cyrilzakka/clinical-trials huggingface dataset:
"Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study

Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the treatment of rectal cancer because of its postoperative non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics. Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to divert feces and protect the anastomosis. For such patients, rectal anterior resection surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also realizing the absence of additional abdominal incision. However, this procedure is prone to stoma infection and has a high complication rate (20-40%), which limits the popularization of NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure method (Dumpling Suture Method), which reduces the size of the incision by folding the suture to achieve the effect of hiding the skin incision and reduce stoma infection. The study aimed to introduce the "Dumpling suture method" of protective loop ileostomy in laparoscopic anterior resection and compare this new method with the traditional method. From August 1st 2019 to August 1st 2023, 22 cases of the new procedure were completed in our center, and 30 patients with stoma closure by the traditional method were included in the same period for control purposes. A retrospective analysis was conducted on 52 patients in the study center, and the intraoperative details and postoperative outcomes of the two groups were measured.


Eligibility Criteria:
Inclusion Criteria:

1. All patients underwent successful laparoscopic anterior rectal resection plus protective loop ileostomy with specimen extraction through stoma incision;
2. All patients were pathologically diagnosed with rectal carcinoma or ulcerative colitis;
3. Patients aged 18 - 80 years
4. ASA (American Society of Anesthesiologists) classification ≤ grade 3.
5. Patient participate voluntarily and sign an informed consent form

Exclusion Criteria:

1. Patients with distant metastasis;
2. Patients with colon cancer;
3. Patients with a history of previous abdominal surgery;
4. ASA (American Society of Anesthesiologists) classification \> grade 3;
5. Patients who underwent emergency surgery;
6. Patients who underwent surgery ≤ 3 weeks from the last chemotherapy ;
7. Patients lost to follow-up.
Quantitative Evaluation of Parafoveal Microvasculature Changes in Eyes With Exudative Circumscribed Choroidal Haemangioma: An Optical Coherence Tomography Angiography Study

The study aims to quantitative evaluation of parafoveal microvasculature changes in eyes with exudative circumscribed choroidal haemangioma using optical coherence tomography angiography.

Circumscribed choroidal haemangioma (CCH) is an uncommon, potentially congenital benign vascular hamartomas which typically manifests as an elevated mass with reddish-orange pigmentation located posteriorly to the equator, mostly in the macular and peripapillary region. Despite its benign nature, cystoid macular edema (CME) or SRF due to the exudations from the exudative CCH can cause visual impairment. Diagnosis is often suspected clinically, and multimodal imaging is useful for the differential diagnosis of CCH from other malignant tumors such as melanoma. Optical coherence tomography angiography (OCTA) is a rapid, non-invasive, new imaging technology which could provide the capillary density (CD) of superficial and deep capillary plexus as well as the CD of choriocapillaris of the superficial, the latter two of which could not be seen on conventional FA or ICGA. However, little knowledge is known about the parafoveal microvasculature changes in eyes with exudative CCH on OCTA. Therefore, it is necessary to quantitative evaluation of parafoveal microvasculature changes in eyes with exudative CCH compared with healthy eyes without any disease. To the best of our knowledge, this is the first cross-sectional, case-control study to use OCTA to quantitative evaluation of parafoveal microvasculature changes in Eyes with exudative CCH compared with age- and gender-controlled healthy eyes.

Eligibility Criteria:
Inclusion Criteria:

* For patients with exudative CCH, the inclusion criteria were treatment naïve patients with exudative CCH which caused subfoveal retinal detachment and/or intraretinal fluid. For the healthy eye control group, only one eye (randomized by computer) of a subject was included, and the included eyes should have no ocular diseases and the best-corrected visual acuity (BCVA) should be 20/20 or better.

