cyrilzakka/clinical-trials huggingface dataset:
Early Detection of Epstein-Barr Virus Related Disease.

Epstein-Barr virus (EBV) is one of several herpesviruses that cause disease in humans. EBV virus has an oncogenic potential, and it has been associated with the development of a wide range of cancers. Previous studies have shown a close association between EBV and Post-Transplant Lymphoproliferative disorder (PTLD) in transplant recipients. As part of a preventive approach against PTLD, several transplantation units now monitor the occurrence of EBV-DNAemia after transplantation. However, there is little evidence to guide this strategy; nor is there consensus concerning either the best specimen to use for EBV analysis (whole blood or plasma).

In this study investigators aim to optimise and validate a polymerase chain reaction (PCR)-test for EBV-DNA on, respectively, whole blood, plasma and a combination of plasma and lymphocytes.

The investigators wish to determine which of the three tests best predicts current and future risk of development of EBV-related diseases such as mononucleosis and PTLD.

EBV is one of several herpesviruses that cause disease in humans. Primary EBV infection usually occurs in early childhood and is generally asymptomatic, while later infection may cause mononucleosis. As with other herpesviruses, primary infection is followed by persistent (lifelong) infection. EBV virus has an oncogenic potential, and it has been associated with the development of a wide range of cancers. Previous studies have shown a close association between EBV and PTLD in transplant recipients. As part of a preventive approach against PTLD, several transplantation units now monitor the occurrence of EBV-DNAemia after transplantation. However, there is little evidence to guide this strategy; nor is there consensus concerning either the best specimen to use for EBV analysis (whole blood or plasma) or the appropriate clinical action to take if EBV-DNAemia is detected.

In this study investigators aim to optimise and validate a polymerase chain reaction (PCR)-test for EBV-DNA on, respectively, whole blood and a combination of plasma and lymphocytes.

Results obtained with the two new methods will be compared with those from the already established World Health Organization (WHO) standardised EBV-PCR test on ethylenediaminetetraacetic acid (EDTA)-plasma. The result of all three tests will be evaluated relative to EBV-related symptoms and other diseases.

The investigators wish to determine which of the three tests best predicts current and future risk of development of EBV-related diseases such as mononucleosis and PTLD.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected for having EBV disease.

Exclusion Criteria:

* If the patients has any contraindications for blood sampling.
Lymphatic Anomalies Registry for the Assessment of Outcome Data

Lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the understanding of the natural history, long-term outcomes, risk factors for morbidity and mortality, and the relative benefit of medical therapies and procedures is limited.The goal of this project is to better understand these diseases and improve the care of theses rare patients. To do this, the investigators are conducting an observational study of patients with lymphatic anomalies, including an annual follow-up questionnaire to gather prospective data on mortality, morbidity, treatments, and functionality as well as quality of life.

The purpose of the Lymphatic Anomalies Registry, created at Boston Children's Hospital, is to create a database to help current and future patients diagnosed with a lymphatic anomaly. The ultimate goal of the registry is to better understand and predict responses to therapies and risk factors for complications. Although the Lymphatic Anomalies Registry exists at Boston Children's Hospital, patients can be entered into the registry regardless of whether or not they visit Boston Children's Hospital, thus increasing the program's accessibility. The Lymphatic Anomalies Registry includes patients who have vascular anomalies with a lymphatic component across various diagnoses. From the patient's perspective, participation in the Lymphatic Anomalies Registry means taking part in a short, thirty minute interview, and providing the registry with access to medical records. The interview is conducted verbally with study staff of the Lymphatic Anomalies Registry, and can take place either at the hospital, or over the phone. During the interview, the registry will inquire about the patient's diagnosis, disease features, medical therapies, and procedures. Interested prospective patients will receive an introductory packet from the registry with information on how to proceed in the registry process. All obtained patient information is housed on a secure, HIPPA compliant, internal database, managed by Boston Children's Hospital staff. Patient information entered into the external database is de-identified. The research teams will also obtain a medical record release form to request the patient's medical record for review in our study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of complex vascular tumor, malformation or overgrowth syndrome with significant lymphatic component
Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles

Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* Female between ≥ 30 and ≤ 65 years old at the time of the screening.
* Subjects seeking improvement of décolleté wrinkles.

