cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)

Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

Post operative chemotherapy +/- radiotherapy according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

* Low risk group :

  * No optic nerve involvement.
  * Intra and prelaminar involvement
  * No choroidal involvement.
  * Minimal superficial choroidal involvement .
* Intermediate risk group, 2 sub groups :

  * Sub group 1 :

    * Retrolaminar involvement without Invasion of surgical margin associated or not to massive choroidal involvement
    * Anterior segment involvement.
    * Intrascleral involvement.
  * Sub Group 2 :

    * Isolated massive choroidal involvement.
* High risk group :

  * Invasion of the surgical margin of the optic nerve
  * and/or microscopic extrascleral involvement
  * Optic nerve meningeal sheat involvement .

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines;
2. Male or female ≥2 months and \<10 years of age at the time of signing the informed consent form;
3. Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation
4. In case of post operative chemotherapy, patients must have adequate organ function:

   * Adequate hematopoietic function Neutrophils\>1.0x109/l, Platelets \>100 x 109/l.
   * Adequate hepatic function: grade II NCI CTC
   * Adequate renal function: serum creatinemia \<1.5 x ULN for age with normal creatinine clearance estimated by SCHWARTZ formula
   * Audiometry \< Grade II de Brock.
   * Echocardiography normal in case of high dose cyclophosphamide chemotherapy (3 g/m²).
5. Patients affiliated to a Social Security Regimen or beneficiary of the same
6. No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor types
7. Without medical cons-indication to study drugs.

Exclusion Criteria:

* Bilateral and/or familial or trilateral retinoblastoma.
* Unilateral retinoblastoma with indication of primary chemotherapy before enucleation:

  * One or several surgical risk factors
  * Buphthalmia Exophthalmia.
  * Peri ocular inflammatory signs.
  * Extraocular extension :
  * Radiological retrolaminar extension (more than 3 mm behind the lamina cribrosa) and or meningeal sheat optic nerve extension.
  * Extrascleral extension
  * Lymp nodes extension
* Unilateral retinoblastoma with possibility of conservative treatment:
* Metastatic extension at diagnosis
* One inclusion criteria non observed
* Uncontrolled medical conditions, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

This is a non interventional prospective study. Centers will enroll adult participants with partial onset seizures with or without secondary generalisation for whom the clinician has decided to initiate eslicarbazepine acetate (ESL) as an adjunctive therapy or monotherapy prior to the decision to take part in this study. Participants to be enrolled into the study will receive ESL either as an adjunctive therapy to one baseline antiepileptic drug (AED) or to at least two baseline AEDs or as monotherapy. Participants will be seen at baseline and at a follow-up visit after approximately 6 months to assess retention, efficacy, tolerability, quality of life (optional), and cognitive performances (optional).


Eligibility Criteria:
Inclusion Criteria:

1. Partial onset seizures with or without secondary generalisation in conjunction with a diagnosed epilepsy of symptomatic or unknown course.
2. The decision to prescribe Eslicarbazepine acetate (ESL) was taken independent of and prior to enrollment into this study.
3. Treatment with ESL is in agreement with the valid summary of product characteristics (SmPC) version, particularly with the licensed indication.
4. Age 18 years and older.
5. Participant's written consent.

Exclusion Criteria:

1. Known psychogenic non-epileptic attacks.
2. Participation in an interventional study.
3. Previous enrollment in the current study.
Neuromuscular Control of the Ankle With External Support

Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the combined use of the 3D motion analysis and the surface electromyography, the influence of the devices with respect to a mechanical effect and to an influence on the neuromuscular control are examined. The tests will simulate situations with a higher risk of injury. In the experimental set-up, an element of surprise will be integrated in order to analyze any muscular compensation mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* chronic ankle instability
* "giving way"
* repeated ankle sprains

Exclusion Criteria:

* other injuries of the lower extremities
* surgery on the lower extremities
Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma

Extended pelvic lymph node dissection in bladder carcinoma provides staging and, in selected patients, a survival beneﬁt. Recent studies showed the therapeutic beneﬁt of retroperitoneal lymph node dissection (RPLND) in advanced stage of upper tract urothelial carcinoma (UTUC). Also laparoscopic extended RPLND is still a technical challenge in urology, considering the high rate of severe complications and difﬁculties in manipulation. In Renji Hospital, laparoscopic extended RPLND at time of nephroureterectomy was performed via an extraperitoneal approach, avoiding interference with abdominal organs and achieving better exposure.The aim of the present study was to determine the safety and feasibility of performing an extraperitoneal laparoscopic extended RPLND at the time of radical nephroureterectomy (RNU) for UTUC in a prospectively collected cohort of patients.

