linjc16/ctgov huggingface dataset:
Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study

Study Overview
=================
Brief Summary
-----------------
There are no clear recommendations concerning the management of patients on ECLS (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so as to avoid accidents, notably decannulation. Moreover, there are few publications on the subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support) is a recent practice. Nonetheless, it is becoming more and more frequent in the cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits of this practice by comparing 2 populations: those with extubation while on ECLS (Extra-Corporeal Life Support) and those without.

Official Title
-----------------
Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study

Conditions
-----------------
Extra-Corporeal Life Support

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients over 18 years who were placed on ECLS between 1/01/14 and 31/12/15 Exclusion Criteria: Patients under 18 years old Patients on ECLS for a heart transplant Patients who died within the first 48 hours following the initiation of ECLS

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 |
| --- | --- |
| Patients with extubation while on ECLS<br> | |
| Patients without extubation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU |  | At baseline |
Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

Study Overview
=================
Brief Summary
-----------------
Patients with resistant metastatic solid tumors failing all conventional modalities who are eligible for immunotherapy by bispecific antibodies. First step: NST Second step: Patients with tumor cells expressing positive Her-2Neu and/or EpCAM with residual or recurrent disease following NST will be candidates for donor lymphocytes immunotherapy using bispecific antibodies. Patients with no matched donor available, expressing positive Her-2Neu and/or EpCAM tumor cells, will be eligible for donor mismatched lymphocytes using in-vitro rIL-2 activated allogeneic lymphocytes targeted to the tumor by bispecific antibodies, Her-2Neu and/or EpCAM.

Official Title
-----------------
Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

Conditions
-----------------
Metastatic Solid Tumors

Intervention / Treatment
-----------------
* Drug: Cell therapy with bispecific antibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic solid tumors expressing Her-2/Neu or EpCAM, with available match donor for NST. Patients with metastatic solid tumors not expected to be cured failing available conventional modalities, age >18, with no upper age limit. Patients with metastatic breast cancer failing treatment with Herceptin. Patients with metastatic cancer cells expressing Her-2/Neu or EpCAM. Patients with evidence of disease following allogeneic stem cell transplantation with tumor cells expressing Her-2/Neu or EpCAM. Karnofsky performance status >60% Life expectancy > 3 months, to be able to assess response. Exclusion Criteria: Patients not fulfilling any of the above. Patients with active or ongoing infection that may endanger their life, whenever immunosuppression may be counter-indicated. Pregnant or lactating women. Patients positive for HIV.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cell therapy with bispecific antibodies|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients. |  |  |
Diet, Insulin Resistance, and Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
To elucidate dietary factors that elevate risk for cardiovascular disease (CVD) in conjunction with insulin resistance.

Detailed Description
-----------------
BACKGROUND: Clinical studies indicate that high carbohydrate intake may exacerbate the dyslipidemia often seen with insulin resistance. Consequently, there is much debate as to the optimal dietary pattern for individuals with NIDDM to minimize risk for microvascular disease. Data on this topic from free-living populations are scarce. In addition, associations of dietary antioxidants with CVD risk have not been evaluated in large community samples of persons with diabetes. DESIGN NARRATIVE: Potential dietary determinants of hyperinsulinemia or of insulin resistance were evaluated, including high intake of dietary fats and of simple sugars and low alcohol consumption. As a major focus, dietary factors that may contribute to elevated CVD risk among persons with existing insulin resistance, including impaired glucose tolerance (IGT) and non-insulin-dependent diabetes mellitus (NIDDM) were examined. Five datasets from epidemiologic studies were available to evaluate specific hypotheses for men and women of Black, Hispanic and non-Hispanic white ethnicity. The unique contributions of each dataset were as follows. The San Luis Valley Diabetes Study and the San Antonio Heart Study enabled prospective analyses for large numbers of subjects with IGT or NIDDM; the Mexico City Study provided a sample with contrasting dietary patterns in a non-white population; the Kaiser Permanente Women Twins Study allowed for the removal of genetic influences by evaluating associations within monozygotic twin pairs; and the Insulin Resistance Atherosclerosis Study (IRAS) provided direct measurement of insulin sensitivity and subclinical atherosclerosis across the spectrum of glucose tolerance in three ethnic groups. An understanding of the accuracy of the dietary assessment instruments used in the three ethnic groups was critical to the interpretation of the findings related to diet and CVD risk variables. Therefore, a second component of research was also conducted, that being an evaluation of the comparative validity of the food frequency interview used in the multi- cultural IRAS population using a series of 24-hour dietary recalls as the standard.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Insulin Resistance, Hyperinsulinism, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus

