linjc16/ctgov huggingface dataset:
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)

Study Overview
=================
Brief Summary
-----------------
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Detailed Description
-----------------
WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.

Official Title
-----------------
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Conditions
-----------------
Non-valvular Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Watchman FLX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications; Subject who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre; Subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the Subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); Documented life expectancy of less than 12 months.

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: Watchman FLX|Patients who are receiving the Watchman FLX device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedural success |  | 7 days post-implant | 
| incidence of stroke, leak, thrombus and death |  | 1 year | 
| procedural complications |  | 7-days post implant |
Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase II study is to determine the efficacy of fenretinide in the treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular degeneration (AMD).

Official Title
-----------------
A Phase II Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose-Comparison Study of the Safety and Efficacy of Fenretinide in the Treatment of Geographic Atrophy in Subjects With Age-Related Macular Degeneration

Conditions
-----------------
Geographic Atrophy, Dry Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Fenretinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males or females, 50 to 89 years of age must have GA from AMD in one or both eyes Exclusion Criteria: GA due to any disease other than AMD (eg, drug-induced)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 89 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 100 mg fenretinide softgel capsules<br>Three (3) 100-mg fenretinide softgel capsules | Drug: Fenretinide<br>* Once daily 30 minutes after the evening meal for 24 months<br>|
| Active Comparator: Fenretinide and placebo softgel capsules<br>One (1) 100-mg fenretinide softgel capsule and two (2) placebo softgel capsules | Drug: Fenretinide<br>* Once daily 30 minutes after the evening meal for 24 months<br>|
| Placebo Comparator: Placebo softgel capsules<br>Three (3) placebo softgel capsules | Drug: Fenretinide<br>* Once daily 30 minutes after the evening meal for 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GA lesion progression |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Age Related Macular Degeneration, Geographic Atrophy
Validity and Reliability of Commercially Available Metabolic Carts

Study Overview
=================
Brief Summary
-----------------
The validity (by alcohol burning and gas infusions) and reliability (day-to-day variability in healthy subjects) of six metabolic carts will be compared.

Official Title
-----------------
Validity and Reliability of Commercially Available Metabolic Carts

Conditions
-----------------
Metabolism and Nutrition Disorder

Intervention / Treatment
-----------------
* Device: Assessment of resting energy expenditure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female. Age 18-65 y. BMI between 18.5 kg/m2 and 40 kg/m2 (inclusive). Are willing to fast and not consume non-caloric stimulant for 10h before the assessments, and during the stay in the center. Are willing to avoid moderate or vigorous physical activity during 24h before the visits. Exclusion Criteria: Smoking or use of tobacco products within the last 3 months Diagnosed with diabetes. Previous bariatric surgery (or other surgeries) for obesity or weight loss. Use of medications affecting metabolism or sleep. History of neurological disease. History of cardiovascular disease, including hypertension, or other chronic diseases. Pregnant, planning to become pregnant, or breastfeeding Claustrophobia impeding to stay calm under a plastic canopy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Assessment of resting energy expenditure|We will assess the resting metabolic rate and respiratory exchange ratio of twenty healthy adults, with every metabolic cart on two days in the morning. The assessment will last 30 minutes on each metabolic cart, with 15-minute breaks between measurements. The order of the metabolic carts will be randomly selected and replicated the second day.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting metabolic rate | Indirect calorimetry | 30 minutes |
Radial Artery Cannulation and Perfusion Index

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate if radial artery cannulation of the dominant hand affects its peripheral perfusion during cardiac surgery using cardiopulmonary bypass.

Detailed Description
-----------------
Invasive blood pressure monitoring is mandatory in cardiac surgeries. Radial artery cannulation is the most common technique used for monitoring of invasive blood pressure and for arterial blood gas analysis. Perfusion index derived from pulse oximetry is a new method for monitoring of peripheral perfusion. this study aims to investigate if radial artery cannulation affects the intra-operative peripheral perfusion in the dominant cannulated hand

Official Title
-----------------
Does Radial Artery Cannulation Affect the Perfusion of the Dominant Hand in Patients Undergoing Open Cardiac Surgery? Data Derived From the Peripheral Perfusion Index.

Conditions
-----------------
Peripheral Perfusion

Intervention / Treatment
-----------------
* Procedure: Radial artery cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cardiac surgery using cardiopulmonary bypass Exclusion Criteria: Peripheral vascular diseases previous upper limb surgeries planned radial artery harvesting

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C. hand<br>Radial artery cannulation | Procedure: Radial artery cannulation<br>* Radial artery cannulation<br>|
| No Intervention: N.C. hand<br>No cannulation of the radial artery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The perfusion index |  | Intraoperative | 
| The peripheral temperature |  | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perfusion index, Cardiac Surgery, Radial artery cannulation
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.

Detailed Description
-----------------
In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.

Official Title
-----------------
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)

Conditions
-----------------
Leukemia, Promyelocytic, Acute

Intervention / Treatment
-----------------
* Drug: all-trans retinoid acid
* Drug: idarubicin
* Drug: mitoxantrone
* Drug: daunorubicin
* Drug: cytarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa no contraindication for chemotherapy written informed consent Exclusion Criteria: - severe comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: all-trans retinoid acid|nan|
|Drug: idarubicin|nan|
|Drug: mitoxantrone|nan|
|Drug: daunorubicin|nan|
|Drug: cytarabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity of the regimen |  |  | 
| evaluation of additional risk factors |  |  | 
| effectiveness of MRD as guidance for therapy decisions |  |  | 
| relapse free survival |  |  | 
| complete remission rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute promyelocytic leukemia, risk adapted therapy
Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer

Study Overview
=================
Brief Summary
-----------------
The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.

