linjc16/ctgov huggingface dataset:
A Drug-Drug Interaction Study of Furosemide and PA21

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Furosemide is affected by PA21.

Official Title
-----------------
A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Furosemide in Healthy Male and Female Adults

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

Intervention / Treatment
-----------------
* Drug: PA21 and Furosemide with food
* Drug: No PA21; Furosemide with food
* Drug: PA21 with food and Furosemide 2hrs later


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Written informed consent Exclusion Criteria: No significant medical conditions Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA21 and Furosemide with food<br> | Drug: PA21 and Furosemide with food<br>* The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day<br>|
| Experimental: No PA21; Furosemide with food<br> | Drug: No PA21; Furosemide with food<br>* The maximum dosage of Furosemide will be 40 mg/day<br>|
| Experimental: PA21 with food and Furosemide 2hrs later<br> | Drug: PA21 with food and Furosemide 2hrs later<br>* The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PA21 on Furosemide | To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2). | PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-drug interaction, Pharmacokinetics, PA21, Drug Interaction Potentiation
Airway Ultrasound Assessment in the Prediction of Difficult Airway

Study Overview
=================
Brief Summary
-----------------
To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway.

Official Title
-----------------
Review of Classical Predictors and Role of Airway Ultrasound in the Prediction of Difficult Airway

Conditions
-----------------
Airway Complication of Anesthesia, Anesthesia Intubation Complication

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients risk ASA I-IV Non-urgent surgery under general anesthesia with orotracheal intubation Acceptance to participate and grant written consent Exclusion Criteria: Urgent surgery Patients with a history of craniocervical pathology (trauma, tumor, malformations) Pregnancy Patient Refusal

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasound test|Ultrasound evaluation of airway|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pretracheal fat thickness for intubation complexity | The pretracheal fat at the level of the vocal cords will be evaluated with ultrasound, to discern if a certain thickness is related to a difficult laryngoscopic vision (understood as cormack 3 or 4) | 5 minutes |
Physical Activity in Chronic Obstructive Pulmonary Disease(COPD) Acute Exacerbation Patients

Study Overview
=================
Brief Summary
-----------------
Patients who are suffering from Chronic Obstructive Pulmonary Disease (COPD) had a decreased level of physical activity which is consequentially related to another acute exacerbation event. In this study, we selected patients from those who were admitted for acute exacerbation of COPD, evaluated physical activity by accelerometer (wearable multisensory armband devices) to find out the correlation between physical activity in COPD acute exacerbation patients.

Official Title
-----------------
The Association of Physical Activity With Readmission Due to Exacerbation in COPD Patients

Conditions
-----------------
COPD Exacerbation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patient who have forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) < 70% by spirometry and those who have not been admitted for acute exacerbation in recent 3 months Exclusion Criteria: Those who does not consent or those who have drug addiction, psycho-socially or medically not feasible to this study

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Re admission rate after COPD acute exacerbation |  | 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic obstructive pulmonary disease, Chronic obstructive pulmonary disease acute exacerbation, Physical activity, Wearable arm device
Reliable Hypertension Diagnosis Based on 24 ABPM

Study Overview
=================
Brief Summary
-----------------
24 h blood pressure monitoring can help to define which is the optimal timing and frequency of measurements

Detailed Description
-----------------
Hypertension is a common condition in modern society. As blood pressure fluctuates with time, a single blood pressure measurement is useless to diagnose hypertension. Nevertheless, a questionable not well-defined number of measurements still is often used for this purpose. Diagnosis and therapeutic control of hypertension are therefore suboptimal. This study's objective is to determine the number and timing of measurements needed to give a trustworthy approximation of an individual's average blood pressure. Therefore, 24 h ambulatory blood pressure measurements were retrospectively analyzed.

Official Title
-----------------
How to Reliably Diagnose Arterial Hypertension: Lessons From 24h Blood Pressure Monitoring.

Conditions
-----------------
Arterial Hypertension

Intervention / Treatment
-----------------
* Diagnostic Test: 24 h ambulatory blood pressure measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 70 per cent of valid measurements Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| persons with arterial hypertension<br>patients referred to consultation cardiology for hypertension. They get a 24 h blood pressure monitoring to define the exact mean arterial blood pressure | Diagnostic Test: 24 h ambulatory blood pressure measurements<br>* 24 h ambulatory blood pressure measurements : an ambulatory 24 h blood pressure device that automatically measures blood pressure every 15 minutes is given to the patient for 24 h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of measurement | 9:00-13:00 - 13:00-17:00 - 17:00 - 21:00: there intervals were analyzed to assess the predictive value of each interval compared with the overall daytime diagnosis of hypertension. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correct number of measurements | Within the intervals, the correct number of measurements needed to diagnose hypertension will be evaluated. | day 1 |
Effects of Regular Exercise on Adult Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of regular exercise on physical fitness, asthma control, and quality of life among adult asthmatics.

