linjc16/ctgov huggingface dataset:
DeepView SnapShot Portable (DV-SSP): Device Training Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.

Official Title
-----------------
DeepView SnapShot Portable (DV-SSP): Device Training Study

Conditions
-----------------
Burns, Wound Heal

Intervention / Treatment
-----------------
* Device: DeepView SnapShot Portable (DV-SSP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so; Life expectancy > 6 months; Thermal burn mechanism (flame, scald, or contact); The Study Burn(s) occurred less than 72 hours prior to the time of first imaging; and Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn. For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn Exclusion Criteria: Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints; Subject has burns involving > 50% total body surface area (TBSA); Sepsis at the time of enrollment; Immunosuppression/radiation/chemotherapy < 3 months prior to enrollment; Concurrent use of investigational products with a known effect on the burn sites; and/or Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Thermal Burn Injury<br>An initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury. | Device: DeepView SnapShot Portable (DV-SSP)<br>* DV-SSP assistive imaging to collect observational data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient | Test that the Burn Segmentation Algorithm's predicted severe burn area (i.e., deep second degree and third degree) within an image of a burn injury, will be equivalent to the true area of severe burn as determined by the expert panel. The analysis for this study would only include data obtained from participants in the study. | 3 weeks |
Role of ST2 in Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Acute pancreatitis is characterized by an inflammatory storm which regulatory pathways are not well known. The IL-1 cytokine family is activated early during acute pancreatitis and secretion of alarmins is speculated during pancreatic necrosis. IL-33 is a member of the IL-1 family, it can act as an alarmin and its receptor, ST2, is known to sequester MyD88 which might regulate the acute pancreatitis inflammatory storm. The aim of this study is to investigate ST2 pathway in human acute pancreatitis and in murine experimental models of acute pancreatitis.

Official Title
-----------------
Study of ST2-IL-33 Pathway in Acute Pancreatitis

Conditions
-----------------
Acute Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Time to take blood sample less than 24h after the onset of symptoms of AP Two of the following: typical pain, amylase and lipase concentrations more than 3x the upper normal limit, compatible modifications on imaging techniques Exclusion Criteria: Chronic pancreatitis

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 |
| --- | --- |
| Acute pancreatitis<br>Patients admitted in our institution for an episode of acute pancreatitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of soluble ST2 in serum | Concentration of soluble ST2 will be assessed in the serum of patient with an episode of acute pancreatitis, on the day of admission to the hospital as well as 24h, 48h, 7 days and 30 days later. | Within 30 days after onset of acute pancreatitis |
A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant

Study Overview
=================
Brief Summary
-----------------
To determine whether zidovudine (AZT) in conjunction with bone marrow transplantation prevents the reinfection of donor hematopoietic/lymphoid cells in patients with positive HTLV III antibody and large cell/diffuse histiocytic lymphoma. Patients who are candidates will be evaluated for HTLV III activity and drug levels.

Official Title
-----------------
A Pilot Study To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients Receiving a Bone Marrow Transplant

Conditions
-----------------
Lymphoma, Non-Hodgkin, HIV Infections

Intervention / Treatment
-----------------
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with current life-threatening infection at time of transplant that would preclude a transplant are excluded. Concurrent Medication: Excluded: Other anti-retroviral agents. Patients with current life-threatening infection at time of transplant that would preclude a transplant are excluded. Patients must be: HTLV III antibody positive by ELISA or Western blot or HTLV III viremia. At high mortal risk with a diagnosis of AIDS or AIDS Related Complex (ARC). Also patient must fall into one of the following categories: Have an HIV seronegative identical twin to serve as a bone marrow donor. Have documentation of large cell/diffuse histiocytic lymphoma/DPDL. Be a good risk candidate for bone marrow transplant.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 50 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: Zidovudine|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
-----------------
Lymphoma, Large-Cell, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Bone Marrow Transplantation
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized children in Gaza will result in improvement of posttraumatic stress symptoms, depression, and decreased hopelessness compared to a control group.

