linjc16/ctgov huggingface dataset:
Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo & to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate Sustained Release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Exclusion Criteria: Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment, Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status. Patients whose current episode of depression>12 months or <4 weeks from enrollment

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine Fumarate Sustained Release|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate quetiapine SR compared to placebo on health related quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seroquel SR™, Major Depressive Disorder
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.

Official Title
-----------------
Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose Escalation, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACU-4429 in Subjects With Dry Age-Related Macular Degeneration (Geographic Atrophy)

Conditions
-----------------
Dry Age-related Macular Degeneration, Geographic Atrophy

Intervention / Treatment
-----------------
* Drug: ACU-4429
* Drug: Matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a clinical diagnosis of geographic atrophy, as defined in the protocol Exclusion Criteria: Currently receiving or has received a medication prohibited by the protocol
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACU-4429 tablet<br> | Drug: ACU-4429<br>* ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days<br>|
| Placebo Comparator: Matching placebo tablet<br> | Drug: Matching placebo<br>* Matching placebo tablets taken orally once daily for 90 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire |  | Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as measured by plasma ACU-4429 drug levels |  | Baseline; Treatment Days 2, 7, 14, 30, 60 and 90 |
ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg and a calculated aortic valve area of < 1cm2. However, a considerable proportion of patients do have a MTPG < 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF > 50%). This entity is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with a worse prognosis. ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. There is significant overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in PLFLG AS patients.

Official Title
-----------------
ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

Conditions
-----------------
Aortic Stenosis Symptomatic, Amyloidosis Cardiac

Intervention / Treatment
-----------------
* Diagnostic Test: Tc-99m-DPD scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic, severe aortic stenosis Exclusion Criteria: More than mild valvular disease of any other valve Other severe disease with a life expectancy < 1 year Participating in trial interfering with routine clinical practice or use of a non-CE marked device
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 with symptomatic severe aortic stenosis<br>Elderly patients referred for TAVR evaluation | Diagnostic Test: Tc-99m-DPD scintigraphy<br>* Myocardial scintigraphy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with grade 2 or 3 cardiac uptake in scintigraphy and without pathological light chains in immunological assays | Evaluation of incidence rate | In-Hospital [7 days] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and cardiovascular mortality | Clinical Endpoints | 30 days, 12months | 
| CPET - maximal exercise capacity | Functional Endpoints | In-Hospital [7 days] |
15-year Mortality After Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The investigators examine the 15-year mortality after an admission for an exacerbation of Chronic Obstructive Pulmonary disease (COPD).

Detailed Description
-----------------
Several prognostic factors will be examined. Cause of death will be examined. Data will be recruited from medical records and calling general practitioners to find out if a patient is still alive. Statistical analysis will be done with Kaplan Meier, Cox proportional hazards and Chi square

Official Title
-----------------
15-year Mortality After Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Exacerbation Copd, Mortality

Intervention / Treatment
-----------------
* Other: no interventions. observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission with exacerbation of COPD Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no interventions. observational study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients that died after 15 years | Mortality after 15 years | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic factors for mortality | Age (years), Gender (M / F), Previous hospitalization in the past year (yes/no), Re-admission in the next 5 years (number of readmissions per year), forced expiratory volume in 1 second (in liter), Hypercapnia (carbon dioxide in arterial blood in stable condition above 5.9 kiloPascal (kPa) or not), TLCO (transfusion capacity of the lung for carbon monoxide in percentage of predicted, ml / min / kPa), Comorbidity (Charlson Comorbidity Index) Date and cause of death | 15 years | 
| Cause of death | Chronic obstructive pulmonary disease, lung carcinoma, cardiovascular, other | 15 years |
Post-ERCP Pancreatitis Prevention by Stent Insertion

Study Overview
=================
Brief Summary
-----------------
The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.

Official Title
-----------------
Study to Reduce Incidence of Post-ERCP Pancreatitis by Stent Insertion in the Main Pancreatic Duct After Unintended Cannulation of the Main Pancreatic Duct

Conditions
-----------------
Post-ERCP Acute Pancreatitis

Intervention / Treatment
-----------------
* Device: Stent insertion into the main pancreatic duct


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct age > 17 years signed informed consent Exclusion Criteria: intention to intervene main pancreatic duct age < 18 years pregnancy absent of signed informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stent<br>Stent insertion into the main pancreatic duct | Device: Stent insertion into the main pancreatic duct<br>* Stent insertion into the main pancreatic duct<br>|
| No Intervention: No stent<br>No stent insertion into the main pancreatic duct | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-ERCP pancreatitis |  | up to 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, endoscopy, pancreatitis
Open and Laparoscopic Hernia Repair. A Comparative Study

Study Overview
=================
Brief Summary
-----------------
A retrospective comparative study in a pediatric surgery center to compare the outcomes of 2 approaches of hernia repair in the pediatric population.

