linjc16/ctgov huggingface dataset:
Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
Asynchrony during mechanical ventilation has been poorly described in patients suffering from acute respiratory distress syndrome. The purpose of this study is to describe the frequency of asynchronies (ineffective efforts and double triggering) in these group and evaluate potential risk factors and prognosis implications.

Detailed Description
-----------------
Major patient-ventilator asynchronies have been described during assisted mechanical ventilation in different settings. Few studies have evaluated double cycling in ARDS patient. No clear predictors of this finding beside low tidal volume have been found, and clinical outcome implications have not been addressed. This study has 3 main objectives: evaluate the frequency of double cycling and ineffective efforts, seek for potential predictors and clinical outcomes related to asynchronies. Subjects with less than 72 hours of mechanical ventilation due to ARDS will be recruited. Thirty minutes of mechanical ventilation will be recorded and automatically analyzed with a custom-made program to detect asynchronies. A blood sample will be drawn to measure inflammatory and lung tissue damage biomarkers. Clinical and outcome data will be recorded.

Official Title
-----------------
Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Conditions
-----------------
Respiratory Distress Syndrome, Adult, Ventilator-Induced Lung Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Respiratory Distress Syndrome according to Berlin definition Intubation and mechanical ventilation within 72 hours of inclusion Exclusion Criteria: Known severe neuromuscular disease Continuous neuromuscular blocking agents infusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Asynchrony rate | Asynchronies per minutes of mechanical ventilation | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of mechanical ventilation |  | From the date of intubation to the date of complete weaning from mechanical ventilation or death which ever comes first, up to 90 days | 
| ICU mortality |  | From the date of admission to the date of discharge from the ICU, up to 90 days | 
| Hospital mortality |  | From the date of admission to the date of discharge from the ICU, up to 90 days |
A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.

Official Title
-----------------
A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: UFT (uracil, tegafur)
* Drug: cyclophosphamide, methotrexate, and fluorouracil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 75 Performance status 0 or 1 (ECOG) Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN Renal Creatinine ≤ ULN Exclusion Criteria: Prior anticancer treatment

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

Sexes Eligible for Study
-----------------
Female

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>UFT (uracil, tegafur) | Drug: UFT (uracil, tegafur)<br>* uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years<br>|
| Active Comparator: 2<br>CMF(cyclophosphamide, methotrexate, and fluorouracil) | Drug: cyclophosphamide, methotrexate, and fluorouracil<br>* cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival |  | every course for first three courses, then every other course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, adverse events, and the quality of life |  | any time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients

Official Title
-----------------
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore

Conditions
-----------------
Pressure Ulcer

Intervention / Treatment
-----------------
* Other: sericin and chitosan cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years old 2-digit Stirling Pressure Sore Severity Scale less than or equal to 2.4 No chitosan, sericin, and dimethicone allergy Without skin diseases Without Autoimmune diseases Willingness to participate Exclusion Criteria: Have uncontrolled diseases Have complication or adverse effects during the time of participation Cannot follow protocol Pregnancy or lactation Participate in other study

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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sericin and chitosan cream<br>Apply sericin and chitosan cream on pressure ulcer 2 times/day for 21 days. | Other: sericin and chitosan cream<br>* sericin and chitosan cream<br>|
| Active Comparator: Cavilon cream<br>Apply cavilon cream on pressure ulcer 2 times/day for 21 days. | Other: sericin and chitosan cream<br>* sericin and chitosan cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure ulcer scale for healing | Score 0 to 17, higher scores mean a worse outcome | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema index | Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. | 21 days | 
| Melanin index | Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. | 21 days | 
| Transepidermal water loss | Transepidermal water loss index of skin will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy skin. | 21 days | 
| Moisture index | Moisture index of skin will be measured using Cutometer (Corneometer). There is no unit. Higher value mean lower risk of unhealthy skin. | 21 days | 
| Adverse events | Adverse events will be observed. They will be recorded as present or not present | 21 days |
Autonomic Testing in Subclinical Carotid Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with alterations in the sensitivity of carotid and subclavian baroreceptors. Aim: The aim of this study is to investigate if carotid IMT is associated with changes in the autonomic modulation of the heart rate variability (HRV). Methods: This is a prospective cross-sectional study. The carotid IMT is determined by B-mode and duplex ultrasonography. The cardiovagal function was determined through linear and nonlinear measures of HRV. Linear regression models, adjusted for demographics, comorbidities, body mass index, waist-hip-ratio, and left ventricular ejection fraction will be used to evaluate the association between HRV parameters and carotid IMT.

Official Title
-----------------
Early Detection of Subclinical Carotid Atherosclerosis Through Autonomic Testing

Conditions
-----------------
Subclinical Carotid Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic patients aged 18 years and older without a history of transient ischemic attack, stroke, or other neurologic signs or symptoms are selected to participate in the study. Exclusion Criteria: Patients with symptomatic carotid artery stenosis were excluded if the patient had transient or permanent focal neurologic symptoms related to the ipsilateral retina or the cerebral hemisphere. Patients with heart rhythm disorders, pacemaker, heart failure, ejection fraction less than 0.45, chronic renal failure on hemodialysis, severe liver failure, myocardial infarction, endarterectomy, carotid angioplasty, carotid dissection and carotid occlusion were excluded. Patients receiving drugs known to interfere with autonomic function, such as beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, vasodilators, statins, neuroleptics and nasal vasoconstrictors, were discontinued for 24 hours before the tests.

