linjc16/ctgov huggingface dataset:
Measuring Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

Study Overview
=================
Brief Summary
-----------------
Collection of quantitative data to demonstrate the accuracy (bias) and precision (repeatability) of the Apieron INSIGHT(tm) eNO Breath System as compared to the FDA cleared NIOX eNO Breath System when testing is performed by asthma patients.

Detailed Description
-----------------
A non-randomized, prospective study of up to 150 subjects with asthma. Patients will perform eNO testing with the Apieron INSIGHT(tm) eNO system and the NIOX eNO system at the physician's office/clinic after a short demonstration and training by a healthcare professional trained in the use of the devices. Exhaled NO testing involves inhaling to lung capacity, and then performing a controlled exhalation into a mouthpiece connected to each of the Apieron INSIGHT(tm) and NIOX systems. Patients will perform an eNO measurement with the Apieron INSIGHT(tm) system and with the FDA cleared NIOX system for the accuracy portion of the study. Patients will perform 2 sequential eNO measurements on each system for the precision part of the study. Subjects that measure eNO values over 100 ppb will be asked to repeat 2 sequential eNO measurements on each system.

Official Title
-----------------
Measuring the Fractional Concentration of Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Device: Exhaled nitric oxide (eNO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 5 or older Pre-existing diagnosis of asthma Non-smoker Exclusion Criteria: Chronic inflammatory lung disease other than asthma Medical conditions that preclude hand-eye coordination

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| Asthmatics<br>Subjects with asthma | Device: Exhaled nitric oxide (eNO)<br>* Subjects will perform a controlled breath maneuver using both the Apieron and NIOX devices. The devices will measure nitric oxide in the subjects' exhaled breath.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eNO using Apieron INSIGHT(tm) System and Aerocrine NIOX at 50 ml/s |  | Single point in time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, nitric oxide, eNO, FENO, Apieron INSIGHT, Aerocrine NIOX
Palmitoylethanolamide for Post-operative Pain Prevention

Study Overview
=================
Brief Summary
-----------------
Postsurgical pain becomes chronic when it lasts more then two months after surgery. A neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates after urologic and gynecologic surgeries. Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors release, without adverse events. The investigators assume that perioperative administration of PEA can reduce chronic postsurgical pain incidence of patients undergoing to urologic and gynecologic elective surgery.

Official Title
-----------------
Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.

Conditions
-----------------
Chronic Post-operative Pain

Intervention / Treatment
-----------------
* Dietary Supplement: Palmitoylethanolamide
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective gynecological or urological surgical procedures Exclusion Criteria: age < 18 pregnancy or nursing pre-existing chronic pain severe hepatic or renal failure post-operative progression of local cancer disease post-operative infection or inflammation of surgical wound

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEA<br>Administration of PEA from 8 days before surgical operation until 30 days after surgery. | Dietary Supplement: Palmitoylethanolamide<br>* Before surgery: 600 mg cp twice a day After surgery: 600 mg microgranules twice a day for 10 days then 600 mg cps once a day for 20 days<br>|
| Active Comparator: Sugar pill<br>Administration of placebo from 8 days before surgical operation until 30 days after surgery. | Dietary Supplement: Placebo<br>* Before surgery: 1 sugar pill twice a day for 8 days After surgery: 1 sugar microgranules twice a day for 10 days then 1 sugar pill once a day for 20 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of chronic post-surgical pain | Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound. | 2 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical pain, chronic pain, prevention, palmitoylethanolamide
Preclinical Validation of New Anti-melanoma Compounds

Study Overview
=================
Brief Summary
-----------------
This research program is in keeping with the chemistry/biology/clinical interface and gathers 4 teams with complementary expertise in these respective fields. It will allow deciphering the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will use melanoma cell lines and primary cells from patients to validate these compounds in collaboration with clinical team 2 and 4. In conclusion, the investigators expect to establish the proof of concept that this new class of bioactive molecules (first in class) we developed in collaboration with Team 3 have the potential to go to the clinic for the treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of restoring the sensitivity of these melanoma cells.

Official Title
-----------------
Preclinical Validation of New Anti-melanoma Compounds: Study on Patient Melanoma Cells Sensitive and Resistant to BRAF/MEK Inhibitors

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with metastatic melanoma Not opposition of the patient will have been looked for Exclusion Criteria: Primary resistance, Absence of resistance, Patient already included in other trials

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 |
| --- | --- | --- |
| BRAF mutation | The status of the BRAF mutation will be expressed through laboratory analysis of the samples collected, i.e. positive or negative. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin metastasis, Resistance, Endoplasmic reticulum stress, Metastasis
Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Study Overview
=================
Brief Summary
-----------------
Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.

Official Title
-----------------
Project Bloom Regulatory Clinical Evaluation - System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Blood Glucose Monitoring System.


Participation Criteria
=================
Eligibility Criteria
-----------------
Summary of Inclusion Criteria: Able to voluntarily provide written informed consent to participate in the study. User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose. For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45. Summary of Exclusion Criteria: Female subjects who are pregnant or lactating. Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study. User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Glucose monitoring System (BGMS)<br>Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) | Device: Blood Glucose Monitoring System.<br>* In vitro diagnostic medical device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument. | UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( Health Care Professional) | Up to 1 hour | 
| System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument. | Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only. | Up to 1 hour | 
| System Use Evaluation questionnaire. | Assessment of how the patient uses the BGMS. | Up to 15 minutes | 
| Instructions for Use Evaluation questionnaire. | Questionnaires to assess the effectiveness of the instructions for use. | Up to 6 days. | 
| Marketing Claims Evaluation questionnaire. | Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims. | Up to 6 days. |
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.

