linjc16/ctgov huggingface dataset:
Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

Official Title
-----------------
An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies

Conditions
-----------------
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: brentuximab vedotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory CD30-positive malignancy Adequate organ function ECOG performance status <2 Exclusion Criteria: Cardiac abnormalities (abnormal rhythm, history of significant cardiac event) Current diagnosis of primary cutaneous ALCL Acute or chronic graft-versus-host disease Prior hematopoietic stem cell transplant within specified timeframe

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>brentuximab vedotin | Drug: brentuximab vedotin<br>* 1.8 mg/kg IV every 21 days<br>* Other names: SGN-35;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval |  | 2-4 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG parameters |  | 2-4 days postdose | 
| Blood MMAE levels |  | Through 4 days postdose | 
| Incidence of proarrhythmic adverse events |  | Through 1 month following last dose | 
| Incidence of adverse events and laboratory abnormalities |  | Through 1 month following last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Drug Therapy, Hematologic Diseases, Immunotherapy, Lymphoma, monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic
Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections

Study Overview
=================
Brief Summary
-----------------
The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.

Official Title
-----------------
Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissections

Conditions
-----------------
Aortic Dissection

Intervention / Treatment
-----------------
* Device: Endovascular Treatment (Zenith)


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: < 18 years of age Other medical condition(e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., < 2 years) Pregnant, breast-feeding, or planning on becoming pregnant within 60 months Unwilling to unable to comply with the follow-up schedule Inability or refusal to give informed consent Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study)

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

| Intervention/Treatment |
| --- |
|Device: Endovascular Treatment (Zenith)|Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.|

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
-----------------
Aorta, Thoracic, Aortic dissection, Type B, DeBakey type III, Endovascular
ChildObesity180 - Social Marketing Campaign to Encourage Healthful Eating in Restaurants for Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a messaging campaign affects the calories ordered for and consumed by children in a quick serve restaurant setting.

Detailed Description
-----------------
ChildObesity180 seeks to develop and implement a messaging campaign informed by evidence-based behavioral theory as well as perspectives from parents, children, and the restaurant industry. The campaign aims to help parents choose healthful options for their children when dining in the quick-serve restaurant setting. Aim 1 is campaign development. Aims 2 and 3 are assessment (i.e., Randomized controlled trial and revenue analysis). Hypotheses are that the messaging campaign will be associated with fewer calories ordered/consumed by children in the quick serve setting; and the campaign will not negatively impact quick serve restaurant revenue.

Official Title
-----------------
ChildObesity180 - Social Marketing Campaign to Encourage Healthful Eating in Restaurants for Children

Conditions
-----------------
Child Overnutrition

Intervention / Treatment
-----------------
* Behavioral: Social marketing campaign


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent or legal guardian of a 4 - 12 year old child (who is present) Have not participated in the study before <<Intervention community only>> live, work, or frequently travel to community Exclusion Criteria: -

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Social marketing messaging campaign | Behavioral: Social marketing campaign<br>* Messaging campaign designed to help mothers in choosing healthful options when dining out.<br>|
| No Intervention: Control<br>No messaging campaign | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kilocalories ordered | Receipt data will be used to determine what items were ordered for the parent and child, and kcals will be calculated using nutrition information from the restaurant and bomb calorimetry. | change from baseline to follow-up 3-5 months later | 
| kilocalories consumed | Child plate waste will be collected, weighed and digitally imaged; a subset will be analyzed using bomb calorimetry. | change from baseline to follow-up 3-5 months later |
The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Pediatric postoperative patients are at increased risk for post-operative respiratory complications such as hypoventilation. There is no objective measure of early respiratory parameters that would predict respiratory compromise after surgery efficiently in pediatric patients. Current respiratory assessment in non-intubated patients relies on oximetry data, impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. New advances in technology and digital signal processing have led to the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in pediatric patients.

Official Title
-----------------
The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia

Conditions
-----------------
Respiratory Complications

Intervention / Treatment
-----------------
* Device: Respiratory Motion Inc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients between the ages of 1 year and 17 years ASA status of 1-3 scheduled to undergo a procedure with general anesthesia at Boston Children's Hospital Exclusion Criteria: Patients undergoing an emergency procedure or a patients undergoing a procedure where the study monitor will interfere with the surgical procedure site or standard of care preexisting respiratory disease muscular disease affecting the respiratory system

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Respiratory Motion Inc|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation. |  | intraoperative | 
| Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation. |  | intraoperative | 
| Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation. |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
general anesthesia
Expanded Access for Abatacept

Study Overview
=================
Brief Summary
-----------------
This is an expanded access designed to provide access to abatacept for eligible participants.

Intervention / Treatment
-----------------
* Biological: Abatacept


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Abatacept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cardiac Arrest Registry of the Lombardia Region (Lombardia CARe)

Study Overview
=================
Brief Summary
-----------------
The registry enroll all the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region with a follow-up up to ten years after the event.

