cyrilzakka/clinical-trials huggingface dataset:
Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study

The Juvenile Idiopathic Arthritis (JIA) affects joints mobility and leads pain, impacting the practice of physical activities. Adapted Physical Activities are rehabilitation methods increasingly used, but additional studies are needed to define the nature of the physical activity for patients with JIA. The ATHLETIQUE project aims to evaluate the impact of a program integrating APA sessions together with the wearing of a pedometer watch on disease activity of patients with JIA.


Eligibility Criteria:
Inclusion criteria:

* Children (boys and girls) aged 6 to 17 years
* Children with juvenile idiopathic arthritis (JIA) : oligoarticular, polyarticular, psoriatic or enthesitis-related arthritis, with more than one year of disease progression
* Children on stable conventional or biotherapy 3 months prior to inclusion
* Children with a computer/tablet/connected phone that allows them to follow adapted physical activities sessions online
* If sexually active adolescents, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double barrier method, contraceptive patches)
* Signed informed consent to participate indicating that the parent(s) understand the purpose and procedures required for the study and agree(s) that their child(ren) will participate in the study and abide by the requirements and restrictions of the study
* Affiliation with a French social security system or beneficiary of such a system.

Non-inclusion criteria:

* Treatment by intra-articular infiltration less than 1 month old (immobilization required after the procedure and temporary cessation of physical activity unavoidable)
* Contraindications to physical activity
* Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
* Subject without health insurance
* Pregnant adolescent
* Subject in the exclusion period of another study or is the "national volunteer register"

Exclusion criteria :

* Intra-articular infiltration treatment during the 3 months of the adapted physical activity (APA) program (except for the temporomandibular joint)
* Change of biotherapy during the 3 months of the APA program if the treatment is ineffective
* Physical inability to engage in physical activity, unrelated to JIA, during the 3-month of the APA program
Dexmedetomidine in Patients After Intracranial Surgery

Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent sedation and analgesia without respiratory depression. Dexmedetomidine has been used in critically ill medical, surgical, and pediatric patients. No study has been designed specifically to evaluate dexmedetomidine uses in the neurocritical care population. The primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic analgesia and sedation in patients after intracranial surgery.

The PASTrial is a non-commercial, multi-center, randomized, placebo-controlled, double blinded clinical trial. The study compares dexmedetomidine versus normal saline (placebo) in patients after intracranial surgery with delayed extubation. In dexmedetomidine group, infusion (0.4μg/kg/h) is started when patients are admitted to neuro-intensive care unit for postoperative recovery. In control group, patients receive normal saline infusion at the same rate and volume in dexmedetomidine group. The patient's level of sedation is assessed by Sedation-Agitation Scale (SAS) per hour. Midazolam is administered in 0.3-0.5 mg bolus or continuous infusion as SAS above 4. The study is designed primarily to compare the percentage of patients with agitation and requiring midazolam infusion in the 2 study arms.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients after intracranial surgery with delayed extubation

Exclusion Criteria:

* emergency operation
* brain stem operation
* preoperative consciousness disorders or epilepsy
* bradycardia, hypotension, acute myocardial infarction, second- or third degree heart block, or need continuous infusions of vasopressor before the start of study drug infusion
* patients enrolled in another trial
Virtual Family Participation in ICU Rounds: a Pilot Study

Barriers to family participation in ICU rounds exist at the health care system level (e.g., restriction on visitation, infection control) and the individual level (e.g., caretaker role, illness, disability, inability to miss work). While virtual family participation in ICU rounds may contribute to addressing these barriers, its feasibility, impact, and effectiveness are yet unknown. The primary objective of this study is to assess the feasibility of virtual family participation in adult ICU rounds. The secondary objectives are: to assess the effect size of virtual family participation in ICU rounds on family engagement, satisfaction, and anxiety and depression; and to explore family and physician experiences of family participation in ICU rounds.

This will be a pilot prospective trial of 72 family members at 4 Canadian adult ICUs, with an embedded qualitative study that will sample family members and critical care physicians. The primary outcome will reflect feasibility metrics (i.e., recruitment, uptake, technical, and follow-up). Secondary outcomes include data regarding family engagement, satisfaction, mental health, and perceived experiences of participation in ICU rounds. This study will assess the feasibility of conducting a larger, hypothesis-testing randomized controlled trial to assess virtual family participation in adult ICU rounds.


Eligibility Criteria:
Inclusion Criteria:

* Family member of ICU patient with expected ICU stay \> 48 hours (as per treating team)
* Age ≥ 18 years old
* Willing and able to participate in virtual ICU rounds
* Ability to communicate in English or French
* Able: technological capability and understanding to participate virtually in ICU rounds (must have a phone or computer with internet and audio/video capabilities).
* "Family member" is anyone with a biological, legal, or emotional relationship with the patient.

Exclusion criteria

* Intends to participate in in-person rounds (if available and offered at participating site)
* Another family member already participating in the study
Sensory Effects of Rapidly-Changing Magnetic Fields

This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing the time required for imaging. Experience has shown that unpleasant side-effects from magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced when the magnetic pulses are shortened. In this study, we will explore whether this effect holds true when very short magnetic pulses are applied.