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 |
| --- | --- | --- |
A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet

Study Overview
=================
Brief Summary
-----------------
A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.

Conditions
-----------------
Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Fimasartan/Atorvastatin Combination Tablet
* Drug: Fimasartan
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a Healthy male subject, aged 19- 50 years Exclusion Criteria: History of clinically significant hypersensitivity to study drug, any other drug Hypotension or hypertension Active liver disease History of gastrointestinal disease History of excessive alcohol abuse Participation in any other study within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day. | Drug: Fimasartan/Atorvastatin Combination Tablet<br> <br> Drug: Fimasartan<br> <br> Drug: Atorvastatin<br> <br> |
| Other: Group 2<br>Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day. | Drug: Fimasartan/Atorvastatin Combination Tablet<br> <br> Drug: Fimasartan<br> <br> Drug: Atorvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin |  | 0 48 hour after medication | 
| Area under the curve(AUCt) of Fimasartan and Atorvastatin |  | 0 48 hour after medication |
The Pathogenesis of Hepatitis C Virus Vertical Transmission

Study Overview
=================
Brief Summary
-----------------
To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples. Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a barrier that must be crossed during vertical transmission and that cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV regulation should be revealed. Based on our preliminary data, our working hypothesis is that HCV Core protein is differentially processed in cytotrophoblasts compared to hepatocytes.

Official Title
-----------------
The Pathogenesis of Hepatitis C Virus Vertical Transmission

Conditions
-----------------
Hepatitis C, Infection Transmission, Maternal-Fetal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with HCV infection Pregnant women without HCV infection Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV-infected mothers<br>in situ hybridization | |
| Uninfected mothers<br>in situ hybridization | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. | We will begin by examining paraffin-embedded sections from HCV-infected mothers who had the placentas sent to pathology for analysis.We will perform a combination of immunohistochemistry (IHC) and immunofluorescence (IF) to analyze the level of SPP expression in the trophoblast cell layer, as well as if HCV Core protein expression was detectable in this layer or in any cell type within the placental section. We would also plan to identify other patient-derived tissues that were not paraffin embedded, both from uninfected patients and infected patients to validate different parts of our preliminary data. We would plan to use dissected fetal membranes, which contain both chorion and amnion, to investigate the level of SPP expression in these tissues. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C (HCV), Infection Transmission, Maternal-Fetal, Placenta, Trophoblast
Vasospasm in Pediatric Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic brain injury (TBI) patients who have experienced a mild to severe head injury.

Official Title
-----------------
Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury

Conditions
-----------------
Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission to Duke University Children's Hospital; age 5 days to 15 years; a diagnosis of a TBI with a GCS 3-15; capable of adequate TCD ultrasound examination; and presence of intravenous or arterial access (blood) and/or an EVD for cerebrospinal fluid (CSF) and/or Foley catheter/ability to void unassisted (urine) biomarker collection unless they are excluded based on the exclusion criteria. Exclusion Criteria: the presence of previously diagnosed significant neurodevelopmental delay, a diagnosis of non-traumatic intracranial hemorrhage and parents/legal guardians who do not speak or understand English.

