cyrilzakka/clinical-trials huggingface dataset:
Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure

Many factors have been proven that may affect NLS in BA patients after KP;however,the early predictors for NLS were not be finally detected.This study was designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.

Biliary atresia (BA) is the most common cause of neonatal cholestasis, occurring in approximately 1: 8000 to 1:15000 in Asian populations compared with those in Europe and the USA, with a ratio of 1: 1.56 in males and females.Until now, Kasai procedure(KP) remains the preferred treatment for biliary BA;however,nearly 60-70% patients after KP need liver transplants to achieve long-term survival.Therefore, it is meaningful to seek and analyze the factors affecting the native liver survival(NLS) in BA patients with KP for prediction. Luckily， A lot of studies have designed to seek the risk factors for death or liver transplants in BA patients after KP,and many factors have been proven that may affect NLS,including old age at KP,low gamma-glutamyl transpeptidase(GGT) level,Cytomegalovirus(CMV) Infection,early jaundice clearance(JC) and postoperative cholangitis(PC),etal.However,the predictors for NLS were not be finally detected.Otherwise,the safety of liver transplants has been improved in the past few years and performing liver transplant in young infants has been proven to be feasible.Then,it is important to seek early NLS predictors for counseling the necessity and timing of liver transplant.Unfortunately,early predictors of NLS focus on preoperative and early postoperative period after KP were insufficient.

This study is primarily designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.

Eligibility Criteria:
Inclusion Criteria:

Biliary Atresia(BA) patients performed with Kasai Procedure patients completed the follow-up\>6 months

Exclusion Criteria:

BA patients without KP patients lost of follow-up BA patients with other severe complications lead to death
Oximetry Guided Versus Traditional Rapid Deflation Technique for Achieving Hemostasis After Radial Procedures

After performing a radial angiography/percutaneous coronary intervention (CAG/PCI), the sheath is removed and a compression device is used to achieve hemostasis. Recent studies have indicated that rapid deflation techniques resulting in early removal of the compression device is associated with a low incidence of radial artery occlusion (RAO).

The purpose of the present study is to evaluate whether an even faster removal of the compression device can be achieved if using oximetry guided rapid deflation compared to traditional rapid deflation, and whether this is associated with a lower incidence of RAO.

3600 patients are randomized 1:1 to a traditional rapid deflation technique (Group A) versus an oximetry guided rapid deflation technique (Group B).

Before randomisation between the two deflation techniques French size of the sheath is chosen. If the operator has a preference for the size of the sheath then this size is used (5F/6F, estimated N=1200). If the operator has no preference for the size of the sheath then patients are randomized between 5 and 6 French sheath (N=2400).

Randomization between traditional rapid deflation technique (Group A) versus oximetry guided rapid deflation technique (Group B) is then stratified according to French size of the sheath used (5 French, 6 French). Terumo Glidesheath Slender is routinely used in both arms.

Assuming that the incidence of RAO (Barbeau type D, see below) can be reduced from 1.5% to 0.5% a total of 1547 patients are needed in each group if using an alfa=0.05 and beta 0.80. Assuming that the incidence of RAO or subocclusion (Barbeau type C or D, see below) can be reduced from 4% to 2% a total of 1141 patients are needed in each group to document this difference if using an alfa=0.05 and beta 0.80. The investigators plan to randomize 1800 in each group comparing oximetry guided rapid deflation with traditional rapid deflation. Assuming that the time from sheath removal to transradial-band (TR-band) removal (hemostasis) is 125 minutes with the traditional rapid deflation technique, and 110 minutes with the oximetry guided deflation technique, and the standard deviation is 60 minutes, then a total number of 253 patients are needed in each group to document a possible difference.

Data are analyzed by the intention-to-treat principle.

4-5 centres are expected to include patients.

Oral and written informed consent is collected at the ward or in the Cath.lab. The informed consent is signed before intervention.

