linjc16/ctgov huggingface dataset:
Semirecumbent Position by Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
It's based in an observational trial in mechanical ventilated patients. The investigators assess the head of bed elevation angle in the routine treatment of the unit. The investigators decide to assess the time the patient has a semirecumbent position >35°.

Detailed Description
-----------------
A Semirecumbent-bed position in mechanical ventilated patients is recommended in every international guidelines in order to avoiding Ventilator Associated Pneumonia (VAP). Despite being a simple and cheap measure, the literature describe a low compliance. Globally, every intensive care unit tends to use different maneuvers that help or improve compliance of this recommendation. However, there are multiple factors in daily work that hinder compliance. Before taking actions, it would be convenient to know the current state of the unit. Investigators aim to evaluate the quality with which the recommendation is carried out in the unit in order to maintain a semirecumbent position. To conduct the Trial it will be used a device that measures continuously (every 5 minutes) the angle of the bed without giving any information to caregivers. Once patients are extubated the data will be collected.

Official Title
-----------------
Compliance of Recommended Semirecumbent Position in Ventilated Patients

Conditions
-----------------
Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Compliance, Treatment

Intervention / Treatment
-----------------
* Device: simple blind observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every ventilated patients Exclusion Criteria: Patients excluded are those lower that 18 years old or neurocritical patients that require flat position.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: simple blind observation|Device that measures continuously the angle of bed by mechanical Ventilation to assess the time the bed is above 35°.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of semirecumbent position in mechanical ventilated patients | Assess how long are mechanical ventilated patient with a head of bed elevation above 35°. | November 2019 to April 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic and disease characteristics of involved patients. |  | November 2019 to April 2020 |
Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

Study Overview
=================
Brief Summary
-----------------
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.

Official Title
-----------------
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan 80mg
* Drug: Chlorthalidone 25mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects Age(yr)between 20 and 50 Signed written informed consent Exclusion Criteria: Known hypersensitivity to investigator product, thiazide, sulphonamide and other drugs or additive. History of any siginificant Sickness, Cardiovascular, Respiratory, Renal, Endocrine, Neurological, Psychic, Cancer, Gasstrointestinal, Hematologic. History of drug and/or alcohol abuse Over 10 tobaccos a day Other condition which in the opinion of the investigator preclude enrollment into the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part A: Telmisartan, Chlorthalidone + Telmisartan<br>telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally | Drug: Telmisartan 80mg<br> <br> Drug: Chlorthalidone 25mg<br> <br> |
| Active Comparator: Part B: Chlorthalidone, Chlorthalidone + Telmisartan<br>telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally | Drug: Telmisartan 80mg<br> <br> Drug: Chlorthalidone 25mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A : AUC, Cmax of Telmisartan |  | Over a 24-hour sampling period | 
| Part B : AUC, Cmax of Chlorthalidone |  | Over a 24-hour sampling period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A : Cmin, tmax, CL/F of Telmisartan |  | Over a 24-hour sampling period | 
| Part B : Cmin, tmax, CL/F of Chlorthalidone |  | Over a 24-hour sampling period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Safety, Male
Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis

Study Overview
=================
Brief Summary
-----------------
Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

Detailed Description
-----------------
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

Official Title
-----------------
A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects With Chronic Antibiotic-resistant Pouchitis

Conditions
-----------------
Pouchitis

Intervention / Treatment
-----------------
* Drug: AMT-101 (oral)-Dose A
* Drug: AMT-101 (oral)-Dose B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Chronic or recurrent pouchitis Exclusion Criteria: Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease. History or current evidence of colonic or abdominal abnormalities. Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AMT-101 (Dose A)<br>Dose A: AMT-101 Tablet | Drug: AMT-101 (oral)-Dose A<br>* AMT-101 is an orally administered biologic therapeutic, taken once daily.<br>|
| Active Comparator: AMT-101 (Dose B)<br>Dose B: AMT-101 Tablet | Drug: AMT-101 (oral)-Dose B<br>* AMT-101 is an orally administered biologic therapeutic, taken once daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Frequency Response |  | 12 weeks | 
| Histologic Healing | based upon the Geboes scoring system and PDAI | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic Response | based upon the Geboes scoring system and PDAI | 12 weeks | 
| Change in Endoscopic Score |  | 12 weeks | 
| Change in Stool Frequency |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory Bowel Disease
Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison

Study Overview
=================
Brief Summary
-----------------
This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.

Official Title
-----------------
A Double-blind, Double-dummy, Randomized, Crossover Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) During Initial Dose Escalation in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate
* Drug: Quetiapine Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Weight of at least 50 kg Exclusion Criteria: A history or presence of neurological, hematological, psychiatric, gastrointestinal, hepatic, pulmonary, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs Positive test results for alcohol or drugs of abuse Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Quetiapine Fumarate Immediate Release | Drug: Quetiapine Fumarate<br>* Tablet, Oral, once daily<br>* Other names: Seroquel IR;|
| Experimental: 2<br>Quetiapine Fumarate Extended Release | Drug: Quetiapine Fumarate<br>* Tablet, Oral, once daily<br>* Other names: Seroquel XR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) 1 hour post dose at Day 1 |  | 1 hour after dose administration at the first dosing day (i.e. Day 1) of each period | 
| Area under the VAS-time curve |  | Calculated daily from the 13 assessments for 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic relationship between maximum VAS and PK concentration |  | On last day of period (Day 5) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Non-Interventional Study In Patients With Peripheral Or Central Neuropathic Pain Treated With Lyrica

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain more data about efficacy and safety of the study drug Lyrica.

