cyrilzakka/clinical-trials huggingface dataset:
Double-J PLUS Postmarket Registry

A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents


Eligibility Criteria:
Inclusion Criteria (for all Ureteral stent types except Urinary Diversion Stents):

* Subject is undergoing placement of a Boston Scientific Ureteral Stent
* Subject anatomy is appropriate to accommodate a stent size available in the study
* Subject is able to accurately detect and report bladder function and pain
* Subject is willing and able to:

  * Complete patient QoL questionnaire at specified time points (for subjects aged ≥ 18 years)
  * Return for all follow-up visits

Inclusion Criteria (for Urinary Diversion Stents):

* Subject is undergoing placement of a Boston Scientific Urinary Diversion Stent(s)
* The anatomical features of the involved renal collecting system are known by either prior or concurrent urography or axial CT imaging
* Subject is willing and able to return for all follow-up visits

Exclusion Criteria (for Ureteral stents and Urinary Diversion Stents):

* Subjects who meet any of the contraindications per individual stent DFU
* Subjects receiving different stent type in case of bilateral/multiple stenting
* Subjects with an indwelling ureteral stent(s) not planned to be removed prior to/or concurrently with the study stent implant
EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding

RATIONALE:

Transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach.

Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. Whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding.

Peri-procedural anemia is also an independent predictor of mortality and MACE.

With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been associated with a significant reduction in access-site and non-access site related bleeding.

In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins IIb-IIIa.

HYPOTHESES:

In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa.

In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.

OBJECTIVES:

The primary objective is to compare the incidence of major bleeding and anemia 24h post-PCI in patients at high-risk of bleeding after transradial PCI with heparin or bivalirudin.

Eligibility Criteria:
Inclusion Criteria:

* At least two of the following additional criteria
* At least 70 yrs old
* Female gender
* Diabetes
* Creatinine clearance \<60mL/min
* History of gastro-intestinal or other organ bleeding
* Baseline anemia
* Current treatment with glycoproteins IIb-IIIa inhibitors

Exclusion Criteria:

* Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months
* Concurrent participation in other investigational study
* Femoral sheath (artery)
Digital Therapeutic vs Educational App for Depression Among Adolescents

The primary aim of this study is to investigate the difference in depression symptoms at 4-weeks across two types of programs for addressing depressive symptoms, including Woebot (WB002) and Digital Education (ED002). The secondary aim of this study is to investigate the difference in anxiety symptoms at 4-weeks across the two programs. The tertiary aim of this study is to evaluate the feasibility, acceptability, and satisfaction of each program.


Eligibility Criteria:
Inclusion Criteria:

1. Be 13-17.5 years of age
2. Be a U.S. Resident
3. Able to read and write in English
4. If currently on medication: regular, stable dose of antidepressant medications (e.g., escitalopram/Lexapro, fluoxetine/Prozac) for at least 60 days at screening
5. If currently receiving psychotherapy: must be in therapy for at least 4 weeks at screening
6. Own or have regular access to a smartphone (operating systems: Android 6 or later and iOS 13 or later) that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with study app
7. Available and committed to engage with the program for a 8-week duration and complete assessments
8. Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
9. Willingness to provide parent/guardian contact information to provide eConsent and participate in clinical interviews

Exclusion Criteria:

1. PHQ-A score less than 10
2. Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
3. Lifetime diagnosis of bipolar disorder
4. Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g., Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
5. Current (past year) diagnosis of a substance use disorder
6. Suicide attempt or suicidal ideation with plan and intent within the past 12 months
7. Previous Woebot application use
8. Enrollment of more than one member of the same household
Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)

The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.

Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Expected to continue to require daily administration of an NSAID for at least the coming 6 months.
* Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303

Exclusion Criteria:

* Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303
* Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303
* Malignant Disease of the gastrointestinal tract
* Erosive esophagitis
* Clinically significant cardiac, renal or hepatic disease
* Uncontrolled diabetes
* Positive pregnancy test on Study Day 0
* Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.
Clock'N' Test: Development and Validation of a Test to Evaluate Emotional Disorders

This study concerns the validation of a clinical test that aims to reveal "first level" emotional disorders in neurological diseases.

In order to bring to light such disorders, it is necessary to begin by establishing reference values in healthy individuals. This test is based on the priming effect and time estimations. The test procedure has two successive phases. The first phase aims to determine the judgement of time inherent to each participant and then to assess whether or not this judgement varies during the second phase with the introduction of emotional priming. First, we set out to look for and to calibrate video stimuli able to activate emotions. To this end, we used a battery of 70 sequences developed recently by Schaefer, Nils, Sanchez and Philippot. We determined their degree of physiological activation by measuring the electrodermal response at the laboratory for the exploration of the nervous system in Dijon. These measurements also allowed us to define and refine our paradigm, notably by deciding at what moment the time estimation task should be done and by eliminating the influence of attention. We decided to select only seven video sequences because we noticed a reduction in the measurement effect on time estimations due to habituation of the subject. We also conducted pre-tests in a control population made up of twenty men and women aged from 20 to 60 years.