Official Title
-----------------
A Phase 2 Double-Blind, Placebo Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a Gemcitabine Regimen With Placebo, in Patients With Post-resection R0/R1 Pancreatic Cancer With Tumor Sequence Confirmation of Ras Mutations.

Conditions
-----------------
Pancreas Cancer

Intervention / Treatment
-----------------
* Biological: GI-4000
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
(A few general items required) Inclusion Criteria: Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation >18 years of age Negative skin test for hypersensitivity to Saccharomyces cerevisiae Exclusion Criteria: Metastatic pancreas cancer patients post-resection Patients with no product-related ras mutation.

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gencitabine | Biological: GI-4000<br>* Heat-killed yeast cell transfected with target ras mutation.<br>|
| Experimental: 2<br>Gemcitabine with GI-4000 | Drug: Gemcitabine<br>* Chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free time and survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreas Cancer, resected pancreas cancer, non-metastatic pancreas cancer
Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the cost-effectiveness of remote ischemic conditioning as an adjunct to primary percutaneous coronary intervention from the perspective of a Danish healthcare system.

Official Title
-----------------
Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction

Conditions
-----------------
ST-elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: Remote ischemic conditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) age ≥ 18 years, (2) symptom duration of ≤ 12 hours prior to admission, and (3) ST-segment elevation ≥ 0.1 mV in two or more contiguous electrocardiogram (ECG) leads Exclusion Criteria: (1) diagnosis not confirmed during hospital admission, (2) history of previous myocardial infarction, (3) previous CABG, and (4) chest pain > 12 hours prior to admission

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 |
| --- | --- |
| Experimental: Intervention group<br>Remote ischemic conditioning through intermittent arm ischemia with four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff performed in the ambulance during transport to primary percutaneous coronary intervention. | Procedure: Remote ischemic conditioning<br>* Intermittent arm ischemia through four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff placed around the upper arm.<br>* Other names: RIC;|
| No Intervention: Control group<br>Standard treatment with primary percutaneous coronary intervention alone. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost-effectiveness ratio (ICER) = [difference in total cardiovascular medical care costs between treatment groups] / [difference in major adverse cardiac and cerebrovascular event (MACCE)-free survival between treatment groups] | Data for the economic evaluation are collected from Danish nationwide registries and validated with medical record review. Charges from the Diagnosis Related Group (DRG) and the Danish Ambulatory Grouping System /DAGS) are used to calculate total cardiovascular medical care costs in the two treatment groups. | 4-years of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote ischemic conditioning, Cost-effectiveness analysis
Evaluation of Post Infectious Inflammatory Reaction (PIIR) Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection

Study Overview
=================
Brief Summary
-----------------
As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.

Official Title
-----------------
Evaluation of Post Infectious Inflammatory Reaction (PIIR) in a Retrospective Study Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection

Conditions
-----------------
Streptococcus Pneumonia, Streptococcus Pyogenes Infection, Neisseria Meningitides Meningitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Less than 18 years of age Fever associated with GAS, NM, or SP invasive infection Exclusion criteria: age > 18 years Impossibility to obtain the consent of parents / legal representatives.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the frequency PIIRs | Describe the frequency PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection | Describe the characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-infectious inflammatory reactions, Neisseria Meningitis
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma

Study Overview
=================
Brief Summary
-----------------
Emerging from a differential proteomic study of sample pairs of prostate cancer and benign tissue, annexin A3 (ANXA3) was chosen as a potential novel biomarker for the early and non-invasive diagnosis of prostate cancer. We wanted to show or investigate, that: ANXA3 can be detected in urine after standard digital rectal examination. ANXA3 has better specificities than tPSA, in particular in the grey zone of PSA ANXA3 can help avoid unnecessary biopsies ANXA3 can in the long run replace PSA as a marker

Detailed Description
-----------------
The aim of this multi centre and double-blinded study was to investigate specificities and sensitivities of early detection of prostate cancer with a new protein biomarker, annexin A3, using urine after digital rectal examination/massage (exprimate urine) in direct comparison to the corresponding measurements of the gold standard, total PSA. The material obtained by this non-invasive procedure was moreover used to determine appropriate cut-off values and optimal fractions (e.g. after centrifugation) and calibrations for quantitative measurements of this novel marker. Patients (500-750) were (and are) continuously recruited from four clinical centres in Germany (Berlin, Tübingen, Ludwigshafen) and Austria (Innsbruck). The major aspect was: • Can annexin A3 provide a better specificity than tPSA, in particular in the grey zone of PSA (2-10 ng/ml) and can annexin A3 thus contribute to a significant reduction of invasive transrectal biopsies?

Official Title
-----------------
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma

Conditions
-----------------
Prostate Cancer, Benign Prostatic Hyperplasia, Prostatic Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a histological confirmation of adenocarcinoma of the prostate Patients with benign prostatic hyperplasia (confirmed by histology of lance biopsies or TUR-P) Exclusion Criteria: Patients with rectal extirpation Patients with renal or bladder tumors
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, annexin A3, early detection, exprimate urine