cyrilzakka/clinical-trials huggingface dataset:
An Observational Monocentric Study Investigating the Association Between Trough Serum Levels of Etanercept, Antibodies Towards Etanercept and Its Effectiveness in Psoriasis Patients

The purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 years on, male or female
* Established diagnosis of psoriasis
* Etanercept either on monotherapy or in combination with acitretin (Neotigason®), given according to the current EU SmPC including the safety measures.
* Patients who give informed consent for this study
Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® in Korean Patients With Acute Myocardial Infarction

To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations:

1. Unexpected adverse drug reactions
2. Frequency and nature of adverse events (AEs)
3. Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of Metalyse® was also assessed.


Eligibility Criteria:
Inclusion Criteria:

* none

Exclusion Criteria:

* none
Gabapentin and Chronic Post Surgical Pain

The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

Pain after surgery can last for a long time. When it lasts for over two months, it is considered chronic postsurgical pain (CPSP). This is a problem in kids and adolescents that can impact many areas of the patient's life and their family. Many patients who undergo surgery for their scoliosis develop CPSP. The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

Eligibility Criteria:
Inclusion Criteria:

* Be aged 10-18 years at the time of surgery
* Have a diagnosis of idiopathic scoliosis and/or kyphosis
* Be undergoing elective posterior spinal fusion
* Have only mild systemic disease

Exclusion Criteria:

* A diagnosis of neuromuscular scoliosis and/or kyphosis
* A diagnosis of chronic pain
* Used opioids in the past 6 months
* Developmental delay
* Liver or kidney disease
* Obstructive sleep apnea
* Body mass index \>40
* Be pregnant or breastfeeding
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)

Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.

Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.

In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Patients is suspected indetermined biliary strictures
* Patients have the indication for ERCP

Exclusion Criteria:

* ERCP failed, or can not obtain bile
* Sever comorbidities
* Predicted overall survival less than 1 year because of other disease
* Patients who are unlikely to comply with the protocol, inability to return for subsequent visits
Treatment of Tibial Plateau Fractures With Bone-graft and Bone Tamp Technique

Autologous ICBG and bone tamp methods are often applied to manage depressed tibial plateau fracture (DTPF), but previous iliac bone harvesting and bone tamp techniques remain controversial. The purpose of this study is to describe and evaluate the technique of using structural bicortical autologous iliac crest bone-graft (ICBG) combined with tunnel bone tamps method (TBTM) in treating DTPFs.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (age ≥ 18 years);
* diagnosis of DTPFs;
* agreeing to receive structural bicortical autologous ICBG combined with TBTM treatment and subsequent internal fixation treatment;
* agreeing to participate in regular follow-up after surgery.

Exclusion Criteria:

* open fracture;
* pathologic fractures;
* bone metabolic disease;
* previous ICBG;
* infection or soft tissue injury of the iliac bone donor site;
* pelvic fractures or bone tumors;
* associated peripheral nerve injury;
* non-completion of 30 months follow-up.
Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction

Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages.

The most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment.

The immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition.

The objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.


Eligibility Criteria:
Inclusion Criteria:

Patients should have signed written informed consent. Adult patients ≥18 years of age at the time of enrolment Patients recipients of a uni or bipulmonary transplant An established diagnosis of BOS ≧ 0p (FEV1≤90% and / or FEF 25-75% ≤ of the baseline value with no other justifying cause) in the last 6 months.

Exclusion Criteria:

* History of lobar transplantation History of heart-lung transplantation Active infection at the time of inclusion. Active Acute Rejection not treated at the time of inclusion. Oncological history (except cutaneous basal cell or carcinoma in situ) Systemic autoimmune diseases. Active HIV / HBV / HCV infection (confirmed by serology or PCR) Proximal airway stenosis Pregnancy Performance status 3 or 4 (confined to bed or chair for more than 50% of waking hours, able only to perform some self-care activities) Estimated survival less than 3 months. Known hypersensitivity to components used in the production of allogeneic MSCs. Any circumstance that, in the opinion of the investigator, compromises the patient's ability to participate in the clinical trial.
Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3

This study will enroll parents/guardians of children who receive treatment at one of the pediatric primary care practice settings in the Pediatric Research in Office Settings (PROS) network or at the Children's Hospital of Philadelphia's Pediatric Research Consortium (PeRC) network.

The study will use an evidence-based conceptual model to study determinants of implementation success, implementation outcomes, and health care outcomes resulting from implementing an already functional, electronic health record (EHR)-linked asthma portal, MyAsthma. The study will measure the portal's feasibility and determine the impact on providing asthma education and fostering patient engagement as well as the ability to collect patient-reported outcomes for children, evaluate medication use and side effects and track parents' preferences and goals.

