cyrilzakka/clinical-trials huggingface dataset:
Comparison of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia in Children Undergoing Orchiopexy

Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.

However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.

In order to decrease postoperative analgesic requirements after caudal block, various drugs such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been investigated. However, their use has been limited by adverse effects in children.

Recently, many study suggested that epidurally administered dexamethasone could reduce the incidence and severity of postoperative pain in adults. But there is no study concerning the use of dexamethasone, as an adjuvant agent for the caudal epidural block in children.

The investigators performed prospective randomized double-blind study to examine the analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal analgesia on postoperative pain control in pediatric patients undergoing orchiopexy.

80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this prospective, randomized, double-blinded study. After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R , dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration of hospital stay, an expected average of 3 hours.

After discharge, rescue analgesic consumption, pain scores, and adverse effects were evaluated for 24h.

The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.


Eligibility Criteria:
Inclusion Criteria:

* ASA status I-II
* Children aged 6 months to 5 years
* Undergoing day-case unilateral orchiopexy

Exclusion Criteria:

* Hypersensitivity to any local anesthetics
* Bleeding diathesis
* Infections at puncture sites
* Preexisting neurological disease
* Diabetes mellitus
A Study of HM10760A (Long-acting Erythropoietin (EPO)) in Healthy Korean Subjects

Study design:

* Randomized, double-blind, placebo-controlled, sequential dose escalation
* Six ascending dose cohorts are planned

Primary Objective:

* To evaluate the safety profile of single escalating intravenous dose levels of HM10760A

Secondary objectives:

* To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters including hemoglobin, reticulocyte count, and reticulocyte hemoglobin content
* To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A
* To determine the pharmacologically active dose(PAD) of HM10760A
* To assess the immunogenicity of a single IV dose of HM10760A

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 55 years
* Able and willing to provided written informed consent
* Hemoglobin \< 16 g/dL

Exclusion Criteria:

* Prior exposure to EPO, darbepoetin, other EPO support proteins
* hypersensitivity to EPO, darbepoetin, E.coli derived proteins
* Hemoglobinopathy
* SBP \> 140 mmHg or \< 90 mmHg or DBP \> 95 mmHg
* Chronic, uncontrolled, or symptomatic inflammatory disease
* Malignancy(except non-melanoma skin cancer)
Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from lower limb spasticity following stroke
* With at least a 12-week interval between the last BoNT-A injection and inclusion
* Decision already been agreed to inject BoNT-A

Exclusion Criteria:

* Documented positive antigenicity to botulinum toxin
* Any neuromuscular junction indication
* Severe muscle atrophy in any muscle to be injected
* Any other indication that might interfere with rehabilitation or the evaluation of results
The Use of Optical Oximetry in Determining Gastrointestinal Complications After the Hybrid Procedure

This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Advances in the technology and recent approval of the use of CASMED devices for this purpose will allow us to use this technology more effectively. We aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (BAS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of single ventricle and undergoing the hybrid procedure pathway.

Exclusion Criteria:

* None
Efficacy of Ultrasound-Guided Needle Knife Release for Trigger Finger

Efficacy of ultrasound-guided tri-directional needle knife release in treating patients with trigger finger. The study evaluates safety, effectiveness, and recovery outcomes of a minimally invasive procedure compared to conventional approaches.

This is a clinical trial designed to investigate the efficacy and safety of ultrasound-guided tri-directional needle knife release in patients with trigger finger, especially those patients for whom conservative treatments have failed. Trigger finger is caused by of thickening of the A1 pulley, leading to pain and stiffness, which results in limitation of the hand. The procedure will be carried out under local anesthesia and guided by ultrasound to be very accurate and safe, avoiding all possible risks. Patients will be assessed for better improvement in hand functioning, pain scale basing on visual analog scale, and above all patient overall satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic TF at the level of A1 pulley
* Trigger finger of Green's grades II or III or IV (moderate to severe)
* Symptoms persist for at least three months despite conservative treatments.
* Ability to provide informed consent and comply with follow-up requirements.