This brought to light a warp in time estimation opposite to that we found using olfactory stimuli. This first finding suggests that there are two types of emotion, one which is anticipative and the other immediately experienced.


Eligibility Criteria:
Inclusion Criteria:

* persons who have given their consent to participate
* aged between 20 and 92 years.
* persons who understand and speak French.
* persons informed about the study

Exclusion Criteria:

* persons without national health insurance cover
* disease likely to cause emotional disorders (history of paralimbic brain tumour, MS, Parkinson, history of depression, bipolar disorder...).
* heart disease, spasmophilia.
* cognitive disorders likely to interfere with understanding the instructions.
* visual or auditory, sensory or motor disorders.
* refusal to participate in the study.
Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)

The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients


Eligibility Criteria:
Inclusion Criteria:

* Refractory Glaucoma
* IOP \> 21 mm Hg
* No previous intraocular surgery or laser treatment during the 90 days before HIFU day
* Age \> 18 years
* Informed consent sgned by the subject

Exclusion Criteria:

* Normal Tension Glaucoma
* Glaucoma drainage device implanted and still present in the eye to be treated
* History of ocular or retrobulbar tumor
* Ocular infection within 14 days prior to the HIFU procedure
* Aphakic patient
* Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)
* Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child
The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. To analyze the number and timing of recurrence based on a long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 20 yrs or greater
2. Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection
3. Symptom persisted more than 6 months
4. Pain VAS ≥4

Exclusion Criteria:

1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS
2. Child-bearing potential, pregnant or nursing women.
3. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
4. Urinary tract infection during run-in periods.
5. Genitourinary tuberculosis or bladder,urethral and prostate cancer
6. Recurrent urinary tract infection
7. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
8. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
9. Using a indwelling catheter or execution of intermittent self catheterization
Hybrid Mathieu Urethroplasty

the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.

background: Distal hypospadias repair is one of most frequent surgical interventions in pediatric age group. Successful hypospadias repair should provide a functional penis and good cosmesis. Mathieu urethroplasty is one of the most popular techniques used. Authors aimed at performing a modification that expanded the scope of indications and improved final cosmetic results of classic Mathieu urethroplasty.

Methods: forty-three patients with distal hypospadias were operated by hybrid Mathieu urethroplasty (HMU) during the period from March 2012 to December 2020. Creation of the peri meatal based flap was performed as Mathieu disrobed. This was followed by developing of glanular wings. The additional step was deep incision of the urethral plate. Then, urethroplasty was performed. The catheter was left in place for one to three days.

Eligibility Criteria:
Inclusion Criteria:

* distal penile hypospadias

Exclusion Criteria:

* sever hypospadias
* cases need redo
Comparison of Nebulized Budesonide and Intranasal Budesonide Spray in Children With Adenotonsillar Hypertrophy

Budesonide is one of the most common drugs uesd in children with adenotonsillar hypertrophy. This study aim to evaluate the efficacy of a short course of budesonide inhalation suspension via transnasal nebulization in children with adenotonsillar hypertrophy. The second aim is to compare budesonide inhalation suspension with budesonide aqueous nasal spray in adenotonsillar hypertrophy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children are ≥3 years and ≤10 years, have habitual mouth breathing or snoring, and without current or previous use of any corticosteroids or leukotriene receptor inhibitors within 4 weeks preceding the initial study.

Exclusion Criteria:

* Children with craniofacial, neuromuscular, syndromic, or defined genetic abnormalities; acute upper respiratory tract infection; whose symptoms are not caused by adenotonsillar hypertrophy; and who have had adenotonsillectomy in the past.
EFFECTS OF REPEATED GENERAL ANAESTHESIA ON THE LEVEL OF PRE-PROCEDURE ANXIETY IN CHILDREN UNDERGOING RADIOTHERAPY.

Observation of pre-precedure anxiety in pre-operative suite in children from age 2-12yrs, undergoing radiotherapy under general anesthesia.

