linjc16/ctgov huggingface dataset:
Saliva Modification Related to Fat Perception in Human

Study Overview
=================
Brief Summary
-----------------
The perception of fat represents major scientific and nutritional issues. This research aims to identify salivary markers that could predict and possibly explain this perception in healthy human being. This would help to develop nutritional strategies for a more rational consumption of fat.

Official Title
-----------------
Perception Ortho-nasale du Gras Chez l'Homme Sain : Relations Entre Typages olfactométriques, Sensoriels et Composition de la Salive.

Conditions
-----------------
Fat Sensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18-60 years Exclusion Criteria: Female Non healthy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Registry to Evaluate the Performance of the BDX-XL2 Test

Study Overview
=================
Brief Summary
-----------------
The purpose of the ORACLE Registry is to demonstrate clinical utility of the BDX-XL2 test; specifically, the potential to reduce unnecessary invasive procedures, such as biopsies and surgeries, on benign lung nodules while not significantly increasing the number of malignant lung nodules routed to CT surveillance. Clinical data will be collected from participating patients to evaluate the impact of the BDX-XL2 test when used in the clinical management of recently identified lung nodules assessed to have a low to moderate risk of cancer.

Official Title
-----------------
An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test

Conditions
-----------------
Nodule Solitary Pulmonary, NSCLC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has provided informed consent to participate in the registry and agrees to comply with all protocol requirements. Patient meets the criteria for the intended use population of Nodify Lung testing: Patient is > 40 years of age at the time of the discovery of the lung nodule of concern. The maximal dimension of the patient's lung nodule of concern is > 8mm and < 30mm. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less. The first CT scan identifying the lung nodule of concern was performed within 60 days of patient enrollment in the registry. Exclusion Criteria: Nodule work-up before the time of patient enrollment indicating any attempted or completed biopsy procedure after the first CT scan identifying the lung nodule of concern. High risk per physician assessment (i.e. > 65% by physician pCA) Current diagnosis of any active cancer. Prior diagnosis of lung cancer. Prior diagnosis of any cancer within 5 years of lung nodule detection, except for non-melanomatous skin cancer. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the patient's nodule of concern. Any illness or factor that will prevent compliance with follow-up as recommended.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Registry Patients With Nodify Lung Results<br>Patients providing consent to have data collected to observe how Nodify Lung results were used in the clinical management of their lung nodules. | |
| Contemporaneous Group Without Nodify Lung<br>Contemporaneous group who did not have Nodify Lung test results for use in the clinical management of their lung nodules. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures. |  | Up to 2 years |
Changes in Circulatory I-FABP in Elderly Persons in Daily Life

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to detect changes in circulatory I-FABP values (50% increase) in elderly volunteers following the combination of moderate physical activity and a standard meal.

Official Title
-----------------
Changes in Circulatory I-FABP in Elderly Persons in Daily Life: A Pilot Study

Conditions
-----------------
Malnutrition, Intestinal Integrity, Intestinal Fatty Acid Binding Protein (IFABP)

Intervention / Treatment
-----------------
* Behavioral: Walking test
* Behavioral: Standard Meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 75 years or older (both sexes) Participating in the Embrace project. Exclusion Criteria: Previous gastrointestinal resections Chronic inflammatory gastrointestinal disease

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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 |
| --- | --- |
| Experimental: IFABP assessment (1 study group)<br>30 elderly volunteers | Behavioral: Walking test<br>* Walking test to increase cardiac output, maximum 12 minutes<br>Behavioral: Standard Meal<br>* After the walking test, volunteers eat a standard warm meal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% increase of I-FABP in plasma. |  | 2 hours |
Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

Study Overview
=================
Brief Summary
-----------------
This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

Detailed Description
-----------------
This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.

Official Title
-----------------
An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201

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

Intervention / Treatment
-----------------
* Drug: QGE031


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: forced Expiratory Volume in one second ( FEV1) >= 40% predicted patients who completed CQGE031B2201 study Key Exclusion Criteria: life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study new malignancy ongoing SAE from CQGE031B2201 that was assessed as related to study drug patient experienced platelets drop to < 75,000/uL patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions patient is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 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: QGE031 every 4 weeks (q4w)<br>QGE031 240 mg subcutaneously q4w | Drug: QGE031<br>* QGE031 120 mg/mL solution for subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | Safety was monitored throughout the study. | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, allergic asthma, QGE031, open-label, IgE, long-term safety
Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function

Study Overview
=================
Brief Summary
-----------------
To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours).

Official Title
-----------------
A Phase I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function

Conditions
-----------------
Normal Renal Function, Mildly Impaired Renal Function, Moderately Impaired Renal Function

Intervention / Treatment
-----------------
* Drug: Genasense (oblimersen, G3139)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria: Age > 18 years Adequate organ function as determined < 7 days prior to starting study medication (except for renal function, as specified per protocol) Creatinine clearance > 80 mL/min based on the Cockcroft-Gault formula for subjects in Group 1; or 50 to less than or equal to 80 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 2; or 30 to 49 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 3 Key exclusion criteria: Significant medical disease Prior organ allograft Coexisting condition that would require the subject to continue therapy during the treatment (infusion) phase of the study with a drug known to alter renal function

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Genasense (oblimersen, G3139)|3 mg/kg/day by intravenous infusion for up to 48 hours|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of oblimersen (G3139) |  | Up to 58 hours after start of Genasense infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Function, Adult, Genasense, oblimersen, G3139, Genta, Pharmacokinetics
Machine Learning Ventilator Decision System VS. Standard Controlled Ventilation

