linjc16/ctgov huggingface dataset:
Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg

Study Overview
=================
Brief Summary
-----------------
Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry. Improving quality of life observed in the visual analogue scale (VAS).

Conditions
-----------------
Children

Intervention / Treatment
-----------------
* Dietary Supplement: Joalis Bambi Analerg
* Dietary Supplement: Joalis Bambi Bronchi
* Dietary Supplement: Placebo
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with other allergic symptoms treating with classic pharmacological treatment 9-18 years signed Infromed Conset Exclusion Criteria: subjects who have previously used a food suplemts Joalis subjects with known intolerance or hypersensitivity to the components of food supplements subjects with alcohol abuse or drugs at the time of recruitment into the study subjects enrolled in another clinical trial in the last 1 month before enrollment in this study subjects in a situation which in the opinion of a doctor may interfere with optimal participation in the study or can pose a risk to the subjects pregnant girls, lactating girls and girls of childbearing age without adequate contraception

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 18 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Joalis Bambi Bronchi & Joalis Bambi Analerg<br>10 days, 2 times per day 2,5/5 ml | Dietary Supplement: Joalis Bambi Analerg<br> <br> Dietary Supplement: Joalis Bambi Bronchi<br> <br> |
| Placebo Comparator: Placebo & Placebo<br>10 days, 2 times per day 2,5/5 ml | Dietary Supplement: Placebo<br>* Sugar pill manufactured to mimic Joalis Bambi Analerg<br>Dietary Supplement: Placebo<br>* Sugar pill manufactured to mimic Joalis Bambi Bronchi<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the total IgE (IU/ml) antibody. |  | 1 year | 
| Improving of vital capacity measured by spirometry (litre). |  | 1 year | 
| Improving of lung volume measured by spirometry (litre). |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving of quality of life observed in the visual analogue scale (VAS). |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food supplements, Asthma bronchiale
Chewing Capability Study for Infants and Toddlers

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to conduct a pilot study on the characterization of the mastication abilities of infants and toddlers using different commercial cereal based products in order to gain knowledge and be able to plan future studies.

Official Title
-----------------
Effect of Food Structural Properties on Infants and Toddlers Mastication Abilities

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born at term (37+ weeks) Familiar with solid foods No known history of food allergies Child must be within 2 weeks of the targeted age group for 9 months, within 1 month for 12 months, within 2 months for 18 and 24 months, and within 3 months for 36 months for this study. English must be the primary language of the participant and family. Having obtained his/her caregiver's or legal representative's informed consent. Exclusion Criteria: History of speech/language, cognitive, or physical impairments as indicated on the self-reported medical history questionnaire completed by caregiver or legal guardian Any previously undiagnosed speech/language or cognitive impairment detected by the Investigator. In the case a subject is identified as being at risk for a communication or feeding impairment, the caregiver will be notified and provided with a list of local speech-language pathology providers who could perform a formal assessment History of poor weight gain/ weight loss, food allergies, difficulties with sucking, difficulties with chewing and/ or swallowing, frequent drooling (for age groups 18, 24, and 36 months), frequent choking, gastro-esophageal reflux, frequent spitting up/ vomiting (for age groups 18, 24, and 36 months) or irritability after feedings/ eating Latex allergies Currently participating in or having participated in a similar clinical trial related to food/diet within the last 9 months Caregiver must not be under the age of 18 years old.

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 36 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 9 month old infant<br> | |
| 12 month old infant<br> | |
| 18 month old toddler<br> | |
| 24 month old toddler<br> | |
| 36 month old toddler<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle activities involved in the mastication using Electromyography (EMG) |  | One day during the study visit 2 |
Mitochondrial Metabolism and Hepatic Complications of Obesity

Study Overview
=================
Brief Summary
-----------------
The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.

