linjc16/ctgov huggingface dataset:
Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia can bring out the disability in daily life, the majority of previous reports only ascertained no significant association between the presence of fibromyalgia and the severity of SLE. It is necessary to make unremitting effort to reduce the mortality and life-threatening disease flare-up due to SLE disease itself. Additionally, we think that physicians need to pay more attention to improve health-related quality of life (HRQoL) in the patients with SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the clinically important and constructive theme to investigate that which is the most important factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration. The objective of this study is to evaluate the degree of contribution of fibromyalgia for reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with SLE.

Conditions
-----------------
Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman between 30 and 60 years of age, inclusive Have a diagnosis of Systemic lupus erythematosus according to the 1997 updated American college of Rheumatology criteria for classification of systemic lupus erythematosus Exclusion Criteria: Patients were excluded if they had had a history of head injury that led to unconsciousness Have unstable disease necessitating an increase in prednisone dose or the addition of another immunosuppressive medication Have a current malignancy Have a history of or current evidence of substance abuse (drug or alcohol) problem within the previous 2 years

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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 |
| --- | --- | --- |
| EuroQoL (EQ-5D) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
systemic lupus erythematosus, disease activity, sleep, quality of life
EEG@HOME (Phase 3b of the Project, Interviews)

Study Overview
=================
Brief Summary
-----------------
The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined. Phase 3 of this Project will be divided into Phase 3a and Phase 3b. In Phase 3b of the project epilepsy patients and their family will be interviewed about different EEG-cap models in development. This interview is anticipated to take approximately 1 hour. Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed. The results of the interviews will be analysed by the design company pilipili nv.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: Interview about prototype EEG-cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epilepsy patient Exclusion Criteria: No experience with EEG

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interview<br>Interview of epilepsy patients and their family about their opinion on different EEG-cap models in development. | Other: Interview about prototype EEG-cap<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User opinion (questionnaire) |  | 1 hour |
Intraperitoneal Mesh-Implementation After Laparotomy

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.

Official Title
-----------------
Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Device: Mesh implementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Median Laparotomy Exclusion Criteria: Bowel perforation Pregnancy Palliative surgery Drug abuse Age under 18 Mental disability Allergy to mesh components

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: No Mesh<br> | |
| Experimental: Mesh Implementation<br> | Device: Mesh implementation<br>* Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy | Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia. | Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years. | 5 Years |
S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.

Official Title
-----------------
Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam (Keppra)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partial onset seizures, whether or not secondarily generalized; at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline; using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry. Exclusion Criteria: Presence of known pseudoseizures within the last year; presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives; on felbamate with less than 18 months exposure; on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months; uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam (Keppra)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in seizure frequency. |  | 16-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further assess safety. |  |  | 
| The patient-weighted Quality Of Life In Epilepsy inventory. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, Keppra
Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find out whether inflammation markers including cardiac markers have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological patients.

Detailed Description
-----------------
Adult AML and ASCT patients with neutropenic fever. Observation of possible progress to severe sepsis or septic shock. Blood sample collection on days 0-3 (from the beginning of neutropenic fever).

Official Title
-----------------
Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Severe sepsis vs. non-severe sepsis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis: acute myeloid leukaemia age under 70 years neutropenic fever Exclusion Criteria: age above 70 years no neutropenic fever

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 |
| --- | --- |
| Neutropenic patients<br>Adult AML and ASCT patients with neutropenic fever. | Other: Severe sepsis vs. non-severe sepsis<br>* To compare these two groups<br>* Other names: Severe sepsis vs. non-severe sepsis adult ASCT patients;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study evaluates epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of inflammatory markers. | This study evaluated epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of specific inflammatory markers. | Within neutropenic period after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe sepsis in neutropenic haematological patients
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Study Overview
=================
Brief Summary
-----------------
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis. Bilateral drainage is more physiologic and have more long patency than unilateral drainage. There are two methods of bilateral drainage: Y-stent and side by side. However there are no clinical data about comparing the effectiveness of these two methods. Therefore the investigators want to compare the clinical outcomes of two methods: Y-stent and side by side.

