linjc16/ctgov huggingface dataset:
Study of the Use of LUMA Lightwire

Study Overview
=================
Brief Summary
-----------------
This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon dilation procedures.

Detailed Description
-----------------
50 patients undergoing functional endoscopic with balloon dilatation sinus surgery will be studied using the light wire technology. This will be used as a guide for the surgeon to know when they are safely in the sinus by trans-illumination through the sinus wall prior to utilizing balloon dilation. Routine fluoroscopy will be used as well to verify the position of the wire, which is currently standard practice. The ease, time required, and accuracy of placement will be recorded for each case and compared to data previously collected when suing standard wire technology.

Official Title
-----------------
LUMA Lightwire Study

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Procedure: Functional Endoscopic Sinus Surgery with Balloon Dilatation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients needing endoscopic sinus surgery initial or previous sinus surgery subject will be included Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Functional Endoscopic Sinus Surgery with Balloon Dilatation|Luma lightwire technology will be utilized in conjunction with fluoroscopy for patients with sinusitis undergoing functional endoscopic sinus surgery with balloon dilatation. Trans-illumination of the sinus will be compared to fluoroscopy for accuracy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy |  | at conclusion of subject enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sinusitis
Association Between the Support of NICU Team and Subjective Health of Parents

Study Overview
=================
Brief Summary
-----------------
Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. The NICU team is the main support source for these parents. Support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. The hypothesis of this study is that better support to parents lead to better subjective health feeling by them. The study will be held among mothers to infants in NICU who are at least 7 days old. The study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. Sample size is about 150 mothers.

Detailed Description
-----------------
Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. The NICU team is the main support source for these parents. Support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. The hypothesis of this study is that better support to parents lead to better subjective health feeling by them. The study will be held among mothers to infants in NICU who are at least 7 days old. The study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. Sample size is about 150 mothers.

Official Title
-----------------
Association Between the Support of Neonatal Intensive Care Unit (NICU) Team and Subjective Health of Parents to a Premature Infant

Conditions
-----------------
Conditions Influencing Health Status

Intervention / Treatment
-----------------
* Other: Questionaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers to preterm infants in NICU Exclusion Criteria: Mothers to Infants in NICU who are not preterm Mothers to Infants in NICU who died during hospitalization Mothers to Infants in NICU who were transferred to another hospital during hospitalization

Ages Eligible for Study
-----------------
Maximum Age: 60 Years

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 |
| --- | --- |
| Mothers<br>Mother of infants in NICU | Other: Questionaire<br>* Questionaire to mothers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good subjective health feeling of mother. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjective health feeling, NICU, team support
Performance for French Pediatric Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
Introduction. The measurement of severity scores in adult and pediatric resuscitation provides a tool for evaluating the clinical performance of resuscitation services. No pediatric studies have investigated the association between current procedure and diagnostic cost indices with pediatric ICU patient severity and mortality. Objectives. The main objective of this project in real-life situations, in 14 French pediatric intensive care units, is to validate the recently available PIM3 and PRISM IV severity scores, which take into account the clinical dimension of performance in pediatric intensive care. This project is a French multicenter prospective observational research project involving 14 French pediatric intensive care units belonging to the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP). All patients under 18 years of age admitted to the 14 pediatric intensive care units affiliated with the GFRUP and voluntarily participating in the project will be included in the study. Expected outcomes are: Validation of PIM3 and PRISM IV scores in a French population to assess clinical performance. To develop a predictive model of mortality and a predictive model of cost in French pediatric intensive care units.

Official Title
-----------------
Creation of a Composite Indicator of Clinical and Economic Performance for French Pediatric Intensive Care Units

Conditions
-----------------
Severity of Illness Index

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients under 18 years of age admitted to the 14 pediatric intensive care units and voluntarily participating in the project will be included in the study. Exclusion Criteria: - Children of age of reason or parents/legal guardians of children refusing participation in this project will be excluded from the study.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Survival : yes / no |  | At PICU discharge,through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost of PICU stay |  | At PICU discharge,through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severity of Illness, Pediatric, intensive care, economic, scoring system
Medical Data Collection of Patients With Head and Neck Cancer Treated With Proton Therapy

Study Overview
=================
Brief Summary
-----------------
This trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy. Collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer and help doctors improve therapy for future patients with head and neck cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To evaluate the outcomes in patients who have received treatment for their head and neck malignancy with proton radiation therapy. OUTLINE: Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed.

Official Title
-----------------
Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies

Conditions
-----------------
Head and Neck Carcinoma

Intervention / Treatment
-----------------
* Other: Medical Chart Review
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients documented to have head and neck cancer treated with proton therapy at MDACC from January 1, 2008 through April 30, 2012 and patients who receive treatment from May 1, 2012 through December 31, 2018

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire, medical chart review)<br>Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed. | Other: Medical Chart Review<br>* Review of medical records<br>* Other names: Chart Review;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival analysis of proton therapy for head and neck malignancies | Retrospective chart analysis will be performed on all patients documented to have head and neck cancer, treated with Proton Therapy at MDACC from January 1, 2008 through April 30, 2012. Prospective chart analysis will be performed on head and neck cancer patients currently being treated at MD Anderson Cancer Center beginning May 1, 2012 through December 31, 2018. Overall survival estimated using Kaplan-Meier method. Cox proportional hazards regression used to explore predictors of time-to-event outcomes. Mann-Whitney test used to compare continuous parameters between temporal cohorts. | 7 years |
Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection

Study Overview
=================
Brief Summary
-----------------
This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.

