cyrilzakka/clinical-trials huggingface dataset:
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

The GlaxoSmithKline's Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is established to meet a post marketing commitment agreed upon with CBER to prospectively collect data on pregnancy exposures to Meningococcal quadrivalent CRM-197 conjugate vaccine.

It is an observational study of women inadvertently immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy as part of routine care.

The objective of the pregnancy registry is to evaluate pregnancy outcomes among women immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.


Eligibility Criteria:
Inclusion Criteria:

* Sufficient evidence to confirm that MENVEO exposure occurred within 28 days prior to conception or at any time during pregnancy
* Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
* Date the pregnancy exposure is registered
* Full reporter (ie, HCP) contact information to allow for follow-up (name, address, etc.)

Exclusion Criteria:
Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children (PREMILOCAP)

The risk of Arterial Hypertension (HTA) is increased in very premature infants and hydrocortisone administered in the neonatal period could modify this risk.

The main objective is to assess whether the administration of hydrocortisone in the perinatal period in children born prematurely is associated with an increase in Pulse Wave Velocity (PWV) by comparing the future of children included in the PREMILOC trial (hydrocortisone versus placebo) at the age of 7-13 years. The primary endpoint will be the carotid-femoral pulse wave velocity in m/s.

Descriptive cross-sectional study of the subjects included in the double-blind, monocentric randomized controlled trial (children included and followed up at the Robert Debré hospital in the PREMILOC trial): follow-up of these children approximately 10 years later on vascular parameters.

Eligibility Criteria:
Inclusion Criteria:

* Child included in the PREMILOC trial on the Robert Debré site
* Age from 7 to 13 years old (eve of 14 years old)
* Consent of the holders of parental authority and agreement of the child

Exclusion Criteria:

* Absence of affiliation to a social security scheme
* Patient under state medical aid
Pharmacokinetic of Posaconazole in Critically Ill Patients

The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.

The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Plasma specimens will be retrieved on consecutive days (max. 7 days) in order to measure posaconazole levels during the treatment episode.

Eligibility Criteria:
Inclusion Criteria:

* treatment with intravenous posaconazole
* critically ill patient
* written declaration of consent

Exclusion Criteria:

- no declaration of consent
Pancreatic Cyst Fluid Glucose: New Armamentarium in the Diagnosis of Mucinous Pancreatic Cystic Lesion

All participants undergoing radiological imaging and found to have pancreatic cyst of size \> 2cm will be subjected to EUS (Endoscopic ultrasound) examination and cystic fluid will be aspirated for analysis, including cystic fluid Glucose, CEA, amylase. Morey's biopsy will be done in the cases feasible for biopsy. The sensitivity and specificity of cystic fluid glucose level will be analysed taking CEA (carcinoembryonic antigen) level with EUS findings, amylase level as gold standard for diagnosis, in cases with no surgical management.

Pancreatic cystic lesion prevalence noted to be increased dramatically in last few decades. Earlier record showed the prevalence rate of 2.4-2.6% with magnetic resonance imaging (MRI), though sometimes reaching 13.5%.Recent study showed prevalence of pancreatic cysts to be 49%. Most of the pancreatic cyst are benign and require conservative management and regular evaluation only. Malignant cystic lesion on the other hand require immediate attention and surgical excision in most of cases. Thus, diagnosis of pre-malignant \& malignant pancreatic cyst are essential, to predict the prognosis and decide further management.

Most widely accepted biochemical test for preoperative differentiation of mucinous from benign pancreatic cysts is cystic fluid carcinoembryonic antigen (CEA). CEA with cutoff value of 192 ng/ml has sensitivity, specifivcity and accuracy of 75%, 84% \& 79% respectively. This is expensive and requires a longer duration for obtaining the results. Few recent studies proposed the role of cystic fluid glucose level in the diagnosis of malignant cyst.

Eligibility Criteria:
Inclusion Criteria:

* Patients (between 18 to 60 years of age)
* Pancreatic cyst of size \>2 cm noted on radiological imaging

Exclusion Criteria:

* Patient's age \<16yrs or \>80 yrs.
* Prior history of pancreatitis (within 3 months)
* Pregnant female
* Unfit for endoscopic ultrasound
* Not wiling for consent
Posture Correction in Cubital Tunnel Syndrome

The primary objective of this study is to determine whether the UpRight Go posture trainer reduces the symptoms of cubital tunnel syndrome in patients who have not had corrective surgery, as determined by improvements in VAS scores for pain, numbness, and weakness.