Included patient can withdraw their assignment from the study at any time without consequence

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for radial angiography or angioplasty.
* Patients with normal flow in a.ulnaris before the procedure (Barbeau type A or B).
* Age \> 18 years.
* Patients able to cooperate and understand information given by the hospital staff.

Exclusion Criteria:

* Patients not able to give informed consent.
Imaging Synapses With [11C] UCB-J in the Human Brain

The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer \[11C\]UCB-J to test the neural synaptic pruning hypothesis of schizophrenia. This imaging method allows for the quantification of synaptic density in the living human brain and has the unprecedented ability to directly examine the synaptic pathology underlying neuropsychiatric disease. The neural synaptic pruning hypothesis posits that a key pathogenic process of schizophrenia is the over-exuberant elimination of neural synapses during development. The confirmation of reduced synaptic density in schizophrenia as evidenced by \[11C\]UCB-J has the potential to lead to a number of ground-breaking clinical innovations, such as laboratory-based diagnostics and prognostics, and novel, disease-modifying treatments.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years in age
* For SZ participants:

  * On a stable medication regimen for at least two weeks prior to testing
  * A clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
  * Able to complete a PET-MR scan without the use of sedation

Exclusion Criteria:

* Active substance use within three months of testing
* IQ \< 70
* Major medical neurological illness or significant head trauma
* Pregnancy or breastfeeding
* Contraindication to MR scanning, including magnetic-resonance incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ
* Weight \> 350 lbs or a large body habitus that MR scanner cannot accommodate
* History of or current claustrophobia
* Inability to comply with basic study requirements such as following directions and punctuality
* For HC participants:

  * Presence of a first degree relative with a psychotic disorder
  * Lifetime diagnosis of major psychiatric illness
* For SZ participants:

  * Unstable psychiatric symptoms at the time of testing, e.g. acute suicidality, prominent psychosis, or behavioral dyscontrol
Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)

The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by MultiSpot LV pacing (either simultaneously or sequentially) in comparison to the response achieved by the current (standard) BiV pacing configuration in patients indicated/recommended for cardiac resynchronization therapy.

The following pacing configurations will be evaluated.

Biventricular pacing (BiV):

Pacing will be performed on one LV electrode pair, (at 3 different longitudinal locations), and on the tip of the RV-lead. In total, three different pacing BiV settings will be evaluated. Configuration 1: RV + LV lateral Apex, Configuration 2: RV + LV lateral Mid, Configuration 3: RV + LV lateral Base (Reference: Standard CRT)

MultiSpot simultaneous LV-ventricular pacing (MultiSpot-SYN):

Pacing will be performed on 3 electrodes on the LV wall, placed at different longitudinal locations, and on the tip of the RV-lead simultaneously. Configuration 4: RV + LV lateral Apex + LV lateral Mid + LV lateral Base

MultiSpot sequential LV-ventricular pacing (MultiSpot-SEQ):

3 electrodes on the LV wall will be paced sequentially. The RV electrode will be paced simultaneously with last paced LV electrode.The timing-sequence and the amount of spots will depend on the electrical delays measured during the experiments. Configuration 5: LV lateral Apex =\> LV lateral Mid =\> LV lateral Base + RV

Eligibility Criteria:
Inclusion Criteria:

* Subject is indicated or recommended for CRT-P or CRT-D device according to current applicable ESC/AHA guidelines
* Subject is in sinus rhythm
* Subject receives optimal heart failure oral medical therapy
* Subject is willing to sign the informed consent form
* Subject is 18 years or older

Exclusion Criteria:

