linjc16/ctgov huggingface dataset:
PET/CT to Identify Vulnerable Arterial Plaque

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to evaluate the presence, location and intensity of FDG uptake in the large arteries using the new technology of fused PET/CT imaging and to compare FDG uptake with the presence of arterial calcifications as seen on the simultaneously acquired CT, in order to determine if FDG was increases incalcified plaque or in a different location in the arterial wall. we will also evaluate the relationship between FDG localization and future cardiovascular events in out patient population

Official Title
-----------------
PET/CT to Identify Vulnerable Arterial Plaque

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: PET/CT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for clinical FDG-PET/CT studies Patients 50 yr or older Patients signed informed consent Exclusion Criteria: Patients unable or unwilling to tolerate the scan until its completion

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PET/CT imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of the imaging modality on patient management |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of the imaging modality on patient management |  |  |
Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

Study Overview
=================
Brief Summary
-----------------
The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas.

Conditions
-----------------
Vitamin A Deficiency

Intervention / Treatment
-----------------
* Other: Provitamin A-biofortified transgenic bananas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General good health as determined by interview, blood biochemistry profile, and complete blood count Antecubital veins amenable to blood collection Exclusion Criteria: Adverse reactions to blood sample collection History of anemia or excessive bleeding Cigarette smoking, frequent alcohol consumption Use of vitamin/mineral supplements Food allergies Lactose intolerance Abnormal thyroid status Chronic disease, lipid malabsorption or gastrointestinal disorders Hyper- or hypolipidemia Body mass index (BMI) > 28 History of eating disorder or restrained eating Current or planned pregnancy; menstrual cycle irregularities or abnormalities Use of hormonal contraceptives (affects chylomicron clearance); use of medications that may affect lipid absorption or transport

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Provitamin A-biofortified transgenic bananas|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction |  | 0 - 9.5 hours postprandially | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bananas, biofortified, carotenoids, vitamin A
Acute Evaluation of the Safety of Left Ventricular-left Ventricular (LV-LV) Delays and Its Effects on Mechanical Dyssynchrony

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of various LV-LV delays during multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac resynchronization therapy (CRT) patients post-implant.

Official Title
-----------------
Acute Evaluation of the Safety of LV-LV Delays and Its Effects on Mechanical Dyssynchrony

Conditions
-----------------
Cardiac Resynchronization Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an approved indication for a CRT implant Undergoing or previously received the implant of a St. Jude Medical Promote Q 3221-36 CRT-D with a Quartet Model 1458Q LV lead at participating clinical study site Ability to provide informed consent for study participation and be willing and able to comply with the prescribed evaluations Exclusion Criteria: Have persistent or permanent atrial fibrillation Have an intrinsic heart rate of <50 beats per minute Have Cheyne-Stokes breathing Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures Have had a recent CVA or TIA within 3 months prior to enrollment Be less than 18 years of age Be pregnant

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
-----------------
CRT
Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge

Study Overview
=================
Brief Summary
-----------------
Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge

Official Title
-----------------
Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of Technosphere®/Insulin in Subjects With Diabetes Mellitus After a Meal Challenge

Conditions
-----------------
Diabetes Mellitus, Upper Respiratory Infection

Intervention / Treatment
-----------------
* Drug: Technosphere Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will have met the same inclusion criteria as MKC-TI-030 Clinical diagnosis of URI with in 24 hrs prior to clinic visit and/or day of clinic visit At least 3 URI symptoms Exclusion Criteria: Prior participation in MKC-TI-112 MedHist, PE or lab findings of acute bacterial infection including but not limited to sputum prod., nasal/eye discharge, chest exam abnormalities, CXR findings of pneumonia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| 1: TI Inhalation Powder<br>Technosphere® Insulin (TI) Inhalation Powder | Drug: Technosphere Insulin<br>* Technosphere® Insulin (TI) Inhalation Powder, prandial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure Serum FDKP AUC |  | 4 Hours |
LMWH to Prevent Preeclampsia and Fetal Growth Restriction

Study Overview
=================
Brief Summary
-----------------
The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.

Detailed Description
-----------------
The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. We also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.

Official Title
-----------------
Low Molecular Weight Heparin Vs No Treatment in Pregnant Women With Previous Preeclampsia or Fetal Growth Restriction Who Were Heterozygote for Factor V Leiden or Prothrombin Gene G20210A Mutation

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Drug: Dalteparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous severe preeclampsia Previous severe fetal growth restriction Heterozygous Factor V Leiden Heterozygous G20210A prothrombin gene mutations Exclusion Criteria: renal disease chronic hypertension preexisting diabetes mellitus homozygosity for Factor V Leiden homozygosity for prothrombin G20210A mutation hyperhomocysteinemia protein C deficency protein S deficency antithrombin deficiency positive anticardiolipin antibodies positive lupus anticoagulant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dalteparin|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
-----------------
Low molecular weight heparin, Preeclampsia, Fetal Growth Restriction, Thrombophilia, Factor V Leiden, G20210A prothrombin gene mutation
Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer

Study Overview
=================
Brief Summary
-----------------
Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy.

Official Title
-----------------
Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer

Conditions
-----------------
Metastatic Cancer

Intervention / Treatment
-----------------
* Procedure: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic solid tumor Age> 18 years Signed consent Exclusion Criteria: Patients with diseases associated with vascular lesions known. Patients protected by law, in accordance with Articles L1121-5 to L1121-8 of the Code of Public Health. Mental pathology that can interfere with the proper conduct of the study. Refusal of consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with metastatic cancer<br> | Procedure: Blood samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement and characterization of CEC and CEP and circulaing DNA rate using flow cytometry | Measurement and characterization of initial CEC and CEP circulaing DNA and their evolution under treatment | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.