Exclusion Criteria:

* Patients with secondary causes of TF like diabetes mellitus, rheumatoid arthritis, gout, hypothyroidism, amyloidosis, and sarcoidosis.
* Patients with TF of Green's grade I.
* Previous surgical intervention on the affected digit.
* Allergy or contraindication to local anesthetics.
* Pregnancy or lactation.
* Inability to comply with follow-up assessments.
Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis

Antimicrobial resistance has emerged as a global threat, and multidrug resistance organisms (MDROs) form one of the foremost challenges in the setting of decompensated cirrhosis. In a worldwide study, a high prevalence (34%) of infection with MDR bacteria in patients with cirrhosis and associated with higher in-hospital mortality.

Previous study indicated that the pattern of colonized bacteria in heterogeneous and the colonization by MDROs is associated with increased risk of infection. Effort should be made to reduce the spread of MDR bacteria and improvement in prognosis in patents with cirrhosis. Currently, strategies suggested to prevent the spread of MDROs in cirrhosis, including rapid microbiological tests, new first-line antibiotic schedules, infection control practices and epidemiological surveillance.

Thus, for the aims of this cohort study are as following. Firstly, to characterize the burden, dynamics and risk factors associated with rectal colonization by MDROs in patients with cirrhosis. Secondly, to completely characterize the risk that asymptomatic carriers of MDROs, both to other patients and to themselves via collecting detailed longitudinal sampling and high-resolution typing. Lastly, to generate evidence for future policymaking for individualized antimicrobial decision rather than umbrella guidelines since the variance in the bacteriological profiles in different settings.


Eligibility Criteria:
Inclusion Criteria:

1. Age\>18 years old;
2. Inpatients;
3. Cirrhosis patients with acute decompensation;

Exclusion Criteria:

1. Patients decline any swab type;
2. Patients had liver resection or other organ transplantation;
3. Patients who had participated in, or are planning to participate in other clinical trial within the 3 months prior to enrollment;
4. Hospital stays \<48 hours;
5. Not suitable to participate in this study judging by researchers;
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)

The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity


Eligibility Criteria:
Inclusion Criteria:

* Active IgG4-RD
* Compatible pattern of organ involvement consistent with IgG4-RD that cannot be attributed to other causes
* Histopathologically-proven diagnosis of IgG4-RD
* Peripheral blood plasmablast count \>900 cells/mL and/or elevated IgG4-RD levels during screening
* Able and willing to complete the entire study according to the study schedule
* Able and willing to provide written informed consent

Exclusion Criteria:

* History or evidence of a clinically unstable/uncontrolled disorder, condition or disease other than IgG4-RD that, in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
* Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no recurrence ≥3 years following prostatectomy)
* Presence of recurrent or chronic infections, defined as ≥3 infections requiring antimicrobials over the past 6 months prior to screening
* Active infection requiring hospitalization or treatment with parenteral antimicrobials within the 60 days prior to randomization or oral antimicrobials within the 21 days prior to enrollment
* Patient is taking \>40 mg of prednisone QD
* Prior use of rituximab (or other B cell depleting agents) within 6 months of enrollment. Prior use of any B cell depleting agent greater than 6 months from enrollment is allowed if the CD19+ B cell count is within the normal reference range during screening
* Use of any investigational agent within 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment
* Immunosuppressive agent use within the three months prior to enrollment
* Has received live vaccines within 2 months of enrollment
* Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to end-of-study visit
* Unable or unwilling to partake in the follow-up assessments or required protocol procedures
Contrast Enhanced MRI of the Prostate

Prostate cancer detection and disease progression monitoring relies on systematic multi-core biopsies. Minimal invasive imaging capacities for lesion targeting and monitoring are badly needed. The purpose of this study is to determine if a new MRI technique can identify and monitor prostate disease progression. If so biopsy core number can be reduced to as small as one, and frequency for biopsy repeat can be reduced. The new technique is about a new way of analyzing the pictures taken as part of prostate MRI exam. This part is called dynamic contrast-enhanced MRI. It involves an injection of contrast reagent (or dye) through the arm vein during a time period when prostate MRI pictures are continuously taken.

