linjc16/ctgov huggingface dataset:
Validation of Automated Cardiac Output Measurement

Study Overview
=================
Brief Summary
-----------------
Automated software analysis now allows for quick estimation of cardiac output from the echocardiographic 5-chamber view. This study will validate the automated software method against pulmonary artery thermodilution and against conventional cardiac output measurement with echocardiography.

Official Title
-----------------
Validation of Automated Ultrasound Method for Measurement of Cardiac Output: A Clinical Observational Study

Conditions
-----------------
Cardiac Output, Low, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postoperative cardiac surgery patient Pulmonary artery catheter in situ Extubated Exclusion Criteria: No echocardiographic image available No consent Moderat-severe aortic insufficiency Moderat-severe tricuspid insufficiency Moderat-severe mitral valve insuffficiency Arythmia Intracardiac shunt Moderat-severe hemodynamic instability

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 |
| --- | --- |
| Cardiac surgery patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of cardiac output measurement | Mean bias with limits of agreement for cardiac output measurement between automated cardiac output measurement and pulmonary artery thermodilution | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trending ability | Trending ability for cardiac output measurement for automated cardiac output measurement compared to pulmonary artery thermodilution | 120 minutes | 
| Accuracy of cardiac output measurement | Mean bias with limits of agreement for cardiac output measurement between automated cardiac output measurement and conventional echocardiographic cardiac output measurement | 10 minutes | 
| Trending ability | Trending ability for cardiac output measurement for automated cardiac output measurement compared to traditional echocardiographic cardiac output measurement | 120 minutes | 
| Accuracy of cardiac output measurement | Mean bias with limits of agreement for cardiac output measurement between traditional cardiac output measurement and pulmonary artery thermodilution | 10 minutes | 
| Trending ability | Trending ability for cardiac output measurement for traditional echocardiographic cardiac output compared to pulmonary artery thermodilution | 120 minutes |
Physiopathology and Sequelae of COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
The data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). These disorders are autoimmune or linked to degeneration. The main objective is to assess the thyroid function (thyrotropic axis) as well as the corticotropic adrenal function of patients who have had Copvid-19 pneumonia. The secondary objectives is to describe the pathophysiological mechanisms of pulmonary and vasculothrombotic involvement of Covid-19

Official Title
-----------------
Physiopathology and Sequelae of COVID-19 Infection

Conditions
-----------------
Covid19, TSH, Cortisol

Intervention / Treatment
-----------------
* Biological: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient having a covid19 infection hospitalized at the Amiens Picardie University Hospital Patient who is seen in Pneumology consultation for a respiratory assessment at 3 months of his hospitalization (between M2 and M4) to evaluate presence of respiratory sequelae Patient who agreed to participate in the protocol Patient affiliated to a Social Security Exclusion Criteria: patient under guardianship or curators patient refusing to participate

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: blood test|covid19 infected patient will have a blood test in order to make an autoimmune assessment (antinuclear antibodies, soluble nuclear anti-antigen, ANCA, antiphospholipid antibodies, FT3, FT4 , TSH, antithyroid antibodies, ACTH cortisol, and creation of a serotheque).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8-hour cortisol level in patients with Covid19 pneumonia | 8-hour cortisol level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae. | day 0 | 
| TSH level in patients with Covid19 pneumonia | TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae. | day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, TSH, cortisol
Glioblastoma Response Prediction to Apatinib

Study Overview
=================
Brief Summary
-----------------
Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. Our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma. Some patients showed durable responses and prolonged survival, with recorded survival times of over 30 months in 6.4% patients. However, a subset of patients progressed in 2 months. There is a strong need to better predict and monitor apatinib treatment response to prevent patients from adverse effects of ineffective therapy. In this study, whole genome sequencing and RNA-sequencing of formalin-fixed, paraffin-embedded tumor materials from the participants who received apatinib and temozolomide treatment will be performed to identify the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary potential toxicity and cost for those who are unlikely to benefit from the drug.

Official Title
-----------------
Study on Predicting Response of Recurrent Glioblastoma to Apatinib

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Other: genetic characteristic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years old recurrent glioblastoma received apatinib plus temozolomide treatment，response and survival data were available tumor tissues were acquired Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| effective group<br>After treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months. | Other: genetic characteristic<br>* the underlying genetic characteristics that prodicting response<br>|
| stable group<br>After treatment, tumor remains stable and the progression-free survival time was more than 1 month and less than 6 months. | Other: genetic characteristic<br>* the underlying genetic characteristics that prodicting response<br>|
| Early progressed group<br>After treatment, tumor got progressed and the progression-free survival time was no more than 1 month. | Other: genetic characteristic<br>* the underlying genetic characteristics that prodicting response<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genetic outcome | response prodicting biomarker | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, Vascular Endothelial Growth Factor Receptor 2, glioblastoma
Optimization of MRI for Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
Currently, appropriate patients undergo MRI imaging with immobilization and sequences optimized for diagnostic radiology purposes. Using a mutual information algorithm, these images are then registered to a treatment planning CT obtained with custom immobilization to minimize intra-and inter-treatment motion and positional variation. This image registration process is time-consuming and introduces additional layers of geometric uncertainty into what should be a highly precise treatment planning process. However, it is necessary, since radiation dose calculations cannot be performed on MRI data due to the lack of crucial density information. The investigator envisions CT-less treatment planning, using only MRI, due to superior imaging characteristics, fully integrated into the radiation oncology clinic. This study will begin this process.

