linjc16/ctgov huggingface dataset:
MS Detection of Somatic Mutations in Hematological Malignancies

Study Overview
=================
Brief Summary
-----------------
Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS. The goal of the study is to assess whether MS can represent or not a faster and cheaper way to detect key point mutations in patients suffering from hematological malignancies

Official Title
-----------------
Evaluation of MassArray Platform Versus Illumina Miseq for the Detection of Driver Mutations in Hematological Malignancies

Conditions
-----------------
Hematological Malignancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults >18 years old anonymized samples already studied with NGS in Strasbourg university hematology center for somatic mutations non-opposition of the patient for testing the archive sample with the new method Exclusion Criteria: opposition for testing the archive sample with the new method insufficient archival material patient under protection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of somatic mutations in hematological malignancies by using mass spectrometry (MS) | Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS. | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematological Malignancy, mutations, NGS sequencing, mass spectrometry
A Pilot Study Using Photo-plethysmographic (PPG) Camera

Study Overview
=================
Brief Summary
-----------------
The researcher want to use video signals to monitor heart rate, respiration rate and oxygen saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method: periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using light.

Detailed Description
-----------------
The Researcher want to use ambient light to monitor heart rate, respiration rate and oxygen saturation (SpO2) in infant patients in a hospital setting. The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window.

Official Title
-----------------
Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.

Conditions
-----------------
Infant Development

Intervention / Treatment
-----------------
* Device: Photo-plethysmography monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infant and toddler Exclusion Criteria: non-infant

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infant Development<br>Photo-plethysmography monitoring | Device: Photo-plethysmography monitoring<br>* monitoring vital sign in infant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
assessment
Single Ascending Dose Study of CM326 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.

Official Title
-----------------
A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: CM326
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy adult male participant,18 to 65 years of age, inclusive. Body Mass Index (BMI) 18 to 26 kg/m2, inclusive. History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant. Males must abstain from sex or use highly effective methods of birth control. Having given written informed consent prior to undertaking any study-related procedure. Key Exclusion Criteria: Positive for HIV, or Hepatitis B, or C. Positive result on urine drug screen. Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease). With any condition that inappropriate for entry into this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM326<br>subcutaneous injection | Drug: CM326<br>* subcutaneous injection<br>|
| Placebo Comparator: Placebo<br>subcutaneous injection | Drug: Placebo<br>* subcutaneous injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs |  | Day 1 through Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of CM326 | Serum concentrations of CM326 over time | Day 1 through Day 85 | 
| Pharmacodynamics of CM326 | Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time | Day 1 through Day 85 | 
| Immunogenicity | anti-drug antibody (ADA) | Day 1 through Day 85 |
Biomarker Study for Prediction of aGVHD

Study Overview
=================
Brief Summary
-----------------
This is a prospective study in patients receiving allogeneic stem cell transplantation. The blood samples on Day-14, -7, 0 and every 7 days until D100 were collected together with clinical data. In the final analysis, cytokines and biomarkers analysis will be carried out and compared between patients in No aGVHD and grade II-IV aGVHD.

Detailed Description
-----------------
This is a prospective study, observation study in patients receiving allogeneic stem cell transplantation in 4 BMT centers in Shanghai. The blood samples (on Day-14, -7, 0 and every 7 days until D100) and clinical data will be collected. In the final analysis, a panel of cytokines and biomarkers analysis of serial blood samples will be carried out and compared between patients with no aGVHD and grade II-IV aGVHD.

Official Title
-----------------
Biomarker Identification for aGVHD After Allogeneic Stem Cell Transplantation: a Multiple Center Study

Conditions
-----------------
aGVHD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing allogeneic stem cel transplantation with informed consent patients survived without aGVHD or relapse and patients with development of grade II-IV aGVHD Exclusion Criteria: patients with blood sample and clinical data not available

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of grade II-IV aGVHD | clinical diagnosis and grade of aGVHD | 100 days after allogeneic stem cell tansplantation |
Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury

Study Overview
=================
Brief Summary
-----------------
The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral white matter injury. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.

Detailed Description
-----------------
Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as standard of care. All infants with a birth weight < 1500 grams will be offered DTI, and infants > 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well as the subsequent delivery born within 7 days of that gestational age without brain injury. All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of prematurity, and will also have a formal neurological assessment at that time.

Official Title
-----------------
Diffusion-Tensor Magnetic Resonance Imaging and the Evaluation of Perinatal Brain Injury

Conditions
-----------------
Brain Injury, Fetus and Neonate

Intervention / Treatment
-----------------
* Procedure: Diffusion-tensor imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All infants born at our hospital at < 1500 grams All infants born at our hospital at > 1500 grams with brain injury or severe metabolic acidosis Exclusion Criteria: Major congenital malformations Chromosomal abnormality

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 18 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Diffusion-tensor imaging|Obtain a Diffusion tensor MRI of brain.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffusion-tensor imaging differences between brain injured cases and controls without brain injury |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical cord gas results |  | 2 years | 
| Placental pathology |  | 2 years | 
| Electronic fetal monitoring |  | 2 years | 
| Nucleated red blood cells |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perinatal brain injury, Diffusion-tensor imaging
Mechanisms Underlying Abnormal Ambulatory BP Patterns

Study Overview
=================
Brief Summary
-----------------
To understand the mechanism(s) underlying sodium-dependent blood pressure control, and to determine the consequences thereof.

