cyrilzakka/clinical-trials huggingface dataset:
Exercise Intervention in Primary Open-angle Glaucoma

EYE-FIT is a randomized clinical trial with a two-arm parallel design aimed at assessing the impact of performing a structured and supervised physical training program on the different variables associated with glaucoma progression in pharmacologically treated primary open angle glaucoma patients. This intervention will include a supervised 24-weeks concurrent (endurance + resistance) training program comparing its influence to the standard care.

There are claims that more physically active individuals are less likely to glaucoma onset and progression. However, to date, there is not a single randomized controlled clinical trial assessing the impact of performing a structured and supervised physical training program on glaucoma progression. A randomized controlled clinical trial with a two-arm parallel design will be used to determine the chronic effects of a 24-weeks concurrent (endurance + resistance) training program in comparison to a control group (no training prescribed) on the ocular function and physical fitness of primary open angle glaucoma patients. Participants will be randomly divided in one of the two groups (experimental or control \[wait-list\]), while ocular function and physical fitness will be assessed before and after the intervention by researchers blinded to the group allocation of each participant. In addition, primary open angle glaucoma patients will be subdivided according to their medical treatment in two groups (prostaglandin analogues and combination of prostaglandin analogue and beta-blockers). Therefore, four groups will be considered in this clinical trial. The results of the EYE-FIT clinical trial will provide novel information on the influence of exercise on different markers of glaucoma, and may help to reduce the clinical, economic and social burden of this disease.

Eligibility Criteria:
Inclusion Criteria:

* Have an age between 50 and 70 years old
* Primary open angle glaucoma diagnosis based on objective criteria (i.e., glaucomatous optic nerve head changes and visual field defects consistent with glaucoma, after the exclusion of other possible causes).
* No have undergone any surgical intervention for glaucoma treatment
* Be medically treated with prostaglandin analogues or with a combination of prostaglandin analogue and beta-blockers

Exclusion Criteria:

* Have an scheduled surgery for the following 6 months
* Have a sufficient level of mobility to perform supervised physical exercise
* Suffer any disease that prevent the practice of physical exercise
Quantitative Ultrasound Assessment of Abdominal Cavity Space

This is a prospective observational study to observe the diagnostic efficacy of a quantitative ultrasound assessment plan for pathological accumulation in the abdominal cavity space of critically ill patients, and to explore its correlation with patient clinical outcomes.

Intra-abdominal lesions, such as hemorrhage and inflammation/infection, often lead to pathological accumulations, posing serious challenges for critically ill patients. These lesions can rapidly induce intra-abdominal hypertension and organ damage, which may progress to hemorrhagic or septic shock, endangering patients\&#39; lives. Intra-abdominal hemorrhage, especially surgery-related hemorrhage, is difficult to detect early, and existing assessment methods like CT scans have limited applicability in critically ill patients. Intra-abdominal infections account for a high proportion of infections in critically ill patients, with concurrent sepsis or shock having high mortality rates. Despite advancements in critical care medicine, the mortality rate from intra-abdominal infections remains stubbornly high. Accurate assessment of the source and extent of infection is crucial for treatment, yet routine physical examinations have low sensitivity in critically ill patients, making imaging examinations the primary method. However, while abdominal CT is considered the gold standard, it is limited by insufficient dynamic monitoring and difficulties in patient transport. Bedside ultrasound plays a significant role in the monitoring of critically ill patients due to its portability, non-invasiveness, and real-time dynamic capabilities. It can assess sources of hemorrhage and infection, quantify the extent of lesions, and monitor hemodynamic changes. Therefore, this study aims to develop a comprehensive ultrasound assessment protocol that covers the peritoneal cavity and posterior peritoneal space. Through a prospective observational study, we aim to validate its sensitivity and specificity in diagnosing pathological accumulations such as intra-abdominal hemorrhage/infection and explore its correlation with patient clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age \&gt; 18 years old;
* Expected ICU stay ≥ 72 hours;
* Meeting one of the diagnostic criteria for intra-abdominal infection: 1) Single organ infection (such as cholecystitis, appendicitis, diverticulitis, cholangitis, pancreatitis, salpingitis, etc.), which may be accompanied by or without peritonitis, even without perforation; 2) Peritonitis, classified as primary, secondary, or recurrent; 3) Intra-abdominal abscess.

