linjc16/ctgov huggingface dataset:
Depression and Anxiety in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive disorders, and their relationship with disease activity, in patients with rheumatoid arthritis treated with biological drugs

Detailed Description
-----------------
The prevalence of anxiety and depressive disorders will be assesed with the HADS questionnaire at the time of the visit

Official Title
-----------------
Depression and Anxiety in Rheumatoid Arthritis: Prevalence and Relation With Disease Activity

Conditions
-----------------
Rheumatoid Arthritis, Depression, Anxiety

Intervention / Treatment
-----------------
* Other: Hospital Anxiety and Depression Scale (HADS) questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years diagnosis of rheumatoid arthritis according to 2010 Classification American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Criteria being able to compile questionnaire current treatment with biological disease-modifying antirheumatic drug Exclusion Criteria: Current treatment for anxiety or depressive disorder

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 |
| --- | --- |
| Patients RA-BIO<br>Patients with rheumatoid arthritis treated with biological drugs (infliximab, adalimumab, etanercept, abatacept, tocilizumab, golimumab, certolizumab, rituximab) | Other: Hospital Anxiety and Depression Scale (HADS) questionnaire<br>* Patients filled in the Hospital Anxiety and Depression Scale (HADS) questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. | 1 day of enrollement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Depression, Anxiety, DAS28, HADS
Home-based Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD. The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.

Official Title
-----------------
Randomised Clinical Study on the Effect of Home-based Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Behavioral: closer collaboration between hospital and primary healthcare system
* Behavioral: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of COPD (III-IV) receive help from homecare nurse not suffering from any other serious disease, with expected lifespan less than 6 months Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 95 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 |
| --- | --- |
| Other: usual care<br>follow-up according to todays best practice. | Behavioral: usual care<br>* follow-up according to todays best practice<br>|
| Experimental: cooperation<br>Follow-up from the hospital and the primary healthcare in cooperation | Behavioral: closer collaboration between hospital and primary healthcare system<br>* Follow-up from the hospital and the primary healthcare in cooperation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalizations |  | 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 2011 | 
| lung function |  | 2011 | 
| use of medication |  | 2011 | 
| cost-effectiveness |  | 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, home-based treatment, early intervention
Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This was a compassionate use, open treatment safety study of Pennsaid topical lotion (diclofenac) for osteo or rheumatoid arthritis.

Official Title
-----------------
A Non-blinded, Non-placebo Controlled, Compassionate Use, Open Treatment, Open-ended Program of the Safety of Pennsaid Topical Lotion (Diclofenac) in the Treatment of Osteo or Rheumatoid Arthritis

Conditions
-----------------
Osteoarthritis of the Hand

Intervention / Treatment
-----------------
* Drug: Diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed osteo or rheumatoid arthritis Oral NSAIDs were not deemed appropriate treatment Completed diclofenac sensitivity patch test with negative result Signed informed consent form Exclusion Criteria: At the discretion of the physician and HPB
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diclofenac|diclofenac topical lotion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.

Detailed Description
-----------------
A total of 1616 patients with chronic hepatitis C was included. At 5 years, 79 patients were dead (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival was 91.7% and survival without liver-related death 94.4%. Survival was significantly decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used. All these methods were able to predict a shorter survival in this large population. Patients had their prognosis decreased as liver stiffness increased. By multivariate analysis, only FibroTest > 0.74 (OR 4.41, 95%CI 1.62-12.01, p=0.004) was associated with overall survival, and liver stiffness > 9.5 kPa (OR 4.71, 95%CI 1.06-21.01, p=0.04) associated with liver-related death.

Official Title
-----------------
Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years

Conditions
-----------------
Liver Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic hepatitis C chronic hepatitis B alcoholic liver disease non alcoholic steatohepatitis Exclusion Criteria: ascitis

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Chronic liver disease<br>All patients with chronic liver disease followed using FibroScan and non-invasive markers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without liver complications |  | 3 months | 
| Survival without liver transplantation |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver fibrosis, survival, transient elastography
Clinical Utility of Postoperative Hemoglobin Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how many patients have hemoglobin less than 10 g/dL at post-operative day 1

Detailed Description
-----------------
Obtaining a complete blood count (CBC) on post-operative day 1 to assess postoperative hemoglobin levels is routine practice at Cincinnati Urogynecology Associates, TriHealth Inc. after pelvic reconstructive surgery. There is minimal data supporting this practice. Multiple studies throughout the gynecology literature suggest that this is not a necessary or cost effective strategy to assess for postoperative anemia. Most patients who require blood transfusion or reoperation for bleeding will show clinical signs of anemia. The investigators aim to determine if checking a routine CBC results in clinically relevant changes to patient care in women undergoing pelvic reconstructive surgery with vaginal hysterectomy for treatment of pelvic organ prolapse.

