linjc16/ctgov huggingface dataset:
Chronic Pain, Life Style Factors and Quality of Life

Study Overview
=================
Brief Summary
-----------------
Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that aims to analyze life style factors, socioeconomic and psychometric properties, metabolic problems, drug use, quality of life and biochemical variables in chronic non-cancer pain patients. The life style factors will be compared to those of normal population. At baseline, the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and blood pressure are measured, pain-related factors are recorded and blood samples taken. Changes in the quality of life of the study patients will be evaluated by questionnaires during follow-up at 2 years and 5 years.

Detailed Description
-----------------
Chronic pain co-occurs with risk factors for cardiovascular diseases, depression, smoking and sleep problems. Nutrition and low physical activity may predispose to chronic pain. To gain information on the life style factors of adult chronic pain patients referred to university hospital or central hospital pain clinics in Finland, 477 patients have been recruited to the study. The patients fill in questionnaires on sociodemographic factors, pain, medication, use of health services, physical activity, smoking, use of alcohol or other substances, sleep, quality of life, nutrition and psychological factors at their first visit to the pain clinic. Height, weight, waist circumference, blood pressure and pulse are measured by the study nurse. A blood sample for analysis of blood sugar, cholesterol (total, LDL, HDL), triglycerides, HbA1c and sensitive C-reactive protein (CRP) is taken. The pain clinician records the pain diagnosis, medication and other methods of pain management chosen. The patients will be sent follow-up questionnaires at 2 years and 5 years after baseline.

Official Title
-----------------
Chronic Pain, Life Style Factors and Quality of Life

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 75 years chronic non-cancer pain Finnish-speaking referred to a multidisciplinary pain management center Exclusion Criteria: inability to fill in questionnaires in Finnish cancer pain

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic pain patients<br>Finnish speaking, adult chronic pain patients, aged 18 - 75 years, referred to pain clinic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of quality of life as assessed by 15 Dimensions questionnaire between baseline and 2 years | Baseline and 2 years | 2 years |
Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010 expert consensus guideline.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: PVI, CTI block
* Procedure: PVI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with documented AF Drug refractory AF Non-valvular AF No structural cardiac disease No intracardiac thrombi in cardiac CT and TEE Exclusion Criteria: permanent AF refractory to electrical cardioversion LA size >55 mm as measured by echocardiography AF with valvular disease associated structural heart disease other than left ventricular hypertrophy prior AF ablation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: CTI group<br>CTI(Cavo-Tricuspid Isthmus) | Procedure: PVI, CTI block<br>* PVI (pulmonary isolation) Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial fibrillation Catheter is inserted into inferior venacava (IVC) and right atrium (RA) via femoral vein. And the procedure is to block bidirectionally between inferior venacava (IVC) and the annulus of tricuspid valve (TV) by using electrical energy of catheter tip.<br>* Other names: radiofrequency catheter ablation (RFCA), Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial flutter;|
| Placebo Comparator: Non CTI group<br>Non CTI (Cavo-Tricuspid Isthmus) | Procedure: PVI<br>* PVI (pulmonary isolation)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Atrial fibrillation (AF free survival) | clinical recurrence of AF after catheter ablation | 3 month after catheter ablation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, atrial flutter, catheter ablation, cavo-tricuspid isthmus block
Obstructive Sleep Apnea in Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall may ensue. An increased tendency for coagulation has also been reported in OSA. Venous stasis, vascular endothelial activation and hypercoagulability are also known risk factors for thromboembolism. All of these pathophysiologic changes in OSA may predispose patients for the development of pulmonary embolism (PE) however there is limited data about role of thromboembolic events in OSA.

Official Title
-----------------
Obstructive Sleep Apnea is Prevalent in Patients With Pulmonary Embolism

Conditions
-----------------
Pulmonary Thromboembolism, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients diagnosed with pulmonary embolism Exclusion Criteria: less than 18 years of age any restrictive or obstructive lung disease

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 |
| --- | --- |
| Pulmonary embolism<br>Patients who were diagnosed with pulmonary embolism | Other: polysomnography<br>* full night supervised laboratory polysomnography<br>* Other names: PSG;|
| control group<br>age and sex matched adults with osa and no thromboembolism | Other: polysomnography<br>* full night supervised laboratory polysomnography<br>* Other names: PSG;|

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
-----------------
Sleep disordered breathing, gender, hypercoagulability
Evaluation of Efficacy and Safety of SDN-037

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.

Official Title
-----------------
A Randomized, Double-Masked, Parallel Group, Multicenter, Study To Evaluate Efficacy And Safety of SDN -037 Twice Daily Compared With Vehicle For The Treatment Of Inflammation And Pain Associated With Ocular Surgery.