Official Title
-----------------
A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Mind-Body Skills Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having experienced a political violence or war-related criterion A stressor meeting the American Psychiatric Association (DSM-IV-TR) criteria for PTSD according to screening scores on the Child PTSD Symptom Scale Exclusion Criteria: former psychosocial or medical treatment for mental health conditions significant cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 8 Months
Maximum Age: 13 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Skills Groups<br> | Behavioral: Mind-Body Skills Group<br>* Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child PTSD Symptom Scale |  | Change from Baseline (Week 1) at 6 weeks | 
| Child PTSD Symptom Scale |  | Change from Week 6 at 18 weeks | 
| Child PTSD Symptom Scale |  | Change from Baseline (Week 1) at 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Depression Inventory -2 Short Form |  | Change from Baseline (Week 1) at 6 weeks | 
| Children's Depression Inventory -2 Short Form |  | Change from Week 6 at 18 weeks | 
| Children's Depression Inventory -2 Short Form |  | Change from Baseline (Week 1) at 18 weeks | 
| Hopelessness Scale for Children |  | Change from Baseline (Week 1) at 6 weeks | 
| Hopelessness Scale for Children |  | Change from Week 6 at 18 weeks | 
| Hopelessness Scale for Children |  | Change from Baseline (Week 1) at 18 weeks |
The Genetics of Cardiomyopathy and Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure.

Detailed Description
-----------------
The purpose of this research study is to explore the causes and inheritances of cardiomyopathies. Cardiomyopathies are serious medical conditions that result in a wide range of cardiac problems, from no symptoms at all to heart failure. The underlying genetics of cardiomyopathies are poorly understood. This study will collect personal, family, and medical history information to create a database of participants with cardiomyopathies. This information will be used to identify inheritance patterns within families with cardiomyopathies. In addition, samples from participants will be studied in the lab to see if any changes in their genetic information can be identified that would cause a cardiomyopathy. Overall, the research study is aimed at determining the cause of these cardiac conditions so that tests and treatments might be developed in the future.

Official Title
-----------------
The Genetics of Cardiomyopathy and Heart Failure

Conditions
-----------------
Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Mitochondrial Cardiomyopathy, Noncompaction Cardiomyopathy, Restrictive Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with a diagnosis of cardiomyopathy Family members of individuals with a diagnosis of cardiomyopathy Individuals with a nuclear mutation shown to confer risk of cardiomyopathy but who do not themselves have cardiomyopathy Exclusion Criteria: Individuals who do not have cardiomyopathy, a relative with cardiomyopathy, or a nuclear mutation predisposing to cardiomyopathy
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
-----------------
Genetics, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Mitochondrial Cardiomyopathy, Noncompaction Cardiomyopathy, Restrictive Cardiomyopathy, Heart Failure
Tissue Factor Expression in Stage C Heart Failure

Study Overview
=================
Brief Summary
-----------------
Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25 age-matched volunteers. TF was 2.9 fold higher (p < 0.001) in HF patients vs. controls. HF patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant activity above/below median. HF is associated with increased TF expression.

Detailed Description
-----------------
Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25 age-matched volunteers. TF was 2.9 fold higher (p < 0.001) in HF patients vs. controls. HF patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant activity above/below median. HF is associated with increased TF expression. Previous studies suggest that markers of coagulation are elevated in heart failure (HF). Tissue factor (TF) plays the cardinal role in initiating the coagulation cascade. This study determines TF expression in HF and its association with disease progression. Methods: Monocytes were obtained from 50 NYHA function class II-IV HF patients and 25 age-matched disease-free volunteers. TF protein, TF procoagulant activity, and tissue factor pathway inhibitor (TFPI) were determined.

Official Title
-----------------
Tissue Factor Expression in Stage C Heart Failure

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure subjects with symptomatic heart failure (New York Heart Association [NYHA] functional class II to IV) due to either idiopathic dilated cardiomyopathy or ischemic cardiomyopathy and had a left ventricular ejection fraction < 0.35.
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 |
| --- | --- |
| Age-Matched Healthy Controls<br>Age-Matched Healthy Controls | |
| Heart Failure<br>Subjects with LVEF < 40% | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study determines TF expression in HF and its association with disease progression. |  | Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thromboembolic disease, thromboplastin, hypercoagulability, congestive heart failure
Specified Drug Use-results Survey of Betanis Tablets

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma.