Similar to urothelial carcinoma of the bladder (UCB), UTUC can follow routes of metastases to involve regional lymph nodes. Nodal metastasis is an adverse prognostic indicator and results in poor outcome, irrespective of the use of systemic chemotherapy or radiation. The ' gold standard ' treatment for UUT-UC is RNU.

Extended pelvic lymph node dissection in bladder carcinoma provides staging and, in selected patients, a survival beneﬁt. Recent studies showed the therapeutic beneﬁt of RPLND in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive UCUT on the basis of insufﬁcient evidence. But no prospective studies have standardized the ideal extent of RPLND or the optimum number of total lymph nodes that should be removed in patients with UUT-UC. Also more and more interest has been paid to establish standardized node dissection templates.

Also laparoscopic extended RPLND is still a technical challenge in urology, considering the high rate of severe complications and difﬁculties in manipulation. In Renji Hospital, laparoscopic extended RPLND at time of nephroureterectomy was performed via an extraperitoneal approach, avoiding interference with abdominal organs and achieving better exposure.

The aim of the present study was to determine the safety and feasibility of performing an extraperitoneal laparoscopic extended RPLND at the time of RNU for UTUC in a prospectively collected cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed with upper tract urothelial carcinoma
* have no distant metastasis
* have an ECOG 0 to 2
* expected to receive radical nephroureterectomy

Exclusion Criteria:

* had no previous abdominal surgeries
* contra-indications to laparoscopic surgery (e.g. severe chronic obstructive pulmonary disease)
* patients with cT4 disease before surgery
Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores

Patients candidates for total hip replacement are, generally elderlies and have hip pain, we will check if the pressure to the soft tissue changes before and after operation using a tapet with pressure sensors sending the information to specific software.

one hundred Patients 60 years old and more will be considered for this study, both sexs, that have schedule for elective unilateral total hip replacement and have not bedsores previously.

All the data will be collected by FSA software, classified in an excel table. A crossover study will be performed and analyzed by a paired test.

Eligibility Criteria:
Inclusion Criteria: 60 y/o/ and more

* Both sexes
* Schedule for total hip replacement

Exclusion Criteria:

* Patient with previous bedsore
* Patients under 60 y.0.
* Previous CVA
Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children

To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.

o study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.

our study include 2 patient groups:

1. st group included 100 child diagnosed Helicobacter pylori infection by upper gastrointestinal endoscopy and biopsies with pathology, will receive H.pylori eradication treatment and vitamin D as an adjuvant therapy .
2. nd group will also diagnosed Helicobacter pylori infection by upper gastrointestinal endoscopy and biopsies with pathology, will receive H.pylori eradication treatment only.

Helicobacter pylori treatment :

1. amoxcillin on 50 mg/kg/day for 2 weeks
2. clarithromycin 20mg/kg/day for 2 weeks
3. proton pump inhibitor 1mg/kg/day for 1month Vitamin d dose..1000unit /day for 1 month

Eligibility Criteria:
Inclusion Criteria:

- Age:4-18 years children with symptomatic H pylori infection presenting with (epigastric pain, persistent vomiting and hematemesis)diagnosed by upper gastrodeudonoscopy , rapid urease test and histopathologic examination of gastric biopsies from antrum and body of the stomach.

