linjc16/ctgov huggingface dataset:
A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome.

Official Title
-----------------
A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome

Conditions
-----------------
Dry Eye Syndromes, Sjögren Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to participate in this clinical study, and signed informed consent age from 18 to 70 years old,both genders are permitted diagnosed as the Sjögren syndrome have the symptoms and signs of dry eye disease as below: have at least 2 symptoms such as dryness,foreign body sensation ,eye strain,conjunctival congestion,secretion.The summed up score of symptoms greater than 6. the score of tear-film break up time less than 5 seconds or the score of Schirmer test less than 5mm/5min. the score of corneal fluorescein staining greater than 3. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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>using the 0.1% fluorometholone eye drops combined with the 0.1% sodium hyaluronate eye drops | |
| Group 2<br>using the 0.5% cyclosporin A eye drops combined with 0.1% sodium hyaluronate eye drops | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear-film breakup time | stain the cornea with the fluorescein; close the eye; open the eye and keep the eye open,count the seconds until the first black spot appears. | the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment | 
| Schirmer test I without anesthesia | put the Schirmer test strip into the lower conjunctival sac; close the eye for 5 minutes; read the score of the test strip | the enrolling day,2 weeks after treatment,4 weeks after treatment, 8 weeks after treatment | 
| corneal fluorescein staining | Fluorescein staining scores were measured on 0-3 point scale, in each quarter of corneal zone: 0(No staining), 1(some staining), 2(Staining in more than a half of the area), 3(Staining in the whole area). | the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corticosteroids Dry Eye Sjögren syndrome inflammation treatment
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if women with chest pain and clean heart blood vessels have impaired blood flow to the heart due to problems with the small blood vessels that provide blood and oxygen to the heart. Impairment in the small blood vessels will be tested using ultrasound pictures of the heart, called myocardial contrast echocardiography. Since these small blood vessels are not seen in a coronary angiogram, which is an x-ray of the heart vessels using a dye containing iodine injected in the heart vessels, the problem may remain undiagnosed in women until the heart muscle becomes severely damaged. A second purpose is to identify if there is a common trait in the population of women with this tiny blood vessel dysfunction, which will be investigated by checking blood levels of certain chemical and hormones related to heart disease. Finally, we would like to investigate the relationship between depression and stress, and heart disease. We will do this by measuring cortisol (a hormone that serves as a measure of stress) and administering questionnaires that help to identify depression and stress.

Official Title
-----------------
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women

Conditions
-----------------
Microvascular Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 45 to 75 years of age Exclusion Criteria: Pregnancy Allergy to any component of the drugs: Definity®. Dipyridamole Aminophyllin or Iodine. Known coronary heart disease, significant valvular disease (valvular stenosis or insufficiency greater than moderate) left ventricular systolic dysfunction, congenital heart disease or cardiac shunt, pulmonary hypertension, moderate or severe asthma. Inability to reach the patient by mail, fax, e-mail or phone Active infection Malignancy Uncontrolled hypertension Smoking Severe asthma Kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women with chest pain and Clean heart vessels | |
| 2<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women | Data collection | 2008-2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac disease, vascular dysfunction, women, chest pain, echocardiography
18F-FDG PET/CT in the Diagnosis of Tuberculous Pericarditis

Study Overview
=================
Brief Summary
-----------------
A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study to analyze the diagnostic value of 18F-FDG PET/CT for tuberculous pericarditis.

Detailed Description
-----------------
A total of 11 patients with tuberculous pericarditis, who underwent 18F-FDG PET/CT from January 2015 to February 2022 in the affiliated hospital of Jiangnan university were retrospectively reviewed in this study to analyze the diagnostic value of 18F-FDG PET/CT in tuberculous pericarditis.

Official Title
-----------------
18F-FDG PET/CT in the Diagnosis of Tuberculous Pericarditis

Conditions
-----------------
Diagnostic Self Evaluation

Intervention / Treatment
-----------------
* Diagnostic Test: 18F-FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients confirmed as tuberculous pericarditis through follow-up. Exclusion Criteria: patients confirmed as other pericarditis through follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 48 Years
Maximum Age: 81 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 |
| --- | --- |
| tuberculous pericarditis with 18F-FDG uptake<br>patients confirmed with tuberculous pericarditis presenting 18F-FDG uptake | Diagnostic Test: 18F-FDG<br>* 18F-FDG intravenous injection<br>|
| tuberculous pericarditis without 18F-FDG uptake<br>patients confirmed with tuberculous pericarditis presenting no 18F-FDG uptake | Diagnostic Test: 18F-FDG<br>* 18F-FDG intravenous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the diagnostic sensitivity of 18F-FDG PET/CT for tuberculous pericarditis | the diagnostic sensitivity of 18F-FDG PET/CT for tuberculous pericarditis | 01,2015-02,2022 |
Pilot Study of BOTOX for Migraine Headaches

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to assess whether subjects treated with BOTOX will: have a decrease in the frequency and intensity of migraine headaches experience improvements in quality of life experience a reduction in the frequency of health care services obtained.