Ages Eligible for Study
-----------------
Minimum Age: 5 Days
Maximum Age: 15 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 |
| --- | --- |
| Pediatric Traumatic Brain Injury<br>Children from 5 days to 15 years of age who have been admitted to the hospital with a traumatic brain injury. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasospasm detection by Transcranial Doppler Ultrasound | Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients. | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of biomarkers in pediatric traumatic brain injury | Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours. | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic brain injury, brain injury, head injury, vasospasm
DVT Ultrasound in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency Department (ED) employing the two point compression method. This study endeavors to investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in the ED by EM Residents by comparing the results of that exam against the gold standard of a DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.

Detailed Description
-----------------
For subjects with suspicion of DVT to the Emergency Department, an EM Resident will perform a bedside non-diagnostic two point compression DVT Ultrasound. Subjects will then receive a diagnostic DVT Ultrasound in the Radiology Department with official radiologist interpretation. The bedside ultrasound will not interfere with or delay the diagnostic ultrasound. Patient demographic and clinical data will be collected for validation purposes. Validation of the The EM Resident interpretation will be accomplished by comparison to the official Radiologist interpretation.

Official Title
-----------------
An Observational Study of Emergency Medicine Resident Performed Ultrasonography for DVT.

Conditions
-----------------
DVT, Deep Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Suspect of having DVT Exclusion Criteria: Known DVT DVT with in previous 6 months DVT Ultrasound within the last 6 months

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome measures is the proportion of agreement between Resident performed two point DVT ultrasaound and the Radiologist interpertation of a formal DVT ultrasound. | Two point Emergency Medicine Resident preformed DVT Ultrasound (5 minute procedure) results will be compared as a proportion to Radiologist interpreted ultrasonographer performed DVT Ultrasound results. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DVT, Deep Vein Thrombosis, Leg Swelling, Leg Pain, Blood Clot
Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.

Study Overview
=================
Brief Summary
-----------------
This study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. The development of a questionnaire in a Rasch environment and specifically developed for parents of conservatively treated patients will ensure greater sensitivity and specificity of the questionnaire.

Official Title
-----------------
Quality of Life in Parents of Conservatively Treated Adolescents With Spinal Deformities: Development of a New Questionnaire.

Conditions
-----------------
Quality of Life, Spinal Deformity, Scoliosis; Adolescence

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have at least one child between the ages of 10 and 18 with adolescent idiopathic scoliosis of 10 degrees or more, or with Scheuermann's kyphosis or idiopathic hyperkyphosis prescription of a brace or specific exercises for the child's vertebral deformity. Exclusion Criteria: Child with a history of spinal surgery Child with a history of significant diseases with possible impact on the quality of life of the parents Child with a history of spinal trauma Child with positive neurological evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Quality of life<br> | Other: Questionnaire<br>* All parents of patients visited at an outpatient service dedicated to the treatment of vertebral deformities will be recruited at the end of the medical clinical evaluation. The doctor will invite all subjects to complete the questionnaire anonymously at the end of each follow-up visit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents' quality of life | New questionnaire developped to assess quality of life of parents of patients with spinal deformity treated conservatively | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scoliosis, Quality of life, Spinal Deformity
Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.

Official Title
-----------------
Polyethylene Glycol Adhesion Barrier Reduces Adhesions After Gynecologic Laparoscopy; a Prospective Randomized Controlled Pilot Study

Conditions
-----------------
Postoperative Adhesion, Peritoneal Adhesion, Nos

Intervention / Treatment
-----------------
* Device: Spraygel
* Device: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years Undergoing gynecologic laparoscopy Exclusion Criteria: Suspected malignancy Incomplete adhesiolysis during initial laparoscopy Pregnancy Lactating Stage IV endometriosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spraygel<br> | Device: Spraygel<br> <br> |
| Active Comparator: Control<br> | Device: Control<br>* Good surgical technique, no adhesion barrier<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful adhesion prevention | Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LABS adhesion score |  |  | 
| Adhesion sites | Reduction in the number of sites covered with adhesions |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tissue adhesions, Laparoscopy