Exclusion Criteria:

* Patient on vitamine D supplémentation
* Patient who has defect in vitamin D metabolism (chronic renal and hepatic patients, malabsorption syndromes)
* Patients who had received treatment of H.pylori previously .
to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection

to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged 19 to 50 at the time of screening tests
2. Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
3. In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
4. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc

Exclusion Criteria:

1. Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
2. A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
4. A person who has been tested positive for Helicobacter pylori
5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc
Biomarker Profiling in Abdominal Aortic Aneurysm Patients

The BIOMArCS-AAA study aims to investigate the associations of (temporal patterns of) blood biomarkers with aneurysm growth in patients with abdominal aortic aneurysm (AAA), with particular attention to biomarkers that have demonstrated prognostic value for adverse disease outcomes in coronary artery disease and biomarkers for the main genetic pathways associated with AAA.

BIOMArCS-AAA is an observational, multicenter study. Patients with an abdominal aortic aneurysm (AAA) will be recruited through the vascular surgery outpatient clinic of Erasmus MC and Maasstad Ziekenhuis, the Netherlands. The prospective, longitudinal part of the study will include an arm with 120 AAA watchful waiting patients and an arm with 120 AAA patients undergoing endovascular aneurysm repair (EVAR), both with a 24-month follow-up period. Clinical data collection, and blood sampling will be conducted at baseline, at 1 month after EVAR and at 6, 12, 18 and 24 months for all patients. CT will be conducted at baseline and 12 and 24 months, plus at 1 month in the EVAR patients. Quality of life and depression questionnaires will be performed at baseline, at 12 and 24 months of follow-up in all patients, and at 1 month only in EVAR patients. Additionally, a cross-sectional study will be performed in 200 patients treated for AAA with EVAR in the past years. In these patients, clinical data collection, blood sampling, ultrasound and CT will be performed at their next regular outpatient clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Capable of understanding and signing informed consent AND one of the following

  1. Diagnosis of AAA, with a diameter ≥40mm, based on any imaging technique and treated by watchful waiting strategy (Prospective longitudinal study, Arm 1 watchful waiting group)
  2. Planned to undergo EVAR for AAA (Prospective longitudinal study, Arm 2 EVAR group)
  3. Underwent EVAR for AAA in past years (Cross-sectional study)

Exclusion Criteria:

* Patients with isolated iliac artery aneurysm, traumatic aneurysm, anastomotic aneurysm and infectious aneurysm
* Patients with a clinical diagnosed thoracic aneurysm (i.e. located in the chest, above the diaphragm)
* Coexistent condition with life expectancy ≤ 1 year
* Dialysis dependent, (end stage) renal disease patients
* Women of childbearing age
* Linguistic barrier
* Unlikely to appear at all scheduled follow-up visits
Effects of a Mindfulness-Based Intervention Delivered Via Instant Messaging on Parents' Wellbeing: A Randomized Controlled Trial and Investigation of Moderators

This research investigates the effects of mindfulness practice on mental wellbeing with the instruction recordings delivered via existing instant messaging applications, Whatsapp. The two-week mindfulness program targets parents with children in Secondary School or below. This research also explores how parenting and attachment styles moderate the intervention effects.


Eligibility Criteria:
Inclusion Criteria:

Parents with at least one child who is in Secondary School or below
Magnetic Resonance (MR) Spectroscopy and Diffusion Tensor Imaging in Determining Brain Injury and Subsequent Clinical Outcome in Patients of Moderate Brain Trauma

The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may reveal areas of injury and quantification of the metabolites from these areas may be used to correlate with imaging findings and clinical evaluation. White matter disruption in these areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in the long term outcomes in these patients, but has been difficult to assess by standard radiologic studies.

By the use of DTI it may be possible to demonstrate damaged white matter tracts which could be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that involved torque to the brain. This results in a shearing injury to the long white matter tracts, which has been hypothesized to be related to cognitive outcome.

Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and, if clinical indicated, farther scanning can be done at a later date.

By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS in the adult and pediatric populations, may help to assess differences in recovery.

Lastly, a comparison between the two groups in changes in brain metabolism and/or white matter tract disruption/re-connection after TBI with and/or without links to outcome can be done.