Detailed Description
-----------------
The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis. The protocols involves a per-operative hepatic needle biopsy for mitochondria characterization and histological scoring of steatosis, inflammation, and fibrosis

Official Title
-----------------
Prospective Physiopathology Study of the Links Between Mitochondrial Dynamics and Fatty Liver Disease During Obesity

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

Intervention / Treatment
-----------------
* Other: liver biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult men and women affiliated to a social security candidate for laparoscopic obesity surgery Exclusion Criteria: Excessive alcohol consumption:> 20 g / day (woman),> 30 g / day (male) Chronic viral hepatitis B or C Genetic hemochromatosis Taking the following drugs for at least 3 months up to 6 months before the scheduled date of obesity surgery: systemic corticosteroids, amiodarone, methotrexate Wilson's disease autoimmune hepatitis alpha 1-antitrypsin deficiency abetalipoproteinemia Contraindications to liver biopsy

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: patients with obesity surgery with a laparoscopic approach scheduled in the department of digestive surgery of the CHU de Nantes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe | Other: liver biopsy<br>* the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between nonalcoholic steato-hepatitis and mitochondria morphological markers |  | Until 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mitochondria, Obesity surgery, liver, steatosis
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the feasibility of using thermal images to diagnose bacterial pneumonia instead of a chest x-ray in the future. More specifically, the objectives of this study are: 1) to determine if thermal imaging, using a commercial thermal camera can detect areas of heat emitted from the chest in similar locations to where a chest X-ray shows focal consolidation consistent with bacterial pneumonia; 2) to evaluate whether changes in heat emitted from the chest changes over time if it is possible to obtain serial images of the chest.

Official Title
-----------------
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections

Conditions
-----------------
Infections, Bacterial, Pneumonia, Bacterial

Intervention / Treatment
-----------------
* Device: FLIR ONE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject sent for a clinical chest X-ray (not research) to rule out pneumonia Thermal images obtained using FLIR ONE within 4 hours of the chest x-ray Signed informed consent obtained Subject is a patient at a participating clinic at Massachusetts General Hospital Exclusion Criteria: None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLIR ONE thermal camera<br>Thermal camera (FLIR ONE) | Device: FLIR ONE<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of diagnosis of bacterial pneumonia | Thermal imaging will be compared to the chest x-ray taken within 4 hours to see if bacterial pneumonia is present | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
imaging, diagnostic, feasibility
Evaluation of Syncope,Its Diagnosis, Treatment, Outcome and Prognosis

Study Overview
=================
Brief Summary
-----------------
The investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope.

Official Title
-----------------
E-STOP Registry: A Registry for the Evaluation of Syncope,Its Diagnosis, Treatment, Outcome and Prognosis Using Our SELF-Pathway

Conditions
-----------------
Syncope

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients (age 18 or older) admitted with syncope or near-syncope Exclusion Criteria: Patients who do not speak/read the language of the consent form Prisoners Patients who are of altered mental status or had head trauma Refusal or inability to sign 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Syncope<br> | |

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
-----------------
Syncope, Pre-Syncope, Fainting
Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)

Study Overview
=================
Brief Summary
-----------------
Drug-drug interaction study of Digoxin and AT-527 (R07496998)

Official Title
-----------------
A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Digoxin in Healthy Adult Subjects

Conditions
-----------------
Healthy Volunteers Study

Intervention / Treatment
-----------------
* Drug: AT-527 + digoxin
* Drug: AT-527 + digoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug Females must have a negative pregnancy test at Screening and prior to dosing Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2 Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2 Abuse of alcohol or drugs Use of other investigational drugs within 28 days of dosing Concomitant use of prescription medications, or systemic over-the-counter medications Other clinically significant medical conditions or laboratory abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-527 + digoxin (simultaneous)<br>n=14 | Drug: AT-527 + digoxin<br>* Day 1: A single dose of digoxin will be administered. Day 15: A single dose of AT-527 and digoxin will be co-administered.<br>* Other names: AT-527 is also know as R07496998;|
| Experimental: AT-527 + digoxin (staggered)<br>n=14 | Drug: AT-527 + digoxin<br>* Day 1: A single dose of digoxin will be administered. Day 15: A single staggered dose of AT-527 and digoxin will be administered (2 hours later).<br>* Other names: AT-527 is also know as R07496998;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin | Maximum plasma concentration (Cmax) | Day 1, Day 15 | 
| To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin | Area under the concentration-time curve (AUC) | Day 1, Day 15 | 
| To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin | Maximum plasma concentration (Cmax) | Day 1, Day 15 | 
| To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin | Area under the concentration-time curve (AUC) | Day 1, Day 15 |
Phase I Chinese PK

Study Overview
=================
Brief Summary
-----------------
An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.