Conditions
-----------------
Inflammation and Pain Associated With Ocular Surgery

Intervention / Treatment
-----------------
* Drug: SDN-037
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 2 years of age on the date of assent or 18 years of age at the date of consent Be able and willing to follow study instructions and complete all required visits Females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test Able to self-instill the IP or have a caregiver available to instil all doses of the IP Exclusion Criteria: Any known allergy or hypersensitivity to difluprednate therapy An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye Any active corneal pathology noted in the study eye Currently suffering from alcohol and/or drug abuse

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SDN-037<br> | Drug: SDN-037<br>* twice daily<br>|
| Placebo Comparator: vehicle<br> | Drug: Placebo<br>* twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 | Grade Cell Count 0 0 1-10 11-20 21-50 > 50 ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of >0 at Day 15 visit was considered a failure (or non-responder) | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Who Achieve a Pain Score of 0 at Day 15 | Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent >100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity. | Day 15 |
Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials

Study Overview
=================
Brief Summary
-----------------
To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin

Official Title
-----------------
A Study to Determine the Skin Barrier Effect of Tetrix Cream

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

Intervention / Treatment
-----------------
* Device: Tetrix
* Device: Tetrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal subjects who are sensitized to nickel, neomycin, or fragrance mix. Exclusion Criteria: Under 18 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Twice daily topical application | Device: Tetrix<br>* Twice daily topical application<br>|
| Placebo Comparator: 2<br>Twice daily topical application | Device: Tetrix<br>* Twice daily topical application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of delayed bype hypersensitivity reaction following application of antigen |  | up to 96 hours after antigen application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tetrix crea, skin barrier, antigen reaction, prevention, The efficacy of Tetrix Cream to prevent an antigen reaction on the skin.
Effective Lens Position After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Cataract patients were implanted with different types of intraocular lenses for grouping. SSOCT scanning was used to measure ELP and optometry.

Detailed Description
-----------------
Cataract patients were implanted with different types of intraocular lenses for grouping. Perform SSOCT scan that was used to measure effective lens position and optometry at different postoperative follow-up time .

Official Title
-----------------
Comparison of Changes in Effective Lens Position of Different Types of Intraocular Lens

Conditions
-----------------
Age-related Cataract

Intervention / Treatment
-----------------
* Other: different types of intracular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a.Diagnosed as cataract; b.Implanted intraocular lens: SN6CWS, Aspira-aA, MI60; c.Cataract phacoemulsification and intraocular lens implantation. Exclusion Criteria: a.Combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye diseases; b.A history of intraocular surgery or trauma other than cataract surgery; c.Intraoperative complications such as tearing of the capsule and IOL failure to implant; d.Endophthalmitis, corneal endothelial decompensation and other postoperative complications; e.Those with incomplete data collected during the follow-up period of postoperative patients.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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（SN6CWS）<br>Group（SN6CWS）：Implant SN6CWS intraocular lens | Other: different types of intracular lens<br>* different types of intracular lens<br>|
| Group（MI60）<br>Group（MI60）：Implant MI60 intraocular lens | Other: different types of intracular lens<br>* different types of intracular lens<br>|
| Group（Aspira-aA）<br>Group（Aspira-aA）：Implant Aspira-aA intraocular lens | Other: different types of intracular lens<br>* different types of intracular lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective lens position | Changes of effective lens position at different time points after cataract surgery | up to 3 months after cataract surgery |
Can Pregnancy be Predicted According to ATR-FTIR Spectrophotometry of Incubation Medium of Embryos in IVF

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the variability of culture media composition based on the ATR-FTIR (Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy) technique on the day of embryo transfer/vitrification. In addition, the study will explore whether variations detected in the culture medium can be linked to embryo quality and the chances of achieving pregnancy.

Official Title
-----------------
Can Pregnancy be Predicted According to ATR-FTIR Spectrophotometry of Incubation Medium of Embryos in IVF

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: ATR-FTIR Spectrophotometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing IVF treatments with at least 4 embryos Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ATR-FTIR Spectrophotometry|Spectrometry imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectrometry in embryo culture media | Definition of spectrometry in embryo culture media | One year | 
| Embryo quality | The spectrometry results will be linked to embryo quality through the linkage between spectrometry results as indicated on Absorbance Graph and embryo quality judged by accepted criteria | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle outcomes | Prediction of pregnancy rates as linked to the spectrometry results of the culture media | One year |
Usefulness of Calprotectin for Colon Adenoma Screening

Study Overview
=================
Brief Summary
-----------------
The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin level, which could mean the role of fecal calprotectin as a screening marker for colon adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for screening in this study.

Official Title
-----------------
Usefulness of Fecal Calprotectin for Screening Colon Adenoma in Korean Population

Conditions
-----------------
Colon Adenoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years old adult population Exclusion Criteria: none

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal calprotectin level |  | 1 day (at the hospital visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenoma, calprotectin
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).

Official Title
-----------------
Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: HGNS Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria Previously diagnosed with moderate to severe obstructive sleep apnea. Subject has failed or does not tolerate CPAP treatment. Age between 21 and 70 years. Body mass index (BMI) less than or equal to 40

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: HGNS Treatment<br> | Device: HGNS Treatment<br>* The Apnex Hypoglossal Nerve Stimulation (HGNS) System is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping, and off when the patient is awake.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline |  | 6 months post-implant | 
| Adverse event profile interoperatively, perioperatively, and long term post implant |  | 1, 3, 6, 12, 24, and 36 months post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline |  | 6 months post-implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea, OSA, hypoglossal nerve stimulation, sleep apnea