Official Title
-----------------
Optimization of MRI for Radiation Therapy

Conditions
-----------------
Cancer Brain, Cancer Liver, Cancer Head &Neck, Cancer Pelvis

Intervention / Treatment
-----------------
* Procedure: MRI Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years of age A working diagnosis of malignancy in the liver, brain, H&N, or pelvis A plan to treat with radiotherapy Exclusion Criteria: Patients with contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Radiology Department.

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 |
| --- | --- |
| MRI group<br>Patient receives one research MRI prior to radiation treatment. | Procedure: MRI Group<br>* A single research MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with MRI images suitable for analyses | Patients will be off protocol immediately after the single MRI scan. Comparative treatment planning will occur off-line and will not be used for patient care. | Day One | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Cancer
Effect of Fetuin A in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examined the effect of fetuin A on atherosclerosis and prognosis in hemodialysis patients.

Detailed Description
-----------------
Fetuin A is known to be a potent inhibitor of ectopic calcification in plasma, and the concentration of fetuin A is closely associated with protein nutritional status. The purpose of this study is to examine whether the plasma concentration of fetuin A is associated with atherosclerosis and 5-year prognosis in hemodialysis patients.

Official Title
-----------------
The Effect of Serum Fetuin A Concentration on the 5-Year Prognosis in Hemodialysis Patients

Conditions
-----------------
Hemodialysis, Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis for at least 6 months Exclusion Criteria: Disabled patients

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 70 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis
Mass Balance Study of ASP1941

Study Overview
=================
Brief Summary
-----------------
This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.

Official Title
-----------------
An Open Label Study to Evaluate the Pharmacokinetics of ASP1941 After a Single Oral Dose of 14C-labeled ASP1941 in Healthy Male Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: ASP1941


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive Exclusion Criteria: Pulse <40 or >90 bpm; Systolic Blood Pressure > 140 mmHg; Diastolic Blood Pressure >90 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ASP1941|Oral solution|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ASP1941 to evaluate metabolism and excretion |  | up to 216 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of metabolic profile of ASP1941 |  | up to 216 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mass Balance, ASP1941, Pharmacokinetics
Trial to Evaluate Safety and Tolerability of ALN-TTR01 in Transthyretin (TTR) Amyloidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR01 in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

Official Title
-----------------
A Phase 1, Randomized, Single-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Tolerability of a Single Dose of Intravenous ALN-TTR01 in Patients With TTR Amyloidosis

Conditions
-----------------
Transthyretin Mediated Amyloidosis (ATTR)

Intervention / Treatment
-----------------
* Drug: ALN-TTR01
* Drug: Sterile Normal Saline (0.9% NaCl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of TTR amyloidosis Adequate blood counts, liver and renal function Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control Males agree to use appropriate contraception Willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent. Exclusion Criteria: Known human immunodeficiency virus (HIV) positive status Receiving antibiotics for bacterial infection within 7 days of screening Known or suspected systemic viral, parasitic or fungal infection Receiving an investigational agent within 30 days prior to study drug administration Poor cardiac function Considered unfit for the study by the Principal Investigator Known sensitivity to oligonucleotides Employee or family member of the sponsor or the clinical study site personnel.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ALN-TTR01<br> | Drug: ALN-TTR01<br>* Dose levels between 0.01 and 1.0 mg/kg by intravenous (IV) infusion<br>|
| Placebo Comparator: Sterile Normal Saline (0.9% NaCl)<br> | Drug: Sterile Normal Saline (0.9% NaCl)<br>* Calculated volume to match active comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients experiencing adverse events (AEs), serious adverse events (SAEs), and study drug discontinuation. |  | Up to 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of ALN-TTR01 (Cmax, tmax, t1/2, AUC0-last, CL) |  | Up to 70 days | 
| Effect of ALN-TTR01 on Circulating TTR Levels (Determination of % Lowering of TTR to Pretreatment/Baseline TTR Level) |  | up to 70 days |
Service Dogs for Veterans With PTSD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the impact service dogs have on the mental health and quality of life of Veterans; (2) to provide recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3) To determine cost associated with total health care utilization and mental health care utilization among Veterans with PTSD.

Official Title
-----------------
Service Dogs for Veterans With PTSD: A Randomized Clinical Trial

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Other: Service Dogs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Referral from provider. PTSD diagnosis In active treatment for PTSD for at least three months at time of enrollment, with plans to remain in active treatment Acceptance by the dog vendor for the service dog Ability to adequately care for a dog - physically/financially Able to travel to vendor for pairing with dog Exclusion Criteria: Been hospitalized for mental health reasons in the prior 6 months Not living at the same residence for 6 months. Diagnoses: Psychoses, Delusions, dementia, active alcohol/substance dependence. Moderate to severe TBI. Any other diagnosis deemed by PI to limit ability to participate or give informed consent At time of enrollment - Active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study. Children under age 10 living in the home

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 |
| --- | --- |
| Experimental: Arm 1<br>Service Dogs | Other: Service Dogs<br>* Service dogs will be trained to help Veterans with PTSD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Outcomes | Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms | 3,6,9,12,18 and 24 months after receipt of service dog | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Service Dogs
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.

Official Title
-----------------
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

Conditions
-----------------
Cytomegalovirus Infections, HIV Infections

Intervention / Treatment
-----------------
* Drug: Ganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV. Documented confirmation of present or past CMV infection. Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain. Concurrent Medication: Excluded: Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug. Patients with the following are excluded: Any concomitant conditions listed in Exclusion Co-Existing Conditions. Karnofsky score < 70. Hypersensitivity to acyclovir. Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule. Prior Medication: Excluded: Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease. Excluded within 4 days of study entry: Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT).

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ganciclovir|nan|

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
-----------------
AIDS-Related Opportunistic Infections, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Biological Availability