Official Title
-----------------
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Conditions
-----------------
Bile Duct Neoplasm, Obstructive Jaundice

Intervention / Treatment
-----------------
* Procedure: parallel stent
* Device: Y-stent (BONASTENT M-Hilar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy Exclusion Criteria: patients with endoscopic retrograde cholangiogram is not possible bleeding tendency (PT INR > 1.5, platelet < 50,000) poor general condition (ECOG 3-4) or cardiopulmonary deterioration 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: parallel stent<br>parallel stent insertion group | Procedure: parallel stent<br>* bilateral parallel stent insertion (right and left side)<br>* Other names: bilateral pig tail plastic stent;|
| Active Comparator: Y-stent<br>Y-stent insertion group | Device: Y-stent (BONASTENT M-Hilar)<br>* Bilateral Y-stent insertion (stent in stent type)<br>* Other names: BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time taken to insert bilateral stent |  | After the ERCP procedure |
Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases

Study Overview
=================
Brief Summary
-----------------
Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.

Detailed Description
-----------------
Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. Inclusion Criteria: Chronic respiratory disease (COPD, ILD, OHS...) Admission in ICU for acute respiratory failure Patient's non-opposition Exclusion Criteria: Patients < 18 year-old Protected patients Pregnant women The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.

Official Title
-----------------
Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes

Conditions
-----------------
Acute Exacerbation of COPD, Acute Exacerbation of Bronchiectasis, Acute Exacerbation of Asthma, Interstitial Lung Disease, Neuromuscular Diseases, Obesity Hypoventilation Syndrome, Acute Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic respiratory disease (COPD, ILD, OHS...) Admission in ICU for acute respiratory failure Patient's non-opposition Exclusion Criteria: Patients < 18 year-old Protected patients Pregnant women

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 |
| --- | --- | --- |
| Survival | Survival at day 28 | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ventilation | Duration of non-invasive ventilation and/or mechanical ventilation | Day 28 |
Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if there are differences in the final height or hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now routinely used to increase stature: Anastrozole and Letrozole. It also should determine if there are differences in the side effect profiles of the two drugs to be used.

Official Title
-----------------
Randomization to Letrozole vs. Anastrozole in Short Pubertal Males

Conditions
-----------------
Short Stature

Intervention / Treatment
-----------------
* Drug: Letrozole
* Drug: Anastrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current height less than 5th percentile AND/OR Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height) Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl Exclusion Criteria: Bone age reading more than 14.0 years Follicle stimulating hormone > 20 IU/L

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Active Comparator: Letrozole<br>Letrozole 2.5 mg daily | Drug: Letrozole<br> <br> |
| Active Comparator: Anastrozole<br>Anastrozole 1 mg daily | Drug: Anastrozole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predicted Adult Height at Year 3 | Heights will be obtained by physical exam every 6 months during treatment. Skeletal maturation will be assessed from an x-ray by the method of Greulich and Pyle at baseline and every 12 months until the end of treatment. Predicted adult height will be calculated at baseline and at the end of treatment based upon measured height and skeletal maturation (bone age). | Year 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Testosterone |  | Baseline, year 3 | 
| Dihydrotestosterone |  | Baseline, year 3 | 
| Androstenedione |  | Baseline, year 3 | 
| Luteinizing Hormone |  | Baseline, year 3 | 
| Follicle Stimulating Hormone |  | Baseline, year 3 | 
| Insulin-like Growth Factor Type 1 |  | Baseline, year 3 | 
| Inhibin B |  | Baseline, year 3 | 
| Estradiol |  | Baseline, year 3 | 
| Estrone |  | Baseline, year 3 | 
| Number of Adverse Events Related to Acne or Bone Fracture |  | 3 years |
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

Study Overview
=================
Brief Summary
-----------------
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA012JP.

Official Title
-----------------
An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MRA(Tocilizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients must suffer from RA, and must have participated in the preceding study. Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography. Exclusion criteria Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug Patients who have not been registered by 3 months after week 52 of the preceding study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MRA(Tocilizumab)<br>* 8mg/kg(i.v.)/4weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP) |  | 0W,4W,8W,12W,LOBS | 
| Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria |  | 0W,4W,8W,12W,LOBS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set |  | 0W,4W,8W,12W,LOBS | 
| Frequency, severity, and seriousness of adverse events and adverse drug reactions |  | Throughout study |