cyrilzakka/clinical-trials huggingface dataset:
Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients

Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries.

The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size.

Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits).

Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.


Eligibility Criteria:
Inclusion Criteria:

* primary joint replacement

Exclusion Criteria:

* no prior joint surgery
* no infection
Comparison of Skin Prick Testing, Extract-specific IgE Antibody Testing and Component Resolved Diagnosis in Diagnosing of Legume Allergy

The study is aimed at improving the diagnosis of food allergy, specifically allergy to commonly consumed legumes such as peas, lentils, chickpeas or green beans. Patients suspected of allergy to these legumes will be examined using traditional methods of IgE-mediated allergy diagnosing (skin prick test, testing for specific IgE antibodies against food extract), but also by testing for specific IgE antibodies against relevant allergenic molecules of these legumes. The results of performed tests will be compared with the result of the oral food challenge, which is considered to be the gold standard of food allergy diagnosis.

Legumes are one of the major food allergens, but these are usually peanuts or soybeans. Other legumes, such as peas, lentils, chickpeas or green beans, have been overlooked, but some studies suggest that they may also cause allergic reactions ranging from urticaria to anaphylaxis. The prevalence of allergy to these neglected legumes can range widely (0.5-39.6%) depending on the patient group and the method of allergy diagnosis.

The main allergens of legumes are the seed storage proteins, including 7S and 11S globulins and especially 2S albumins, which can cause the most severe, often systemic allergic reactions. These proteins are characterized by their considerable resistance to heat and other physical or chemical influences. Other important legume allergens in our geographical area are the PR-10 proteins cross-reacting with the major allergen of birch pollen (Bet v 1), which in turn are more sensitive to heat treatment and tend to be the source of milder, more local reactions. In contrast, sensitization to other allergen groups, such as lipid transfer proteins (LTPs), oleosins or profilins, is less significant.

Eligibility Criteria:
Inclusion Criteria:

* age: ≤ 65 years
* signing informed consent to the study
* a positive history of an immediate allergic reaction to one or more of the legumes studied (peas, lentils, chickpeas, beans) with skin, gastrointestinal, respiratory or cardiovascular symptoms occurring within 2 hours after ingestion and a positive result of specific IgE testing against ALEX and/or skin prick test with the legume
* patients with a positive OFC with any of the legumes studied

Exclusion Criteria:

* disagreement with the implementation of the oral food challenge
* history of severe systemic allergic reaction to the legume in question (Ring-Messmer grade ≥ 3)
Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH

The objective of this research was to evaluate the clinical effect of photodynamic therapy on dentin infected by caries lesion in permanent teeth with Molar Incisor Hypomineralization (MIH). The study was composed of Groups (1 and 2). The methodology was based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided. The selected teeth had deep dentin caries lesions on the occlusal surface, and sensitivity, indicated for clinical restorative treatment. Photodynamic therapy was applied with the use of low-intensity laser in permanent teeth selected for the treatment of infected dentin in G1. In this group, antimicrobial photodynamic therapy (aPDT) and atraumatic restorative treatment (ART) were made. In G2, only ART was performed. The teeth were restored with high viscosity glass ionomer cement. All patients had clinical and radiographic follow-up with a time interval of 6 and 12 months. Data were submitted to descriptive statistical analysis. For the evaluation of the association of categorical variables like age and gender, the Chi-square test and Fisher's exact test were used. To analyze the correlation between the continuous variables, the Pearson correlation test was applied. ANOVA and Kruskal-Wallis were applied for the analysis of dentin density in the radiographic images scanned and the microbiological results for colony forming units.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children, without systemic alterations;
* Collaborative children;
* Present at least one permanent molar with active and acute caries lesion in dentin, not exceeding 2/3 and involving only the occlusal, with direct vision and access, without clinical and radiographic signs and symptoms of pulp involvement.

Exclusion Criteria:

* Child with systemic impairment;
* Non-cooperative behavior;
* Carious lesion of Class II, III, IV or V type of Black;
* Clinically: carious lesion involving enamel, deficient restorations, small carious lesions in dentin (without access to hand excavators), occult caries lesions, clinical sign and/or symptom of pulp involvement, clinical impossibility of restoration;
* Radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3 of the dentin.
Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.

Arthroscopic suture for complete and partial \>50% thickness Rotator Cuff Tears (RCT) is the gold standard. However, there is no evidence of superiority of delayed postoperative mobilization protocols versus early ones, in terms of ROM, pain, quality of life and complications in last review published in 2019 by AAOS. Although, excessive immobilization can lead into stiffness, neuropathic pain or adhesive capsulitis. All of these are complications which can diminish patient quality of life or prolong their return to work or sports activities.