Exclusion Criteria:

* without any other ocular diseases or any severe uncontrolled systemic diseases, including uncontrolled hypertension, coronary heart disease, liver failure, and kidney failure. all the subjects with high diopter \> -6D, long eye axis \> 26.0 mm, or the quality of the acquired OCTA images below 7/10 should be excluded from this study.
Prevention and Management of Food Allergies

This pilot study will test the use of visual cues to engage food service workers in protecting patrons with food allergies. Food service workers from Philadelphia quick-service restaurants were recruited to participate in a survey of attitudes that includes an embedded randomized experiment testing an experimental cue (photograph of an allergic child) to increase workers' engagement and empathy.

Aim: Investigators pilot-tested a novel strategy to engage food service workers, by using a visual cue to increase the workers empathy for and desire to protect the patrons health and safety.

Why intervene with food service workers? Both food allergies and allergenic foods are common, as is eating, making accidental ingestion of allergenic foods almost inevitable. Risks may be particularly pronounced in out-of-home contexts (restaurants, school cafeterias, etc.), where the food allergic person must rely on service workers to assure their safety. Therefore, food service workers are important partners in the prevention of adverse events.

Design: Within the context of a survey of food service workers, investigators embedded a randomized experiment. In this experiment, investigators randomly assigned survey participants to one of two conditions: a Personalized vs. Depersonalized Chef Card. Depersonalized Chef Cards included simple written instructions regarding the patron's specific food allergies, including explicit guidance regarding foods to be avoided and information regarding the seriousness of the allergy. Personalized Chef Cards included identical written instructions and information, as well as a photograph of a patron with food allergies.

Hypothesis: Service workers exposed to the Personalized (compared to Depersonalized) Chef Cards will demonstrate greater empathy, sympathy, willingness to help, and vigilance regarding food allergies and their management.

Eligibility Criteria:
Inclusion Criteria:

* Employed at a quick-service restaurant
* Speaks English

Exclusion Criteria:

* Work at a table-only establishment
Palliative Care For Me (PCforMe)

The purpose of this study is to test the usability of PCforMe, a web-based preparation and engagement tool about palliative care, during a pre-visit pilot trial in outpatient palliative care at the Duke Cancer Institute Palliative Care Clinic.

The Investigator will 1:1 randomize patients to an Active Control arm or Intervention arm. Both arms will receive a tablet computer (iPad or Galaxy Tab based on preference) connected to the internet with disposable headphones to use for up to 30 minutes. Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative_care). Intervention Arm subjects will receive access to PCforMe.

PCforMe is an online, web-based, interactive tool to prepare patients for a clinical palliative care encounter. PCforMe is accessible through www.pcforme.org. It does not collect any patient information, including identifiers (e.g. name, email address, disease, location) or health information (e.g. disease, symptom severity or location). The system uses a combination of animated videos and user-answered questions to generate a "Palliative Care Passport", which is a summary of information entered into the system. Research staff will print out the Passport for patients and hand it to them prior to the appointment.

Queries for users include standard-of-care questions asked by palliative care clinicians, including areas that patients want to more learn about. No diagnoses, medication advice, or clinical assessments are made or given.

Eligibility Criteria:
Inclusion Criteria:

* Potential participants will be identified by reviewing clinic appointment listings in EPIC (e.g., diagnosis, date of diagnosis, date of clinic appointment, physician), and deemed eligible by the RA by meeting the following criteria:

  * Age \>18
  * capacity to give consent
  * has a scheduled outpatient visit (initial consult) with a palliative care provider
  * ability to speak and understand English

Exclusion Criteria:

* Not meeting the inclusion requirements
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of alprazolam extended release (XR) for the treatment of adolescents with panic disorder

Due to recruitment difficulties in this adolescent population, the clinical program for alprazolam XR was cancelled and this study was terminated on 1 September 2004. There were no safety concerns that led to this decision.

Eligibility Criteria:
Inclusion Criteria:

* A primary DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on the Mini International Neuropsychiatric Interview for Children and Adolescents
* At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening
* At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline
* At least one 4-symptom panic attack in the 7 days prior to baseline

Exclusion Criteria:

* Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence
* Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, conduct disorder, oppositional defiant disorder, or attention deficit hyperactivity disorder
* Any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an Axis I eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder
* A CDRS-R score \>35
Fetal Copeptin After Oxytocin Challenge Test

The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is studied.