This is a randomized controlled, non-blinded trial. All patients who are eligible to participate and who consent to participate will be randomized to either receive standard of care treatment alone, or standard of care treatment with the additional intervention of posture training. The nature of the intervention prevents blinding. All patients will be followed for 6 weeks and evaluated for symptom improvement or resolution.

All patients aged 18 and older who present to clinic with cubital tunnel syndrome of any severity and who have not previously undergone surgical intervention for this condition will be eligible to participate in this study. All participants must be amenable to conservative management of CuTS, wearing a posture training device daily, completing the accompanying questionnaires throughout the study, and returning for follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Adult patients, between 18 and 99 years old
* Exhibiting signs and symptoms consistent with cubital tunnel syndrome including but not limited to pain, numbness, or paresthesia in an ulnar distribution, loss of grip strength, or loss of fine motor control of the fingers.
* Nerve conduction study, electromyography, MRI or ultrasound results consistent with the diagnosis of cubital tunnel syndrome
* Ability to wear a posture trainer daily and manage the associated smartphone application and questionnaire

Exclusion Criteria:

* History of spinal surgery, hand surgery or hand/wrist fracture
* History of cubital tunnel release surgery or carpal tunnel syndrome
* Pregnancy or lactation
* Known allergic reactions to silicon
* Long-standing history of T2DM, documented neuropathic pain
Pediatric Ward Discharge Quality Improvement

This study will utilize an iterative quality improvement process to identify and address delays in the pediatric hospital discharge process.

Hospital crowding has been associated with increased hospital length of stay in pediatric populations and adverse outcomes in adult populations. This study focuses on a 36-bed general pediatric inpatient care unit whose occupancy has seen exponential growth over the past several years. With the growth in patient population, the study hospital is experiencing increasing difficulty with hospital crowding, particularly during key times of year, such as the winter viral respiratory season. During these times, pediatric patients may experience high emergency room wait times, and admitted patients may be required to board in the emergency room or post-anesthesia care unit while they await an inpatient bed. Lack of inpatient bed availability has also, at times, required cancellation of surgical cases and denial of outside hospital patient transfers to the institution, resulting in inconvenience to patients and delays in care.

The pediatric hospital discharge process has come under particular scrutiny as an area in which both the efficiency and the effectiveness of patient care can be improved. Currently, around 10% of patients ready for discharge in a given day from the general pediatric hospitalist service are discharged prior to noon, freeing up this bed space for a new patient. While for some patients, discharge is postponed for medical reasons, others must remain in the hospital for non-medical delays. For example, they may remain hospitalized because they have not yet been seen by a physician, their medications are not available for pick-up from the pharmacy, or they do not have transportation from hospital to home. Several studies in pediatric populations have shown that quality improvement processes can improve discharge efficiency without compromising care quality or patient/family satisfaction. The investigators aim to determine if an iterative quality improvement process can reduce barriers to discharge and therefore decrease pediatric patients' length of stay. They will simultaneously analyze several secondary outcomes to evaluate patient flow, patient/family satisfaction, and subsequent hospital utilization to evaluate for unintended consequences of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Children or young adults less than 21 years of age admitted to the University of California Davis Children's Hospital Pediatric Hospitalist Service on the general pediatric inpatient ward

Exclusion Criteria:

* Adults greater than 21 years of age, including those unable to consent
* Pregnant women
* Prisoners
* Children admitted to other services (i.e. Ear, Nose and Throat Surgery, Pediatric Surgery, Pediatric Gastroenterology, Trauma, Pediatric Nephrology, Pediatric Hematology/Oncology, Pediatric Intensive Care Unit, Neonatal Intensive Care Unit, Newborn Nursery, etc.)
A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases

Vertebral fracture is a common clinically significant skeletal related event in cancer patients. Stratification of patients diagnosed with one or more vertebral metastases according to the risk of pathological fracture is an unresolved problem despite the fact that fractures strongly influence the quality of life (QoL) and also the overall survival. The multidimensional nature and the strong patient specificity of the risk for fracture have not been considered in previously published risk estimation models and these methods were developed and validated only on retrospective data focusing on prevalence of life-time fracture which is not really relevant at the time of the diagnosis of a vertebral metastasis. To overcome these shortcomings, the METASTRA models (METASTRA-AI and METASTRA-VPH) and the decision support system (METASTRA-DSS) are developed considering the highest possible level of patient specificity to stratify the individuals according to their risk for fracture in a clinically considerable period (within next 6 months). The prospective data collection and analysis will provide reliability and validity results on the performance of METASTRA tools as well as structured information on user's experience helping the future integration of the developed patient-specific stratification tool into the everyday clinical practice.