Exclusion Criteria:

* Patients with wounds, redness, swelling, bleeding, or other conditions at the abdominal measurement points that prevent ultrasound assessment;
* Patients with intra-abdominal gas accumulation that affects abdominal ultrasound imaging, making ultrasound quantitative scoring impossible;
* Patients who have not undergone abdominal CT examination within 72 hours of ICU admission;
* Patients who do not consent to participate in this study.
Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS

When the flow of blood ejected by the heart drops significantly, that is to say when there is "shock", one of the first treatments undertaken is often volume expansion. This treatment consists of injecting a liquid intravenously, generally in the form of a bolus, that is to say a dose of solute administered all at once, of 250 to 500 mL of fluid over approximately 10 to 30 minutes. The injected fluid expands the blood volume and fills the heart pump, in order to increase the flow it ejects.

However, this treatment poses two problems. First, it is only inconsistently effective. It is possible that of the 250-500 mL of fluid administered in the standard way, only a part is effective, whereas, as the effectiveness decreases during the infusion, the rest does not increase cardiac output significantly.

However, the average part of the total volume that is ineffective on a large population of patients is not well known.

Second, the effects of volume expansion on cardiac output decrease rapidly after the end of administration. However, the average duration of effectiveness of a 250-500 mL fluid bolus, and the factors that influence this duration of effectiveness, are not well determined.

The main objective of this research is to measure, among the volume of a fluid bolus, which part does not significantly increase cardiac output. The secondary objective is to measure the average time of effectiveness after the end of the infusion and the factors that influence it.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Hospitalisation in intensive care
* Haemodynamic monitoring already in place with a pulse wave contour analysis-derived estimation of cardiac output (either calibrated or uncalibrated)
* Decision taken by the clinicians in charge of the patient to perform volume expansion by intravenous infusion of a 6 mL/kg crystalloid bolus

Exclusion Criteria:

* Pregnancy
* Refusal to participate by relatives of the patient or the patient himself
* Other therapeutic modification during volume expansion
Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of atopic dermatitis
* Family history of atopy
* 3 to 18 months of age at baseline
* At least mild atopic dermatitis at baseline (investigator global assessment \[IGA\] greater or equal to 2)
* Clinical evidence of atopic dermatitis for no longer than 3 months

Exclusion Criteria:

* Diagnosis of or substantial clinical evidence for food or other allergies at baseline

Other protocol related criteria may apply
WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)

The study will assess the hypothesis that the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both indications for warfarin use and dual antiplatelet (clopidogrel 75mg/day + aspirin 80mg/day) treatment.

Chronic oral antithrombotic treatment is necessary in patients with mechanical heart valves and in the majority of patients with atrial fibrillation. When these patients have to undergo Percutaneous Coronary Intervention (PCI) with stenting, there is also an indication for treatment with aspirin and clopidogrel. However, triple therapy is known to augment the risk for bleeding complications.Unfortunately, no prospective data are available to solve this issue. Nevertheless, it all comes down to finding the ideal therapy in patients with both atrial fibrillation and percutaneous intervention to prevent thrombotic complications (e.g. stent thrombosis) without increasing the risk of bleeding. This prospective randomised study will assess the hypothesis that in patients on warfarin therapy and indication for elective percutaneous intervention, the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy treatment in reducing the risk of bleeds while equally safe with respect to the prevention of thrombotic complications

Eligibility Criteria:
Inclusion Criteria:

* Patients is on oral anticoagulation therapy and this will be continued throughout the period of 1 year-and deployment of at least 1 coronary stent (bare metal stent (BMS) or drug eluting stent (DES)). -age of more than 18 years

Exclusion Criteria:

* cardiogenic shock,
* contra-indication for aspirin or clopidogrel
* allergy to aspirin or clopidogrel,
* documented peptic ulcer disease within the previous six months,
* pregnancy and
* previous intracerebral haemorrhage or
* significant thrombocytopenia (platelet count \< 50x10 9/L).
* major bleeding according to timi criteria within the past 12 months
* age \> 80 years
Participate While Pregnant Survey

The main goal for this study is to assess concerns and barriers to research participation by pregnant women through an anonymous online survey (www.pbrc.edu/ParticipateWhilePregnantSurvey).

