linjc16/ctgov huggingface dataset:
The Assessment of Airway Resistance and Airtrapping in Elderly COPD Patients by Forced Oscillation Technique (FOT)

Study Overview
=================
Brief Summary
-----------------
The study hypothesize that parameters of new function machine---'forced oscillation technique' (FOT) can correlate well with the conventional lung function data for measurement of airway resistance and airtrapping in elderly COPD patients.

Detailed Description
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INTRODUCTION: Forced oscillation technique (FOT) may be a good supplementary tool to assess lung function in elderly since it is a simple and fast tool requiring minimal patients' cooperation. AIMS: To investigate the accuracy of forced oscillation test FOT in assessment of airway resistance and airtrapping in elderly COPD patients by comparing FOT parameters to various conventional lung function parameters including FEV1, FEF 25-75, RV/TLC ratio, IC etc. The best FOT parameter for airway resistance and airtrapping is also determined. STUDY DESIGN: A cross-sectional study conducted in Kwong Wah Hospital, Hong Kong, SAR METHODS: COPD patients were recruited from 1st Jan, 2010 to 31st Dec 2011. Both of the lung function tests (forced oscillation technique (FOT) and conventional lung function test) were performed. Parameters of FOT (FRes FDep, RAvr, XAvr, were compared with conventional lung function test for assessment of both airway resistance and airtrapping in COPD subjects. Adjusted FOT parameters (FResRatio and FDep) were also compared with %FEV1 and different GOLD stages. Statistics: Comparison between FOT parameters and spirometric parameters was done by correlation test and expressed as Spearman coefficient. ANOVA test is used to compare FOT parameters among different groups of GOLD stages (stage 1 to 4) and groups with various degree of airtrapping (stage 1 to 3). Post hoc analysis was estimated by Bonferroni test.

Official Title
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The Assessment of Airway Resistance and Airtrapping in Elderly COPD Patients by Forced Oscillation Technique (FOT)

Conditions
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COPD

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: COPD patients with previous lung function tests confirming irreversible obstructive pattern Exclusion Criteria: Lung function test failed to show any obstructive pattern Paitents with co-existing pulmonary diseases including asthma, interstitial lung diseases, lung malignancy etc. Patients with active infectious diseases like tuberculosis

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?
-----------------
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
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forced oscillation technique, COPD, elderly, airway resistance, airtrapping
L-Arginine, Vascular Response and Mechanisms

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to employ the supplement L-arginine to test the hypothesis that activation of blood flow to the brain during cognitive tasks is regulated by nitric oxide in older subjects with diabetes mellitus and/or hypertension (high blood pressure).

Official Title
-----------------
L-Arginine, Vascular Response and Mechanisms

Conditions
-----------------
Hypertension, Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: L-Arginine
* Dietary Supplement: Placebo Supplement


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: diabetes and/or hypertension Exclusion Criteria: alzheimers disease, dementia, stroke, active herpes, recent angina or heart attack

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-arginine<br> | Dietary Supplement: L-Arginine<br>* Dietary Supplement<br>|
| Placebo Comparator: Placebo Supplement<br> | Dietary Supplement: Placebo Supplement<br>* Dietary Supplement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional transcranial doppler measures |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated Dilation (FMD) |  | 6 weeks | 
| Finger Blood Flow - Plethysmography (PAT) |  | 6 weeks |
OTX-14-002: Device Exposure Registry

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions

Official Title
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Device Exposure Registry: A Post-Approval Observational Registry of ReSure Sealant to Track the Incidence of Endophthalmitis After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery

Conditions
-----------------
Endophthalmitis

Intervention / Treatment
-----------------
* Device: ReSure Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
All patients that receive at least one application of the ReSure Sealant on the operative eye following cataract surgery will be enrolled.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ReSure Sealant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of endophthalmitis |  | Day 30 |
Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

Study Overview
=================
Brief Summary
-----------------
This clinical trial compares two psychological treatments for back pain.

Detailed Description
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The primary objective is to examine the incremental efficacy of a patient-centered and tailored self-management treatment approach, Tailored Cognitive-Behavior Therapy (TCBT), for persons with chronic musculoskeletal pain. TCBT will be compared with a Standard Cognitive- Behavior Therapy (SCBT) condition. The hypothesis is that TCBT will be associated with improved outcomes following treatment. Outcome will be assessed by multiple standardized measures of key domains of the chronic pain experience. Secondary objectives are to examine the process of successful self-management treatment.

Official Title
-----------------
Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

Conditions
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Back Pain

Intervention / Treatment
-----------------
* Behavioral: tailored cognitive behavior therapy
* Behavioral: standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic back pain for at least 6 months Treatment by medication or physical therapy Exclusion Criteria: Acute or life threatening physical illness Current alcohol or substance abuse or dependence Current psychosis or suicidal ideation treatment by anesthesiology, chiropractic care or surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Standard and Tailored Conditions | Behavioral: tailored cognitive behavior therapy<br>* tailored psychological treatment<br>Behavioral: standard care<br>* standard psychological treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple standardized measures of key domains of the chronic pain experience |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic back pain, cognitive-behavioral, pain, stages of change
Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the practical usability of EGFR mutation detection in ctDNA from early NSCLC.