* Subject has permanent atrial fibrillation/flutter or tachycardia
* Subject has pure right bundle branch block (= no additional left ventricular conduction delays)
* Subject has left bundle branch block and QRS-duration of \> 150 ms and no sign of myocardial scar indicated by late gadolinium enhancement MRI
* Subject experienced recent myocardial infarction, within 40 days prior to enrollment
* Subject underwent valve surgery, within 90 days prior to enrollment
* Subject is post heart transplantation, or is actively listed on the transplantation list
* Subject is implanted with a left ventricular assist device
* Subject has severe renal disease (up to physicians discretion)
* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
* Subject has severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated within study period)
* Subject has complex and uncorrected congenital heart disease
* Subject has a mechanical heart valve
* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
* Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager
Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients

To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 and older
* English and Spanish speaking patients
* Active on the waiting list for kidney transplantation
* Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
* HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
* Willing and able to provide written informed consent

Exclusion Criteria:

* Participants co-infected with HIV
* Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
* Known allergies or hypersensitivity to DAA or RBV
* Pregnancy and/or actively breastfeeding
Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation

The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.

The study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. This is a post-market surveillance study

Eligibility Criteria:
Inclusion Criteria:

* Adult patient subjects not responding to conservative management of neck / arm or back/leg pain and requiring spinal fusion between levels C1 - T2 or L1 - S1
* Informed Consent

Exclusion Criteria:

* Hypersensitivity to i-FACTOR Bone Graft Devices
* Adult Spinal deformity, Spinal Cord Injury
* Infection
* Compromised renal function
Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain

The purpose of the study is to determine the effectiveness of cognitive-behavioral therapy on functional outcomes, pain, and pain-related anxiety in patients with chronic nonspecific low back pain

Back pain has considerable negative effects on the quality of life of affected individuals. Individuals with new-onset back pain have an increased risk of lower quality of life scores, and the negative effect on quality of life increases with persistent pain. Patients with chronic back pain report a quality of life that is lower than individuals without pain and that is comparable to those of individuals with life-threatening diagnoses. In addition, back pain is associated with worry and fears, particularly about the (sense of) self and socialrelationships and especially when pain persists longer than expected.

Eligibility Criteria:
Inclusion Criteria:

1. Thirty patients with non-specific chronic low back pain from both sexes will be included.
2. Subjects with normal body mass index (18 to 25).
3. The age of patients range from 20 to 35 years.
4. Duration of pain more than 3 months up to 2 years.
5. Normal cognition score 26 or above according to MoCA Scale.7. Highly educated at least high school.

Exclusion Criteria:

The patients will be excluded if they have any of the followings:

1. Lumbar canal stenosis.
2. Lumbar discogenic lesions.
3. Any inflammatory arthritis, tumors, infection involving the lumbar spine.
4. Patients with decreased range of motion secondary to congenital anomalies, muscular contracture or bony block.
5. Previous lumbar surgery or trauma.
6. Subjects with a history of any neurologic disease.
7. Cauda equina Syndrome.
8. Patients suffering from psychological, cognitive or emotional disturbance.
9. Patients who had previously participated in cognitive behavioral therapy.
10. Deafness and blindness.
Home Chemotherapy Intervention for Children With Cancer - a Feasibility Study

Children with cancer undergo intensive treatment with many serious side effects and frequent in- and outpatient visits. Studies show that the frequent hospitalizations are very disruptive to children and their families, who strive to maintain a normal everyday life. The aim of the study is to test a parent-led home-administered low-dose cytarabine intervention that will not compromise the quality of treatment and care, increase the caregiver burden or the experienced symptoms of the children. The methodical approach is based on The Medical Research Council's framework to develop and evaluate complex interventions in health care using both clinical observational methods, participatory methods, surveys and qualitative ethnographic methods. The overall goal of the project is to support and ease the everyday lives of children with cancer and their families during the intensive treatment periods.