This is an experimental, prospective, non-blind, comparative, randomized clinical trial, between two options of treatment. On one treatment branch, we will continue applying our standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation. On the other treatment branch, we will start passive mobilization during second week after surgery, including controlled external rotation movements. All recruited patients will be followed-up during 12 months.

Our main objective is to compare differences in terms of functionality (using ASES scale). Secondary objectives are to compare differences in terms of ROM, functionality (using CMS and UCLA scales), pain (using VAS score), need of analgesic drugs, quality of life (using EQ-5D scale), return to previous work and sports activities, patient adhesion to protocol, complications and MRI rotator cuff retear ratio at 12 months follow-up.

After this study, we hope to develop a new postoperative mobilization protocol for patients. This protocol will be focused on timing, and self-administrated exercises in order to involve patients in their recovery, in the fastest and safest way for them.


Eligibility Criteria:
Inclusion Criteria:

* Age: Less tan 70 years old.
* Sex: Male or Female.
* Treatment: Arthroscopic RCT suture.
* RCT type: Degenerative, total or partial \>50% thickness, less than 3 cm length tear.
* MRI Tear Classification: Patté's in coronal view I or II, Goutalier's \<2, Fukuda's \<2 and Seebauer´s 1A maximum.

Exclusion Criteria:

* Not meet the inclusion criteria.
* Previous surgical procedure in affected shoulder.
* Have been treated with 2 or more glucocorticoid injections in last year.
* High anesthetic risk.
"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"

Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can persist for hours. Despite regular use of eye protection for mydriatic-induced light sensitivity for infants, children and adults, eye protection after mydriasis has not been addressed in neonates. This study examines the use of eye patches to protect the dilated pupil from light exposure and their impact on vital signs and pain scores. prevents tachycardia, tachypnea and discomfort in neonates after ROP screening.

Pain management for Retinopathy of prematurity (ROP) screening focuses on pharmacological and non-pharmacological interventions during the actual eye examination. Management of pain related to increased light sensitivity during the post-mydriasis period has not been described.

This prospective, randomized study evaluated the impact of protecting the eyes from ambient light exposure post mydriasis. Vital signs and pain scales were recorded in infants randomized to either wear or not wear eye patches after mydriasis for their ROP exam. Infants less than 30 weeks gestational age or less than 1500 grams at birth were included. Standard statistical methods were used to compare vital signs and pain scores for each group at baseline, 1 and 3 hours after mydriasis.

Eligibility Criteria:
Inclusion Criteria:

* All infants with gestational age at birth of 30 weeks or less or with birth weight less than 1500g undergoing their first ROP exam in the Infant Special Care Unit (ISCU) at UTMB.

Exclusion Criteria:

* Infants were excluded if they had any congenital malformation or syndrome; a history of eye surgery or were receiving inotropics medications.
Sphenoid Nasalization in Allergic Fungal Sphenoidal Sinusitis

To study the outcome of different two endoscopic sphenoid procedure for management of allergic fungal sphenoidal sinusitis : sphenoidotomy versus sphenoid nasalization with posterior septectomy .

Fungal rhinosinusitis classified into invasive and noninvasive subtypes. Phenotypes of noninvasive fungal rhinosinusitis occur in immunocompetent subjects and include: local fungal colonization, fungal ball, and allergic fungal rhinosinusitis. Subtypes of invasive fungal rhinosinusitis include acute invasive fungal rhinosinusitis, chronic invasive fungal rhinosinusitis and granulomatous invasive rhinosinusitis.

The estimated incidence of sphenoid sinusitis is only 2.7% of all nasal sinus infections, also the diagnosis of sphenoid sinus fungal infection is sometimes difficult. Clinical signs are often non specific and nasal endoscopy can be strictly normal.Early diagnosis is therefore difficult and diagnosis is often delayed with headache that may sometimes persists for several years before diagnosis of the disease.

In most cases of sphenoid sinusitis, enlargement of the obstructed sinus ostium is sufficient to provide drainage of retained secretions and reestablish mucociliary clearance.According to Simmen and Jones, a type I sphenoidotomy entails identification of the ostium without further intervention; a type II sphenoidotomy entails enlargement of the ostium upward to the level of the cranial base, and inferiorly to one-half of the sinus height; and a type III sphenoidotomy involves widening the ostium to its most lateral extent.

Eloy et al in 2017 stuited that,In more extensive sphenoid sinus surgery is reserved for cases where in the disease process is extensive or previous surgery has failed. In some cases sphenoid nasalization in which bilateral extended sphenoidotomy is necessary. In this procedure, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway . It also allows access to the lateral recesses of this sinus.