See above

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18, capable of informed consent

Exclusion Criteria:

* History of arrhythmia. Has implanted pacemaker or defibrillator, right wrist-to-sternum distance of less than 60 centimeters, visible tattoos of the right hand or wrist, or with any metallic objects that cannot be removed from the right hand or wrist. Irregular or imperceptible pulse. Heart rate less than 50 beats per minute or more than 100 per minute, resting respiratory rate greater than 25 per minute, diastolic blood pressure less than 50. Solid meal ingested within 2 hours prior to the study.
Mindfulness and Intercare Based Intervention for Physicians Burnout Reduction

During the coronavirus disease 2019 (COVID19) pandemic, many physicians have presented burnout. A range of associated factors need to be considered for effective prevention and intervention. Objective 1: To assess the association of burnout in medical doctors with individual factors, self-reported medical errors, medical leave, and demands of the work environment demand. Objective 2: to assess the effectiveness of a online mindfulness, compassion and intercare based intervention to reduce burnout.


Eligibility Criteria:
Inclusion Criteria:

* Physicians enrolled in the database of the medical college of Chile

Exclusion Criteria:

* Recent Grief
* Severe acute depression disorder
* Active suicidal ideation
* Active Psychosis
* Active addiction
* Post Traumatic Stres Disorder
Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03

This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
* The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
* Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language.

Exclusion Criteria:

* Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period
* Acute disease at the beginning of the study
* Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests
* Pregnancy
* Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
* Known allergic reactions that might have been caused by one or more ingredients of the vaccine
Infant Nutrition and Brain Development

Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference.

This nutritional intervention study involved assessments in both the mother and her infant. The mother was asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother was not breastfeeding, a study product was provided and was consumed by the infant daily up to 12 months of life. The study also involved magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation of cognitive outcomes, including general cognitive development, and social-emotional development.

Once all trial subjects completed the 6-month timepoint (intervention part), an inferential statistical analysis of all data up to 6 months was performed.

Product codes (blinding) were broken to compare groups and an appropriate operational framework was put in place to maintain the individual assignment unknown to the Sponsor and Sites until the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Term infants (≥ 37 weeks)
* Neuro typical development
* No major risk factors for learning, neurologic, or psychiatric disorder
* Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks.
* Parents/legal guardians willing and able to complete the informed consent process

Exclusion Criteria:

* Delayed birth (\> 41 weeks gestation)
* Birth Weight \< 2000 g or small for gestation age or large for gestational age
* Psychopharmacological treatment of mother using prohibited medications during pregnancy
* In utero exposure to alcohol abuse or illicit substances as per the American College of Obstetricians and Gynecologists
* Abnormalities on fetal ultrasound
* Complicated pregnancy
* Neonatal intensive care unit admission and/or emergency surgical delivery
Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Although cataract surgery is generally considered a safe procedure resulting in a favourable visual outcome, surgical complications do occur. The most feared complication is postoperative endophthalmitis which is an infectious condition caused by micro-organisms introduced to the interior of the eye during or after the surgical procedure.

As endophthalmitis is an infection, it should be preventable by antibiotic treatment.

Prophylactic antibiotic treatment can be given as topical treatment preoperatively, or during surgery directly into the anterior chamber, or as a subconjunctival, or it can be given as topical treatment postoperatively.

The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of visually significant cataract

Exclusion Criteria:

* Has known allergies to moxifloxacin
* Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason
* Has a known history of a condition which causes an immuno-compromised host state
Catheter Guided Chemo-infusion in Breast Cancer

In the present prospective study, we will analyze the outcome of image-guided delivery of intra-arterially infused chemotherapeutic drugs for patients with breast cancer in III, IV stages.

Breast cancer is one of the most common malignancies affecting women worldwide, and its incidence has seen a steady increase over the years with the involvement of women at a much younger age, which poses a serious health threat to women and has a staggering global impact.

Lymph node and hematogenous metastasis occurs at the early stage of breast cancer and is the principal cause of mortality of breast cancer patients.

Surgical resection is the most effective method for the treatment of breast cancer, and neoadjuvant chemotherapy reduces the risk of disease recurrence and death in women who have operable breast cancer.

For patients with inoperable breast cancer, neoadjuvant chemotherapy reduces tumor bulk and tumor stage, thereby increasing the chance of surgical resection and reducing postoperative tumor recurrence and metastasis.

Local or regional chemotherapy is an alternative for reducing metastatic lesions and increasing patient survival .Intra-arterial infusion chemotherapy (chemoinfusion), a form of regional chemotherapy, has been used in the treatment of gastrointestinal tumors, liver cancer, and pancreatic cancer.

In the present prospective study, we will analyze the outcome of image-guided delivery of intra-arterially infused chemotherapeutic drugs for patients with breast cancer in III, IV stages.

Eligibility Criteria:
Inclusion Criteria:

* Adult female had stage III,IV breast cancer.
* Female had received no prior chemotherapy, radiotherapy, or definitive surgical therapy for breast cancer.
* Patient had adequate organ function.

