cyrilzakka/clinical-trials huggingface dataset:
A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.

The study aims to compare the outcomes of a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) and the standard brachiocephalic arteriovenous fistula (BCAVF) for long-term hemodialysis patients. Briefly, in mNT-BBAVF, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. All the perforating in the surgical field should be ligated. All patients will be followed up for 12 months after surgeries. The outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, Complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency).

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years;
* Radial artery diameter \<2.0 mm or cephalic vein diameter in the forearm \<2.5 mm;
* Brachial artery diameter ≥ 2 mm

Exclusion Criteria:

* Stenosis or thrombosis present in the draining vein;
* A history of peripheral ischemia in upper extremities;
* Active local or systemic infections;
* Inability to consent for the procedure;
* Patients with previous dysfunctional forearm fistula.
Peer Coaching Intervention in Young Adults With Congenital Heart Disease

The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.

Our research team has developed a peer coaching intervention that has been deployed to promote activated self-management for AYAs with several conditions, and this has been modified adolescents and young adults (AYA) with with congenital heart disease (CHD). This study will be conducted over two years and pair AYA with CHD with a peer coach who also has CHD has successfully navigated the transition to adult medical care and over six months will work to promote the motivation for self-care as well as the development of self-management skills. This pilot study will test feasibility and acceptability, as well as preliminary efficacy and long-term effects on successful transfer to adult cardiology.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-26
* Diagnosis of congenital heart disease
* Patient at a Duke pediatric cardiology clinic
* Access to a smart phone

Exclusion Criteria:

* Cognitive delay
* Patient at an adult cardiology clinic
Role of Interleukin 18 (IL-18) and Interleukin 18 Binding Protein (IL-18BP) in the Diagnostic Work-up of Systemic Juvenile Idiopathic Arthritis and Autoinflammatory Diseases: Possible Biomarkers in the Differential Diagnosis of Other Febrile Diseases

Literature data suggest that elevated blood values of IL-18 and IL-18 Binding Protein and alterations in their ratio may be significantly correlated with various autoinflammatory diseases, such as systemic juvenile idiopathic arthritis, recurrent autoinflammatory fevers etc. In this view, the clinical implication of this observational, prospective, single-centre, non-pharmacological study will be the definition of new laboratory markers that may be useful in the early differential diagnosis of certain rare and serious paediatric diseases.

The primary aim of this study is to investigate the role of IL-18 and IL-18 Binding Protein as biomarkers of systemic Juvenile Idiopathic Arthritis and recurrent autoinflammatory fevers, while the secondary one is to investigate the superiority of IL-18 and IL-18 Binding Protein over other cytokines and inflammatory indexes in the differential diagnosis of systemic Juvenile Idiopathic Arthritis and recurrent fevers of an autoinflammatory nature.

The study will enroll patients referred to the Pediatric Rheumatology Outpatient Clinic of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy, for suspected Juvenile Idiopathic Arthritis or suspected recurrent fever/self-inflammatory disease.

Patients will be enrolled during the acute phase of the disease and, prior to the start of immunosuppressive therapy (i.e. corticosteroids, colchicine, biological drugs), a blood sample will be taken for haematochemical investigations, according to clinical practice, as well as an additional blood sample for the assay of IL-18 and IL-18 Binding Protein.

The following variables will be considered for each patient: demographic data; key clinical features; haemochromocytometric test; liver and kidney function tests; indexes of inflammation and acute phase proteins; inflammatory cytokines panel; serum values of IL-18 and IL-18 Binding Protein.

Eligibility Criteria:
Inclusion Criteria:

* Age between 2 years and 18 years;
* Being affected by 1 of the following: Juvenile Idiopathic Arthritis; recurrent fever/ autoinflammatory disease; rheumatic disease; severe infectious diseases (sepsis, meningitis, urinary tract infection, lower respiratory tract infection);
* Obtaining informed consent from parents/legal guardians of paediatric patients.

Exclusion Criteria:

• Patients in whom the suspicion of rheumatic disease is based on a finding of subclinical carditis or chorea.
Evaluation of Learning Curve of Manual Skills in Anesthesia Residents

To determine number of cases need to perform in new anesthesia residents to be proficient in manual skills.

Manual skills in anesthesia are complex and unique to learn. The adequate cases need to be done to reach optimal success rate for each procedure is still varied from data available from the publications.

This study is designed to evaluate the number of cases need to perform in new anesthesia residents to be proficient in anesthesia skills, which are intubation, laryngeal mask insertion, spinal anesthesia, epidural anesthesia, radial artery cannulation and internal jugular vein cannulation.

Eligibility Criteria:
Inclusion Criteria:

* new anesthesia residents

Exclusion Criteria:

* none
3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis (FLACON)

3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D FLAIR sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS).