Radiotherapy procedures are used to damage or destroy growing cancer cells.(1) This strategic use of ionized radiation is being practiced since the early 20th century and is very effective in destroying diseased cancer cells while sparing the healthy ones.(2) These procedures require patients to stay absolutely still, hence requiring general anesthesia in case of children compared to the adults. The treatment also requires multiple cycles of radiotherapy for which children have to undergo general anaesthesia multiple times.(3) Multiple anaesthetics for the same child may lead to preoperative anxiety, increased autonomic fluctuations, increased demand for anaesthetics and nausea/vomiting.(4-5) Pre-operative anxiety not only causes physical but also emotional and psychological trauma.(6) Such patients, subjected to anxiety, may face fear and potential hesitance in visiting the pre-anesthesia clinics for evaluation, induction and problems in pre-operative and recovery span.(7-8)It is therefore important to gauge the extent of this anxiety and to see whether it increases or decreases with subsequent cycles of treatment .Unless this is identified it will be difficult to put appropriate treatments in place.

Though previous studies are available on pre-operative anxiety in children but there has been little research about level of a child's anxiety under going repeated general anesthesia, especially during radiotherapy sessions. We were unable to identify any study on the subject in our literature search, a gap that needs research.

Several scales are available to evaluate anxiety in children(9), mYPAS scale is a standard It is also important to measure the anxiety levels of the parents accompanying the child, since this may have an effect on behavior.

Eligibility Criteria:
Inclusion Criteria:

1. Child of either gender
2. 2-12 years of age
3. ASA status (1,2 and stable 3)
4. Pre-school, school and non-school going
5. Scheduled for a radiotherapy procedure under general anesthesia for at least 3 cycles under GA

Exclusion Criteria:

1. Procedure to be done under sedation alone
2. Children with developmental delay
3. Children coming with other relatives apart from parents.
Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)

This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product
* Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
* Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing
* Ability to be examined by Magnetic Resonance Imaging (MRI)
* Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs

Exclusion Criteria:

* Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
* Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start
* Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m\^2
The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy

This study is conducted to determine whether the occurrence of hypotension is reduced by the combined use of remimazolam and remifentanil compared to the conventional combination use of propofol and remifentanil. Patients enrolled in the study are infused continuously with either propofol or remimazolam from the start of anesthesia to the end of surgery.


Eligibility Criteria:
Inclusion Criteria:

1. patients 19 years of age or older
2. the American Society of Anesthesiologists classification 1-3
3. patients undergoing laparoscopic cholecystectomy at Severance Hospital

Exclusion Criteria:

1. Emergency surgery,
2. patients with heart disease or arrhythmias,
3. patients undergoing concurrent surgery other than laparoscopic cholecystectomy,
4. obesity (BMI\>30),
5. patients who were admitted on the surgery day,
6. foreigners,
7. illiteracy
Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia

Termination Reason: On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia: Current symptoms were to be present for at least 7 days before screening.
* At the Screening and Baseline visits, subjects must have had a Brief Psychiatric Rating Scale - Anchored score ≥35 and a score of ≥4 on at least 1 of the following items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or conceptual disorganization.
* Age 13 - 17 years

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator
* Any history of serious or unstable medical illness, including risk for QT prolongation
Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway

The aim is to implement the Patient Activation Measure in paramedical practices as a tool to measure activation of patients in cancer care


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Cancer patient with an estimated life expectancy of at least one year
* Patient requiring immunotherapy or intravenous chemotherapy for any cancer according to the decision of the Multidisciplinary Consultation Meeting
* Patient affiliated or entitled to a social security scheme

Exclusion Criteria:

* Refusal to participate, protected adult patient under guardianship.
* Patient disability to understand the course of the study
* Patient with documented history of cognitive or psychiatric disorders.
* Patient not understanding French
iCanCope With Pain: A Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain

Chronic pain in adolescents and young adults (AYA, aged 15-25) is a common problem. Pain that is not treated properly can reduce quality of life. Programs to help AYA learn to live with and manage pain are very important. Our team is developing a smartphone application (app) and website for AYA with chronic pain. The app will help AYA to track pain, sleep, mood, activities, and exercise and help AYA set and achieve goals. The website will give information about pain and how to manage it independently. We will build the program and make sure it is easy to use and understand. We will also test if the program can be put into practice as planned and if AYA using the program feel less pain, have less limitations, and a better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic pain of at least 3 months duration according to medical chart
* Able to speak and read English
* Willing and able to complete online measures
* Participants are active patients at pain clinic at one of the respective participating study sites
* Have access to an Internet-connected computer according to self-report.

Exclusion Criteria:

* Moderate to severe cognitive impairments, as assessed by reviewing medical chart and consultation with the patient's healthcare provider
* Major co-morbid psychiatric (e.g. conversion disorder, depression, anxiety disorder) illness that may impact patient's ability to understand and use the iCanCope with Pain intervention via self-report, as determined by their health care provider
* Patient from the department of haemology/oncology
* Participated in the Phase 2B iCanCope usability study
* Requires urgent CBT treatment as per their health care provider
* Individuals who have received more than 4 CBT sessions for pain management in the past 6 months, as per their health-care provider and self-report