linjc16/ctgov huggingface dataset:
Blood Pressure in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This is a cohort study based on a large sample (> 600 000) of emergency department (ED) visits from two university hospital EDs. Information on incident disease after discharge from the ED will be collected through linkage to Swedish national in-patient register and cause of death register. The importance of blood pressure measured at the ED for incident atherosclerotic cardiovascular disease during long term follow up will be studied by Cox-regression analysis

Official Title
-----------------
Prognostic Relevance of Elevated Blood Pressure in the Emergency Department

Conditions
-----------------
Blood Pressure, Hypertension, Emergencies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending the Emergency departments (ED) at Karolinska University hospital in Solna or Huddinge during the specified time period Record of blood pressure measurement from the ED-visit 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident Atherosclerotic Cardiovascular Disease (ASCVD) | ASCVD was defined as a combination of fatal coronary heart disease (CHD ), (I210-I214, I219, I220, I221, I228, I229, I461 or I469), non-fatal MI (I210-I214, I219, I220, I221, I228 or I229), fatal and non-fatal ischemic stroke (I630-I635, I638 or I639). According to the International Classification of Diseases 10th edition (ICD-10). | 20161231 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident Myocardial infarction (MI) | Fatal and non-fatal Myocardial infarction (MI) I210-I214, I219, I220, I221, I228 or I229. I200 were included if combined with intervention procedure codes FNA-FNG, FNW) , according to the International Classification of Diseases 10th edition (ICD-10). | 2016-12-31 | 
| Incident All-cause stroke | Fatal and non-fatal all-cause stroke. I61, I630-I635, I638, I639, I64, according to the International Classification of Diseases 10th edition (ICD-10). | 2016-12-31 | 
| Incident Heart failure | I50 according to the International Classification of Diseases 10th edition (ICD-10). | 2016-12-31 | 
| Incident chronic kidney disease (CKD) | I120, I131 E10.2-E10.5,E10.7,E11.2-E11.5, E11.7,E12.2-E12.5,E12.7, E13.2- E13.5,E13.7,E14.2-E14.5, E14.7 N032-037, N052-057, N18, N19, N250, Z49,Z49.0,Z49.1, Z49.2,Z49.01, Z49.02,Z49.3,Z49.31,Z49.32, Z99.2, I77.0 Z94.0 according to the International Classification of Diseases 10th edition (ICD-10). | 2016-12-31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure, emergency department, atherosclerotic cardiovascular disease, myocardial infarction, stroke, long-term prognosis
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study. Study Hypothesis: N/A (Long-term follow-up study)

Official Title
-----------------
A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial

Conditions
-----------------
Venous Leg Ulcer

Intervention / Treatment
-----------------
* Device: Dermagraft
* Device: Profore


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has completed study ABH-Dermagraft-001-08 Subject understands study requirements Subject is available to participate in the 1 year-long observational follow-up. Exclusion Criteria: Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion Subject is not available for the 1 year-long observational period. Subject has any condition(s) which seriously compromises the subject's ability to complete the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold | Device: Dermagraft<br>* Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).<br>|
| Active Comparator: Reference Therapy<br>Profore - Four-layer compression bandaging therapy | Device: Profore<br>* Four-layer compression bandaging therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of study ulcer recurrence |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete study ulcer healing |  | 1 year | 
| Incidence of study ulcer infection-related events |  | 1 year | 
| Time to study ulcer recurrence |  | 1 year | 
| Change in ulcer size |  | 1 year | 
| Time to study ulcer healing |  | 1 year |
Factors Affecting the Time to Start Postoperative Chemotherapy in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Colorectal cancers are common tumors and have undergone a great change in the last 20 years in terms of treatment principles. Significantly improved results in local recurrence and overall survival have begun to be obtained with chemotherapy protocols given after surgery, which is the main element of the treatment system (1). It is known that postoperative chemotherapy protocols are commonly given within 6-8 weeks and this period is optimal. However, it was found that this period was prolonged in approximately 20% of these patients in the methanalysis performed (2). It has been shown that delay in applied chemotherapy causes a decrease in overall survival (3,4). The factors causing this delay have not been adequately examined in the literature. It is necessary to investigate these factors that affect the overall survival outcomes, which are the main pillars of treatment principles, and to regulate the factors that have the opportunity to improve. In this study, our aim is to investigate the perioperative (preop-perop-postop) factors affecting the duration of postoperative chemotherapy initiation in patients with colorectal cancer treated in our hospital.

Official Title
-----------------
Factors Affecting the Time to Start Postoperative Chemotherapy in Colorectal Cancer

Conditions
-----------------
the Time to Start Postoperative Chemotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent colorectal resection Exclusion Criteria: patients with missing data

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Start Postoperative Chemotherapy | time elapsed to start chemotherapy after the operation | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopy, overall survival, local recurrence, tumor, chemotherapy, colorectal cancer
Effect of an Extract of Green Tea on Adults With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to determine if taking an extract of green tea for three months could improve glucose control in adults with diabetes.

Detailed Description
-----------------
Background: Recent evidence suggests that tea from Camellia Senensis (e.g., green, oolong and black tea) may have a hypoglycemic effect. Objective: We evaluated the ability of an extract of green and black tea to improve glucose control over a three month period using a double blinded randomized multiple dose (either placebo, 375mg or 750mg) study in adults in with Type 2 Diabetes. Patients: The 49 subjects who completed this study were predominantly whites with an average age of 65, a median duration of Diabetes of 6 years, and 80% reported using hypoglycemic medication. Measurements: HbA1c at three months was the primary endpoint. Results: After three months the mean changes in HbA1c were +0.4, +0.3 and +0.5, in the placebo, 375mg and 750mg arms, respectively. The changes were not significantly different between study arms. Limitations: Evaluation of a particular extract that contained components of black teas as well as green tea. Power insufficient to detect changes in HbA1c < 0.5. Conclusions: We did not find a hypoglycemic effect of extract of green tea in adults with Type 2 Diabetes, but cannot rule out the possibility that tea may have a small beneficial effect.