Eligibility Criteria:
Inclusion Criteria:

* Any age.
* Any case of allergic fungal sinusitis unilateral or bilateral involving the sphenoid sinus

Exclusion Criteria:

* Acute invasive fungal sinusitis.
* Previous Sinonasal surgery.
* Unfit patient for surgery.
Cardiac Involvement in Wilson's Disease

Heart damage by copper accumulation has been reported in Wilson's Disease. However, the disease epidemiology is still poorly understood. A number of studies on pediatric populations have not shown any significant cardiac involvement apart from early dysautonomia. This could suggest that the clinical manifestations related to the copper accumulation in the heart appears with the duration of the disease. Case-control studies on adult populations have highlighted various electrocardiographic (ECG) abnormalities more frequent in patients with Wilson's Disease than in healthy volunteers, but all these studies involved small number of patients (maximum 60). The hypothesis is that there is cardiac involvement in Wilson's Disease, requiring screening, follow-up and appropriate support.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient with Wilson's disease confirmed by a Leipzig score ≥ 4
* Express consent to participate in the study by the patient or legal guardian in the case of patients under guardianship or by the patient assisted by his curator in the case of patients under guardianship
* Member of or beneficiary of a Social Security scheme

Exclusion Criteria:

* Absolute or relative contraindication to MRI or contrast media
* Pregnant, parturient or breast-feeding women: a urine pregnancy test will be carried out in women of childbearing age
* Patient with hepatic decompensation (Child-Pugh score stage C)
* Patient in neuro-psychiatric decompensation
INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

The objective of this study is to compare treatment with an endograft prothesis versus antihypertensive treatment in patients with a dissection of the thoracic aorta.

Patients older than 18 years with type B aortic dissection as diagnosed by computed tomography or magnetic resonance angiography are randomized to either a thoracic aortic endoprosthesis and antihypertensive treatment, called "stent grafting," or a tailored antihypertensive treatment, called "medical treatment."

Only patients in a clinically stable condition and without spontaneous thrombosis of the false lumen after 14 days of the index dissection are considered eligible for study inclusion.

Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (\>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study design calls for 136 patients to be randomized and monitored for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* No contraindication for an anesthetic procedure with intubation
* Type B aortic dissection that occurred 2-52 weeks before randomization
* Diameter of the targeted aortic segment ≤6 cm
* Aortic kinking \<75°
* The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
* Availability for the appropriate follow-up visits during the follow-up period
* Capability to follow all study requirements

Exclusion Criteria:

* Pregnant woman
* Thrombocytopenia or ongoing anticoagulation therapy
* Renal failure and/or creatinine \>2.4 mg%
* Complete thrombosis of the false lumen
* Ongoing infection
* Cancer is likely to cause death within 1 year
* Enrolment in another clinical study
* Unwillingness to cooperate with study procedures or follow-up visits
Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma

Pain is the leading cause of access to the paediatric emergency department (ED) and present in up to 78% of cases.

Acute osteoarticular traumatic pain is often treated inadequately, and there is little data about the best treatment for children. The ibuprofen and ketorolac are respectively the most used and one of the most powerful NSAIDs. In literature, there is no direct comparison between those two medications.

The objective of the study depends on the level of pain:

* in severe traumatic acute pain (\>=7 points): to evaluate if ketorolac is superior to ibuprofen in the treatment of pain (n=130 children, 65 allocated to ketorolac and 65 to ibuprofen)
* in moderate traumatic acute pain (\<7 points): to evaluate if ibuprofen is not inferior to ketorolac in the treatment of pain (n=120 children, 60 allocated to ketorolac and 60 to ibuprofen)


Eligibility Criteria:
Inclusion Criteria:

* Age between 8 and 18 years
* Moderate to severe pain (value\>= 4 on the Numerical Rating scale / NRS)
* Pain due to a trauma at limbs that has occurred in the last 48 hours

Exclusion Criteria:

* Administration of any analgesic in the previous 8 hours.
* Allergy known to one of the active ingredients
* Known hepatopathy or nephropathy
* Suspicion of violence by others
* Chronic use of painkillers
* Inability to report pain due to the presence of: intellectual disability (IQ \<70); moderate-severe hearing loss; communication limitations such as patient mutism; unable to write; inability to speak Italian
* Chronic neurological or metabolic diseases,
* Positive history for ease of bleeding, coagulation disorder or
* thrombocytopenia
* A history of gastritis or esophagitis in the last 30 days
* Multiple trauma
* Vascular-vascular deficit
* State of pregnancy
Guided Meditation as an Adjunct to Enhance Postoperative Recovery

The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.