Detailed Description
-----------------
The investigators reviewed the records of all children who underwent open or laparoscopic hernia repair between January 2017 and July 2019 at the pediatric surgery center at the Jordan University Hospital. Data collection included the age, gender, laterality of the hernia, the surgical approach, duration of surgery, time to discharge and time to full recovery.

Official Title
-----------------
Is the Open Approach Superior to the Laparoscopic Hernia Repair in Children? A Retrospective Comparative Study.

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: hernia repair/ligation of the hernial sac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children within the age limit specified were included in the study Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 13 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open repair group<br>children with inguinal hernia who were repaired with open high ligation of the hernia sac through an inguinal incision. | Procedure: hernia repair/ligation of the hernial sac<br>* the inguinal hernia sac is ligated using sutures at the level of internal ring throught an inguinal incision in the open group and using laparoscopic instruments in the laparoscopic group<br>|
| Laparoscopic repair group<br>children with inguinal hernia who were repaired laparoscopically by closing the the PPV at the level of internal ring with a purse string suture | Procedure: hernia repair/ligation of the hernial sac<br>* the inguinal hernia sac is ligated using sutures at the level of internal ring throught an inguinal incision in the open group and using laparoscopic instruments in the laparoscopic group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OR duration |  | During surgery | 
| Length of stay LOS |  | 1 year | 
| Post operative complications |  | 1 year | 
| Hernia Recurrence |  | 1 year | 
| Total Cost of Surgery |  | 1 year | 
| Cosmesis | What does the parents of the children think of the cosmetic outcomes of the surgery on a scale from 1-5 | 1 Year | 
| Recovery | Time from discharge to resuming normal daily activities | year |
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
High-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. In this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline (placebo) in the other hip.

Conditions
-----------------
Postoperative Pain, Hip Arthroplasty

Intervention / Treatment
-----------------
* Drug: ropivacaine 0,2%
* Drug: saline.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for bilateral total hip arthroplasty able to speak and understand Danish Exclusion Criteria: treatment with opioids or steroids
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hip 1<br>high volume local anesthetic infiltration | Drug: ropivacaine 0,2%<br>* Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL<br>|
| Placebo Comparator: Hip 2<br> | Drug: saline.9%<br>* Wound infiltration with 170 mL sterile saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | 0-48 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, total hip arthroplasty
Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)

Study Overview
=================
Brief Summary
-----------------
Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The investigators performed the first randomized-prospective trial comparing ROSE(R) to no on-site cytopathology assessment (NR). Methods: All patients referred were eligible. 78 patients were randomized to R or NR groups. For R procedures, further specimens were deferred until results were available from the on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary end-points were specimen adequacy and diagnostic yield.

Official Title
-----------------
A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens

Conditions
-----------------
Bronchoscopy

Intervention / Treatment
-----------------
* Other: ROSE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients included all adults referred for bronchoscopy with anticipated TBNA. Exclusion Criteria: Patients were to be excluded only if the attending physician felt ROSE must be used for diagnosis or if the patient refused consent.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROSE for TBNA<br> | Other: ROSE<br>* rapid on-site evaluation by cytopathology<br>|
| No Intervention: NR<br>no on-site cytopathology assessment (NR) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic yield |  |  |
Evaluating Safety of NovoPen® 3 and/or FlexPen® Devices in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of of this study is to evaluate the safety of NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of adverse events and technical complaints in patients with type 1 and type 2 diabetes in routine clinical practice.

Official Title
-----------------
A Study Evaluating the Safety of NovoPen®3 and FlexPen® in Subjects With Type 1 and Type 2 Diabetes. A 24-week, Prospective, Multi-centre, Open-labelled, Non-interventional Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Device: FlexPen®
* Device: NovoPen® 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subjects who are previously using Actrapid®, Insulatard®, and Mixtard® 30 with vial / NovoLet® or insulin human with ErgoPen®2 for type 1 and type 2 diabetes treatment, will be eligible for the study after the physician has taken the decision to use study insulin products with the study devices Exclusion Criteria: Subjects treated with Actrapid® Penfill®, Insulatard® Penfill®, or Mixtard® 30 Penfill® with NovoPen®3 or Actrapid® FlexPen®, Insulatard® FlexPen®, or Mixtard® 30 FlexPen® for more than 4 weeks before inclusion into this study Subjects who were previously enrolled in this study Subjects with a hypersensitivity to insulin human or to any of the excipients Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total study population<br> | Device: FlexPen®<br>* Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice<br>Device: NovoPen® 3<br>* Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events and technical complaints |  | Week 0-24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse drug reactions (ADR) including hypoglycaemic events |  | Week 0-12, week 24 | 
| Number of serious adverse drug reactions including major hypoglycaemic events |  | Week 0-12, week 24 | 
| HbA1c (haemoglobin A1c) |  | Week 0, week 12 and week 24 |