Official Title
-----------------
Specified Drug Use-results Survey of Betanis Tablets in OAB Patients With Coexisting Glaucoma

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: mirabegron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as OAB and treated with mirabegron diagnosed as glaucoma (including normal tension glaucoma) having intraocular pressure measurement conducted more than twice within six months before the start of the mirabegron treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Betanis group<br>mirabegron treated group | Drug: mirabegron<br>* oral<br>* Other names: YM178;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in OABSS (Over Active Bladder Symptoms Score) | OABSS is judged by investigator | Baseline and 12 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mirabegron, Overactive Bladder, Betanis®, glaucoma
Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This study will collect and evaluate information on the safety and efficacy of Sovaldi-based regimens in routine clinical practice in Mexico. The primary objective of this study is to assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV) infection treated with Sovaldi in routine clinical practice.

Official Title
-----------------
A Prospective, Non-Interventional Cohort Study of Approved Sofosbuvir-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

Conditions
-----------------
HCV Infection

Intervention / Treatment
-----------------
* Drug: Sovaldi


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: HCV-infected patients living in Mexico Treatment with a Sovaldi-based regimen, per the approved prescribing information, as determined by the patient's treating physician Key Exclusion Criteria: Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products) Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country prior to their SVR12 visit) Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 |
| --- | --- |
| Sovaldi-based regimens<br>Adult patients with chronic HCV infection living in Mexico who take Sovaldi as part of routine clinical care at a participating clinical site. | Drug: Sovaldi<br>* Sovaldi 400 mg tablets administered orally once daily<br>* Other names: GS-7977;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants experiencing adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events (AEs) during the treatment period and posttreatment follow-up period |  | Up to Posttreatment Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of concurrent use of Sovaldi with amiodarone and another direct acting antiviral (DAA) or with potent intestinal P-gp inducers in routine clinical practice |  | Up to 24 weeks | 
| Proportion of patients with sustained virologic response (SVR) at 12 weeks post treatment (SVR12), defined as HCV RNA < lower limit of quantification between 10 and 24 weeks post-treatment |  | Up to Posttreatment Week 24 |
Clinical Features, Outcomes, and Therapeutics of Pregnancy-Related Aortic Dissection

Study Overview
=================
Brief Summary
-----------------
Aortic dissection in pregnancy represents a lethal risk to both the mother and fetus, it has yet to yield the optimal therapeutic strategy. The aim of this study was to characterize the clinical features and outcomes in women with pregnancy-related acute aortic dissection, and to suggest therapeutic guidelines.

Official Title
-----------------
Clinical Features, Outcomes, and Therapeutics of Ppregnancy-related Aortic Dissection

Conditions
-----------------
Aortic Dissection, Pregnancy Related

Intervention / Treatment
-----------------
* Procedure: cesarean section and aortic repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who presented with aortic dissection during pregnancy or post partum ≤12 weeks. Exclusion Criteria: Loss of surgical information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cesarean section and aortic repair|The timing of aortic repair and delivery have to be determined based on the type of the dissection, the stage of pregnancy (the gestation age), and the status of the fetus, as well as the level of local neonatal service.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality |  | 30 days after surgery |
Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line.

Official Title
-----------------
Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Biological: Therapeutic Cellular Vaccine, GM-CSF Producing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo multiple myeloma ECOG 0-2 No serious co-morbid illnesses and adequate organ function > 4 weeks from systemic steroids Exclusion Criteria: No existing secondary malignancies and no history of secondary malignancies in the past 5 years No active autoimmune disease

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Therapeutic Cellular Vaccine, GM-CSF Producing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple myeloma |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Cancer, PSCT, Peripheral Stem Cell Transplant, Chemotherapy, GVAX