Detailed Description
-----------------
The registry is an observational study which enroll all the patients who suffered an out-of-hospital cardiac arrest of any etiology in the Lombardia Region The follow-up of the patients is at 1 month after the event, 6 month and every year up to five years after the event.

Official Title
-----------------
Cardiac Arrest Registry of the Lombardia Region (Lombardia CARe)

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-of-hospital cardiac arrest of any etiology in the Lombardia Region Exclusion Criteria: In-hospital cardiac arrest
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Out-of-hospital cardiac arrest<br>All the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with good neurological outcome for OHCA patients of any etiology | Survival with Cerebral Performance Category of 1 or 2 | From cardiac arrest date up to 10 years or up to death, whichever come first | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CPR, cardiac arrest, resuscitation, Out-Of-Hospital Cardiac Arrest
The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and cost-effectiveness of Cone Beam Computed Tomography (CBCT) compared to panoramic radiography prior to removal of third molars in reducing patient's morbidity. Adults having a close relationship between the mandibular canal and one or both lower third molars, as diagnosed from digital panoramic radiographs will be recruited for this randomised controlled trial. In one trial arm, patients will receive the standard digital panoramic radiograph prior to third molar surgery. In the second arm, subjects will undergo an additional Cone Beam Computed Tomography (CBCT) prior to third molar surgery. All patients require a postoperative visit one week after surgery to assess the outcome.

Official Title
-----------------
The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal; a Multicentre Randomised Controlled Trial

Conditions
-----------------
Inferior Alveolar Nerve Injury

Intervention / Treatment
-----------------
* Procedure: Third molar removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18 year mandibular canal is superimposed more than one half by the roots of the third molar as assessed on panoramic radiograph. Exclusion Criteria: pregnancy radiological evidence of cyst an tumors indication for removal under general anesthesia preoperative neurosensory alterations existence of an external CBCT

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CBCT<br>Cone Beam CT | Procedure: Third molar removal<br>* Surgically removing the third molar in the lower jaw<br>|
| Other: Panoramic radiograph<br> | Procedure: Third molar removal<br>* Surgically removing the third molar in the lower jaw<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with inferior alveolar nerve (IAN) injury |  | 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oral Health related quality of life score |  | 1 week after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CBCT, Third molar removal, Inferior alveolar nerve injury
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).

Official Title
-----------------
A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)

Conditions
-----------------
Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Healthy

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results Smoke less than 10 cigarettes (or equivalent) per day Capable of giving written Informed Consent (IC) Exclusion Criteria: Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation Overt bleeding, including from gastrointestinal tract Hepatitis (B or C) infection HIV (human immunodeficiency virus) infection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CP-rFVIIa<br> | Drug: activated recombinant human factor VII<br>* One single dose administration, injected i.v. (into the vein)<br>|
| Experimental: VII25<br> | Drug: activated recombinant human factor VII<br>* One single dose administration, injected i.v. (into the vein)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve for FVIIa clot activity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration (Cmax) |  |  | 
| Terminal half-life (t½) |  |  |
Using Multimedia Technology for Hypertension Control for Low-Income African Americans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test an interactive DVD intervention to encourage patients to stick to their blood pressure medication in order to achieve blood pressure control for African American patients. The intervention will convey health messages through personal patient stories who have dealt with or continue to struggle with high blood pressure. Hypothesis 1: At the end of 9 months a higher proportion of patients randomized to the intervention group will achieve appropriate blood pressure control. Hypothesis 2: At the end of 9 months a higher proportion of patients who randomized to the intervention group will report high adherence to their hypertension medications.

Official Title
-----------------
Culturally Sensitive Intervention: CSI Birmingham

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: DVD
* Behavioral: Intervention DVD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American Clinical Diagnosis of Hypertension Patient at Cooper Green Hospital Provided Informed Consent Age 18 or older Exclusion Criteria: Pregnant Diagnosed with dementia, schizophrenia, bipolar illness, or other serious acute or chronic medical co-morbidity

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control DVD<br>Control DVD with usual care information | Behavioral: DVD<br>* Control group will receive usual care DVD from health professionals<br>|
| Active Comparator: Intervention DVD<br>Intervention group will receive DVD with patient stories and information from health care professionals | Behavioral: Intervention DVD<br>* Intervention group will receive intervention DVD with patient stories and information from health care professionals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to hypertension medications |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Adherence to medications
Study Evaluating the Etiology of Intra-Abdominal Infections

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to define the etiology of intra-abdominal infections, to study the role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the need for specific enterococcal antimicrobial coverage.

Official Title
-----------------
Study of the Etiology of Intra-Abdominal Infections

Conditions
-----------------
Intra-abdominal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A case will be defined as an intra-abdominal abscess or peritoneal fluid culture that will be positive for enterococcus or an enterococcal bacteriemia in association with an intra-abdominal source of infection. A control will be defined as a culture-positive intra-abdominal infection or bacteriemia due to an intraabdominal focus where enterococci have not been isolated. Exclusion Criteria: -

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal infection