Exclusion Criteria:

* Patients known to have absolute contraindications for contrast.
* Patient known to have systemic organ failure.
Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for PE or Proximal DVT \[Day -14, Day 0\]
* At least 18 years of age

Exclusion Criteria:

* Prior use of a DOAC or warfarin \[Day -180, Day 0\]
* Stage 4 or 5 chronic kidney disease or end-stage renal disease \[Day -180, Day 0\]
* Dialysis or renal transplant \[Day -180, Day 0\]
* Recent major or clinically relevant non-major bleeding \[Day -180, Day 0\]
* Cancer \[Day -180, Day 0\]
* Bypass surgery, obesity, or the use of a weight loss or appetite suppressor \[Day -180, Day 0\]
* Significant liver disease and coagulopathy \[Day -180, Day 0\]
* Use of CYP3A4 or P-gp inhibitors or inducers \[Day -180, Day 0\]
* Other indications for anticoagulation (atrial fibrillation or prosthetic heart valve) \[Day -180, Day 0\]
* Pregnancy or breastfeeding \[Day -180, Day 0\]
* Use of an antiplatelet \[Day -180, Day 0\]
Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.

To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%

To evaluate the change in endothelial cell count in patients after pterygium surgery with mitomycin C (MMC) 0.02% for 2 minutes in 2 groups.

* The control group: application of MMC after excision of the body of the pterygium without the head
* The study group: application of MMC after excision of the body and the head of the pterygium

Eligibility Criteria:
Inclusion Criteria:

* Males/females \>18 Years old
* Pterygium with indication to operate
* Subjects that are able to sign an informed consent

Exclusion Criteria:

* Recurrent Pterygium/suspected tumor lesion
* Patients with endothelial cell diseases
* Patients after anterior segment surgery
* Patients with low compliance
* Patients without judgment ability
* Pregnancy
* Patients participated in another survey
Long-Term Multicenter Evaluation of the E1® Tibial Bearing

This study has been designed to document the long-term outcome of the E1® Tibial Bearings used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic analysis and patient reported outcomes will be used as follow-up measures to track wear, mechanical performance, and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 20 to 75 years of age
* Subjects requiring total knee replacement
* Subjects with the diagnosis of osteoarthritis, or traumatic arthritis
* Subjects who demonstrate the ability to return to Massachusetts General Hospital for follow-up for the next 10 years

Exclusion Criteria:

* Subjects with osteoporosis, osteomalacia, or neuromuscular disease
* Incomplete or insufficient soft tissue around the knee
* Subjects with a limited life span
* Subjects who have difficulty comprehending the study protocol for any reason
* Subjects with disorders which may impair bone formation
* Subjects whose bony structure deviates substantially from the general norm
* Female subjects that are, or may become, pregnant while participating in this study
Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care

Although brachytherapy is an effective treatment modality for gynecological cancer, a significant proportion of patients develop late treatment-related vaginal toxicity, negatively impacting their quality of life and limiting recurrent disease detection by preventing adequate clinical examination during the post-treatment surveillance period. Consistent with the literature, results from a study at Princess Margaret revealed that current vaginal toxicity management education and training may be inadequate. The investigators seek to implement and evaluate a new online brachytherapy discharge education program (BrachDEP) to support patient engagement in self-management.

Background:

Brachytherapy is a type of radiation therapy used to treat patients with gynecological cancers. Brachytherapy delivers radiation to cancerous tissue by inserting or placing the radiation next to the target tissue. A common side effect that develops as a result of repeated brachytherapy is fibrosis, a thickening and hardening of tissue, as well as narrowing of the vagina, known as vaginal stenosis. To reduce the impact of vaginal stenosis, vaginal dilation is recommended upon discharge of brachytherapy. Vaginal dilation involves the insertion of a smooth plastic tube into the vagina 3 to 4 times per week. Despite the benefits of vaginal dilation, use of vaginal dilators is low among patients following brachytherapy. This poor adherence to vaginal dilator use may be due to embarrassment, discomfort, and lack of awareness of the benefits to patients.

Objective:

The primary objective of this study is to evaluate the whether an online brachytherapy discharge education program increases patient satisfaction with education and care. Secondary objectives are to determine whether the online education program increases patient quality of life, improves vaginal dilator compliance and reduces rates of vaginal stenosis post-treatment.

Methods:

The research team will use a randomized, controlled trial study design. The impact of the online education program will be identified by comparing the outcomes of participants in the intervention arm against those patients in the control arm. Participants will be recruited and randomized to one of two arms that will determine whether they will receive the education intervention.

Significance The results from this study will be used to improve the brachytherapy discharge education program.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to receive brachytherapy for treatment of gynecologic cancer at Princess Margaret Cancer Centre.
* Able to provide written informed consent
* Able to read and write in English
* \> 18 years of age

Exclusion Criteria:

* Not receiving brachytherapy treatment
CNAP Accuracy in the Bariatric Surgery Population

This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive arterial line (IBP).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity
* Patients in whom an indwelling arterial cannula will be placed for the surgical procedure

Exclusion Criteria:

* Patients with history of a peripheral neurologic or neuropathic disorder
* Patients in whom an invasive arterial cannula cannot be placed
* Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
* Edematous patients