The aim of the study is to perform contrast-enhanced (CE) magnetic resonance imaging (MRI) at OHSU on subjects with diagnosed prostate cancer. This pilot project will study 20 subjects prior to their next scheduled clinical procedures (biopsy or radical prostatectomy). Data from this project will be used to explore new capabilities of the software platform developed under current SBIR funding. CE-MRI will involve the use of an extracellular (Gadolinium based, Gd) contrast agent. When Gd is used, (dynamic-contrast-enhanced) DCE-MRI signal intensity time-course data will be analyzed analytically using the so called "shutter-speed" paradigm which takes into account of the effects of finite water exchange kinetics. Region of interest (ROI) and high resolution (\~millimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the DCE-MRI data. All parameters will be compared to literature results for software validation and correlated with pathology for clinical potential.

Eligibility Criteria:
Inclusion Criteria:

* Men, age \>18 years.
* Any patient scheduled for prostate biopsy repeat or radical prostatectomy.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* Patients who are unable to cooperate for an MRI exam.
* Major surgery within a month of enrollment.
* Prostate biopsy six weeks prior to enrollment.
* Subject-reported reaction to gadolinium contrast reagent.
Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa

The objective of the study is to evaluate the long-term safety and efficacy of a sub-retinal injection of BIIB111 in participants with Choroideremia (CHM) who have been previously treated with BIIB111 and who have exited an antecedent study; these treated participants will be compared with untreated control participants who have exited the STAR (NCT03496012) study and BIIB112 in participants with X-linked retinitis pigmentosa (XLRP) who have been previously treated with BIIB112 and who have exited an antecedent study.

This study was previously posted by NightstaRx Ltd. In October 2020, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

CHM Participants

a. Have participated in and exited from an interventional study that investigated the safety and efficacy of a sub-retinal injection of BIIB111 for CHM.

XLRP Participants

a. Have received a sub-retinal injection of BIIB112 for XLRP and have exited an antecedent study.

Key Exclusion Criteria:

Participants are not eligible for study participation if they meet the following exclusion criterion.

a. In the opinion of the Investigator and/or the Sponsor, it is not in the participant's best interest to participate in the study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Influence of Resident's Degree of Formation on the Quality of Care Delivered to the Patients.

The aim of this study is to evaluation the influence of the resident in anesthesiology's degree of formation on the quality of care delivered to the patient.

The aim of this study is to evaluation the influence of the resident in anesthesiology's degree of formation on the quality of care delivered to the patient.

To perform it, the investigators will enrolled all of the patients scheduled for an axillary plexus anesthesia technique in the Clinique Saint-Luc of Bouge in September 2018 (end of formation for the residents in anesthesia) and compare the patient's degree of satisfaction with the patients scheduled for the same kind of anesthesia on October and November 2018 (begin of formation for the residents in anesthesia).

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for hand surgery under axillary plexus

Exclusion Criteria:

* Patient's refusal
Effect of Omega-3 Fatty Acid on Cortical Function in ADHD

The study hypothesis is that DHA is more effective than placebo in increasing brain activation and reducing symptoms in psychostimulant-free children with ADHD.

This study aims to determine the effects of 10-week dietary supplementation with the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) or placebo on prefrontal cortical structural and functional connectivity using several neuroimaging techniques: DTI (Diffusion Tensor Imaging), 1H MRS(Proton Magnetic Resonance Spectroscopy), and fMRI (Functional Magnetic Resonance Imaging) in psychostimulant-free children with attention deficit hyperactivity disorder (ADHD). It is postulated that DHA supplements will increase brain activation and reduce ADHD symptomatology.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent/assent
* Ages 5-15 years old
* Meets DSM-IV-TR criteria for ADHD as determined by the KSADS

Exclusion Criteria:

* Contraindication to an MRI scan (i.e., braces, claustrophobia)
* A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy)
* Greater than 1 year outside appropriate age/grade level
* A history of intolerance or hypersensitivity to omega-3 fatty acids
* Currently taking omega-3 supplements
* Not proficient in English language
* Any history of a hematological disorder or concomitant use of anticoagulant medications
* Personal history of an Axis I psychiatric disorder other than ADHD
* Inability to swallow capsules
Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients

To compare the effects of supervised endurance training versus home based exercise plan on functional capacity and fatigue among pulmonary arterial hypertension patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary arterial hypertension, not pregnant and tobacco free.
* Age = 21 to 82
* Patients with documented PAH diagnosed by echocardiography (enlarged RA an enlarged RV with a thick wall, septal shift by enlarged chambers of right side of heart, an elevated mPAP) or a resting mean pulmonary arterial pressure equal to 25mm Hg determined by right heart catheterization.
* Patients on stable PH therapies, sedentary, and had no pulmonary rehabilitation for 6 months prior to enrolment.

