childbearing potential with a negative pregnancy test result at Screening and baseline and agrees to use effective contraception throughout the study or is a postmenopausal woman with a negative pregnancy test result at Screening and baseline.

Exclusion Criteria:

* Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, or chemical burns or any trauma to the cornea.
* Any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures.
* Had previous ocular/refractive surgery (including laser surgery) within the last 6 months.
* Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) within 14 days prior to the first dose of study drug, or who are anticipated to require such medications during the study. Artificial tears may be used up to 72 hours prior to the first dose.
* Is unable to discontinue Restasis. A 28-day washout period prior to the first dose of study drug is required.
* Is a contact lens wearer and cannot discontinue use for the duration of the study.
* Alcohol or drug abuse within the past 6 months.
* Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus test at Screening.
HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE)

Using a randomized controlled trial design, the possible changes induced by the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" in functional, everyday life activities and neuroplastic assessment will be studied in infants and toddlers with cerebral palsy.

Using a randomized controlled trial design, the possible changes in neuroimaging, motor function and everyday life activities of infants and toddlers at risk of or with a diagnosis of cerebral palsy after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied . Changes, scored by parents in case of questionnaires and by experts in the case of tests, will be observed comparing infants/toddlers after their regular care and after receiving HABIT-ILE. Motor function and daily life activities will be correlated with neuroplastic changes. Moreover, possible therapy onset outcomes differences will be observed.

Eligibility Criteria:
Inclusion Criteria:

* children with diagnosed unilateral cerebral palsy or at risk of developing unilateral cerebral palsy or with signs of unilateral cerebral palsy
* age 8 to 18 months inclusive (corrected age if preterm birth)
* ability to follow instructions and complete testing according to the age.

Exclusion Criteria:

* active seizure
* programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 6 months after the intervention time.
* severe visual impairments
* severe cognitive impairments
* contraindications to perform magnetic image resonance (MRI) assessments (metal implants, etc.)
Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer

This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

PRIMARY OBJECTIVES:

I. To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer.

II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer.

SECONDARY OBJECTIVES:

I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review.

TERTIARY OBJECTIVES:

I. All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims.

OUTLINE:

Patients undergo mpMRI within 3 months prior to schedule surgery.

After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated

Exclusion Criteria:

* Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)
* Prior surgical and/or non-surgical treatment for prostate cancer
* Prior hip replacement or other major pelvic surgery
Exergaming for Community-Dwelling Older Adults

This study aimed to utilize an interactive exergame mat system to develop a novel cognitive-physical training program and explore the training effects on physical performance, cognitive function, dual-task walking (DTW), and fall risk compared to the control condition.

The exercise group performed exergames with simultaneous cognitive-physical training, while the control group underwent a multicomponent exercise intervention focused on physical and cognitive training. A 2-hour training session was completed weekly for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* aged 65 years or older, and being able to walk independently without any assistive devices

Exclusion Criteria:

* had severe lower-extremity joint pain, cognitive impairment, or visual problems that impeded their participation
Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years

This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern

Eligibility Criteria:
Inclusion Criteria:

* Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
* Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
* Able to Comprehend and give written informed consent form for the study
* willing to come to the hospital for follow up visits as per the protocol requirements

Exclusion Criteria:

* History of meningitis,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
* Hemodynamically unstable patients
* history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
* peripheral Muscular dystropy