Participants will complete an online survey distributed through HIPAA compliant REDCap database. Collected data will consist of general multiple choice responses and optional "write-in" responses (e.g. providing a personal response for elaboration an "Other" option). No private health information will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Any individual may complete this survey.
Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension: A Single-Arm Retrospective Study

This single-arm, retrospective study aims to evaluate the safety and efficacy of subcutaneous treprostinil as a bridge therapy for lung transplantation in patients with severe pulmonary hypertension (PH). A total of 46 patients with either pulmonary arterial hypertension (PAH) or chronic lung disease-associated PH (CLD-PH) were included, all of whom were referred for lung transplantation between January 1, 2015, and September 1, 2024. The study examines changes in clinical, functional, and hemodynamic parameters following 3-6 months of treprostinil therapy.

This study evaluates the use of subcutaneous treprostinil as a bridge therapy for lung transplantation in patients with severe pulmonary hypertension (PH), including both pulmonary arterial hypertension (PAH) and chronic lung disease-associated PH (CLD-PH). This retrospective, single-center study included 46 patients treated between January 1, 2015, and September 1, 2024. All patients experienced significant clinical and hemodynamic impairment at the time of treprostinil initiation. The primary aim was to assess improvements in NYHA functional class and 6-minute walk distance (6-MWD) following 3-6 months of therapy. Secondary outcomes included NT-proBNP levels, echocardiographic parameters, and post-transplantation survival rates. The study also analyzed the incidence of primary graft dysfunction (PGD) and the continued use of treprostinil post-transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with severe pulmonary hypertension (PAH or CLD-PH) requiring lung transplantation
* Age 18 years or older
* Able to provide informed consent

Exclusion Criteria:

* Patients with PH caused by left heart disease
* Patients unable to undergo lung transplantation due to medical conditions
* Patients with a history of severe drug allergies
MRI (Including Spectroscopy and Fat-Saturations and Diffusion-Weighted Imaging) in Cervical Cancer

To detect differences in MR spectroscopy, diffusion weighted MR, diffusion tensor imaging (DTI) or dynamic contrast enhancement (DCE) MR imaging between primary cervical tumors and normal cervical tissue.

At our institution, all patients receiving external beam and/or brachytherapy as part of the treatment of primary cervical cancer receive CT, PET, and MRI simulation scans as standard of care. Brachytherapy patients also receive weekly T1/T2 weighted MR simulation scans as part of their treatment planning.

We propose the use of additional MR sequences to the standard T1/T2 weighted MR simulation scans. The data obtained from these additional sequences will be used for improving tumor delineation and obtaining prognostic information.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have biopsy-proven newly diagnosed squamous cell cervical cancer (FIGO clinical stages IB2-IVA).
* Patients must be ≥ 18 years of age.
* Patients must be able to receive standard radiation therapy (external beam radiation and brachytherapy) with or without chemotherapy.
* Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least one year.
* Patients must be scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging cervical cancer at Barnes-Jewish Hospital Clinical PET facility on the Siemens Biograph 40 True Point Tomograph Scanner or elsewhere in the WUSM Nuclear Medicine department using the quality controls instituted by Nuclear Medicine.
* Patients must be able to give informed consent.

Exclusion Criteria:

* Patients with another known active malignancy.
* Patients who have received treatment for any malignancy (with the exception of non-melanoma skin cancer) in the past 5 years.
* Pregnant or breastfeeding patients.
* Patients whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging.
* Patients with contraindications to MRI scanning.
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.


Eligibility Criteria:
Inclusion Criteria:

* Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
* Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
* Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
* Subjects with stable nephritis may be enrolled
* 18 years of age or older

Exclusion Criteria:

* Severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes
* Malignancy within past 5 years
* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
* Liver disease
* Anemia, neutropenia, or thrombocytopenia
* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
* History of active tuberculosis or a history of tuberculosis infection
* Pregnant or nursing
Use of Virtual Reality for Pediatric Minor Surgical Procedures

This project is looking to use virtual reality for minor general surgery procedures in addition to local anesthesia instead of general anesthesia.