This single-arm feasibility study is conducted at Copenhagen University Hospital, Rigshospitalet, in Denmark at the Department of Pediatric Oncology and Hematology.The PI started to recruit participants March 2022. Patients with Acute Lymphoblastic Leukemia (ALL), Philadelphia positive Acute Lymphoblastic Leukemia (PH+ALL) and Lymphoblastic Lymphoma (LBL) are eligible for inclusion if their parents speak and understand Danish or English, able to manage basic treatment and care such as oral medication, mobilization, nutrition, central venous catheter care and practice good personal hygiene. The parents' competences are assessed by the PI in collaboration with a team of project- and ward nurses who know them. Participants are recruited between day 15 and 29 from diagnosis. Parents to eligible participants and adolescents aged 15+ receive oral and written information and provide written informed consent before inclusion. Children and adolescents less than 15 years of age receive oral information and provide oral consent if possible according to their age. Parents to the included participants are offered to administer the protocolized low-dose bolus (injection) Cytarabine in their children's CVCs at home. The administration procedure is developed as a simple and safe non-touch technique. The parents receive a video and paper-based guideline and information material followed by a 3-step nurse-led education program. The parents can administer the Cytarabine at home when they (and the child/adolescent) feel safe and comfortable managing the procedure and when the nurses are sure that the parents can manage the procedure at home. The first dose of Cytarabine is always administered at the hospital.

Eligibility Criteria:
Inclusion Criteria:

- Children/adolescents diagnosed with ALL, LBL or PH+ ALL

Exclusion Criteria:

* If their parents did not understand, read and speak Danish
* If the parents did not manage the children/adolescents' basic care and treatment needs (CVC care, oral medication, hygiene, nutrition, mobilization, ect.)
Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.

Endoscopic trans-abdominal preperitoneal plasty (TAPP) for parastomal hernia employing transversus abdominis release component separation (TAR) and reinforcement with mesh after the Sugarbaker principle, but placing mesh extraabdominally, anteriorly to the transversalis fascia. Laparoscopic and robotic procedures. Repair of concomitant midline hernia with endoscopic enhanced-view Rives-Stoppa technique.

Eligibility Criteria:
Inclusion Criteria:

* parastomal hernia with need of repair

Exclusion Criteria:

* \< 18 years
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP.

This study plans to determine:

1. the frequency and types of cardiac arrhythmias that occur in this population and
2. whether these are increased above the general population in the same age group.

Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

By employing long-term electrocardiographic monitoring, this study plans to determine:

1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and
2. whether these are increased above the general population in the same age group.

The specific aims:

1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.
2. Correlate abnormal heart rates and rhythms to specific clinical data:

   1. seizure type,
   2. seizure frequency,
   3. probable location of seizure onset in the brain, when such data are available,
   4. duration of seizures, and
   5. type(s) and number of anticonvulsant medications being used.
3. Correlate cardiac arrhythmias to clinical symptoms

Eligibility Criteria:
Inclusion Criteria:

* Refractory epilepsy

Exclusion Criteria:

* Other pre-existing heart conditions
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of at least 36 weeks.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Extended administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine and seasonal or pandemic influenza vaccine.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Previous vaccination against diphtheria , tetanus, pertussis, polio (with the exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus pneumonia.
* History of receipt of meningococcal vaccine.
* Subjects who received a birth dose Hepatitis B vaccines within the 30 days before the administration of the first study vaccine.
* History of or intercurrent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of th
Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient

Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these complications is shoulder pain which affects about 35 to 70% of cases. The medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions slowing the recovery of independence in activities of daily living.

Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce shoulder pain.

Because no data available to permit us to determine the sample size we set-up this preliminary study to check if efficiency found in these preliminary data are consistent with an estimable real efficacy in a randomized trial feasible.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon)
* Having made a cerebrovascular accident between 30 and 3 days before inclusion
* with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm
* able to understand the question: "Do you have arm pain?"

Exclusion Criteria:

* with visual analogue scale score lower than 20 mm at the inclusion
* with aphasia of comprehension
* with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...)
* opposing to any mobilization
* with shoulder pathology previously known
* history of cerebrovascular accident prior 30 days before inclusion