Recently, a study based on a small number of patients showed the interest of 3D FLAIR in the detection of the hypersignal of the optic nerve.The objective of this retrospective study is to determine whether a single 3D FLAIR sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Decrease in visual acuity explored in MRI between january 2018 and january 2020

Exclusion Criteria:

* Past history of episode of Optic neuritis
High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis

Uterine adenomyosis is a common uterine benign condition. They can cause abnormal menstrual bleeding, and menstrual pain. Although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU) therapy is receiving increasing interest in the management of uterine adenomyosis by inducing focal thermocoagulation of the fibroids. Results obtained by various research groups have shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of uterine adenomyosis.

In this proposed study, 10 patients who have symptomatic uterine adenomyosis who meet the study inclusion criteria will be invited to participate in the study which involves the use of HIFU in the management of the adenomyosis. Background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. Subjects will also be asked to complete an eight-item section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) and menstrual pain score which evaluate the effect of the adenomyosis on the quality of life of women.


Eligibility Criteria:
Inclusion Criteria:

* Age \>40 years old, with no future childbearing plans
* Age \>30 years old, who has tubal sterilization
* Significant symptoms related to adenomyosis, intractable to standard medical therapy, or patient considering radiological intervention (uterine fibroid embolization) or surgery.
* Clinical uterine size less than 20 weeks gestation
* Localized adenomyotic lesion or adenomyoma identified of less than 10 cm in diameter as judged by contrast MRI, involving only anterior or posterior uterine wall and not both.
* No laparotomy scars.
* Women should be able to give consent.

Exclusion Criteria:

* Other pelvic or uncontrolled systemic diseases
* Confirmed or suspected pregnancy
* Patients who are unable to communicate with researchers during the treatment
* Patients who are contraindicated for MRI examination
* Patients with thick abdominal wall (\>5 cm, as measured by MRI)
* Presence or history of acute pelvic inflammatory disease or any pelvic malignancy
* History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion
* Presence of significant sized fibroids which may interfere with the treatment or affect the outcome measures
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.

This was a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter Study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
* Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
* BMI between 18.5 and 38, inclusive.

Exclusion Criteria

* Has chronic active GI disease other than celiac disease
* Has diabetes (Type 1 or Type 2).
* Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
* Has hemoglobin value below 8.5 g/dL
Circulating Tumor Cells for Hepatocellular Carcinoma

To explore the clinical value of circulating tumor cells (CTCs) measurement for Hepatocellular carcinoma (HCC) patients.

Background:The lack of tumor tissue for drug target and biomarker studies significantly limit the development of novel treatment for advanced HCC. In recent years, circulating tumor cells (CTCs) have been shown to be important prognostic biomarkers of overall survival for patients with breast, prostate, and colorectal cancer after anti-cancer therapy.

Methods and Materials:This project plans to enroll 50 HCC patients who receive curative surgery or radiofrequency ablation therapy, 50 patients who receive trans-arterial chemoembolization, and 50 patients who receive systemic therapy at National Taiwan University Hospital in 24 months for CTCs analysis. The eligible patients will receive blood tests before and after anti-cancer therapy. The blood samples will be separated to blood cells and plasma. Blood cells will be used for isolation and enumeration of CTCs. Plasma will be used to extract DNA to measure molecular aberration (gene mutations related to hepatocarcinogenesis or response of HCC cells to molecular targeted therapy)

1. to explore the correlation between CTCs numbers and other clinical characteristics in HCC patients with different stages;
2. to compare the patterns of molecular aberrations between CTC and HCC tumor tissue in HCC patients who have archival tumor tissue available; and
3. to measure the changes of CTCs numbers and molecular aberrations in HCC patients before and after molecular targeted therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be diagnosed with HCC via one of following methods according to present clinical practice:

  1. Diagnosed as HCC by biopsy or cytology
  2. Patients with chronic hepatitis B or other reason induced liver cirrhosis who have diagnosed as HCC based on a typical contrast enhanced CT or MRI profile with malignant lesion \[tumor hyper-vascularization\].
* Asian male or female subjects \>=20 years of age.
* Child-Pugh class A or B liver function..
* HCC patients who will receive anti-cancer therapy, including surgery, radiofrequency ablation therapy, trans-arterial chemoembolization, or systemic therapy (according to current HCC practice guidelines) at National Taiwan University Hospital.
* Signed informed consent.

Exclusion Criteria:

* Other significant organ disease or condition his/her investigator judged that the subject should not participate in the study.
Cavernous Tissue Preservation During Penile Prosthesis Implantation

Spontaneous penile tumescence after penile prosthesis implantation has been previously reported as sporadically occurring during implant surgery. This study aims at systematically preserving residual erectile function, by the preservation of the patients' spontaneous penile tumescence by systematically sparing cavernous tissue during penile prosthesis implantation.

