linjc16/ctgov huggingface dataset:
Gastric Banding After Failed Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.

Official Title
-----------------
Laparoscopic Adjustable Gastric Banding With the Adhesix Bioring After Failed Gastric Bypass: a Prospective Evaluation in a High-volume Center

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Adhesix Bioring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must sign the informed consent form prior to the index-procedure. Patient with failed RYGB defined as patients with EWL <50%. Exclusion Criteria: Patient has a life expectancy of less than 2 year. Patient who is most likely expected not to be compliant with the proposed follow-up visits.

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 |
| --- | --- |
| Patients with failed RYGB (EWL <50%)<br> | Device: Adhesix Bioring<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage excess weight loss |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair. |  | During procedure | 
| Complications (perioperative, early and late) |  | 2 years | 
| Mortality |  | 2 years | 
| Regression of co-morbidities |  | 2 years | 
| BAROS score |  | 2 years | 
| Frequency of revisions |  | 2 years |
Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.

Official Title
-----------------
EZ Steer™ THERMOCOOL® With CF Sensing Capability (THERMOCOOL SMARTTOUCH™) for the Treatment of Atrial Fibrillation and Ventricular Tachycardia

Conditions
-----------------
Atrial Fibrillation, Ischemic Ventricular Tachycardia

Intervention / Treatment
-----------------
* Device: Radiofrequency Catheter Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic atrial fibrillation or ischemic ventricular tachycardia Exclusion Criteria: Longstanding persistent AF Idiopathic VT Congestive Heart Failure

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 |
| --- | --- |
| Other: Single-arm Study<br>This study was completed prior to the implementation of the requirement for specific identification of study arms. As the requirement was not made retroactive to completed studies, we believe this study to be exempt from the stipulation. Also, per PRS definition, since this is for a single-arm/feasibility study, the data elements are optional. | Device: Radiofrequency Catheter Ablation<br>* The Biosense Webster EZ Steer ThermoCool NAV Diagnostic / Ablation Deflectable Tip Catheter with Contact Force Sensing Capability is designed to facilitate electrophysiological mapping and transmit radiofrequency current as well as provide a real-time measurement of contact force.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events. | The primary safety endpoint is the incidence of early onset primary adverse events. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia, Electrophysiology, Fibrillation, Tachycardia, Ablation, Atrial Fibrillation (AF), Ischemic Ventricular Tachycardia (VT)
Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not

Study Overview
=================
Brief Summary
-----------------
Non-tuberculous mycobacteria (NTM) are increasingly common and have a poor prognosis: 5-year mortality can reach 40 to 50%, depending on the type of mycobacteria and the immune system of the host involved. Cancer patients are at higher risk of infectious morbidity and mortality, which may be due to disease-related immune dysfunction, immunosuppressive effects of chemotherapy, or long-term placement of a vascular catheter. However, data on the treatment of NTM species that cause infections and the disease characteristics of these pathogens in cancer patients are limited despite the growing cancer population worldwide. Recently, M. avium infections have been described in patients suffering from cancers (hematological or not), in particular in patients receiving checkpoint inhibitors. Although the proportion of M. avium pneumonia in retrospective series is low (0.8-2%), it has been shown that this population is younger, suffers less from sub-pulmonary pathology. (indicating immunosuppression in these patients) but are therefore treated less than non-cancerous subjects. This retrospective study in CHU Amiens is searching on the number of side effects of NTM treatment in two groups (cancerous and no cancerous) to assess the cause of the decrease of NTM treatment in cancerous patients.

Official Title
-----------------
Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not

Conditions
-----------------
Mycobacterium, Cancer, Treatment Side Effects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal or more than 18 years18 Patients diagnosed by an infection with non-tuberculous mycobacteria according to ATS guidelines. Patients received the NTM treatment. Exclusion Criteria: age less than 18 years Patients diagnosed by NTM without treatment. Patients with a positive sample of NTM but without infection. Exclusion of other disorders such as tuberculous.

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 |
| --- | --- |
| cancerous patients<br> | |
| non cancerous patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of side effects number of non-tuberculous mycobacteria treatment between cancerous and non cancerous patient groups. | The main objective of this study is to determine the number of side effects of the treatment of non-tuberculous mycobacteria in patients with this infection with or without cancer at the CHU Picardie Amiens. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mycobacterium, cancer, Treatment Side Effects
A Study of the Effect of Time on Topical Anesthetic Efficacy.

Study Overview
=================
Brief Summary
-----------------
This is a study of the effect of time on the effectiveness of topical anesthetics in the mouth. The Null Hypothesis is: Regardless of the time of application over a 10-minute period, there is no difference in the clinical effectiveness of the topical anesthetic 5% lidocaine on (a) the pain of needle stick insertion and (b) the pain of local anaesthetic administration.

Detailed Description
-----------------
The study design will be a double blind randomized controlled split-mouth clinical trial. It is proposed to compare the effectiveness of the standard topical anesthetic 5% lidocaine with a placebo over the time period of 2, 5 and 10 minutes after application. The topical will be placed on the palatal soft tissue where the perception of pain is the highest in the oral cavity. Both the pain of needle insertion and the pain of local anesthetic injection will be compared.