Exclusion Criteria:

* Patients will be excluded if they are not able to complete 6MWT.
* A documented pulmonary capillary wedge pressure greater then or equal to 15 mm Hg.
* Significant hepatic, renal, metabolic or mitochondrial dysfunctions; severe psychiatric disease; use of beta-adrenergic blockers or antiretroviral therapies; and any musculoskeletal or neurological condition that would limit walking or exercise performance.
* Patients with a history of heart failure.
The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren

The purpose of this study is to investigate if the blue-light filtering spectacle lenses promote myopia progression in schoolchildren.

The effect of blue light on ocular health has been studied extensively. Shorter wavelength such as blue light could cause damage to the retina. The damage was more evident in the ageing eye. Since the tablets and mobile with blue LED backlight display are widely used, thus blue-light filtering spectacle lenses are now available in the market. However, whether this kind of lenses could affect the eye growth in schoolchildren is unknown. This study is then designed to investigate if the blue-light filtering spectacle lenses affect myopia progression in Hong Kong Chinese schoolchildren. The schoolchildren will be randomly allocated to either blue-light filtering spectacle lens group (treated) or conventional spectacle lens group (control). Their axial length and refraction will be monitored every 6 months for 2 years. The changes between two group will then be compared.

Eligibility Criteria:
Inclusion Criteria:

* Refraction: myopia of -1.00 dioptres (D) to -5.00D
* Astigmatism: equal or less than -1.50D
* Anisometropia: equal or less than 1.00D
* Best corrected monocular visual acuity: 0.0 LogMAR or better after full correction
* Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

* any ocular and systemic abnormalities might affect visual functions or refractive development
* prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
Prospective Feasibility Study of Point-of-care Ultrasound in Suspected Aortic Dissection

Aortic dissection is an uncommon and serious pathology. Its diagnosis is difficult because of the varied and silent clinical presentations. The development of ultrasound in emergency medicine is an asset in certain pathologies. The aim of this study is therefore to study the feasibility of a protocol integrating clinical ultrasound in the suspicion of acute aortic dissection in the hospital setting. This study is a single-center prospective interventional study. In which the investigators perform ultrasound in patients with suspected acute aortic dissection in the emergency department. If the protocol is feasible and if it allows a saving of time in the diagnosis or an increase in diagnoses, the investigators will be able to evoke a profitability to the systematic realization of this examination.

H0: patient selection and inclusion:

* Presentation of the study
* Delivery of the information note / no objection to the patient if he/she is in a state to consent
* Emergency procedure:

In accordance with article L-1122-1-3 of the public health code, patients may be included in the study at the initiative of the physician without seeking prior consent. This procedure will be associated with a prior call to the relatives to obtain an oral consent in principle (traced in the patient's medical file), while waiting for the delivery of the information note / no objection to the relatives and then to the patient as soon as his condition allows it.

H1: inclusion interview then :

Medical interrogation (retrospective collection if already done / but additional requests if missing data).

Clinical examination (complementary if missing data).

Ultrasound with 3 ultrasound sections to be performed: parasternal long axis, supra-sternal and abdominal, looking for the following signs:

Direct signs: presence of an intimal flap, intramural aortic hematoma \> 5mm, penetrating aortic ulcer.

Indirect signs: pericardial effusion, aortic dilatation ≥ 4 cm, tamponade (1).

H4: retrospective collection of the results of complementary examinations if any, biological and radiological, and collection of the final diagnosis retained.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-95 years included
* Non-opposition of the subject to participate in the study
* All patients admitted to the emergency department of the Besançon University Hospital With chest, abdominal, back, lumbar pain, or acute headache
* AORTA score ≥ 1
* Clinical suspicion of AD by the emergency physician

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
* Subject without health insurance
* Pregnant woman
* ECG showing acute coronary syndrome and/or ventricular rhythm disturbances
* Traumatic context, or traumatic cause of pain
* Chronic / subacute dissection (patient with incidental discovery of aortic dissection (city assessment) and then referred to the emergency room).
* Patient refusal to participate in the study