This study uses a newly published, evidence-based conceptual model to study the determinants of implementation success, implementation outcomes, and health care outcomes resulting from implementing an asthma portal, MyAsthma, in the national, Agency for Health Care Research and Quality(AHRQ)-funded, Center for Pediatric Practice Research and Learning. Technically, the portal will be implemented with 2 innovative approaches that facilitate rapid cycle evaluation in multiple Electronic Health Records (EHRs). Although many patient portals are simple vehicles for transferring information about upcoming appointments, test results or laboratory findings, the asthma portal in this project extends this basic functionality to provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' preferences and goals. Because asthma is an AHRQ priority condition which addresses three AHRQ priority criteria (children, low income, and special health care needs), our study will use this population to focus on stage 3 Meaningful Use (MU3) objectives. It is the hope that by conducting this study, translational knowledge will be gained to make recommendations for practice implementation and actionable policy statements.

Eligibility Criteria:
Inclusion Criteria For Parents/Guardians:

1. Parent/guardian of a child who:

   * Is between the ages of 6-12 years old
   * Has a diagnosis of asthma on his/her problem list at the time of recruitment
   * Has had an office visit with asthma as a diagnosis within the past 12 months
2. Must be able to speak and read English

Exclusion Criteria For Parents/Guardians:

1. Child has not had an office visit for asthma with in the last 12 months
2. Parent or guardian does not speak or read English
Video and Brochure and Discharge Instructions for Childhood Fever in the Pediatric Emergency Department

This study was designed to evaluate whether adding Video discharge instructions to usual verbal information improves understanding of the information provided to caregivers of patients presenting to pediatric emergency departments for high fever. As secondary goals, it was aimed to assess whether video discharge instructions increase satisfaction with information received and reduce repeat visits.

The research will be carried out in a randomized controlled manner. There will be three groups in the research: those who received video (intervention), brochure (intervention) and verbal (control) discharge instructions. A power analysis was performed based on the number of children in both groups, in another study in which the scales to be used in the research were used. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 48 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be assigned a random number to the intervention and control groups via http://www.randomize.org/ by numbering the order of arrival at the hospital. Research data will be collected using Descriptive Information Form and Parental Fever Management Scale and Post-Discharge Data Collection Form.

Eligibility Criteria:
Inclusion Criteria:

* The child is between 1 month and 18 years old
* Parent's consent to participate in the research
* Parent's completion of all pre-and post-education follow-up

Exclusion Criteria:

* The child is not between 1 month and 18 years old
* The child does not undergo day surgery.
* Parent's refusal to participate in the research
* Parent not completing all pre- and post-education follow-up
Non Coeliac Gluten Sensitivity in Children

Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is difficult, often resulting in a persistence of chronical abdominal pain.

In adults, many patients affected by IBS improve under a gluten-free diet, even in the absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the pathophysiological mechanisms also remain elusive.

The aim of this study is to determine if NCGS exists in children with IBS and to identify the clinical, serological, and histological characteristics, which could distinguish patients with NCGS from conventional IBS and CD patients.

This is a prospective cohort study in a population of children affected by a moderate to severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks. Then, children who improved under GFD were randomized in two groups for a double-blind placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out period, then a placebo reintroduction, whereas the other group had the placebo first, then the wash-out and the gluten reintroduction.


Eligibility Criteria:
Inclusion Criteria:

* children with Irritable Bowel Syndrome (IBS)

Exclusion Criteria:

* children with Celiac Disease (CD)
* children with wheat allergy
Robotic MIS With Dexter

The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Patient agrees to perform the 30-day follow-up assessment
* Able to provide signed Informed Consent, according to local regulation

Exclusion Criteria:

* Morbidly obese patients.
* Any and all relative and absolute contraindications to endoscopic surgical technique applicable to the use of conventional endoscopic surgical instruments.
* Bleeding diathesis.
* Pregnancy.
* Patients with pacemakers or internal defibrillators.
* Any planned concomitant procedures.
* Patient deprived of liberty by administrative or judicial decision or under legal guardianship.
* Participation in another interventional clinical trial.
Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder

The main objective of the research is to study the effectiveness of an ambulatory rehabilitation program based on mobilization and muscular solicitation, during painful shoulders by full-thickness degenerative rupture of the tendons of the rotator cuff. , with the algo-functional state, ie pain and activity limitation, as judgment criteria, at 3 months.

Our hypothesis is that rehabilitation based on mobilization and muscular solicitation is effective in painful shoulder due to degenerative rupture of the tendons of the rotator cuff; that it reduces pain, functional limitation and the need for surgery.

Research Excluding health products:

Experimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation

Control group: Ambulatory rehabilitation program using of ultrasound physiotherapy

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 55 years old,
2. Painful shoulder for at least 1 month,
3. Shoulder treated with at least one cortisone infiltration one month or more before inclusion,
4. Pain ≥ 40/100 on visual analog scale,
5. Pain reproduced by at least one clinical test of rotator cuff tendons or subacromial impingement (Jobe, Patte, Neer, Yocum test, Hawkins),
6. Full-thickness tear of at least one tendon of the rotator cuff attested by imaging,
7. Affiliation to social security

Exclusion Criteria:

1. Passive glenohumeral mobility of the shoulder limited,
2. Calcifying tendinopathy on standard radiography,
3. Glenohumeral arthropathy;
4. Painful acromioclavicular arthropathy;
5. History of shoulder fracture;
6. Neurogenic pain or neurogenic motor deficit of the upper limb;
7. Cortisone infiltration of the shoulder in the month preceding inclusion;
8. Operated shoulder;
9. Systemic pathologies including inflammatory rheumatism or neoplastic pathology;
10. Patient participating in another experimental research;
11. Patient under legal protection (curators or guardianship)
12. Patient deprived of liberty by a judicial or administrative decision
13. Pregnant or breastfeeding woman
Heart Failure Medication Adherence

The objective of this investigation is to pilot test a medication in-hand intervention (Meds to Beds) compared to standard care for patients with heart failure (ICD-50\[all numbers\]). The study will evaluate if the intervention improves adherence and physical health, and reduces hospital re-admissions. The study will provide evidence for the feasibility and acceptability of the medication-in-hand intervention.


Eligibility Criteria:
Inclusion Criteria:

* Admission diagnosis of heart failure ICD-50, including I50.1, I50.2, I50.20, I50.21, I50.22, I50.23, I50.3, I50.30, I50.31, I50.32, I50.33, I50.4, I50.40, I50.41, I50.42, I50.43, I50.8, I50.81, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, I50.9, or any combination thereof
* Age 18 or older
* New York Heart Association Heart Failure Class II or Class III, with ejection fraction below 45%
* Cognitively intact, without significant psychological impairment affecting medication adherence such as dementia noted in patient record.

Exclusion Criteria:

* Medical conditions, such as active cancer or pregnancy, expected to alter heart failure medication management
* Discharged to nursing homes or hospice care, where patient may not responsible for their own adherence
* High risk of loss to follow-up, e.g., leaving the hospital against medical advice, prisoners, living in a homeless shelter, or unable to provide a phone number
* No plan to fill medications at the Jackson Memorial Hospital pharmacy
Femoral/Sciatic Block for Knee Surgery

Knee arthroplasty has a high potential for postoperative pain. This study compares analgesia and postoperative bleeding from intrathecal morphine with the continuous femoral and a single-shot sciatic nerve blockades.

This study aims to compare intrathecal morphine as a technique for analgesia with the femoral nerve blockade associated with a single-shot sciatic nerve blockade. Analgesic efficacy, the incidence of adverse effects, and postoperative bleeding were evaluated

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old, American Society of Anesthesiologists (ASA) physical status from I to III who underwent total knee arthroplasty

Exclusion Criteria:

* Patients aged below 18 years old, ASA IV or V physical status, infection near the puncture site, coagulation disorders, preexisting neurological disorders, allergy report to local anesthetics, pregnancy and lactation, contraindications to spinal block and refusal to sign an informed consent form
A Novel Portable Upper Gastrointestinal Endoscopy System

The application of conventional endoscopy in remote and outdoor areas lacking facilities remains challenges. Thus, the investigators developed a novel portable upper gastrointestinal endoscopy system that has the same functions as conventional endoscopy. A total of 24 participants from a medical unit on a remote island in China underwent endoscopy with the portable system between March and June 2021. The portable system packed into a suitcase is 68 × 42 × 32 cm in size, weighing less than 35 kg, and comprises a disposable sheathed system.

The application of conventional endoscopy in remote and outdoor areas lacking facilities remains challenges. Thus, the investigators developed a novel portable upper gastrointestinal endoscopy system that has the same functions as conventional endoscopy. A total of 24 participants from a medical unit on a remote island in China underwent endoscopy with the portable system between March and June 2021. The portable system packed into a suitcase is 68 × 42 × 32 cm in size, weighing less than 35 kg, and comprises a disposable sheathed system. The examination time and any malfunctions in the portable endoscopy system during the examination were recorded. After the examination was finished, the disposable sheathed system was removed, and a pressure leak test was performed to check the seal of the system. The patients were followed up within three days to confirm any adverse events such as nausea, vomiting, throat discomfort, bleeding, etc.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endoscopy examination with the portable system were aged from 18-70 years and presented with upper abdominal complaints.

Exclusion Criteria:

* The exclusion criteria were the same as the contraindications for conventional upper GI endoscopy and included latex allergy
The Predictive Factors of Vision Recovery in Patients With Pituitary Tumor

Pituitary adenomas can cause compression of optic nerves and chiasm, which will lead to damage of vision. This study aims to evaluate the predictive factors for recovery of vision in patients with pituitary adenomas following trans-sphenoidal surgery.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* patients with pituitary adenomas, loss of visual field
* patients receive trans-sphenoidal surgery

Exclusion Criteria:

* visual damage caused by other diseases
Placement of Antibiotic Powder in Wounds During the Emergency Room

This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.

Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.

Eligibility Criteria:
Inclusion Criteria:

* Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.
* Adult 18 years of age or older.
* Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
* 24 hours or less has elapsed from the estimated time of injury to study intervention.

Exclusion Criteria:

* Time from injury \> 24 hours.
* Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
* Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).
* High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.
* Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
* Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.
* Prisoners.
* Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.