Official Title
-----------------
A Study of the Effect of Time on Topical Anesthetic Efficacy.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: lidocaine topical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In good health (ASA 1 or ASA 2) Weight between 40-100kg, inclusive. Between ages 18-70, inclusive. Informed consent Exclusion Criteria: ASA 3 or higher. History of allergy to sulfites, lidocaine or mepivacaine. Taking any analgesic 48hrs before testing, such as an NSAID, opioid, or acetaminophen. Pregnancy. Recent oral trauma. Lack of informed consent.

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

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lidocaine topical|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
topical, anesthetic, pain
Promus - Registry Experience at the Washington Hospital Center, Drug-eluting Stent (DES)

Study Overview
=================
Brief Summary
-----------------
Single-center registry of patients treated with at least one Promus, everolimus-eluting, Stent, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Detailed Description
-----------------
Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect real-world data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Promus® Stent for at least 1 year post initial stent implantation.

Official Title
-----------------
P-REWARDS (Promus - Registry Experience at the Washington Hospital Center, DES)

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, male or female, >18 years of age Patients who received at least one Promus drug-eluting stent at the Washington Hospital Center Exclusion Criteria: N/A

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 |
| --- | --- |
| Promus<br>Patients treated with at least one Promus, everolimus-eluting, Stent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Major Adverse Cardiac Events (MACE) post Promus Stent implantation |  | Follow up |
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: PF-03654764
* Drug: Allegra
* Drug: PF-03654764
* Drug: Allegra-D
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 18-60 years allergic to ragweed pollen. Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit. Exclusion Criteria: Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764. Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-03654764 + Allegra<br> | Drug: PF-03654764<br>* PF-03654764 single dose 5 mg<br>Drug: Allegra<br>* Fexofenadine single dose 60 mg<br>|
| Experimental: PF-03654764<br> | Drug: PF-03654764<br>* PF-03654764 single dose 5 mg<br>|
| Active Comparator: Allegra-D<br> | Drug: Allegra-D<br>* Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Congestion scores |  | 6 hours | 
| Other allergic rhinitis symptoms |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 6 hours | 
| Blood pressure/pulse rate |  | 6 hours | 
| Adverse event reporting |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic rhinitis Environmental exposure unit
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.

Detailed Description
-----------------
This is a multi-center uncontrolled continuation study designed to mimic real-world use of the aerSleep II System for subjects that have completed the SOM-029 protocol. Subjects will use the aerSleep II nightly at a fixed pressure of -30 cmH2O. Internal electronics will record various measures of how the device is being used and how it performs. Subjects will have a video visit with the study site approximately every 30 days, and, if the Investigator feels it is warranted or at the subject's discretion, an in-person visit at the study site will occur approximately every 90 days. During these visits, subjects will be queried for adverse events and asked to complete simple subjective evaluations of their experiences. The Investigator will complete a scale rating how well the device is managing the subject's obstructive sleep apnea (OSA). Data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance.

Official Title
-----------------
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial (CO-STAR)

Conditions
-----------------
Obstructive Sleep Apnea, Sleep Apnea

Intervention / Treatment
-----------------
* Device: aerSleep II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject completed study SOM-029 (SUPRA). The Investigator feels that the subject experienced sufficient benefit from aerSleep II to justify its further use. In the Investigator's judgement, the subject will be able to understand and comply with all study procedures. Exclusion Criteria: The Investigator feels that, for any reason, the subject's participation may not be in his or her best interest. Any condition or circumstance that in the opinion of the Investigator is likely to prevent accurate data collection or bias the results. The subject is pregnant or plans to become pregnant during the course of the study.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: aerSleep II|The aerSleep® II System includes a soft silicone collar, which is placed on the anterior neck. Integrated with the collar is a vacuum pump module (VPM), which cordlessly powers the generation of negative pressure within the collar's cavity. This negative pressure pulls the underlying tissues forward, maintaining airway patency.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy

Study Overview
=================
Brief Summary
-----------------
Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer detection was not attempted to date. We hope to learn what is the best approach for detection of cancer and thus to improve cancer treatment.

Official Title
-----------------
Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy

Conditions
-----------------
Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18-year-old, diagnosed with cancer Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them Exclusion Criteria: Patients who cannot complete a PET/CT scan Pregnant women Healthy volunteers Patients participating in other research studies The subjects will not be paid to participate in this protocol. No costs will be charged to the subjects.

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 |
| --- | --- | --- |
| Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT. |  | not defined |
Depodur vs Fentanyl Infusion for Post-C/S Analgesia

Study Overview
=================
Brief Summary
-----------------
Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.

Official Title
-----------------
A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Depodur
* Drug: Depodur
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women (ASA I or II) who are scheduled for an elective cesarean section Patient appropriate for regional anesthesia Patient agrees to receive regional anesthesia Patient willing to have an epidural infusion of medication for two days postoperatively Exclusion Criteria: Morbid obesity History of sleep apnea Allergy to opioids medications History of opioids use during week prior to procedure Emergency cesarean section Significant surgical complications Contraindication or refusal to have regional anesthesia Age less than 18

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

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

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 |
| --- | --- |
| Active Comparator: 1<br>Epidural Depodur after spinal bupivacaine | Drug: Depodur<br>* Depodur 10mg given epidurally at end of cesarean section.<br>Drug: Depodur<br>* Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.<br>|
| Active Comparator: 2<br>Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine | Drug: Fentanyl<br>* Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of analgesia (measured on a 10-point scale) |  | 48 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of minor side effects, such as pruritis or nausea. |  | 48 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia, cesarean section, fentanyl, Depodur, Post-cesarean section analgesia