This is a prospective, randomized, controlled study involving 30 adult patients undergoing cardiac surgery. Investigators will test the feasibility of implementing a meditation program in the perioperative period. Patients will be randomized to one of three groups: those who complete Isha Kriya (IK) meditation before and after surgery, those who complete postoperative IK meditation only, and those who receive the standard of care with no meditation intervention. In addition to testing feasibility, the investigators will explore whether a meditation program can affect recovery after surgery. Patients enrolled will be followed postoperatively for up to one month to assess their cognitive function, pain, and sleep. Blood will also be collected for analysis of biomarkers of inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Undergoing any of the following types of cardiac surgery: CABG with or without valve surgery (aortic and/or mitral); isolated valve surgery; isolated aortic surgery
3. Surgery scheduled for at least 14 days after enrollment

Exclusion Criteria:

1. Urgent and/or emergent surgery
2. Non-English speaking
3. Cognitive impairment as defined by total MoCA score \< 10
4. Baseline DASS-21 depression score \>10
5. Pre-existing history of psychiatric illness as documented in the medical record or divulged in history taking in pre-enrollment patient interview, such as anxiety, depression, or bipolar disorder
6. History of cerebrovascular accident or recent history (\< 3 months) of seizures
7. History of dementia, Parkinson's disease, Alzheimer's disease, or other forms of cognitive decline
8. Current use of cognition enhancing drugs
9. Current management for chronic pain
10. Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
11. Educational attainment below high school level or equivalent
12. Significant visual impairment
The Use of plasmaJet During Operative Laparoscopy for Endometriosis

Endometriosis is a condition where functional endometrial tissue is present outside the uterus. It usually locates in the pelvis, which often includes the ovaries. One of the main concerns when performing surgery is to maintain fertility.

Nevertheless, a disadvantage of using monopolar and bipolar instruments for laparoscopic excision or coagulation of endometriosis lesions is the energy / thermal distribution that can cause damage to the surrounding healthy tissue. Therefore, the use of ultrasound, laser or plasma energy can potentially reduce damage to surrounding tissues and prevent adhesion formation. In addition, ablation of the internal surface of endometriomas can be an effective alternative to cystectomy.

The PlasmaJet system uses argon plasma which is released as kinetic, light and / or thermal energy. In this way the instrument can be applied within three functions, namely cutting, vaporizing and coagulating. Moreover, plasma will dissipate very quickly upon contact with tissue which consequently allows a controlled depth of tissue penetration. Thirdly, pure plasma energy differs from conventional electrosurgery since no electrical current will be spread through the tissue and therefore the thermal effect at surrounding tissues remains minimal.

The aim of this pilot study is to investigate the feasibility, effectiveness and safety of plasma energy in the treatment of endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 45 years old.
* The presence of endometriosis; requiring surgical laparoscopy.

Exclusion Criteria:

* Women younger than 18 years.
* Women older than 45 years.
* Women who are scheduled for surgical laparoscopy where the removal of the uterus and / or ovaries is needed.
* Women who do not give written permission to participate.
Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache

The purpose of this study is to determine whether patients in the emergency department with migraine headache who are administered an intravenous fluid bolus will report greater improvement in pain scores than control patients.

The investigators intend to perform a small-scale pilot study assessing the effectiveness of IV fluid therapy for patients presenting to the ED with migraine headache. Patients will be randomly allocated to receive a bolus of 1000 ml normal saline or no fluid bolus. Patients and outcome assessors will be blinded to the assigned study group. Research assistants will assess pain scores, nausea, and functional disability at time 0 (just prior to starting the intervention), 60 minutes, and 120 minutes. Participants will be contacted 48 hours after leaving the ED to assess symptom burden following discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Fluent in English
* Meets International Classification of Headache Disorders (3rd ed) criteria for migraine headache:

A. At least five attacks fulfilling criteria B-D B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)

C. Headache has at least two of the following four characteristics:

unilateral location pulsating quality moderate or severe pain intensity aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)

D. During headache at least one of the following:

1. nausea and/or vomiting
2. photophobia and phonophobia E. Not better accounted for by another ICHD-3 diagnosis.

Exclusion Criteria:

* Intravenous Fluids are contraindicated in the opinion of the emergency department physician caring for the patient (ex patient has an exacerbation of congestive heart failure).
* Intravenous fluids are required in the opinion of the emergency department physician caring for the patient (ex patient has intractable vomiting, patient has severe dehydration).
* Have already received greater than or equal to 500 ml of intravenous fluid during this emergency department visit, prior to enrollment.
* Currently pregnant