Study population. Patients ages 7-18 undergoing minor surgical procedures at Lucile Packard Children's Hospital will be recruited. Minor surgical procedures include hormone implant placement/removal/exchange, cecostomy tube exchange, incision and drainage of superficial soft tissue abscesses excluding the perineum and buttock, excision of benign masses \<2cm on the extremity (e.g. sebaceous cyst, pilomatricoma, lipoma, etc), and foreign body removal from superficial wounds. Exclusion criteria include those with significant cognitive impairment, history of motion sickness, history of seizures, Glasgow Coma Scale (GCS) \<15, currently taking anxiety medication or narcotics, facial trauma, clinically unstable or require urgent/emergent intubation, claustrophobia, and visual or auditory impairment. The investigators aim to enroll at least 200 patients into the study.

Intervention. Research coordinators will recruit patients and their families prior to their schedule procedures. Informed consent and assent will be obtained from participants and their caregivers when a patient is a minor. Demographic information will be collected from all participants. Patients will complete pre-procedural survey for pain and anxiety. Parents will complete a survey that documents their perception of their child's anxiety level. Patients will be randomly assigned to a treatment arm.

Patients assigned to the general anesthesia arm will have a child life specialist in the pre-procedural period per hospital routine. Anesthesia will be administered at the discretion of the anesthesiologist. Once the procedure is completed, the patient will recover and be monitored in the post-anesthesia care unit (PACU) per hospital guidelines.

Patients assigned to the virtual reality arm will be instructed on how to use the handheld system. A trained research coordinator or child life specialist will be with the patient during the procedure to help with any issues that may arise. They will document any interfering behaviors during the procedure. After the procedure, the patient will be monitored in the PACU per hospital guidelines.

All patients will complete the post-procedural survey for pain and anxiety. Patients, parents and the surgeon will also complete satisfaction surveys.

Eligibility Criteria:
Inclusion Criteria:

* less than 18 years of age
* parental consent/patient assent
* undergoing minor procedure(s)

Exclusion Criteria:

* participants and patients who do not consent
* have significant cognitive impairment
* have a history of severe motion sickness
* currently have nausea
* history of seizures or currently experiencing seizures
* have visual or auditory impairment
* clinically unstable or require urgent/emergent intervention and/or American Society of Anesthesiologist class 4 or 5
* history of claustrophobia
* Glasgow Coma Scale \<15
* currently taking anxiety medication
* currently taking narcotics
* facial trauma
Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures

Background

Pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. Fractures in need of surgery are often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal after 6-12 months is generally advocated. Surgical hardware removal has few complications; however, it is a substantial burden on the child, the family and healthcare economy. Bioabsorbable Intramedullary Nails (BIN) have been developed for the same indications as metal ESIN. The use of bioabsorbable implants would deem hardware removal unnecessary and relieve the child of further surgery and reduce healthcare costs.

Methods

The investigators aim to recruit all children in the catchment area of Herlev and Gentofte University Hospital (Copenhagen, Denmark) with acute unstable diaphyseal forearm fractures. Participants will be operated with BIN and followed consecutively for 2 years with interim analysis of data after 6 months. The investigators will report radiological healing using the Radiographic Union Score (RUS) 3 months after surgery together with any adverse events during follow-up.

Discussion

This study will provide important preliminary data and asses the feasibility of using the bioabsorbable Activa IM-Nail™ in pediatric diaphyseal forearm fractures. This study is a pilot study for initiating an RCT comparing BIN to metal ESIN hypothesizing that BIN is not an inferior treatment.


Eligibility Criteria:
Inclusion Criteria:

* Acute traumatic diaphyseal forearm fracture of the radius, ulna or both
* Fractures need to be complete (not unicortical or green stick)
* Displaced more than 50% of bone width or angulated more than 10° in any plane or irreducible or unstable after reduction

Exclusion Criteria:

We exclude patients

* with fractures that are well managed conservatively (undisplaced or minimally displaced)
* with previous ipsilateral forearm fracture
* with fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)
* with fractures with ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)
* unable to participate in follow-up
* with existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)
* in whom internal fixation is otherwise contraindicated (e.g. active or potential infection)