linjc16/ctgov huggingface dataset:
COPD Assessment Test Can Predict Depression

Study Overview
=================
Brief Summary
-----------------
The frequency of depression in COPD patients are substantial and early detection and prevention of depression is critical. Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD on patients' quality of life. In this prospective study, we will investigate the predictive utility of CAT for predicting depression in COPD patients.

Detailed Description
-----------------
This study is aimed to investigate the association between the COPD Assessment Test (CAT) and depression in stable COPD patients. Stable COPD patients will be enrolled from the tertiary hospitals. All patients will undergo lung function tests. The Korean versions of the CAT (COPD assessment test) and Patient Health Questionnaire-9 (PHQ-9) will be used to assess COPD symptoms and depressive disorder, respectively. We will compare the depresssion frequency among GOLD classifications of airway limitation and among the four CAT groups. And. we will also investigate which items of the CAT are the strongest indicators of depression.

Official Title
-----------------
COPD Assessment Test Can Predict Depression

Conditions
-----------------
Depression,, COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients who aged > or = 40 years Exclusion Criteria: acute exacerbation within 3 months bronchial asthma or an increase in FEV1 of more than 12% of the predicted value with the use of 400 µg of albuterol. other lung diseases such as bronchiectasis, interstitial lung disease, and tuberculosis-destroyed lungs. who denied to consent.

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 |
| --- | --- | --- |
| The predictive utility of the COPD assessment test (CAT) scores for predicting depression in COPD patients | The association of CAT with depression score | 1 year |
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondylitis. The investigators expect that the tripterygium capsule is more effective than placebo and has few adverse effects.

Official Title
-----------------
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical Trial

Conditions
-----------------
Early Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Tripterygium
* Drug: Sulfasalazine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis. Disease is in active status defined by BASDAI>=40mm. DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening. Exclusion Criteria: Intra-articular injection of glucocorticoid within 3 months. Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors. Accompanied by fibromyalgia syndrome or other rheumatic diseases. Female of pregnancy or breast-feeding. Poor compliance or with mental diseases.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tripterygium|Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.|
|Drug: Sulfasalazine|Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.|
|Drug: placebo|Placebo: 2 capsules per time, 3 times per day for 12 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASAS20 |  | 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BASDAI20/50/70 |  | 12th week |
Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period

Official Title
-----------------
Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Bulkamid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Symptomatic stress or mixed urinary incontinence for at least 12 months Having at least 1 incontinence episode per day over three days Exclusion Criteria: Regular or intermittent users of an urethral catheter Pregnant women Suffer from severe allergies or anaphylaxis Suffer from autoimmune diseases or any unstable or sever cardio-vascular disease History of any cancer within the last 5 years Previous surgery for the treatment of urinary incontinence, including bulking

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bulkamid<br>Submucosal injection of Bulkamid into urethra | Device: Bulkamid<br>* initial injection with option for second (if required)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective responder rate after 12 months follow-up |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICIQ |  | Baseline, treatment, 1-, 6-, 12- and 24-months | 
| 24 hour urine leakage |  | Baseline, treatment, 1-, 6-, 12- and 24-months | 
| daily incidence of incontinence episodes |  | Baseline, treatment, 1-, 6-, 12- and 24-months | 
| Qol |  | Baseline, treatment, 1-, 6-, 12- and 24-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary incontinence, Bulkamid
Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle.

Official Title
-----------------
Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of Scandinavian Total Ankle Replacement (STAR) Ankle Among Continued Access Study Patients

Conditions
-----------------
Primary Arthrosis

Intervention / Treatment
-----------------
* Device: Scandinavian Total Ankle Replacement System (STAR Ankle)


Participation Criteria
=================
Eligibility Criteria
-----------------
The study population consists of all living subjects who participated in the continued access arm of the IDE clinical trial. Inclusion Criteria: Only patients that participated in the continued access study make up the patient cohort for this long-term follow-up study. Willing and able to give informed consent. Exclusion Criteria: Subjects who were withdrawn or withdrew consent to participate in the investigation Subjects who do not consent to participate in long-term or provide personal contact information to the sponsor(solely for the purposes of tracking subjects to help ensure follow-up compliance)

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 |
| --- | --- |
| Device<br>Scandinavian Total Ankle Replacement System (STAR Ankle) | Device: Scandinavian Total Ankle Replacement System (STAR Ankle)<br>* Total Ankle Replacement<br>* Other names: STAR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective for this study is to examine the long-term survivorship of the STAR Ankle | Obtain information on the revision and removal rate for the STAR Ankle over time. | 8 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopaedic Foot and Ankle Society questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery. |  | 8 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Traumatic Arthritis, Rheumatoid Arthritis, Osteoarthritis
Clinical Evaluation of Patient Preoperative Prep

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.

Official Title
-----------------
Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation

Conditions
-----------------
Surgical Skin Preparation

Intervention / Treatment
-----------------
* Drug: ZuraPrep
* Drug: ChloraPrep
* Drug: ZP Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of any race. Subjects in good health. Minimum skin flora baseline requirements on abdomen and groin. Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area. Exclusion Criteria: Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics. Subjects with a history of skin sensitivity, skin allergies, or skin cancer. Subjects who are pregnant, attempting pregnancy, or nursing.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZP (70% IPA)<br>Isopropyl alcohol (IPA) 70% | Drug: ZuraPrep<br>* Apply topically.<br>* Other names: ZP;|
| Active Comparator: ChloraPrep<br>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% | Drug: ChloraPrep<br>* Apply topically.<br>* Other names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%;|
| Placebo Comparator: ZP Vehicle<br>ZP without IPA | Drug: ZP Vehicle<br>* Apply topically.<br>* Other names: ZP without IPA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Reduction | A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success. | 10 minutes post product application | 
| Bacterial Reduction - Abdomen | A 2-log per cm2 bacterial reduction on the abdomen region is considered a success. | 10 minutes post product application |
Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting

Study Overview
=================
Brief Summary
-----------------
To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.