Official Title
-----------------
Prospective, Multicenter, Non-controlled Study, Evaluating Safety and Performance of SETALUM™ Sealant as an add-on to Suture in Vascular Reconstruction in Patients Undergoing Carotid Enlargement Procedure Using an ePTFE Patch.

Conditions
-----------------
Vascular Diseases

Intervention / Treatment
-----------------
* Device: SETALUM™ Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old; Surgical placement of an ePTFE patch for large carotid repair; Written informed consent given by the patient. Exclusion Criteria: Known or suspected allergy or sensitivity to any test materials or reagents; Concomitant intake of immunosuppressive medications; Prior radiation therapy to the operating field; Previous surgical procedure performed on the same operating field; Current or recent (<3months) participation in another investigational study; Refusal to receive blood products; Pregnant or breast-feeding women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SETALUM™ Sealant<br>SETALUM™ Sealant to be applied on the suture line | Device: SETALUM™ Sealant<br>* SETALUM™ Sealant to be applied on the suture line<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elapsed time from clamp release to hemostasis at the suture line | The hemostasis is observed by the operating surgeon and timed by an operative room nurse. Anastomotic hemostasis is defined as an anastomosis not requiring any additional intervention to control bleeding. | During surgical procedure | 
| All adverse events occurring from the surgical procedure to Week 12 | Each Adverse Event was described by the seriouness and the nature of its relationship to the SETALUM™ Sealant or to the surgical procedure. The Data Monitoring Committee reviewed all occurred adverse events and provided a conclusion on the SETALUM™ Sealant safety profile. | Week 12 |
Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
This is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (LSG) and LRYGB groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events

Official Title
-----------------
Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity

Conditions
-----------------
Laparoscopic Surgery

Intervention / Treatment
-----------------
* Procedure: Sleeve gastrectomy
* Procedure: Laparoscopic Roux-en-Y gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients of (Body Mass Index) more than 40, with at least 1 comorbidity Exclusion Criteria: All patients of (Body Mass Index) less than 40, No comorbidities Patients who refused the surgical procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LSG<br> | Procedure: Sleeve gastrectomy<br>* Bougie was applied over the lower curvature to adjust the gastric tube then longitudinal amputation of the stomach was performed for about 4 to 6 cm per pecker of the pylorus to the corner of His. No supportive materials were used, and over-suturing of the basic line performed only over the points of bleeding. All resected specimens were sent to histopathology laboratory for examination.<br>|
| RYGB<br> | Procedure: Laparoscopic Roux-en-Y gastric bypass<br>* An antecolic and antegastric RYGB become executed with a 150 cm alimentary limb with both a linearly or circularly kink (25 mm) gastrojejunostomy in step with the desire of the surgeon. A 50-cm-lengthy biliopancreati<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight dissipation | decrease the body mass index by 1 or more | 12 months |
Immediate Dentoalveolar Restoration Compared to Bio-oss

Study Overview
=================
Brief Summary
-----------------
This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Patient centred outcomes will also be evaluated.

Official Title
-----------------
Immediate Dentoalveolar Restoration Compared to Demineralized Bovine Bone in Immediate Implants Placed in Fresh Sockets With Buccal Bone Resorption: 18-months Randomized Controlled Trial

Conditions
-----------------
Fresh Sockets With Buccal Resorption

Intervention / Treatment
-----------------
* Procedure: Immediate dentoalveolar restoration
* Procedure: Demineralized bovine bone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tooth extraction indicated for teeth in anterior area between second premolars Exclusion Criteria: Diabetes and other systemic conditions that may affect osseointegration

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDR<br>Immediate dentoalveolar restoration conducted with bone removed from the tuber | Procedure: Immediate dentoalveolar restoration<br>* Block of bone removed from the tuber and placed in the buccal resorption of the socket together with an immediate implant<br>* Other names: IDR;|
| Active Comparator: Bio-oss<br>Bovine demineralized bone (Bio-oss Collagen) applied on the buccal resorption of the immediate implant | Procedure: Demineralized bovine bone<br>* Block of demineralised bovine bone placed in the buccal resorption of the socket together with an immediate implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Buccal-palatal thickness |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral-health related quality of life | The OHIP-14 will be applied and satisfaction will also be recorded | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immediate dentoalveolar restoration, bio-oss, immediate dental implant, bovine bone
Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.

Study Overview
=================
Brief Summary
-----------------
The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.

Detailed Description
-----------------
The investigators would like to compare operation related technical complications and periprosthetic joint infection rate between the first and second knee.

Official Title
-----------------
Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.

Conditions
-----------------
Osteoarthritis, Knee, Infection, Periprosthetic Fracture Around Prosthetic Joint Implant

Intervention / Treatment
-----------------
* Procedure: First Arthroplasty
* Procedure: Second Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization Exclusion Criteria: no history of malignancy less than 75 years old severe cardiac insufficiency and morbid obesity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: First Knee<br>The first knee is the knee where the surgery will begin to be applied. | Procedure: First Arthroplasty<br>* First Knee<br>|
| Experimental: Second Knee<br>The second knee is the knee where the surgeon will apply secondly. | Procedure: Second Arthroplasty<br>* Second Knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local complications | Local operation related complications rate | 90 days |