Exclusion Criteria:

* Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area.
* Previous treatment with collagen fillers, calcium hydroxylapatite, and/or long-lasting hyaluronic acid (HA) fillers in the décolleté, or with other HA fillers in the décolleté.
* Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels, and/or non-invasive skin tightening in the décolleté.
Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI Study

Osteogenesis Imperfecta (OI) is a heterogeneous group of rare connective tissue hereditary diseases responsible for fragility and bone deformity. OI is caused by an autosomal dominant mutation of COL1A1 or COL1A2, encoding α1 and α2 of the collagen, regardless of their phenotypic severity (1 to 5 OI type).

This observation suggests the existence of a undetermined mechanism that may be found in epigenetic regulation, including particularly micro Ribonucleic Acids (miRs).

Indeed, these small non-coding miRs are involved in the regulation of major steps of cellular processes in different pathologies, especially in bone disease.

Currently, no study can provide a satisfactory answer.

This is an etiologic study to reveal the correlation between micro-RNAs (miR) expression and the type I or III of the Osteogenesis Imperfecta (OI).

The aim of this study is therefore to identify miRs significantly associated with the severity of OI.


Eligibility Criteria:
Inclusion Criteria:

Control population:

* Male or female
* 18 years old and over
* Be part of cohorts STRAMBO, OFELY or MODAM

Patients with OI:

* Male or female ≥18 years old
* Have COL1A1 or COL1A2 mutation
* Have a diagnosis of type 1 or 3 from Silence classification made by a rheumatologist expert in bone pathologies

Exclusion Criteria:

* Refusal to participate in the study
* Have received glucocorticoid treatment for more than 3 months
* Have received anti-osteoporotic treatment for less than 1 year ago
* Have Chronic inflammatory rheumatism
* Have an uncontrolled hypo/hyper thyroidism ou hypo/hyper parathyroidism
* Have cancer or bone metastases (current or in the past two years)
* Have benign bone tumors or Paget's disease
* Have malabsorptive disease (Celiac disease, Whipple's disease, intestinal bypass, short bowel syndrome) and inflammatory bowel disease
* Pregnant or lactating women
* Have psychiatric disorders seriously hindering understanding
* Have difficulties in oral understanding of French language
* Not a beneficiary of french social security
* Patients protected by law
Accuracy of ICCMS Versus Simplified Cariogram

The study aims to compare the validity of the caries risk assessment regarding the comprehensive ICCMs Caries risk and likelihood matrix versus the simplified Cariogram aiming to see if there is a significant difference in the caries risk levels between both models.

The simplified Cariogram has been already established as a simple computerised efficient way to categorise patients according to their risk of developing new lesions. However, since then, more comprehensive ways such as the ICCMS have risen. Such comprehensive models require much more data to be entered and more time for the assessment to be complete.

This study aims to test whether there is a significant difference between the validity of both models that would justify the extra time, effort, and recordings that have to be taken for the ICCMS.

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 18 to 29 years.
* The presence of dental caries or restoration.

Exclusion Criteria:

* Patients with no caries.
* Patients diagnosed of psychiatric disease.
* Patients not willing to be part of the study or ones who refuse to sign the informed consent.
Literacy Promotion for Latinos Study

This study tests the extent to which tailored outreach text messages that provide a cue to action and an intervention that enhances access to poverty-reducing resources, in combination with standard primary care literacy promotion, can improve child language and social- emotional skill acquisition among low-income Latino children.