Official Title
-----------------
Effect of Glycemic Index of a Preparation on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy: Controlled Clinical Trial

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Low glycemic index
* Other: High glycemic index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes mellitus diagnosis. Minimum period of six months under intensive insulin therapy. Fast insulin prescription before breakfast. 35 and 70 years of age. BMI between 25 and 39.9 Kg/m2. HbA1c less than or equal to 10 % (86mmol/mol) Menopausal women under hormone replacement therapy Exclusion Criteria: Pregnant women. Puerperal women. Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus. Subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.

Ages Eligible for Study
-----------------
Minimum Age: 47 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low glycemic index breakfast<br>Low glycemic index breakfast (GI=45) | Other: Low glycemic index<br>* Subjects intake a low glycemic index breakfast<br>|
| Active Comparator: High glycemic index breakfast<br>High glycemic index breakfast (GI=80) | Other: High glycemic index<br>* Subjects intake a high glycemic index breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemia | Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake | -15 up to 120 minutes | 
| Satiety | Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast). | Up to 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycemia, Satiety, Insulin, Breakfast, Low glycemic index, High glycemic index
Risk of Asthma in Infants With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this study is to determine whether we can identify infants who will develop asthma.

Detailed Description
-----------------
Asthma is a disease characterized by recurrent episodes of wheezing, inflammation of the airways, and airways that are very sensitive to stimulation (hyper-responsiveness). Symptoms of asthma frequently begin in early childhood; however, it has been difficult to identify pre-symptomatic, at-risk infants and toddlers. Family history of asthma and allergy is strongly associated with the early onset and persistence of asthma symptoms, and children with early onset persistent asthma are more likely to demonstrate allergies. The development of allergic disease results from complex interactions between genetic susceptibility and environmental factors; however, infants with atopic dermatitis have a 50% chance of developing asthma by 6 years of age. Airway inflammation and airway hyper-responsiveness are characteristics of asthmatic children. We plan to evaluate whether infants with allergic dermatitis have evidence of airway inflammation and hyper-responsiveness, and whether cells from the blood and the nose are also hyper-responsive to stimulation prior to the onset of clinical symptoms of asthma. In addition we will evaluate whether certain genetic profiles are associated with allergic disease in infants.

Official Title
-----------------
Risk of Asthma in Infants With Atopic Dermatitis

Conditions
-----------------
Asthma, Eczema, Dermatitis, Atopic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria- Full term infants born greater than 37 weeks History of atopic dermatitis or eczema Exclusion criteria Heart disease asthma Respiratory illness such as RSV, bronchiolitis or croup Hospitalization for respiratory illness History of wheezing

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 7 Years

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

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

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
-----------------
Asthma, Eczema, Dermatitis, Atopic, Infant
Squatting on the Toilet and Capsule Endoscopy

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of squatting on the toilet on gastric transit time and complete examination rate of capsule endoscopy.In the observation group, the patients could go to squatting on the toilet at any time as they want to after taking the capsule.

Detailed Description
-----------------
The subjects were divided into a control group and an observation group according to whether the patient squatted in the toilet, In the control group, the patients took discontinuous right lateral position, walked on a flat road and climbed the stairs alternately. In the observation group, in addition to the above ways, the patients could go to squatting on the toilet at any time in the first hour after taking the capsule. The operator observed the position of capsule every one hour. The examination was over when capsule endoscopy entered the colon. If the capsule remained in the small intestine, the examination continued until the capsule ran out of power.

Official Title
-----------------
The Effect of Squatting on the Toilet on Gastric Transit Time and Complete Examination Rate of Capsule Endoscopy

Conditions
-----------------
Intestinal Diseases

Intervention / Treatment
-----------------
* Behavioral: squatting on the toilet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unexplained gastrointestinal bleeding, unexplained chronic abdominal pain and diarrhea, suspected Crohn's disease, suspected small intestinal tumor, and patients needing to exclude small intestinal diseases. Exclusion Criteria: suspected intestinal obstruction and intestinal stenosis, esophageal stenosis or dysphagia, history of abdominal operation, or diabetes mellitus.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 75 Years

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 |
| --- | --- |
| observation group<br>the patients can go to squatting on the toilet at any time as they want to after taking the capsule | Behavioral: squatting on the toilet<br>* the patients could go to squatting on the toilet at any time as they want to after taking the capsule<br>|
| control group<br>The patients can move freely | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CER | complete examination rate | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GTT | gastric transit time | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
squatting on the toilet, capsule endoscopy
RS-3000 Lite Agreement Study

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite.

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

Intervention / Treatment
-----------------
* Device: RS-3000 Lite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who do not have pathology in both eyes Exclusion Criteria: Subjects who have any of the following conditions: Diabetes mellitus (DM) and/or diabetic retinopathy Uncontrolled Hypertension (HT) Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision Cardiac, hepatic, renal and hematologic diseases A current condition requiring systemic administration of steroid A history of, or currently receiving, anticancer therapy Epileptic seizures which are optically induced Dementia Note: Additional criteria may apply

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

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 |
| --- | --- |
| Normal (Eyes without pathology)<br> | Device: RS-3000 Lite<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal thickness and Optic Disc Analysis | Time frame is the maximum duration of hospital stay. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 1day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal (Eyes without pathologies)