Patients undergoing the cavernous tissue sparing penile implant procedure will be injected intraoperatively with 40µg alprostadil, a prostaglandin E1 agonist intracorporal injection (ICI). The procedure will begin as soon as maximal tumescence is attained.

In the cavernous sparing group, corporal dilation will be done solely with a size 8 dilator. The insertion of the dilator will be carefully inserted in what we call the path of least resistance. To determine the path of least resistance, the corporotomy is spread apart by pulling on previously set stay sutures. The path of least resistance is the plane with maximum outflow of blood from the intraoperatively pharmaceutically dilated and blood filled corpora cavernosa. This plane can also be anticipated with a preoperative penile duplex.

Eligibility Criteria:
Inclusion Criteria:

* Erectile dysfunction not amenable to treatment by approved medical therapy

Exclusion Criteria:

* Erectile dysfunction amenable to treatment by approved medical therapy
Comparison of Intravenous Lidocaine Vs Ketamine in Colorectal Surgery

Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).

For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.

For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.

Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively.

Patients undergoing open colorectal surgery with tumor resection were randomised prospectively into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).

For the IV-Lido group (n=25), patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 1.5 mg/kg/h over twenty-four hours.

For the IV-Keta goup(n=25), patients received a loading dose of 0.15mg/kg of Ketamine than a continuous injection of 0.15 mg/kg/h of Ketamine over twenty-four hours.

For both groups, plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. Plasma IL-6 concentrations at each point were compared between the groups.

Eligibility Criteria:
INCLUSION CRITERIA:

* Patients aged 18 or older.
* American society of anesthesiologists' (ASA) physical status of I-III.
* Elective open colorectal surgery.

NON INCLUSION CRITERIA:

* Patients with contraindications to lidocaine or ketamine.
* Corticosteroid therapy within the last 6 months.
* History of immunosuppressive therapy.
* History of surgery in the last 3 months.
* Personal medical history of inflammatory bowel disease.
* Personal medical history of cardiac arrythmias or conduction disorders.
* Alcohol or drug abuse.
* Chronic use of opioids or benzodiazepines.

EXCLUSION CRITERIA:

* Severe intraoperative complications.
* Duration of surgery longer than 5 hours.
Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.

Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.

Eligibility Criteria:
Inclusion Criteria:

1. Documented history of BPH for at least 1 year
2. AUA SI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec

Exclusion Criteria:

1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Surgery or MIST in the previous 12 months for treatment of BPH
5. Post-void residual urine volume \> 350 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL
Multi-modality Echocardiography for Cardiac Assessment in Primary Electrical Disease

From 2020 to 2023, patients with primary electrical disease (idiopathic ventricular fibrillation, long QT syndrome, Andersen-Tawil syndrome type I, Brugada syndrome, early repolarization syndrome, CPVT, and short QT syndrome) were first diagnosed at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and clinical data and echocardiographic indicators were recorded. Follow-up is until December 30, 2025 or endpoint event occurs. Endpoint events were defined as sustained ventricular tachycardia, ventricular fibrillation, sudden cardiac death, ICD discharge events, all-cause death, heart failure and heart transplantation, which were statistically analyzed as a composite endpoint of cardiovascular analysis. The predictors of primary electrical disease and the risk factors for adverse cardiovascular events were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* primary electrical disease

Exclusion Criteria:

* Congenital heart disease, poor echocardiographic images, moderate or severe valvular disease
Dysport® Pediatric Lower Limb Spasticity Follow-on Study

The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

Subjects were eligible for participation in the study if they met the following criteria:

1. Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.
2. Without any major protocol deviations and/or any ongoing adverse events (AEs), either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study.
3. Written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable.

Exclusion Criteria:

Subjects were excluded from entering the study for the following reasons:

1. Major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed \<80° (TS angle) in the most affected leg to be injected.
2. Unwillingness or inability to comply with the protocol.
3. Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.
4. Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs.
5. Be pregnant and/or lactating.
6. Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.
7. An infection at the injection site(s).
8. Planned treatment with any new investigational drug or device during the study period.
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow

Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a long time. To optimize this integration we purpose to associate mesenchymal progenitors cells from autologous bone marrow.

All patients will be treated for tibia or femur pseudo-arthrosis. At the beginning of chirurgical intervention, autologous bone marrow will be sampling and will be concentrated during this one.

Meanwhile osseous matrix (Ostéopure™ ) will be incubated in autologous blood serum and finally implanted in the fracture site. And after (at the end of chirurgical intervention), concentrate autologous bone marrow will be injected in the same place.

Eligibility Criteria:
Inclusion Criteria:

* tibia or femur pseudo-arthrosis,
* patient who needs bone graft

Exclusion Criteria:

* - contra indications for chirurgical intervention or bone graft