Official Title
-----------------
A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches

Conditions
-----------------
Migraine Headache

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects > 18 years of age Subject has an established history of migraine headache, with or without aura, per IHS criteria (1.2.1 or 1.1), for at least 6 months prior to screening. Subject receives primary health care from Park Nicollet Health Services. Exclusion Criteria: Subject has received previous injections of botulinum toxin of any serotype for any reason, within the 6 months prior to study participation. Additional eligibility will be discussed at point of contact

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Botulinum Toxin Type A<br> | Drug: Botulinum Toxin Type A<br>* 100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)<br>* Other names: BOTOX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. |  | 190 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. |  | 190 days | 
| To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache. |  | 190 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine headache, Botulinum Toxin Type A, BOTOX, BTX-A
Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients

Study Overview
=================
Brief Summary
-----------------
The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction of inspired oxygen (FiO2), called the oxygen challenge test (OCT), was associated with higher morbidity and mortality in human subjects. Patients had negative O2 challenge test results, indicating that flow-dependent O2 consumption might have been present. Recent reports using the noninvasive transcutaneous PO2 (PtO2) and transcutaneous partial pressure of carbon dioxide probes have observed a relationship between low oxygen challenge test values to mortality and organ failure. The OCT values provides an accessible noninvasive method of detecting early shock. To date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to CI, DO2I、ScvO2. This study explored: relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality; relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2, ScvO2.

Detailed Description
-----------------
PtO2 index = PtO2/PaO2；tissue oxygen index=PtO2/FiO2； 5min OCT value = challenged 5minPtO2 - PtO2baseline； 10min OCT value= challenged 10minPtO2- PtO2baseline； oxygen challenge index = （10minPtO2- PtO2baseline）/(10minPaO2-PaO2baseline)

Official Title
-----------------
Assessment of Transcutaneous Oxygen Tension and Oxygen Challenge Test in Adult Intensive Care Patients

Conditions
-----------------
Sepsis, Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Requiring a artery catheters, and pulmonary artery catheters or PiCCO-plus or central venous catheters FiO2<80% and SpO2>92% Consent informed Exclusion Criteria: Not expected to live

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Survivor Nonsurvivor<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality |  | 28 day after enrollmented | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality |  | 28 day after enrollmented | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxygen challenge test, shock, mortality, Oxygen Delivery Index, cardiac output index
Coordination of Hemiparetic Movement After Post-Stroke Rehabilitation

Study Overview
=================
Brief Summary
-----------------
This study will determine whether a therapeutic exercise program for improving motor coordination in locomotor tasks in post-stroke, hemiparesis patients will result in CNS recovery. The study will develop relationships between the improved motor performance and motor coordination during the locomotor task and the functional effects of the exercise program(e.g., gait variables.)

Detailed Description
-----------------
Primary objective of this study is to determine whether a therapeutic exercise program which targets the functional recovery of persons with the post-stroke hemiparesis results in CNS recovery (improved motor coordination). They will determine whether motor coordination during a locomotor task is improved after an exercise program. They will then develop relationships between the improved motor performance and motor coordination during the locomotor task and the functional effects of the exercise program(e.g., gait variables) Overall goal is to develop a more rational basis for the design of stroke rehabilitation programs which target individuals most likely to recover and which are based on physiological principles. This study will supplement an NIH funded randomized clinical trial to evaluate a post-stroke exercise program designed to increase balance, strength, and endurance. Study will include 60-70 prospective patients enrolled in the randomized clinical trial at Kansas University Center on Aging. between Oct 1999 and Oct 2001.

Official Title
-----------------
Coordination of Hemiparetic Movement After Post-Stroke Rehabilitation

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: Stroke Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functionally impaired elderly Exclusion Criteria:

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Procedure: Stroke Rehabilitation<br> <br> |

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
-----------------
stroke, hemiparesis, CNS, motor coordination
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing general surgery of the lower limb at high risk of developing venous thromboembolism.

Official Title
-----------------
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: Fondaparinux Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism Exclusion Criteria: Patients with a history of hypersensitivity to the ingredients of fondaparinux Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed) Patients with acute bacterial endocarditis Patients with severe renal impairment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed fondaparinux<br>Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism | Drug: Fondaparinux Sodium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux |  | 1 month | 
| Presence of absence of venous thromboembolism after treatment of fondaparinux |  | 1 month | 
| Occurrence of adverse events of bleeding |  | 1 month |
Role of Prohepcidin in Uremic Patients

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. The investigators selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also. Each group has been planned to be formed of about 25 patients. Diabetic patients were excluded. Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine biochemical analysis including hematological ones.

Official Title
-----------------
The Relationship of Prohepcidin Levels With Anemia and Inflammatory Markers in Non-diabetic Uremic Patients: A Controlled Study

Conditions
-----------------
Inflammation, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis and peritoneal dialysis patients who had been on dialysis therapy for more than 3 months, age between 18-80 years, patients with creatinine clearance between 15-30 ml/min. Exclusion Criteria: age less than 18 or more than 80, diabetic patients, current active infectious or inflammatory disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Hemodialysis group<br>Patients on chronic hemodialysis program | |
| Peritoneal dialysis group<br>Patients on chronic peritoneal dialysis program | |
| Pre-dialysis group<br>Patients with chronic kidney disease stage-4 | |
| Control group<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prohepcidin level | Prohepcidin levels will be compared with other inflammatory markers. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia and inflammatory markers | Correlations of prohepcidin levels with anemia and inflamatory markers | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, inflammation, iron, peritoneal dialysis, prohepcidin, uremia
Tumor Phenotypes and Correlation to Clinical Outcomes in Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the genetic makeup of cancers, the cancer response, and the correlation of the cancer response to standardized regimens of cancer treatment.

Detailed Description
-----------------
To identify the genetic makeup of cancers, the cancer response, and the correlation of the cancer response to standardized regimens of cancer treatment.

Official Title
-----------------
Identification of Tumor Phenotypes and Correlation to Clinical Outcomes in Patients Diagnosed With Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Procedure: Tumor biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cancer receiving chemotherapy Have had or will have tissue and/or blood samples 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tumor biopsy|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
-----------------
Cancer, Cancer receiving chemotherapy, Tumor biopsy