Detailed Description
-----------------
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, has led to an unprecedented global pandemic affecting persons of all ages. Pregnant women are in a physiologic immunosuppressed situation and have a greater risk and severity of respiratory infection. However, considerable uncertainty exists regarding the potential for vertical transmission (prenatal/congenital or perinatal) of SARS-CoV-2 from infected pregnant women to their newborns and its potential clinical consequences. This study attempts to provide evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; trasnplacental and human milk antibody transfer and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission.

Official Title
-----------------
Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina

Conditions
-----------------
Covid19, Pregnancy Related, Neonatal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women hospitalized presenting with: Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty) Diagnoses of pneumonia with no other explainable cause. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertical transmission | Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate | 96 hours from birth | 
| Neonatal protection due to maternal antibodies | Presence of IgG in umbilical cord | 24 weeks of gestation to birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase risk of neonatal morbidity | Respiratory distress, hypothermia, poor feeding and others | up to 30 days of life | 
| Increase risk of obstetric complications |  | Up to 14 days of hospitalization |
Concordance Between ctDNA Assay and FoundationOne

Study Overview
=================
Brief Summary
-----------------
Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA (ctDNA) within different solid tumor types and has been developing an assay in order to do so.

Detailed Description
-----------------
The purpose of this study is to assess whether a new ctDNA assay developed by Foundation Medicine is able to detect genomic alterations in peripheral blood that are consistent with the genomic alterations detected in a patient's matched primary and/or metastatic tumor biopsy sample analyzed by the FoundationOne® test. Study sites will provide matched solid tumor and peripheral blood samples of cancer patients to FMI for the purpose of testing the concordance of the FMI ctDNA assay to the FoundationOne® test. Participation in this study is part of a broader 2000 patient study to determine which tumor types are most readily measured via ctDNA profiling, and to learn of the similarity between the alterations found in a patient's tumor biopsy and the ctDNA from their blood.

Official Title
-----------------
Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations

Conditions
-----------------
Circulating Tumor DNA, Cancer, Neoplasms, Genomic Testing, Genomic Alterations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care Exclusion Criteria: Tumor specimens where no cancer representative of the diagnosis is found in submitted tissue Tumor specimens where insufficient DNA (<50 ng) is provided to run the FoundationOne test. Tumor specimens with ≤20% tumor nuclei (all specimens).

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 |
| --- | --- | --- |
| Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples |  | 6-12 months | 
| Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay |  | 6-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating Tumor DNA, Cancer, Neoplasms, Genomic Testing, FoundationOne, Cell Free DNA, ctDNA, cfDNA
Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-

Study Overview
=================
Brief Summary
-----------------
The present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable analgesic effect to PCEA in gastrectomy.

Official Title
-----------------
Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: morphine
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: I or II of preoperative physical status classification by the American Society of Anesthesiologists. more than 20 years old. undergoing gastrectomy due to gastric cancer. Exclusion Criteria: contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly. prior history of abdominal surgery or spine surgery.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITM-IVPCA<br>ITM-IVPCA:intrathecal morphine and IV-fentanyl patient controlled analgesia | Drug: morphine<br>* ITM-IVPCA: intrathecal administration of 0.3 mg morphine before induction of general anesthesia and application of IVPCA (basal infusion: fentanyl 0.4mcg/kg/hr, bolus: 0.16mcg/kg of fentanyl with a lock out time of 15 min)<br>|
| Active Comparator: PCEA<br>PCEA:epidural PCA(patient controlled analgesia) | Drug: Ropivacaine<br>* PCEA: epidural administration of 5ml 0.2% ropivacaine before induction of general anesthesia and application of PCEA (basal infusion: 5ml 0.2% ropivacaine with fentanyl 0.4 mcg/kg/hr, bolus: 2ml 0.2% ropivacaine with fentanyl 0.16mcg/kg with a lockout time 15min)<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
-----------------
patients with, undergoing, gastrectomy
Analgesic Self-medication for Acute Pain by Patients Awaiting a Consultation With a General Practitioner

Study Overview
=================
Brief Summary
-----------------
What are the terms of use of analgesics for acute pain on an outpatient basis before a consultation with a general practitioner? Descriptive epidemiological study of patients in general practice in Rhône-Alpes

Official Title
-----------------
What Are the Terms of Use of Analgesics for Acute Pain on a Patient Before a Consultation With a General Practitioner: Descriptive Epidemiological Study of Patients in General Practice in Rhône-Alpes

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient without cognitive impairment having acute pain for less than 3 months Consultant to the practices participating to the study. Exclusion Criteria: Patients who do not understand French Patients protected by law

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Questionnaire : Taken analgesics<br>the patient will complete a questionnaire | Other: Questionnaire<br>* description of analgesic self-medication in the context of acute pain using a questionnaire evaluating the drug taken, the dosage, the duration of treatment, the type of pain, its intensity, the origin of the drug, the source of information consulted and the factors that prompted the patient to self-medicate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of analgesic self-medication practices while waiting for a consultation with the general practitioner. | dose of analgesic drugs per intake and per frequency | Inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highlighting the reason for misuse of analgesics on an outpatient basis in the population studied while waiting for a consultation. | Incidence of.each reason for misuse as indicated in the questionnaire | Inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute pain, analgesics, self medication