Study Overview
=================
Brief Summary
-----------------
Ventilator-induced lung injury is associated with increased morbidity and mortality. Despite intense efforts in basic and clinical research, an individualized ventilation strategy for critically ill patients remains a major challenge. However, an individualized mechanical ventilation approach remains a challenging task: A multitude of factors, e.g., lab values, vitals, comorbidities, disease progression, and other clinical data must be taken into consideration when choosing a patient's specific optimal ventilation regime. The aim of this work was to evaluate the machine learning ventilator decision system, which is able to suggest a dynamically optimized mechanical ventilation regime for critically-ill patients. Compare with standard controlled ventilation, to test whether the clinical application of the machine learning ventilator decision system reduces mechanical ventilation time and mortality.

Official Title
-----------------
Effect of a Machine Learning Ventilator Decision System Versus Standard Controlled Ventilation on in Critical Care: a Randomized Trial

Conditions
-----------------
Mechanical Ventilation, Critically Ill Patients

Intervention / Treatment
-----------------
* Device: Machine Learning Ventilator Decision System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: only the first ICU stay was eligible; adults ≥ 18 years of age on ICU admission; estimate mechanical ventilation time ≥24 hours;

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
Interventional Model Description: ventilator decision system
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Machine Learning Ventilator Decision System Ventilation | Device: Machine Learning Ventilator Decision System<br>* Artificial intelligence ventilator system for personalized mechanical ventilation<br>|
| Active Comparator: Group B<br>Standard Controlled Ventilation | Device: Machine Learning Ventilator Decision System<br>* Artificial intelligence ventilator system for personalized mechanical ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation time |  | through study completion, an average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay time |  | through study completion, an average of 1 week | 
| Length of hospital stay |  | through study completion, an average of 2 weeks | 
| In-hospital mortality |  | through study completion, an average of 2 weeks |
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine

Study Overview
=================
Brief Summary
-----------------
a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery.

Official Title
-----------------
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine

Conditions
-----------------
HIV Infections, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Procedure: bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected VL suppressed <40c/ml for at least 6 months, blips are allowed planned to have bariatric surgery (gastric bypass or gastric sleeve) Able to sign informed consent Age > or equal to 18 years Using doravirine for at least 4 weeks prior to BS with VL < 40 copies/mL prior to the surgery Exclusion Criteria: History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation Requires or is anticipated to require any of the prohibited medications known to contradict/interact with doravirine Has significant hypersensitivity or other contraindication to doravirine Creatinine clearance <40 ml/min Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C) Pregnancy or planning to be pregnant during first 6 months postbariatric surgery.

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: Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doravirine treatment<br>patients stable on doravirine and candidate for bariatric surgery | Procedure: bariatric surgery<br>* bariatric surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of doravirine | area under the curve, doravirine | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | adverse events | 24 weeks | 
| HIV viral load | HIV viral load | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, doravirine
Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.

Detailed Description
-----------------
To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.

Official Title
-----------------
Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

Conditions
-----------------
Acute Pain, Respiration, Sedation

Intervention / Treatment
-----------------
* Drug: Remifentanil+clonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Clonidine | Drug: Remifentanil+clonidine<br>* iv Remifentanil+ iv clonidine<br>* Other names: Ultiva, Catapressan;|
| Active Comparator: 2<br>Remifentanil | Drug: Remifentanil+clonidine<br>* iv Remifentanil+ iv clonidine<br>* Other names: Ultiva, Catapressan;|
| Experimental: 4<br>Remifentanil+clonidine | Drug: Remifentanil+clonidine<br>* iv Remifentanil+ iv clonidine<br>* Other names: Ultiva, Catapressan;|
| Placebo Comparator: 3<br>Placebo | Drug: Remifentanil+clonidine<br>* iv Remifentanil+ iv clonidine<br>* Other names: Ultiva, Catapressan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of pain(VAS reduction) |  | Experimental | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Minute ventilation |  | Experimental | 
| Reduction in CO2 stimulated Minute Ventilation |  | experimental | 
| Reduction in BIS score |  | Experimental | 
| Performance on Stroop test |  | Experimental | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remifentanil, clonidine, acute pain, respiration, sedation, cognitive function
The Effects on Growth of a Non-Routine Infant Formula

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics

Official Title
-----------------
The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants

Conditions
-----------------
Growth

Intervention / Treatment
-----------------
* Other: infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infant Solely formula fed 14 days of age Exclusion Criteria: History of underlying disease Evidence of formula intolerance Current illness

Ages Eligible for Study
-----------------
Minimum Age: 12 Days
Maximum Age: 16 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Other: infant formula<br>* hydrolyzed infant formula without probiotics hydrolyzed infant formula with probiotics hydrolyzed infant formula with probiotics<br>* Other names: no other names for any of the intervention arms;|
| Experimental: 2<br> | Other: infant formula<br>* hydrolyzed infant formula without probiotics hydrolyzed infant formula with probiotics hydrolyzed infant formula with probiotics<br>* Other names: no other names for any of the intervention arms;|
| Experimental: 3<br> | Other: infant formula<br>* hydrolyzed infant formula without probiotics hydrolyzed infant formula with probiotics hydrolyzed infant formula with probiotics<br>* Other names: no other names for any of the intervention arms;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth (weight) |  | 106 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance |  | 106 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant formula