Background: Vaginal delivery evokes a dramatic surge in stress hormones facilitating the transition of the infant to extra-uterine life. Infants born by elective cesarean section (C-section) are known to have a higher risk for compromised birth adaptation. Labor is vital for vaginal delivery and triggers fetal stress hormone release. Fetal plasma copeptin, a surrogate marker of arginine vasopressin, has been found to be 100 to 1000-fold increased after vaginal delivery as compared to elective C-section. However, the relationship of labor intensity and fetal stress hormone release is largely unknown.

Objective: The purpose of this study is to determine fetal copeptin in newborns delivered by C-section to mothers who had an oxytocin challenge test (OCT) just prior to birth as compared to those without OCT.

Protocol: Pregnant women at term are eligible to participate if no uterine contractions are reported within the last 24 hours and no contractions are recorded in cardiotocogram over 30 minutes. Further inclusion and exclusion criteria see below. After written informed consent, all participants get an infusion line and participants receive OCT or placebo. The OCT is standardized as follows: 5 IE Syntocinon (oxytocin) in 500 mL Ringer, infusion rate begins with 12 ml/h and is increased by steps of additional 12 ml/h until three contractions within ten minutes are recorded. Subsequently, infusion is stopped. The placebo is Ringer infusion without Syntocinon. C-section is done about 1 to 3 hours after OCT or placebo and arterial umbilical cord blood is collected at birth. Maternal and newborn data are recorded within the first few days after birth, including maternal blood loss, neonatal adaptation, and postnatal weight loss.

Eligibility Criteria:
Inclusion criteria:

* Singleton pregnancy
* Gestational age more than 36 weeks
* No contractions reported within the last 24 hours
* No contractions recorded by 30 min cardiotocogram prior to oxytocin challenge test

Exclusion criteria:

* All contraindications for labor, including placenta praevia
* Serious fetal malformations
* Anhydramnios
* Oligohydramnios
* IUGR \< 5. percentile
* Presence of any contractions
* Suspicious or pathological fetal heart rate tracing (cardiotocogram)
* Any clinical or biochemical signs of maternal infection
* Breech presentation
* More than 1 C-section in history
Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Heart Failure

The relationship between peripheral venous saturation and central hemodynamics (including right and left heart filling pressures and cardiac output), mixed venous oxygen saturation, and contemporary biomarkers of heart failure is not clear. We aim to determine the relationship between mixed venous, central venous, and peripheral venous oxygen saturation in patients with advanced (class III or IV) heart failure. We will determine the relationship between cardiac output measured via thermodilution and the Fick equation calculated using concurrent oxygen saturations from the distal PA, central vein, and peripheral vein. We also aim to examine the relationship of selected cardiac biomarkers with cardiac filling pressures and cardiac output over time in patients with decompensated heart failure.


Eligibility Criteria:
The following inclusion criteria will be utilized:

1. Age\>21
2. PA-catheter insertion for therapy of congestive heart failure decided upon by the attending cardiologist

The following will be considered as exclusion criteria for this study

1. Known or suspected septic shock or bacteremia
2. Active bleeding or HCT\<24% at baseline
3. Arterial oxygen saturation \<90% at baseline despite supplemental oxygen therapy.
4. Previous difficulty with venipuncture of upper extremity veins or the presence of a surgical arteriovenous fistula for hemodialysis
5. Insertion of the PA catheter through the femoral vein
6. Subjects unwilling or unable to provide written consent
Soluble CD146 and Proteinuria in Chronic Renal Disease