The purpose of this study is to determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury. This study may show that MRI can provide a clearer picture on the extent of the brain injury and help medical physicians decide how to best treat these patients with a more accurate idea of the brain function of the recovering patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients of acute moderate brain trauma

Exclusion Criteria:

* Patients who are medically unstable or have CT findings that may interfere with the study such as:

  * a large hemorrhage or edema
  * encephalomalacia
  * prior neurosurgeries
  * hardware placed in the head or neck
  * prior head trauma
  * history of neurological conditions
Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients

Measurement of plasma chromogranin A remains the most commonly used biomarkers for both screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours (GEP-NET), despite several limitations that include: lack of a reference CgA standard; wide variations depending on the used assay in different laboratories; and varying sensitivity ranges from 60 to 90% with low specificity \<50%, depending on the population studied.

Surprisingly, and to the best of our knowledge, only three studies with small numbers of participants have been published that have investigated possible effects of food intake on the measurement of CgA. Most have been performed in healthy controls or patients on treatment with proton pump inhibitors for chronic gastritis (up to n = 11 per group) but only one study has investigated patients with GEP-NET, where n = 6 patients with gastric NET were included.

In this study, the investigators aim to assess the time dependent effects of normally ingested diet (5-item English breakfast; or tea or coffee; or ongoing fasted state) on plasma chromogranin A measurements, using timed measurements over 180 min following an \> 10 hours overnight fast, in a randomised double-crossover design. The investigators aimed to include 25 - 35 patients with a histologically confirmed diagnosis of a GEP-NET of varying primary tumour location, tumour stage, grade; and presence or absence of treatment with long acting somatostatin analogues; as well as 10 - 15 healthy controls. In an additional small subgroup of patients who are initiated on treatment with GLP-1 analogues i.e. for type 2 diabetes or obesity, the investigators aim to establish whether injection of GLP-1 analogues has any effects on plasma CgA measurements.


Eligibility Criteria:
Inclusion Criteria:

GEP-NET patients:

* Confirmed diagnosis of NET
* Aged 18 or over
* Able to provide written informed consent
* Able to commit to 3 visits within a 4 week period
* Able to fast overnight
* Able to adequately read/write/speak English

CONTROLS:

* No known diagnosis of NET
* Aged 18 or over
* Able to provide written informed consent
* Able to commit to 3 visits within a 4 week period
* Able to fast overnight
* Able to adequately read/write/speak English

Exclusion Criteria:

- GEP-NET patients

* No confirmed diagnosis of a NET
* Under the age of 18
* Unable to provide written informed consent
* Pregnant women
* Any patients who are un well on the day of their routine appointment
* Unable to fast overnight
* Unable to adequately read/write/speak English

CONTROLS

* Confirmed diagnosis of NET
* Under the age of 18
* Unable to provide written informed consent
* Pregnant women
* Any patients who are un well on the day
* Unable to fast overnight
* Unable to adequately read/write/speak English
Effectiveness of HILT in Shoulder Osteoarthritis

This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis.

Shoulder osteoarthritis (SO) is a musculoskeletal joint disease that affects the elderly. SO is characterized by degeneration of the articular cartilage in the involved joints and its underlying bone within a joint as well as bony overgrowth. It is one of the major causes of physical disability that has a social and public health impact due to pain, stiffness, joint instability, and muscle weakness.

The diagnosed patients with SO will be treated with HILT for a total of ten sessions during the entire duration of the treatment protocol. Parameters to be evaluated are: range of motion, pressure pain (algometer), pain perception (Visual Analog Scale (VAS), Modified Laitinen Pain Questionnaire), quality of life (WHOQoL-BREF) These parameters will be recorded before the first treatment (baseline), after completion of treatment, three and 12 months after completion treatment. A change in above parameters will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. painful osteoarthritis of the shoulder for at least 6 months
2. not engage in any other treatment during treatment period
3. pain ≥4 on the visual analog scale (VAS) in the previous 3 months

Exclusion Criteria:

1. presence of any other musculoskeletal problems associated with the shoulder joint, such as fracture, tendon or ligament tears, meniscus injury, rheumatoid arthritis, or shoulder surgery
2. receiving physical therapy and/or intra-articular corticosteroid or hyaluronic acid injections during the last 6 months
3. absolute and relative contraindications of Laser Therapy