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 |
| --- | --- | --- |
| carotid intima-media thickness (IMT) | carotid IMT is determined by B-mode and duplex ultrasonography | 1 day | 
| cardiovagal function | the cardiovagal function is determined through linear and nonlinear measures of HRV | 1 day |
Patient and Physician Knowledge of Key Safety Messages

Study Overview
=================
Brief Summary
-----------------
This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.

Official Title
-----------------
Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages

Conditions
-----------------
Anticoagulation

Intervention / Treatment
-----------------
* Behavioral: Rivaroxaban (Xarelto, BAY59-7939)
* Behavioral: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
- Inclusion criteria: Physician eligibility: Prescription of rivaroxaban in the past 6 months for adult patients for the Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (SPAF) or Treatment of deep venous thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT. Patient eligibility: Use of rivaroxaban for SPAF or DVT within the previous 3 months; aged 18 years and above; able to understand and complete the consent form and patient questionnaire.

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 |
| --- | --- |
| Group 1<br>Survey to measure physician awareness and understanding of the key messages in the prescriber guide. | Behavioral: Rivaroxaban (Xarelto, BAY59-7939)<br>* Survey to measure physician awareness and understanding of the key messages in the prescriber guide.<br>|
| Group 2<br>Survey to measure patient awareness and understanding of the key messages in the patient card. | Behavioral: Rivaroxaban (Xarelto, BAY59-7939)<br>* Survey to measure patient awareness and understanding of the key messages in the patient card.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire |  | Up to 18 months | 
| Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire |  | Up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survey, Effectiveness of risk minimization measures, Rivaroxaban, Anticoagulants
Internet-Based Depression Screening for College Students

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether using telecommunication tools, specifically web pages containing online screening instruments and real-time video chat, will be an efficient way to implement Major Depressive Disorder screening among college students. The study also aims to determine if proactive depression screening and free online consultation with a psychiatrist will increase the rate of help-seeking among college students with MDD. Eligible participants will complete a demographics survey and depression screening assessment online. Those subjects who express suicidality or depressive symptoms will be offered the opportunity to complete a one-time psychiatric consultation with Skype video-conferencing.

Official Title
-----------------
Internet-Based Depression Screening for College Students

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Other: Skype Consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All who consider themselves current undergraduate from Massachusetts colleges are encouraged to participate.

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Skype Consultation|One-hour Skype consultation with MA-licensed psychiatrist and a written summary of findings.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9-item Patient Health Questionnaire | Subjects are given the PHQ-9 at baseline, and a 8-week follow-up survey that includes PHQ-9 and questions inquiring whether subject has begun treatment for MDD and whether they faced obstacles in seeking treatment. | Baseline, Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telepsychiatry, MDD, Depression, Major Depressive Disorder, Skype, college, university
Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

Detailed Description
-----------------
OBJECTIVES: To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501. To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen. OUTLINE: This is a multicenter study. DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Official Title
-----------------
BRAF, KRAS and EGFR Mutation Detection in Non-Small Cell Lung Cancer Patients Treated With Sorafenib Monotherapy

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Genetic: DNA analysis
* Genetic: mutation analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of refractory non-small cell lung cancer Received sorafenib tosylate on protocol ECOG-E2501 Available blood specimens PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA analysis|nan|
|Genetic: mutation analysis|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR |  | 1 mont | 
| Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.

Official Title
-----------------
A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: IDP-115
* Drug: Vehicle
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of facial rosacea Presence of inflammatory lesions Exclusion Criteria: Dermatological conditions of the face that could interfere with clinical evaluations Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption) Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: IDP-115<br>* Topical application for 12 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Vehicle<br>* Topical application for 12 weeks<br>|
| Placebo Comparator: 3<br> | Drug: Vehicle<br>* Topical application for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of inflammatory lesions |  | 12 weeks | 
| Improvement from baseline in global severity |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in erythema |  | 12 weeks |
Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly

Study Overview
=================
Brief Summary
-----------------
Postoperative delirium has been found to be associated with increased risk of future neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has been found to be associated with an increased risk of postoperative complication including delirium in the elderly.The purpose of this study is determine the factors affecting the incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the Singapore population.

Official Title
-----------------
Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly Undergoing Non-cardiac Surgery: An Observational Study

Conditions
-----------------
Postoperative Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly (> 65 years) frail patients undergoing non cardiac surgery under anaesthesia lasting for >60 minutes Patient willing and able to complete the requirements of this study. Exclusion Criteria: disabling neuropsychiatric or neurological disorders(including severe dementia, Alzheimer's disease, schizophrenia, severe depression) patients suffering from delirium at selection; patients who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial;

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Postoperative Delirium<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative delirium | Confusion assessment method (CAM) will be used to asses delirium | upto 3 postoperative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative Delirium