Detailed Description
-----------------
Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.

Official Title
-----------------
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

Conditions
-----------------
Advanced Prostate Cancer, Prostatic Neoplasms

Intervention / Treatment
-----------------
* Biological: sipuleucel-T


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects must be at least 18 years of age subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment subjects must understand and sign an informed consent form Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sipuleucel-T<br> | Biological: sipuleucel-T<br>* Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.<br>* Other names: PROVENGE, APC8015;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration. | Every 3 months for a minimum of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method. | Every 3 months for a minimum of 3 years |
Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)

Study Overview
=================
Brief Summary
-----------------
In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

Detailed Description
-----------------
38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.

Official Title
-----------------
Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Drug: Atezolizumab
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent patients age 18 years and older histologically confirmed adenocarcinoma of the rectum intermediate risk rectal cancer or low risk distal rectal cancer Exclusion Criteria: evidence of metastatic disease prior radiation therapy for disease under study prior treatment with CD137 agonists or immune checkpoint blockade therapies current or recent use of acetylsalicylic acid history of clinically significant cardiac or pulmonary dysfunction pregnancy or breastfeeding significant auto-immune disease

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
Interventional Model Description: single group, open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bevacizumab and atezolizumab<br>1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy | Drug: Atezolizumab<br>* 3 cycles of atezolizumab 840 mg<br>* Other names: MPDL3280A;Drug: Bevacizumab<br>* 3 cycles of bevacizumab 5mg/kg<br>* Other names: HCA 185 ,Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical complete and near-complete response rate | response rate will be assessed by MRI and endoscopy | 12 weeks post-radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events following treatment (safety) | adverse events will be assessed (according tot CTC-AE v5) during treatment | untill 100 days after last patient last study drug | 
| local recurrence rate at 1 year follow-up | recurrence will be assessed by MRI and CT scans | 1 year post-radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
short term immunotherapy, atezolizumab, bevacizumab, radiotherapy
Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

Study Overview
=================
Brief Summary
-----------------
The effect of deep neuromuscular blockade (NMB) during spine surgery reduced postoperative pain and bleeding in recent studies. Therefore by reducing these two factors, which were the contributing factors for postoperative delirium, deep NMB is expected to reduce the postoperative delirium. This study was designed to determine whether the deep NMB lowered the incidence of delirium after lumbar surgery.

Official Title
-----------------
Effect of the Deep Neuromuscular Block on Postoperative Delirium in Elderly Patients Undergoing Lumbar Surgery

Conditions
-----------------
Lumbar Spine Disease

Intervention / Treatment
-----------------
* Drug: Rocuronium for deep NMB
* Drug: Rocuronium for moderate NMB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 70 and more; Scheduled for an elective lumbar spine surgery; ASA physical status 1-3 Exclusion Criteria: Diagnosed neuromuscular disorder; Contraindications to the study drug, e. g. known allergy or hypersensitivity, hypotension, bradycardia, higher grade atrioventricular block; Patient with pre-existing cognitive impairment or dementia

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep NMB<br>A TOF count of 0, and a PTC of 1 to 3 will be maintained, as close to 2 twitches as possible | Drug: Rocuronium for deep NMB<br>* Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.<br>* Other names: Deep NMB;|
| Active Comparator: Moderate NMB<br>A TOF count of 1 to 3 will be maintained, as close to 2 twitches as possible | Drug: Rocuronium for moderate NMB<br>* Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.<br>* Other names: Moderate NMB;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium by CAM-ICU | Occurrence of delirium assessed by CAM-ICU during the post-operative 5 days | from just after surgery at the PACU to post-operative 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intramuscular pressure | Intramuscular pressure at the para-spinal muscles | intraoperative | 
| Peak inspiratory airway pressure | Peak inspiratory airway pressure (mmHg) | intraoperative |
A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men

Study Overview
=================
Brief Summary
-----------------
Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive gay and bisexual men, which takes place in a group counselling format. All participants provided written informed consent at the outset of the study. Eligible participants filled out a 1-hour computer-assisted self-interview questionnaire. Subsequently, participants attended seven 2-hour group sessions, led by 2 peer facilitators, who were HIV-positive gay men, in groups of 5-8 men. Immediately and 3 months following the completion of the GPS program, participants were scheduled to attend a 1-hour session to complete the same questionnaire package. Participants received an honorarium and a list of community resources, including mental health or substance use counseling services, at the end of each assessment. Participants also participated in a program evaluation interview at the 3-month follow-up assessment.

Official Title
-----------------
A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men

Conditions
-----------------
Risk Behavior

Intervention / Treatment
-----------------
* Behavioral: GPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In order to be eligible to participate in the study, participants had to: identify as male, report engaging in condomless anal sex with another male during the past 3 months, self-report an HIV-positive status, be over the age of 18 years old, and be able to speak and read in English. Exclusion Criteria: Self-reported female gender, no condomless anal sex with another male during past 3 months, HIV-negative

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>GPS program - an 8-week, peer-led group counselling program using motivational interviewing techniques. | Behavioral: GPS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serodiscordant condomless anal sex with a casual partner | Condomless anal sex with an HIV-negative or unknown serostatus casual partner | Past 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconcordant condonmless anal sex with a casual partner | Condomless anal sex with an HIV-positive casual partner | Past 3 months |