The investigators propose a 3 arm randomized clinical trial to test strategies designed to enhance literacy promotion for low-income Latino families. The investigators will recruit 630 parent-child dyads from community health centers that serve low-income, Latino families. Parents will be randomly assigned to one of 3 arms (1) Reach Out and Read (ROR) an evidence-based literacy promotion intervention that is widely disseminated in primary care; (2) ROR plus tailored outreach text messages; (3) ROR plus tailored outreach text messages and enhanced access to poverty-reducing resources using a widely disseminated model that simplifies access and provides care coordination. In Aim 1, the investigators will test their hypotheses that (1) children in the ROR plus text message arm will have higher scores on validated assessments of language and social-emotional development compared to standard ROR alone and (2) children who receive both text messages and enhanced access to poverty-reducing resources will have higher scores compared to the other two arms. In Aim 2, the investigators will examine mechanisms that underlie the effects of the interventions. In Aim 3, the investigators will use mixed methods to conduct a process evaluation to understand how the interventions are implemented, identify barriers, facilitators, and modifications, and explore parents' experiences with the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of a child age 6 months to 12 months
* Identifies as Latino/a/x
* Primary language English or Spanish
* Cell phone ownership
* Age 18 years or older
* Willing to receive text messages
* Willing to accept being placed into one of three study groups

Exclusion Criteria:

* Children with multiple congenital anomalies or genetic disorders and previously identified developmental delays
* Individuals unable to provide informed consent
* Intent to discontinue care at current pediatric clinic / recruitment site
* Discontinued care at one of the three pediatric clinics / recruitment sites
Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors

This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.

This is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy and pharmacokinetics of AMG 337 in MET amplified Gastric/esophageal adenocarcinoma or other solid tumors. Approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified G/E adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor/up to 10 subjects with MET amplified G/E adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior MET antibody therapy). All subjects will self-administer AMG 337 300 mg daily until disease progression or other protocol specified end of treatment criteria is met.

Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.

Tumor assessment by RECIST 1.1 will be followed during study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Able to daily self-administer AMG 337 orally as a whole capsule
* Male or female 18 years of age or over.
* Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy
* Tumor MET amplified by protocol-specified centralized testing.
* Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1
* (ECOG) Performance Status of 0, 1 or 2

Exclusion Criteria:

* Known central nervous system metastases
* Candidate for curative surgery or definitive chemoradiation
* Peripheral edema \> grade 1
* Persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption
* Acute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safety
* Detectable Hepatitis C virus (indicative of active Hepatitis C)
* Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment
* Prior treatment with small molecule inhibitors of the MET pathway.

Other protocol defined inclusion criteria may apply.
PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy

RATIONALE: Imaging procedures, such as PET scans, may determine the extent of cancer and help doctors plan radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial is studying PET scans to see how well they work in patients with head and neck cancer who are undergoing 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy.

OBJECTIVES:

Primary

* To assess the value of pre-treatment PET in determining the target volume in patients with head and neck cancer undergoing three-dimensional conformational radiotherapy and intensity-modulated radiotherapy.

Secondary

* To evaluate variations in weekly fludeoxyglucose F 18 PET imaging during the first 5 weeks of treatment.
* To determine the relationship between changes in tumor metabolism during radiotherapy and control tumor at 3 months and at 1 year post-treatment.

OUTLINE: This is a multicenter study.

Patients undergo fludeoxyglucose F18 PET (FDG-PET) in addition to conventional imaging at baseline. Patients undergo standard three-dimensional conformational radiotherapy and intensity-modulated radiation therapy 5 days a week for 5 weeks.

Some patients also undergo weekly FDG-PET during treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed head and neck cancer

  * No nasopharyngeal or paranasal sinus cancer
  * Locally advanced disease (T3 or T4)
  * Not in complete remission
* Planning to undergo curative radiotherapy (minimum dose of 66 Gy), with or without standard treatment (i.e., platinum-based chemotherapy or biological therapy/rituximab)
* Measurable tumor according to RECIST criteria

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Not pregnant or nursing
* Able to lie still for 1 hour
* No history of progressive neoplastic disease
* No known hypersensitivity to fludeoxyglucose F18 or any of its excipients
* No severe or uncontrolled systemic disease, including any of the following:

  * Kidney disease
  * Liver disease
  * Cardiac disease
  * Unstable or uncompensated respiration
  * Uncontrolled diabetes (i.e., glucose ≥ 1.5 g/L)
* No geographical, social, or psychological conditions that make follow-up impossible

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior surgery
* No concurrent experimental agents
Pulse Oximetry With Clinical Observation to Screen for Lung Disease in Neonates

The investigator assessed the feasibility and reliability of pulse oximetry plus clinical observation for detection the lung disease in neonates.