Official Title
-----------------
Non-Interventional Study In Patients With Peripheral Or Central Neuropathic Pain Undergoing Symptomatic Treatment With Lyrica

Conditions
-----------------
Neuralgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of peripheral or central neuropathic pain Exclusion Criteria: None. Patients recruited by physician decision. Patient's personal data are not collected.

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 |
| --- | --- | --- |
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers

Study Overview
=================
Brief Summary
-----------------
Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival. The current trial addresses the issue if progression free survival (PFS) in patients treated with radiotherapy can be predicted by a multi-variate model derived from a composite of bio-imaging and biomarkers

Official Title
-----------------
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers

Conditions
-----------------
Inoperable Early Stage Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: hypofractionated radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proof of cT1a/b - 2a/b N0M0 NSCLC Informed Consent signed Resectable tumour > 18 years old men and women

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: Radiation therapy<br> | Radiation: hypofractionated radiation therapy<br>* hypofractionated radiation therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development and validation of a multi-variate predictive model | To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years. | from 2 to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the clinical response and complication rate |  | from 2 to 5 years | 
| local, regional or distant failure |  | from 2 to 5 years | 
| progression free survival |  | from 2 to 5 years | 
| disease specific overall survival |  | from 2 to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inoperable early stage non-small cell lung cancer, radiation therapy
Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels < 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.

Detailed Description
-----------------
Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.

Official Title
-----------------
A Phase 3 Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Videx EC
* Drug: Epivir
* Drug: Sustiva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented HIV infection ≥ 18 years of age and weight at least 40kg Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period Patients receiving a PI and ≥ 2 NRTIs Exclusion Criteria: Pregnancy or breastfeeding Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen Active AIDS-defining opportunistic infection or disease Proven or suspected acute hepatitis within 30 days prior to study entry

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

| Intervention/Treatment |
| --- |
|Drug: Videx EC|nan|
|Drug: Epivir|nan|
|Drug: Sustiva|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy at week 48 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV/AIDS
Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One possible explanation is that the patient is unable to inhale the dry powder bronchodilator medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A PIFR < 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device. The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured at two hours after inhalation of the study medication will be higher with arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from the Diskus.

Official Title
-----------------
Efficacy of Inhaling Bronchodilator Medications in Patients With Chronic Obstructive Pulmonary Disease Who Have a Low Peak Inspiratory Flow Rate

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: arformoterol
* Drug: salmeterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patient 60 years of age or older; diagnosis of COPD; current or former smoker; previous or current use of Diskus device; PIFR < 60 l/min using the In-check DIAL against the resistance of the Diskus device; clinically stable. Exclusion Criteria: any patient who has a concomitant disease that might interfere with study procedures or evaluation; inability to withhold short-acting and long-acting bronchodilators on the days of testing

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arformoterol<br>beta-2 agonist bronchodilator | Drug: arformoterol<br>* 15 mcg administered via nebulizer<br>* Other names: Brovana;|
| Active Comparator: salmeterol<br>beta-2 agonist bronchodilator | Drug: salmeterol<br>* 50 mcg delivered vis Diskus<br>* Other names: Serevent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication | FEV1 | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breathing difficulty
Nutritional Status of Patients Before and After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
This study aimed at evaluating the nutritional status of vitB1, B2, B12, folate, A, D, E, Ca, Fe, Zn, Cu, and Se prior- and post- (6-Mo) the sleeve gastrectomy operation.

Detailed Description
-----------------
Bariatric surgery (BS) is the most effective treatment for severe obesity and comorbidities. Among varieties of BS techniques, sleeve gastrectomy (SG) has gained in popularity worldwide. SG is a procedure involved mainly restriction combined slightly with malabsorption (deficiency in intrinsic factors for vitamin B12 absorption). Considering most patients usually have more than one micronutrients deficiency prior the surgery, the aggravated nutritional status is one of post-surgical concerns. For nutrition management, individualized biochemical assessment for micronutrients is highly recommended in guideline, but is seldom been implanted. Instead, a routine supplementation for vitamins/minerals for postoperative patients is practiced in Taiwan. This study aimed at evaluating the nutritional status of vitB1, B2, B12, folate, A, D, E, Ca, Fe, Zn, Cu, and Se prior- and post- (6-Mo) the SG operation. Subjects (n=70-100) will be recruited from patients of Body Science & Metabolic Disorders, International BMI Medical Center of CMUH. The inclusion criteria are Han Chinese, 18-65 years old, and BMI>30 who have arranged for SG operation. Written informed consent will be obtained from participants. Anthropometric data, blood samples, food (including supplements) records and medical history will be collected during the study period. We foresee this study may, not only achieve a personalized dietary plan, but also contribute to indigenous data regarding micronutrient status of obese patients.

Official Title
-----------------
Biochemical Evaluations of Nutritional Status of Patients Before and After Bariatric and Metabolic Surgery

Conditions
-----------------
Nutritional Status

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Han Chinese and Taiwanese BMI more than or equal to 27.5 Surgery type is sleeve gastrectomy Exclusion Criteria: Kidney dysfunction Mental illness Severe eating disorders Alcohol or drug abuse Stomach ulcers Redo bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bariatric surgery|sleeve gastrectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Nutritional status | Blood sample will be collected and used to determine nutritional status which will measured by laboratory biochemical test. | pre-surgery and 6 months after surgery |