Official Title
-----------------
Clinical Utility of Postoperative Hemoglobin Testing Following Vaginal Hysterectomy and Reconstruction for Symptomatic Pelvic Organ Prolapse

Conditions
-----------------
Anaemia Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy (CPT 58260, 58262, 58263, 58270, 58290, 58291, 58292, 58294) At least one of the following vaginal native tissue prolapse repairs Apical repair with uterosacral ligament suspension (CPT 57283) Apical repair with sacrospinous ligament fixation (CPT 57282) Anterior repair (CPT 57240, 57260, 57284, 57285, 57250) Posterior repair (CPT 45560, 56800, 56810, 57200, 57210, 57250) Surgery by one of four fellowship trained urogynecologists at TriHealth Exclusion Criteria: Concomitant surgical procedure by a second surgeon Malignancy identified at the time of surgery or active malignancy Cases converted to open hysterectomy or prolapse repairs Prolapse repair completed robotically Prolapse repair completed with mesh Known coagulopathy Patient on long term preoperative anticoagulant medication (Arixtra, Coumadin, Eliquis, Heparin, Lovenox, Pradaxa, Savaysa, Xarelto)

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

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

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 |
| --- | --- | --- |
| Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL |  | Postop Day 1 |
Eltrombopag Taste Testing in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric thrombocytopenia, this study will help determine the best tasting pediatric formulation of eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a high sensitivity to bitterness will be enrolled. The subjects will evaluate different formulations and rate them based on the bitterness and effectiveness of sweetners. The outcome of this study will help support a decision for a new pediatric formulation of eltrombopag.

Official Title
-----------------
Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers

Conditions
-----------------
Healthy Subjects, Purpura, Thrombocytopenic, Idiopathic

Intervention / Treatment
-----------------
* Drug: eltrombopag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult based on a medical evaluation by a responsible physician male or female adult between 18 and 55 years old female subjects who are not pregnant or lactating females who are unable to have children must have documented medical verification females who are able to have children must have a negative pregnancy test capable of giving written informed consent Exclusion criteria: subjects who are unable to taste bitterness or are extrememly sensitive to bitterness participated in a clinical trial within 30 days exposure to more than four new medicines within 12 months prior to the first day of dosing history of sensitivity to any of the study medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: eltrombopag|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2. |  | at initial dosing, 3hours, and 6 hours on Day 1 & 2. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits |  | all visits | 
| - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2 |  | done at Day 1 & 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy adult volunteers, eltrombopag
Early Results of Empyema Thoracis Treatment in Children by Video-assisted Thoracoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of study is to assess early results of Empyema Thoracis treatment in Children by Video-assisted Thoracoscopic Surgery

Official Title
-----------------
Early Results of Empyema Thoracis Treatment in Children by Video-assisted Thoracoscopic Surgery

Conditions
-----------------
Empyema Thoracis in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients had empyema. All patients had been treated by Video-assisted Thoracoscopic Surgery in Children hospital 1 from 01/01/2015 to 30/04/2019. Exclusion Criteria: The patient had empyema caused by Tuberculosis.

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- | --- |
| Recover | Time of operation | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
empyema thoracis, Thoracoscopic, VATS, Video-assisted Thoracoscopic Surgery, Pediatric Empyema Thoracis
Cerebral Blood Flow Using Transfontanelle Ultrasound

Study Overview
=================
Brief Summary
-----------------
We planned to evaluate cerebral blood flow and its association with age, blood pressure, and end tidal carbon dioxide in small pediatric using transfontanelle ultrasound during general anesthesia.

Official Title
-----------------
A Study on Cerebral Blood Flow Velocity Reference Values Considering Age, Blood Pressure and Carbon Dioxide Partial Pressure i n Small Children: a Prospective Observational Study

Conditions
-----------------
Cerebral Blood Flow

Intervention / Treatment
-----------------
* Other: transfontanelle ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients undergoing general anesthesia Exclusion Criteria: patients with hydrocephalus, brain tumor

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: transfontanelle ultrasound|cerebral blood flow investigation using transfontanelle ultrasound|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral blood flow |  | from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours |
Scandinavian Miller Collar Study

Study Overview
=================
Brief Summary
-----------------
Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage

Official Title
-----------------
Scandinavian Miller Collar Study

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Procedure: Vein collar at the distal anastomosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critical limb ischemia Need for bypass surgery Exclusion Criteria: Can not participate in follow-up Has suitable saphenous vein

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vein collar at distal anastomosis<br>Vein collar at the distal anastomosis | Procedure: Vein collar at the distal anastomosis<br>* Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis<br>|
| Experimental: No vein collar at the distal anastomosis<br>No vein collar at the distal anastomosis | Procedure: Vein collar at the distal anastomosis<br>* Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary graft patency | Follow-up at 1, 3, 6, and 12. Thereafter at most 5 years or until death of patient or amputation of limb. Primary graft patency = patent graft without any intervention to open up or prevent a graft ocklusion. Methods used for verification of patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft. | Up to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Patency | Secondary patency = patent graft after one or several interventions to open up or prevent a graft occlusion. Methods used for verification of secondary patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft. | Up to five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Graft patency, Limb salvage
Pain of Injection of Lipuro Propofol in Children Aged 1-7 Years

Study Overview
=================
Brief Summary
-----------------
Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the pain of injection of the standard formulation

Conditions
-----------------
ASA 1-2 Requiring Intravenous Cannulation for General Anaesthesia

Intervention / Treatment
-----------------
* Drug: lipuro propofol
* Drug: standard formulation propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 or 2 requiring intravenous general anaesthetic Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 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

| Intervention/Treatment |
| --- |
|Drug: lipuro propofol|nan|
|Drug: standard formulation propofol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores on induction of anaesthesia with propofol |  |  |