Chronic renal disease (CKD) is defined as a decrease in glomerular filtration rate (GFR) and / or proteinuria or albuminuria (a protein present in urine). Albuminuria is considered a marker of endothelial dysfunction. Proteinuria and / or albuminuria are recognized as cardiovascular risk factors in both diabetic and non-diabetic populations, independently of GFR. It is also a marker of progression of kidney disease. cluster of differentiation 146 (CD146) is an endothelial adhesion molecule with preferential localization in the junction. Soluble CD146 (or CD146s). CD146s is a biomarker of endothelial dysfunction that is easy to assay. The increase in CD146 levels was described during the MRC, especially in diabetic patients with significant proteinuria. In two independent cohorts of patients with CDR, CD146s did not correlate with creatinine or GFR but appeared to correlate with proteinuria.

The aim of our study is to determine whether the blood concentration of CD146s is correlated with proteinuria independently of GFR. For this purpose, we propose this study in the kidney nephrology and transplantation center of Conception Hospital, with the objective of highlighting the link between proteinuria and serum CD146 levels in patients with CKD, whatever their renal function and / or underlying pathology. 205 patients will be included over two years with dosing of CD146s and proteinuria at the same time. These 205 patients will be recruited at each stage of the CKD (41 in each arm). CD146s could be a new biomarker predicting the risk of renal function impairment or cardiovascular risk independent of renal function.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject aged 18 years or over
* Subject capable of giving informed consent
* Patient with chronic kidney disease (stage 1 to 5 CKD regardless of etiology)

Exclusion Criteria:

* Pregnant or lactating woman
* Person deprived of liberty or hospitalized without consent
* Major under legal protection or unable to express his consent
* Refusal of the patient
* Patient with a history of kidney transplantation
* Evolutionary cancer
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.

Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
* Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
* Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
* Able to keep accurate seizure diaries

Exclusion Criteria:

* Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
* History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
* Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
* History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
* History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment.
* Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
Statin Use in Abdominal Aortic Aneurysm Repair

Aneurysm formation is associated with a chronic inflammatory response, depletion of smooth muscle cell population and excessive matrix metalloproteinases (MMPs) production. 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) are lipid lowering agents with pleiotropic effects including anti-inflammatory activity. Elective open AAA repair patients will be randomised to receive either statin (Atorvastatin 80 mg) or placebo (dummy tablet) for 4 weeks pre-operatively. Tissue samples will be obtained from patient's aneurysm to assess MMP's and their inhibitors TIMP's. It is hypothesized that patients receiving statin will have reduced MMP's.

All patients listed for elective open AAA repair will be screened for suitability to participate within the study. In this double blind randomized control trial patients will be recruited through vascular surgical outpatient clinics. After inclusion, informed consent and evaluation of base line characteristics patients will be given a prescription for study medication. This prescription was exchanged by the patient for medication at the hospital pharmacy. Randomization will be carried out by pharmacy with computer generated sequence with a sub group size of 4. This will ascertain the order of prescribed drug/ placebo. Pharmacy then dispensed the drug/ placebo in this order. Drug used will be Atorvastatin 80 mg, white, elliptical, film coated tablets debossed '80' on one side and 'PD 158' on the other side. The placebo is similar in shape and colour. Drug/ placebo will be given for 4 weeks pre-operatively. Full thickness infrarenal aortic samples will obtained at time of operation and the exact sample site will be recorded. Samples will be washed with 0.9% saline to remove blood and clots, snap-frozen and stored at -80C for subsequent MMP 2, 8 and 9 and TIMP 1 and 2 analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an AAA \>5.5cm diameter listed for open AAA repair at least 3 weeks from screening attendance.

Exclusion Criteria:

* Patients already on statin,
* inability to provide informed written consent,
* contraindication to statin (intrinsic liver disease,
* chronic alcohol abuse, impaired renal function, unstable hypothyroidism,
* unexplained muscle aches, hypersensitivity to atorvastatin or any of its components),
* previous unilateral or bilateral lower limb amputation and concomitant use of fibrates,
* erythromycin,
* immunosuppressive drugs,
* antifungal drugs or lipid lowering drugs.