Official Title
-----------------
An Open Label, Phase I, Rising Multiple Dose, Single Centre Study to Determine the PK and Tolerability of ZD6474 at Different Dose Levels in Chinese Patients With Solid Malignancy Tumor

Conditions
-----------------
Advanced Solid, Malignant Tumors

Intervention / Treatment
-----------------
* Drug: Vandetanib
* Drug: Vandetanib 300 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological and/or cytological confirmation of a malignant solid tumor refractory to standard therapies or for which no appropriate therapies exist WHO performance status 0-2 Exclusion Criteria: patients with brain tumors or symptomatic cerebral metastases systemic anticancer therapy within the last 4 weeks

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 mg Vandetanib eod<br>100 mg Vandetanib every other day dosing | Drug: Vandetanib<br>* 100 mg every other day, 100mg once daily<br>* Other names: ZACTIMA™;|
| Experimental: 100 mg Vandetanib od<br>100 mg Vandetanib once daily dosing | Drug: Vandetanib<br>* 100 mg every other day, 100mg once daily<br>* Other names: ZACTIMA™;|
| Experimental: 300 mg Vandetanib od<br>300 mg Vandetanib once daily dosing | Drug: Vandetanib 300 mg<br>* 300mg once daily<br>* Other names: ZACTIMA™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) (0-24) (ng.h/mL) after single dose |  | Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ZD6474 PK
Drug-drug Interaction Study of FYU-981 and Oxaprozin

Study Overview
=================
Brief Summary
-----------------
This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.

Official Title
-----------------
Drug-drug Interaction Study to Evaluate the Pharmacokinetics and Safety of FYU-981 and Oxaprozin in Healthy Male Adults Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: FYU-981
* Drug: Oxaprozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy subjects Body mass index: >=18.5 and <25.0 Exclusion Criteria: Subject with any disease or any history of disease that might be unsuitable for participation in the clinical study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose<br>Single administration of FYU-981 | Drug: FYU-981<br>* Single administration<br>|
| Experimental: Concomitant administration<br>Concomitant administration of FYU-981 with oxaprozin at steady state | Drug: FYU-981<br>* Single administration<br>Drug: Oxaprozin<br>* Repeated administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax: Maximum plasma concentration) |  | 48 hours | 
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |  | 48 hours | 
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) |  | 48 hours | 
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) |  | 48 hours | 
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (kel: Elimination rate constant) |  | 48 hours | 
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (MRT: Mean residence time) |  | 48 hours | 
| Safety (Incidence of treatment-emergent adverse event) |  | 20 days |
Using Smart Phone Technology To Rural Veterans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if a new Smart Phone application can help Veterans manage their panic symptoms after completing a two-day treatment for panic attacks.

Detailed Description
-----------------
The first goal is to see how helpful the Smart Phone application is in helping veterans with panic symptoms continue to improve after you complete treatment. The second goal of this study is to find out how much veterans like the Smart Phone application. The third goal is to see how practical it is to use the Smart Phone application as a form of follow-up care. We want to see how much time is needed to provide technical support in using the application.

Official Title
-----------------
USING SMART PHONE TECHNOLOGY AS A PLATFORM FOR DELIVERING MENTAL HEALTH CARE TO RURAL VETERANS

Conditions
-----------------
Panic Disorders, Anxiety Disorders

Intervention / Treatment
-----------------
* Behavioral: Panic Control Treatment (PCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veteran currently meet criteria for PD with or without Agoraphobia complete the weekend PD treatment at the Lufkin, Conroe or Texas City CBOC. Exclusion Criteria: current substance dependence organic psychosis symptomatic bipolar disorder severe depression with suicidal intent or plan cognitive impairment (indicated by scores <20 on SLUMS)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Panic Control Treatment (PCT)|2 Day treatment for Panic Disorder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panic Control Treatment (PCT) | A cognitive-behavioral therapy for PD that is highly efficacious, the standard delivery format of these sessions are typically offered once a week over a period of several months. This can pose challenges to rural Veterans who have multiple commitments and face long travel distances for mental health services. To improve accessibility to panic treatment, one innovative approach has been to deliver PCT in an intensive, two-day format. | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Panic, Panic Disorder, Anxiety