At present respiratory disease(RDS) diagnose base on clinical symptom and chest X-ray.But in china, because of the difference of medical conditions, some areas especially the basic level hospitals without the condition of X-ray examination, which can not be clearly diagnosed RDS.In 2013, the scholars analyzed the disease of neonatal intensive care unit (NICU) need to be exposed to radiation, and RDS was in the first place. There is no conclusion whether it bad for newborn to exposure more. But in animal models, there is a correlation between exposure to radiation and cancer.

Hyaline membrane disease(HMD) is common occur in preterm infants .pulmonary surfactant(PS) is a safe and effective treatment for neonatalHMD.Bahadue F L meta analyse conclusion is early application of PS is more benefit for HMD.

So investigator hypothesize that pulse oximetry with clinical assessment have high sensitivity,specificity ,positive and negative predictive value to lung disease.The aim is to reduce radiation exposure to neonate and to preterm infants with RDS can early application of PS.

Symptomatic definition:with grunting,nasal flaring,retraction,cyanosis,tachypnea,stridor.

Pulse oximetry positive criteria:1.atrial oxygen saturation (SpO2)\<90%;2.heart rate\>180 or \<100 per minute.

Clinical assessment:1.respiratory physical examination:non-symmetry,decrease breathing sound,bubbles sound.2.Delivery history:caesarean,premature rupture of membranes,liquor,mother conditions,Apgar score.

Congenital heart disease classification:1.critical:defects causing of the death or needing intervention before 28 days.2.serious:defects needing intervention before 1 year of age.significant:defects persisting longer than 6 months of age ,but not classified as critical or serious.4.non-significant:defects not physically appreciable and not persisting after 6 months of age.

Eligibility Criteria:
Inclusion Criteria:

1. gestation age :28 to 42 weeks
2. birth weight :1000-4000g
3. asymptomatic or symptomatic respiratory symptom

Exclusion Criteria:

1. gestation age \<28 weeks or \>42 weeks
2. birth weight \<1000g or \>4000g
3. critical and serious heart disease
4. congenital malformation
Effects of Probiotics on Neonatal Hyperbilirubinemia

This study was designed as a prospective controlled study to investigate the effects of probiotic support started immediately after birth on newborn jaundice in breastfed babies born by normal spontaneous vaginal delivery.

Objectives: Enterohepatic circulation of bilirubin imposes an extra burden of approximately 30% on total serum bilirubin levels. Intestinal microflora is the main factor affecting enterohepatic circulation. This study investigated the effects of probiotic support started immediately after birth on neonatal hyperbilirubinemia in babies born by normal spontaneous vaginal delivery and breastfed only.

Methods: A total of 150 healthy term newborns were included in the study and allocated in the study and control groups. Immediately after birth, newborns in the study group received probiotic in liquid drop form (Maflor® drops containing Lactobacillus Rhamnosus GG 109 Colony Forming Units(CFU), Mamsel Pharmaceuticals, Turkey), at a dose of 5 drops a day orally for 10 days. Newborns in the control group received 5 drops of saline solution per day orally, instead. In addition to routine biochemical examinations;serum bilirubin levels in the cord blood, and blood samples of the newborns on the 3rd, 5th and 10th days of birth were measured in all subjects in both groups. Defecation frequency was recorded for all subjects.

Eligibility Criteria:
Inclusion Criteria:

* A total of 150 full-term (gestational age ≥37 - \<42 weeks) normal spontaneous vaginal delivery healthy newborns
* Birth weight between the 10th-90th percentiles
* Fed by breast milk only

Exclusion Criteria:

* Newborns with familial hematologic disorders
* Having signs of hemolysis due to blood group incompatibilities
* Bleeding into closed spaces due to birth trauma complications (e.g. cephalohematoma)
* Suspected or documented neonatal infection such as chorioamnionitis, intrauterine infection, sepsis and urinary tract infection
* Perinatal and neonatal hypoxia
* Having thyroid dysfunction, respiratory distress or insufficiency, metabolic and thermoregulatory dysfunction, hemodynamic instability and congenital heart disease
* Maternal phenobarbital usage history during the last month of the pregnancy
* Having venous hematocrit (Htc) levels≥65%