The study is a prospective clinical data collection from minimum 200 patients to determine the validity (i.e. Precision) in fracture risk stratification of the METASTRA-AI and METASTRA-VPH computational models and to determine the reliability of METASTRA-AI and METASTRA-VPH as well as human decision making process in patient stratification.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years or older
* Patient diagnosed with a metastatic tumor in the thoracic and/or lumbar spine (one or more vertebral metastases in the spinal region between T1 and L5 vertebrae)
* Min. 1 vertebra is potentially unstable based on SINS score (SINS is 7-12) and it has not been surgically stabilized previously (level of interest - LOI)
* Adjacent vertebrae are not surgically stabilized at the time of the enrollment
* Patient willing to complete 6-month follow-up
* Patient is willing and able to provide written informed consent after the nature of the study has been explained:

  * Ability to understand the content of the patient information/ ICF
  * Willingness and ability to participate in the study according to the protocol
  * Signed and dated EC approved written informed consent

Exclusion Criteria:

* Poor general status at baseline (Karnofsky scale less than 40%)
* Expected life expectancy is less than 3 months at baseline
* Spinal infection
* Ongoing litigation
* Participation in investigational clinical study at the same time or within 3 months
* Vertebral lesion/metastasis from a hematologic condition (e.g. multiple myeloma)
Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls

The purpose of the study was to observe therapeutic effects of combined resistance and aerobic exercise training (CRAE) on hyperinsulemia in obese adolescent girls. Forty obese adolescent girls (14±1 years) participated in this study. The participants were randomly separated into two groups; no-exercise group (n=20) and exercise group (n=20). The exercise group performed 12 weeks of CRAE.


Eligibility Criteria:
Inclusion Criteria:

* Obese with Hyperinsulinemia
* Obese with Abdominal obesity

Exclusion Criteria:

* Hypertension
* Pregnancy
* Chronic diseases
* Weight loss diet within the last 6 months
A Study to Learn About the Study Medicine - Precedex in Children From Japan.

The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.

This study is seeking for children who are 1 month to less than 18 years old.

The patients are planned to be looked over:

* From the time of patient check before receiving Precedex
* To 1 hour after the completion or stop of using Precedex.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (1 month to \< 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"

Exclusion Criteria:

* No exclusion criteria is set out in this study.
A Study on Safety of tDCS One-shot in UCP

The study aims to evaluate the safety and the feasibility of transcranial Direct Current Stimulation (tDCS) session in children and young adults with Unilateral Cerebral Palsy (UCP). Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in very short term, Upper Limb (UL) functions.

Unilateral Cerebral Palsy (UCP) represents the most frequent form of CP; the upper limb (UL) is generally more affected than the lower limb with an impact in "activity" and "participation" areas. The non-invasive brain stimulation techniques (NIBS), such as transcranial Direct Current Stimulation (tDCS), appear able to modulate neuronal plasticity processes even more late in age attracting great interest for their potential fallout in the field of rehabilitation. The effects of tDCS in recovery of motor function has more investigated in adults, while in the pediatric population studies on safety and efficacy are still few and not conclusive. This study aims to evaluate the safety and the feasibility of tDCS session in children and young adults with UCP both in short term and in follow up (up to 24 hrs after the tDCS session). Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in short term, UL functions. For the study 6 children (aged 10-17 years) and 6 young adults (aged 18-28 years) with UCP will be recruited. Each subject receives, randomly, a real session and a sham session of tDCS with BrainStim Stimulator. Before (T0), immediately after (T1) and after 1 hour and half (T2) to each tDCS session (real or sham) heart rate, blood pressure and UL functions will be measured. Moreover the subject fills in an ad hoc questionnaire on safety at T1 and T2 and, on call, at 24 hours after the sessions (T3).

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Unilateral Cerebral Palsy
* Informed consent

Exclusion Criteria:

* Any contraindication for tDCS
Spaeth/Richman Contrast Sensitivity Test

The Spaeth-Richman Contrast Sensitivity (SPARCS) test is a new method of assessing contrast sensitivity. The test, another way to measure vision, is performed on any standard computer with internet access. Patients will be tested with SPARCS and with the standard Pelli-Robson contrast test.

Contrast Sensitivity is another way to test vision. It uses black on a white background and minimally decreases the black (grey) until it blends with the white. The least amount of contrast (faint grey) seen translates into amount of vision. This new method of determining contrast sensitivity uses black and white vertical bars and does not require recognizing letters in the alphabet. It tests various areas of the visual field and central vision. The test takes approximately 3 minutes per eye.