Official Title
-----------------
Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC

Conditions
-----------------
Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer Patients with resectable lung cancer One of followings: 1) Never-smokers or ex-smokers who quit 10 years ago, 2) Female 3) Subsolid nodule in chest CT 4) Biopsy-proven adenocarcinoma Exclusion Criteria: Patients with metastatic lung cancer (Stage IIIB-IV) Patients who underwent chemotherapy or radiotherapy Patients with other malignancies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the EGFR assay | ADPS EGFR Mutation Test using plasma sample from clinical stage IB-IIIA NSCLC patients (reference: EGFR assay in tissue specimen) | Immediately before the surgery |
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

Study Overview
=================
Brief Summary
-----------------
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Detailed Description
-----------------
The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers. Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.

Official Title
-----------------
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

Conditions
-----------------
Peptic Ulcer

Intervention / Treatment
-----------------
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aspirin users who have a peptic ulcer confirmed by endoscopy Exclusion Criteria: serious medical illness (including cardiovascular events within 6 months before endoscopy) acute gastrointestinal bleeding a history of gastric or duodenal surgery allergic to the study drugs require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents pregnancy

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 |
| --- | --- |
| No Intervention: esomeprazole<br>esomeprazole (40 mg/day) for 8 weeks | |
| Active Comparator: esomeprazole plus aspirin<br>esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks | Drug: aspirin<br>* aspirin, 100 mg, qd x 8 weeks<br>* Other names: aspirin protect;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Whom Peptic Ulcer Was Healed | Number of participants in whom peptic ulcer was healed at week 8 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Deveoping Peptic Ulcer Bleeding | Number of participants deveoping peptic ulcer bleeding during 8-week study period | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirin, peptic ulcer
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.

Official Title
-----------------
A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State

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

Intervention / Treatment
-----------------
* Drug: Naproxen
* Drug: PL 3100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years, inclusive. Subject has a Body Mass Index (BMI) between 20 and 32, inclusive. Normal physical examination as determined by the Investigator. Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit. If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing. If female and of child-bearing potential, the subject must agree to use adequate birth control for the duration of the study. Exclusion Criteria: Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol. Subject has had an acute illness within 5 days of study medication administration. Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study. Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PL 3100<br>Active experimental drug | Drug: PL 3100<br>* Single orally administered dose of PL 3100 (500 mg naproxen)<br>* Other names: Naproxen-PC;|
| Active Comparator: Naproxen<br>Active comparator | Drug: Naproxen<br>* Single orally administered dose of 500 mg naproxen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve of Plasma Naproxen From 0 to t | Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration. | 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration. |
Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year. Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: -aminosalicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology Crohn's Disease Activity Index (CDAI) must be between 150 and 450 No ulcerative or infectious colitis or severe perianal disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs Radiotherapy: Not specified Surgery: No impending surgery No prior ileostomy or colostomy Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin --Patient Characteristics-- Age: 18 to 80 Performance status: Ambulatory Hematopoietic: Not specified Hepatic: No hepatic disease Renal: No renal disease Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: -aminosalicylic acid|nan|

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
-----------------
Crohn's disease, gastrointestinal disorders, rare disease
Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences

Study Overview
=================
Brief Summary
-----------------
In this study the investigators will use semi-structured interviews to qualitatively analyse patient and family member experiences with either deep brain stimulation or other forms of psychiatric neurosurgery.

Official Title
-----------------
Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences

Conditions
-----------------
Obsessive-Compulsive Disorder

Intervention / Treatment
-----------------
* Device: deep brain stimulation
* Procedure: anterior capsulotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (family member of) patient who has previously been treated with deep brain stimulation or anterior capsulotomy Exclusion Criteria: none
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 |
| --- | --- |
| Deep Brain Stimulation Patients<br>Patients who have previously been treated with a deep brain stimulation procedure for obsessive compulsive disorder will be included in this group | Device: deep brain stimulation<br>* Electrical stimulation of the anterior limb of the internal capsule or bed nucleus of the stria terminalis<br>|
| Deep Brain Stimulation Family Members<br>Family members of patients who have previously been treated with a deep brain stimulation procedure for obsessive compulsive disorder will be included in this group | |
| Anterior Capsulotomy Patients<br>Patients who have previously been treated with an anterior capsulotomy procedure for obsessive compulsive disorder will be included in this group | Procedure: anterior capsulotomy<br> <br> |
| Anterior Capsulotomy Family Members<br>Family members of patients who have previously been treated with an anterior capsulotomy procedure for obsessive compulsive disorder will be included in this group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-structured Interview | A semi-structured interview of patients and one of their family members will be conducted. Patients and family members will be interviewed separately. The interview will consist of several open ended questions around several themes. The interviews for patients and family members will have their own focus. Patient interviews will focus on living with OCD, living with PNS and the decision making process leading to the PNS procedure. Family member interviews will focus on their own experience in their interaction with OCD patients both before and after PNS | up to 180 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Brain Stimulation, Anterior Capsulotomy