Official Title
-----------------
The Effect of an Extract of Green Tea on Glucose Control in Adults With Type 2 Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Extract of Green and Black Tea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with Diabetes not taking insulin Exclusion Criteria: pregnancy, warfarin therapy

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extract of Green and Black Tea|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  |
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.

Detailed Description
-----------------
This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study. All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or placebo intravenously and then followed by Day 36.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model

Conditions
-----------------
Influenza A

Intervention / Treatment
-----------------
* Drug: CT-P27
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male & Female volunteers Exclusion Criteria: Current clinically significant disease Pregnant or nursing mother Abnormal pulmonary function, nose or nasopharynx

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P27 10mg/kg<br>CT-P27 will be administrated once in IV infusion. | Drug: CT-P27<br>* Influenza A treatment drug.<br>|
| Experimental: CT-P27 20mg/kg<br>CT-P27 will be administrated once in IV infusion. | Drug: CT-P27<br>* Influenza A treatment drug.<br>|
| Placebo Comparator: Placebo<br>Placebo will be administrated once in IV infusion. | Drug: Placebo<br>* Placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR | AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine | Three times a day from Day 1(the day after virus inoculation) to Day 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
efficacy, safety
Molecular Basis of the Growth Axis in Short Stature

Study Overview
=================
Brief Summary
-----------------
To examine the clinical genetic and biochemical characteristics of children with growth hormone deficiency.

Official Title
-----------------
Study of the Molecular Basis of the Growth Axis Among Short Stature Children

Conditions
-----------------
Growth Hormone Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with growth hormone deficiency

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 81 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 |
| --- | --- | --- |
Pegaferon and Ribavirin for Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.

Detailed Description
-----------------
The product is locally produced and needs to be evaluated in terms of efficacy and safety.

Official Title
-----------------
Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Pegaferon (pegylated interferon alpha 2a) + ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hepatitis C Age between 15 and 65 Exclusion Criteria: previous treatment for chronic hepatitis C co-infection with human immunodeficiency virus or hepatitis B virus major thalassemia or hemophilia active drug user being treated for major depression or psychosis decompensated cirrhosis serum creatinine > 1.5 mg/dL solid organ transplant untreated thyroid disease uncontrolled diabetes mellitus uncontrolled autoimmune disease advanced cardiac or pulmonary disease. planning to become pregnant in the next 1.5 years patients with inadequate contraception not consenting to the study

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Drug: Pegaferon (pegylated interferon alpha 2a) + ribavirin<br>* pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4<br>* Other names: Pegaferon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained viral response | Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment | 6 months after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug events | Any adverse event reported by patient or seen in laboratory data | 18 months from start of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C
Management of Fragments During Ureteroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.

Official Title
-----------------
Should we Strive for Absolute Stone Freedom While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.

Conditions
-----------------
Urinary Stones

Intervention / Treatment
-----------------
* Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments
* Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with ureteral stones suitable for endoscopic treatment Exclusion Criteria: presence of ipsilateral kidney stones known ureteral stricture previous placement of ureteral stent use of drugs with known activity on smooth ureteral muscle unwillingness or impossibility to return for follow-up

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>Experimental group: patients in whom stone dust was left for spontaneous elimination | Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment<br> <br> |
| Other: A<br>Control group: Patients in whom all fragments resulting from laser lithotripsy of ureteral stones were actively retrieved | Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unplanned medical visits |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admissions, need for pain killers, time to complete recovery |  | 60 days |
Effects Of Prednisolone On Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of Prednisolone on Rheumatoid Arthritis (RA) patients.

Official Title
-----------------
A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Meet the ACR criteria for diagnosis of rheumatoid arthritis. Required treatment with Prednisolone. Currently on a non-steroidal anti-inflammatory agent (NSAID). Willing to stay on current dose of NSAID for two weeks during study. Exclusion criteria: Major health issues such as osteoporosis, diabetes, heart failure, heart attack, kidney failure, or acute infection.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Modified Disease Activity Score (DAS28), which was composed of swollen and tender joint counts at 28 sites, a patient's global assessment of disease activity using a visual analogue scale (VAS), and ESR. |  | 14 days | 
| The levels of selected markers of inflammation, which could include (but were not limited to) ESR, C-reactive protein (CRP), interleukin-6 (IL-6), Rheumatoid factor (RF), and soluble tumor necrosis factor-receptor (TNF-R) |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis
Total Knee Replacement With Duracon® and Vanguard™ Prostheses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.

Conditions
-----------------
Degenerative Arthritis, Osteoarthritis, Rheumatoid Arthritis, Knee Arthritis

Intervention / Treatment
-----------------
* Device: Duracon®
* Device: Vanguard™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Patients requiring correction of varus, valgus, or posttraumatic deformity. Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Exclusion Criteria: Patients with infection, sepsis, or osteomyelitis.

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 |
| --- | --- |
| 1<br> | Device: Duracon®<br>* This group utilizes the Duracon® prostheses for total knee replacement.<br>|
| 2<br> | Device: Vanguard™<br>* This group will utilize the Vanguard™ prostheses for total knee replacement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion, Knee Society Score, Duration of surgery |  | 1 year |