Pelli-Robson is a commonly used contrast sensitivity test that uses black letters on a white background. The letter size stays the same, only the amount of black changes, becoming greyer, making letters hard to see. The test takes approximately 1 minute per eye.

Hypothesis: A method of determining contrast sensitivity that does not require letter recognition (as does the Pelli-Robson test) eliminates the barriers of literacy and pattern recognition, to permit a more valid determination of contrast sensitivity.

Patients will perform SPARCS and Pelli-Robson twice; once each with two separate observers for reproducibility and intra-observer reliability. The order of testing will be randomized to SPARCS, Pelli, Pelli, SPARCS or Pelli, SPARCS, SPARCS, Pelli.

Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age and older
* able to provide fully informed consent

  70 controls (patients with no ocular disease affecting visual acuity or visual function), 10 from each decade of life: 20-30, 30-40, 40-50, 50-60, 60-70, 70-80, 80+.

  105 patients with ocular hypertension or any type of glaucoma (15 subjects per age decade). Glaucoma patients will not have macular degeneration or visual acuity affected by any function other than glaucoma.

  40 patients with macular degeneration: 10 with visual acuity 20/40 or better, 10 with visual acuity between 20/40 and 20/60, 10between 20/100 and 20/400, and 10 with 20/400 or worse.

  40 patients with cataracts: 10 with lens opacity 1+nuclear sclerosis, 10 with 2 + nuclear sclerosis, 10 with 3 + nuclear sclerosis, 10 with 4 + nuclear sclerosis.

  60 patients with refractive error: 10 with myopia -5 diopters or greater, 10 with myopia between -5 and -2.5, 10 with myopia between -2.5 and -0.5, 10 with myopia between -0.5 and 0.5, 10 with myopia between 0.5 and 2.5, and 10 with myopia \> 2.5.

Exclusion Criteria:

* any other diseases affecting visual acuity
Lyso-Gb1 as a Long-term Prognostic Biomarker in Gaucher Disease

International, multicenter, epidemiological study to demonstrate the correlation and predictive value of lyso-Gb1 concentration with the clinical severity of naïve, initially non-ERT/SRT Gaucher disease type 1 and during the study ERT/SRT-newly started Gaucher type 1 patients and to correlate lyso-Gb1 concentration with the clinical improvement of ERT or SRT treated Gaucher type 1 and the clinical course of non-treated patients based on GD-DS3

Gaucher disease is an autosomal recessive inherited lysosomal storage disorder. The disease is caused by the hereditary deficiency of the glucocerebrosidase, a lysosomal enzyme that breaks down glucocerebroside into glucose and ceramide.

To date a definitive diagnosis of Gaucher's disease can only be made applying biochemical testing measuring the reduced enzymatic activity of the beta-glucosidase together with genetic confirmation. Since numerous different mutations may be the cause of a particular lysosomal storage disease the sequencing of the entire beta-glucosidase gene is applied in Gaucher's disease in order to confirm the genetic diagnosis.

The use of primary storage molecules as biomarker was assessed for glucosylceramide (Gb1) in plasma of Gaucher's disease patients and compared to the level of Gb1 in healthy individuals.

In order to establish a sensitive and specific biomarker for GD, we compared mass spectra of the plasma of healthy controls and GD patients using HPLC and tandem mass spectrometry. Mass spectra that differed most between patients and controls were analysed in more detail. The resulting biomarker, which was patented in June 2011 (PCT/EP2012/002409), was lyso - Gb1. We identified this compound as a reliable, sensitive and specific biomarker for GD in a cohort of GD patients. Furthermore, in a pilot study we evaluated whether lyso-Gb1 is related to the specific genotypes and is reliable for long-term monitoring of the efficiency of therapy.

The aim this study is therefore to investigate lyso-Gb1 as a long-term prognostic marker in naïve, non-ERT/SRT GD type 1 patients by monitoring over the course of 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 6 months or older
* Patients with genetically confirmed diagnosis of Gaucher disease type 1
* No prior treatment with enzyme replacement therapy or substrate reduction therapy ro no traetment for more than 24 months
* Signed informed consent by parents/legal guardian and patient

Exclusion Criteria:

* Male or female patients being younger than 6 months
* Patients without genetically confirmed diagnosis of Gaucher disease type 1
* Gaucher disease 2 or 3
* Patient is currently undergoing enzyme replacement therapy or substrate reduction therapy
* Missing signed informed consent