Detailed Description
-----------------
BACKGROUND: The blood pressure of a significant percentage of the hypertensive population, and the normotensive population at a high risk for the development of hypertension (Blacks and older individuals), is sodium (salt)-dependent. That is to say, increasing the intake of salt will increase blood pressure in these individuals; conversely, and more importantly, decreasing the intake of salt will reduce blood pressure. DESIGN NARRATIVE: The investigators believed that the mechanisms responsible for sodium-dependent blood pressure were only indirectly linked to race, sex, and age. Their research was consistent with the hypothesis that sodium-dependent blood pressure control resulted from decreased responsiveness of the renal and adrenal blood pressure regulatory systems. This produced abnormal daily blood pressure patterns, with reduced fluctuation resulting in extended periods of increased blood pressure. The increased cardiovascular load led to the early development of cardiovascular and renal disease, including hypertension. They tested this hypothesis by identifying 'high risk' and 'normal risk' subjects based on renal responses to sodium restriction. The subjects were equal numbers of healthy males and females, Blacks and whites, between the ages of 55-70 years. Using an innovative approach, they then examined the influence of risk status on 24-hour patterns of blood pressure, hormonal activity, and sodium handling. Finally, they determined the clinical significance of the profiles by examining changes in cardiac and renal status at a two-year follow-up. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Duchenne Muscular Dystrophy Heart Study

Study Overview
=================
Brief Summary
-----------------
Retrospective cohort study including patients with genetically proven Duchenne muscular dystrophy, diagnosed from January 1993 to March 2020. Inclusion of the data relative to genetic diagnosis, clinical characteristics at baseline, cardiac and respiratory workup, medical treatments (ACE inhibitors, steroids), surgical procedures, and occurrence during follow-up of cardiac, respiratory and fatal events. Objectives are to describe long-term natural history of the disease, vital prognosis, genotype-phenotype correlations, effect of treatments.

Official Title
-----------------
Multicenter Cohort Study on Duchenne Muscular Dystrophy Cardiomyopathy

Conditions
-----------------
Duchenne Muscular Dystrophy, Duchenne Muscular Dystrophy-Associated Dilated Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetically-proven Duchenne Muscular Dystrophy (DMD mutation) Covering by social security Exclusion Criteria: Patient refusal to participate to the study
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | Follow-up completed in March 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for heart failure |  | Follow-up completed in March 2020 | 
| Dilated cardiomyopathy |  | Follow-up completed in March 2020 | 
| Hospitalization for acute respiratory failure |  | Follow-up completed in March 2020 |
Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.

Official Title
-----------------
Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

Conditions
-----------------
Acute Pain, Chronic Pain, Hernia, Anesthesia, Intravenous, Anesthesia, Intratracheal

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Sevoflurane
* Drug: Remifentanil
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All male patients undergoing herniorrhaphy surgery that requires general anesthesia. Exclusion Criteria: Subjects unable to communicate directly with the investigators, due to being non-English speaking, loss of hearing, or incompetence. A history of malignant hyperthermia, pseudocholinesterase deficiency, or other disease that prevents anesthetic randomization. Pain-related disorders such as fibromyalgia or other chronic pain syndromes. Emergency surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIA<br>Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only) | Drug: Sevoflurane<br> <br> Drug: Remifentanil<br> <br> |
| Active Comparator: TIVA-K<br>Total intravenous anesthetic with ketamine | Drug: Propofol<br> <br> Drug: Ketamine<br> <br> |
| Active Comparator: TIVA-R<br>Total intravenous anesthetic with remifentanil | Drug: Propofol<br> <br> Drug: Remifentanil<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Chronic Pain, as measured by the Pain Quality Assessment Scale |  | 1 month, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Acute Pain, as measured by the Verbal Response Scale (0-10) |  | Within 30 minutes after arrival to Post-Operative Care Unit (recovery unit), 1 day |
Evaluation of a Resident Curriculum in Firearm Injury Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to evaluate the efficacy of a web-based curriculum designed to teach pediatric practitioners how to provide injury prevention anticipatory guidance, emphasizing firearm injury prevention in a clinic setting. Data will be collected regarding the curriculum's effectiveness using a web-based questionnaire which will be administered to pediatric residents prior to, immediately post, and six months following completion of the curriculum. Pre- and post-test questionnaires will be compared. Residents will also be asked to evaluate the curriculum by completing a survey. We hypothesize that the curriculum will improve residents' knowledge, attitudes and beliefs, and self-efficacy regarding firearm injury prevention anticipatory guidance.

Official Title
-----------------
Evaluation of a Firearm Injury Prevention Web-based Curriculum

Conditions
-----------------
Injury, Training

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric resident at Children's Memorial Hospital Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Education|Firearm injury prevention anticipatory guidance curriculum|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert-scale based testing |  | pre-test, post-test, and 6-months post-test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
injury prevention, firearms, training, counseling, medical education, safety, anticipatory guidance, Firearm injury prevention anticipatory guidance