Official Title
-----------------
Effects of Regular Exercise on Physical Fitness, Asthma Control and Quality of Life of Adult Asthmatics

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

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of asthma made by physician, or reimbursement for asthma medication from the National Social Insurance Institution of Finland (code 203), or patient fulfills the diagnostic criteria for asthma as outlined in the Finnish Guidelines for Asthma Management (Käypä hoito -suositus 2006 and 2012) Exclusion Criteria: FEV1 < 60 % of predicted in spirometry PEF variability > 30 % at least 2 times during a 1-week monitoring period use of bronchodilating medication at least 4 times daily permanent, daily steroid tablet treatment patients who exercise regularly already at baseline at least 3 times a week at least 30 min at a time serious coronary heart disease severe hypotension severe heart failure severe musculoskeletal disorder dementia physician-diagnosed chronic obstructive lung disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Other: Exercise<br>* The exercise group is given a 24-week individualized training program, including aerobic exercise, muscular training, relaxation exercises and stretching. Patients are asked to observe their asthma control daily and to mark in their diary asthma symptoms and activity limitations as well as duration, intensity and form of exercising on daily basis. They are also asked to perform PEF-measurements twice a day for one-week period every 4 weeks. The control group receives ordinary instructions.<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control | Asthma control based on symptom score and PEF-values | 6-month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness | Physical fitness measured with spiroergometry | Baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Exercise, Asthma control, Physical fitness, Quality of life
Study on the Stoma Appliance Flexima®/Softima® 3S

Study Overview
=================
Brief Summary
-----------------
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up. The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.

Detailed Description
-----------------
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.

Official Title
-----------------
Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S

Conditions
-----------------
Ostomy

Intervention / Treatment
-----------------
* Device: 2 piece appliance for stomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years old Patient who has had a colostomy or an ileostomy or a jejunostomy or an urostomy for at least 1 month Patient agreeing to participate to the study and having signed the informed consent form/information letter in accordance with local requirements Patient for whom the use of Flexima®/Softima® 3S has already been decided within the regular planning of his treatment Exclusion Criteria: Patient with cognitive problems, according to the investigator, preventing him from answering a questionnaire or for whom the evaluation could be a problem Patient taking part in another clinical evaluation Patient having more than one stomy Patient vulnerable and under legal protection Patient having had an known allergy to one of the components of the appliance Patient previously using Flexima®/Softima® 3S

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

| Intervention/Treatment |
| --- |
|Device: 2 piece appliance for stomy|Use of the Flexima®/Softima® 3S during 6 months following the patient's usually frequency of appliance change|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up | The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S. For each item, the patient will evaluated the product thanks to a 4 points scale question (very good (4)/good(3)/ poor(2)/ very poor(1)) | the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction. |
Proactive Health Intervention for Tobacco Users (Get PHIT)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior.

Detailed Description
-----------------
The current study will test a community-based, tobacco intervention. The project will compare the effects of a proactive, personally-tailored, biologically-based motivational intervention to those of a proactive, generic motivational intervention for smoking cessation. The biologically-based motivational treatment will include feedback on participants' carbon monoxide (CO) exposure (expired CO and estimated carboxyhemoglobin levels), pulmonary functioning assessed via spirometry, and self-reported smoking-related symptoms. All participants will be given equal access to action-oriented treatment.

Official Title
-----------------
Proactive Cessation Intervention With Biomarker Feedback

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: motivational counseling
* Behavioral: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old, smoke greater than or equal to 15 cigarettes a day, have an expired CO level greater than or equal to 10 ppm, are not currently being treated for smoking cessation, can read and write in English, provide contact information, agree to the study requirements, have no medical contraindications for spirometry assessment, and no an obvious cognitive or physical impairment that would preclude their ability to comprehend or fully participate in the study. Exclusion Criteria: -

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intervention | Behavioral: motivational counseling<br>* behavioral motivational counselling<br>|
| Placebo Comparator: 2<br>Control | Behavioral: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation to quit smoking, utilization of available resources, smoking cessation rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of emotional distress, and mediators/moderators of primary outcomes |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, tobacco, behavior therapy
Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors. As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.

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

Intervention / Treatment
-----------------
* Device: Electronic cigarette


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects sporadic cigarette smoking (<9 cigarettes per month) Exclusion Criteria: Any form of cardiovascular disease Any form of pulmonary disease like asthma or COPD Any form of systemic or chronic disorder like rheumatologic or metabolic diseases. Active allergy within 4 weeks of the study Symptoms of infection or inflammation within 4 weeks of the study Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esmoke<br>Inhaling e-cigarette vapor | Device: Electronic cigarette<br>* Inhaling e-cigarette vapor<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of endothelial progenitor cells |  | 24 hours | 
| Change in number of micro vesicles |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exhaled nitric oxide |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial dysfunction, microvesicles, endothelial progenitor cells, electronic cigarettes
Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

Study Overview
=================
Brief Summary
-----------------
This study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine.

Detailed Description
-----------------
Antidepressant therapy has a delayed onset of action of 4-6 weeks. Pindolol has in some studies shown an accelerating effect. In this study we investigate the effect of 20 mg of pindolol retarded formulation in combination with Venlafaxine compared to placebo Pindolol and Venlafaxine for a duration of 19 days. Effect is measured by the Hamilton Depression rating Scale and the Preskorn Scale (self-rating).

Official Title
-----------------
A Short Term Double Blind Randomised Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: Pindolol and venlafaxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major depression Exclusion Criteria: Allergy towards pindolol, venlafaxine or other tablet constituents Liver or kidney impairment Diabetics Age below 18 years Severe cardiac disease Asthma.

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Venlafaxine and pindolol | Drug: Pindolol and venlafaxin<br>* pindolol 20 mg and venlafaxin 150 mg<br>|
| Placebo Comparator: B<br>Venlafaxin and placebo | Drug: Pindolol and venlafaxin<br>* pindolol 20 mg and venlafaxin 150 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale scores |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preskorn scores |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depression, Pindolol, Venlafaxine, Augmentation, Major depression (DSM-IVR)